[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Institute of Cancer Research, United Kingdom\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":606},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,26,0,25,[9,48,75,97,118,138,166,185,210,232,260,280,306,331,356,388,413,436,461,481,502,517,545,566,585],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":15,"acronym":16,"eligibilityCriteria":17,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":29,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":36,"lastUpdatePostDateStruct":37,"startDateStruct":40,"completionDateStruct":42,"leadSponsor":44,"locationsCount":47},"100054128","phase-2-sbrt-alone-or-followed-by-niraparib-for-oligometastases-or-oligoprogression-in-ovarian-cancer-following-parpi-therapy-100054128",false,"NCT05990192","SBRT Alone or Followed by Niraparib for Oligometastases or Oligoprogression in Ovarian Cancer Following PARPi Therapy","SOPRANO: Stereotactic Radiotherapy Alone or Followed by Niraparib for Oligometastases or Oligoprogression in Ovarian Cancer Following PARP Inhibitor Therapy","SOPRANO","Inclusion Criteria:\n\n1. Patients ≥ 18 years of age.\n2. Histologically confirmed epithelial ovarian, fallopian tube or primary peritoneal cancer. (if cytology report includes immunohistochemistry confirming ovarian cancer, patient should not be excluded).\n3. Radiological disease progression whilst on, or following, any prior PARP inhibitor therapy. The PARP inhibitor is required to have been the patient's last systemic therapy.\n4. Minimum duration of 6 months PARP inhibitor therapy as first line therapy or treatment for recurrent disease.\n5. ≤3 lesions of progressive disease.\n6. Each lesion to undergo SBRT \\\u003C4 cm axial diameter, and feasible for SBRT as discussed in the SOPRANO virtual MDT (vMDT) meeting.\n7. Measurable disease by RECIST criteria v1.1, which can be accurately assessed at baseline by CT or MRI. Patients with CA125 progression in the absence of measurable disease will NOT be eligible. The following is an exception to this criterion: Lymph nodes with a short-axis diameter ≥10 mm may be included when there is clear evidence of malignancy (e.g., PET-positive nodes and radiologically progressive disease), acknowledging that clinically significant nodal disease may occur below the standard RECIST threshold.\n8. No contra-indication to restarting a PARP inhibitor.\n9. Patients for whom surgery for recurrent disease is not planned.\n10. Adequate baseline organ function to allow SBRT to all relevant targets as deemed by the investigator.\n11. ECOG performance status of 0 or 1.\n12. Predicted life expectancy ≥ 6 months.\n13. Women of child-bearing potential who are confirmed NOT to be pregnant. This should be evidenced by a negative urine or serum pregnancy test within 72 hours prior to start of trial treatment. Patients will be considered to be not of child-bearing potential if they are:\n\n    1. Post-menopausal -- defined as aged more than 50 years and amenorrhoeic for at least 12 months following cessation of all exogenous hormonal treatments, OR women under 50 years old who have been amenorrhoeic for at least 12 months following cessation of all exogenous hormonal treatments and have serum follicle- stimulating hormone (FSH), luteinizing hormone (LH) and plasma oestradiol levels in the post-menopausal range for the institution.\n    2. Able to provide documentation of irreversible surgical sterilisation by hysterectomy, bilateral ovarian failure or bilateral salpingectomy but not tubal ligation.\n    3. Radiation or chemotherapy-induced oophorectomy or menopause with \\> 1 year since last menses.\n14. Willingness to commit to scheduled visits, treatments plans, laboratory tests and trial procedures.\n15. Histological tissue specimen (tissue block or 8-10 unstained slides) must be available prior to commencing SBRT (specimen can be the sample at diagnosis or taken at relapse or progression). Otherwise, a biopsy must be carried out to obtain sufficient tissue for translational analyses.\n16. Able to swallow, absorb and retain oral medication.\n17. Able to provide written, informed consent.\n\nExclusion Criteria:\n\n1. Co-morbidities which would preclude the safe use of SBRT.\n2. Progressing or newly diagnosed brain metastases identified at the time of trial entry, not amenable to radical surgery or stereotactic radiosurgery. Previously treated brain metastases (i.e. palliative radiotherapy or systemic therapy) which have remained clinically and radiologically stable for ≥ 6 months are permissible.\n3. Prior radiotherapy near the oligometastatic \u002F oligoprogressive lesion precluding ablative SBRT. Suitability of lesions for ablative SBRT as part of the trial defined in Section 6.1 of this document and will be determined by the SOPRANO virtual MDT.\n4. Treatment with any other investigational medicinal product (IMP) within the 4 weeks prior to trial entry.\n5. Pregnant or lactating women.\n6. Women of childbearing age and potential who are not willing to use a highly effective contraceptive measure.\n7. Any unresolved toxicities from prior therapy should be no greater than CTCAE Grade 1 with the exception of Grade 2 alopecia or chemo-induced neuropathy at trial entry.\n8. Clinical\u002Fradiological evidence of bowel obstruction (e.g. hospitalisation) or symptoms of sub-acute bowel obstruction within 6 weeks prior to trial entry.\n9. Any other malignancy which has been active or treated within the past 3 years, with the exception of non-melanoma skin cancer. If prior treatment for another malignancy has taken place, then confirmation of ovarian\u002Ffallopian tube\u002Fperitoneal cancer progression is required e.g. biopsy, and discussion with the trial Chief Investigator and SBRT Lead\n10. Judgment by the Investigator that the patient is unsuitable to participate in the trial and\u002For the patient is unlikely to comply with trial procedures, restrictions and requirements.","FEMALE","18 Years",{"count":21,"type":22},42,"ESTIMATED","INTERVENTIONAL",[25],"PHASE2","SOPRANO is a multi-centre phase II trial designed to assess the impact of SBRT with or without continuing treatment with a PARP inhibitor (PARPi) for patients with oligometastatic or oligoprogressive ovarian, fallopian tube and primary peritoneal carcinoma. SOPRANO will also establish the feasibility and acceptability of delivering SBRT in this setting.",[28],"Ovarian Cancer Recurrent",[30,31,32,33,34],"Ovarian Cancer","Oligoprogressive","Oligometastatic","SBRT","PARP Inhibitor","RECRUITING","2026-07-10",{"date":38,"type":39},"2026-07-13","ACTUAL",{"date":41,"type":39},"2024-06-20",{"date":43,"type":22},"2027-12-31",{"name":45,"class":46},"Institute of Cancer Research, United Kingdom","OTHER",7,{"id":49,"slug":50,"hasResults":12,"nctId":51,"briefTitle":52,"officialTitle":53,"acronym":54,"eligibilityCriteria":55,"healthyVolunteers":12,"sex":56,"minAge":19,"maxAge":4,"enrollmentInfo":57,"targetDuration":4,"studyType":23,"phases":59,"briefSummary":61,"conditions":62,"keywords":64,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":66,"lastUpdatePostDateStruct":67,"startDateStruct":69,"completionDateStruct":71,"leadSponsor":73,"locationsCount":74},"100593121","phase-1-investigating-sx-682-in-combination-with-apalutamide-in-metastatic-castration-resistant-prostate-cancer-100593121","NCT07002320","Investigating SX-682 in Combination With Apalutamide in Metastatic Castration-resistant Prostate Cancer","ASpiRE: A Proof-of-mechanism and Proof-of-concept Clinical Trial Evaluating the Safety, Tolerability, Biological and Anti-tumour Activity of Apalutamide With Dual CXCR1 and CXCR2 Blockade by SX-682 for Men Suffering From Metastatic Castration-resistant Prostate Cancer (mCRPC)","ASpiRE","Inclusion Criteria:\n\n1. Written informed consent and be capable of cooperating with treatment.\n2. Age ≥ 18 years.\n3. Histologically or biochemically confirmed adenocarcinoma of the prostate and with tumour tissue accessible for research analysis for this trial. Patients who have no histological diagnosis must be willing to undergo a biopsy to prove prostate adenocarcinoma.\n4. Patients recruited to phase 1 dose escalation cohorts must have biopsiable disease and consent to mandatory pre- and post-treatment biopsies (baseline and on Cycle 2 Day 1).\n5. Metastatic castration-resistant prostate cancer.\n6. All patients must have documented resistance to 1 prior next generation antiandrogen therapy (NAAT) defined as:\n\n   For phase 1 and phase 2 Cohorts:\n\n   Patients who have progressed after either enzalutamide, Apalutamide or darolutamide (having received a minimum of 12-weeks of enzalutamide, Apalutamide or darolutamide) will enter phase 1 or phase 2 cohorts directly. Patients that have previously received abiraterone but not an AR antagonist should receive a lead-in with Apalutamide on trial and receive the combination on progression through the lead-in.\n7. Documented prostate cancer progression as assessed by the investigator with RECIST v1.1 and PCWG3 criteria (Section 3.5) with at least two of the following criteria:\n\n   1. Progression of soft tissue\u002Fvisceral disease by RECIST v1.1 and\u002For,\n   2. Progression of bone disease by PCWG3 bone scan criteria and\u002For,\n   3. Progression of PSA by PCWG3 PSA criteria.\n8. PSA ≥ 10ng\u002Fml.\n9. Received prior castration by orchiectomy and\u002For ongoing luteinizing hormone releasing hormone agonist treatment.\n10. Ongoing androgen deprivation with serum testosterone \\\u003C 50 ng\u002FdL (\\\u003C 1.7 nM).\n11. Eastern Cooperative Oncology Group (ECOG) Performance Status of ≤2.\n12. Documented willingness to use an effective means of contraception while participating in the study and for 6 months post last treatment dose.\n13. Able to swallow the study drug.\n14. All efforts should be made to discontinue steroid usage but up-to 5mg BD prednisolone (or equivalent) will be allowed.\n15. Haematological and biochemical indices within the ranges shown below. These measurements must be performed within one week (Day -7 to Day 1) before the patient goes on trial.\n\nHaemoglobin (Hb) ≥ 9.0 g\u002FdL Absolute neutrophil count ≥ 1.5 x 109\u002FL Platelet count ≥ 100 x 109\u002FL WBC ≥ 3.0 x 109\u002FL Calculated creatinine clearance ≥ 50 mL\u002Fmin (uncorrected value) Serum bilirubin ≤ 1.5 x upper limit of normal (ULN) unless documented Gilbert's disease., in which case ≤ 3 x ULN is permissible Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5 x (ULN) unless raised due to known metastatic liver disease in which case ≤ 5 x ULN is permissible\n\nExclusion Criteria:\n\n1. Surgery, chemotherapy, or other anti-cancer therapy within 4 weeks prior to trial entry\u002Frandomisation into the study (with the exception of abiraterone, enzalutamide, Apalutamide or darolutamide). Any other therapy for prostate cancer, other than gonadotropin releasing hormone analogue therapy, such as progesterone, medroxyprogesterone, progestins or 5-alpha reductase inhibitors, must be discontinued at least 2 weeks before the first dose of the study drug.\n2. Participation in another interventional clinical trial of an IMP within 4 weeks prior to trial entry. Participation in trials of licensed medications is allowed provided the medication is not a prohibited concomitant medication.\n3. Prior limited field radiotherapy within 2 weeks and wide field radiotherapy within 4 weeks prior to trial entry.\n4. Clinical and\u002For biochemical evidence of hyperaldosteronism or hypopituitarism.\n5. History of seizures or other predisposing factors including, but not limited to, underlying brain injury, stroke, primary brain tumours, brain metastases and leptomeningeal disease, or alcoholism.\n6. Malabsorption syndrome or other condition that would interfere with enteral absorption.\n7. Any of the following cardiac criteria:\n\n   * QTcF interval \\> 470 msec.\n   * Clinically important abnormalities including rhythm, conduction, or electrocardiogram (ECG) changes (left bundle branch block, third degree heart block).\n   * Factors predisposing to QT prolongation including heart failure, hypokalaemia, congenital long QT syndrome, family history of prolonged QT syndrome, unexplained sudden death (under 40) and concomitant medications known to prolong QT interval.\n   * Coronary artery bypass, angioplasty, vascular stent, myocardial infarction, angina, congestive heart failure (NYHA ≥ grade 2) i or transient ischaemic attack) in the last 6 months (see appendix 4 for NYHA scale).\n   * Uncontrolled hypotension (systolic blood pressure \\\u003C 90mmHg).\n   * Uncontrolled hypertension on optimal medical management.\n8. Clinically significant history of liver disease (Child-Pugh B or C, viral or other hepatitis, current alcohol abuse or cirrhosis).\n9. Any other finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or that may affect interpretation of the results or renders the patients at high risk from treatment complications, e.g., patients with a hypersensitivity to the active substance or any of the excipients.\n10. Malignancy other than prostate cancer within 5 years of trial entry except for adequately treated basal cell carcinoma.\n11. Unresolved significant toxicity from prior therapy (except alopecia and grade 1 peripheral neuropathy).\n12. Inability to comply with study and follow-up procedures.\n13. Predominantly small cell or neuroendocrine differentiated (\\> 20% of cells) prostate cancer.\n14. Immunocompromised patients.\n15. Active or uncontrolled autoimmune disease requiring corticosteroid therapy.\n16. History of thromboembolic disease within 12 months of commencement of trial.\n17. At high-risk because of non-malignant systemic disease including active infection and any serious concurrent illness.\n18. Any known intolerance to Apalutamide, SX-682, or to any constituents.\n19. Symptoms of COVID-19 and\u002For documented COVID-19 infection.\n20. Is taking any of the following prohibited medications:\n\n    * Aminophylline\u002Ftheophylline\n    * Atypical antipsychotics (eg, clozapine, olanzapine, risperidone, ziprasidone)\n    * Buproprion\n    * Lithium\n    * Meperidine and pethidine\n    * Phenothiazine antipsychotics (eg, chlorpromazine, mesoridazine, thioridazine)\n    * Tricyclic and tetracyclic antidepressants (eg, amitriptyline, desipramine, doxepin, imipramine, maprotiline, mirtazapine\n    * Warfarin or coumarin-like anticoagulants\n21. History of previous non-infectious pneumonitis requiring steroid treatment, or active non-infectious pneumonitis.\n22. History of previous severe drug induced severe cutaneous reaction including but not limited to Steven-Johnson's syndrome\u002Ftoxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms (DRESS).","MALE",{"count":58,"type":22},78,[60,25],"PHASE1","ASpiRE will investigate the effect of the drug SX-682 in combination with Apalutamide in men suffering from metastatic castration-resistant prostate cancer (mCRPC).",[63],"Metastatic Castrate-Resistant Prostate Cancer (mCRPC)",[65],"Prostate cancer","2026-04-14",{"date":68,"type":39},"2026-04-15",{"date":70,"type":39},"2025-04-28",{"date":72,"type":22},"2029-10",{"name":45,"class":46},4,{"id":76,"slug":77,"hasResults":12,"nctId":78,"briefTitle":79,"officialTitle":80,"acronym":81,"eligibilityCriteria":82,"healthyVolunteers":12,"sex":56,"minAge":19,"maxAge":4,"enrollmentInfo":83,"targetDuration":4,"studyType":85,"phases":4,"briefSummary":86,"conditions":87,"keywords":4,"overallStatus":89,"whyStopped":4,"lastUpdateSubmitDate":90,"lastUpdatePostDateStruct":91,"startDateStruct":92,"completionDateStruct":94,"leadSponsor":96,"locationsCount":4},"100633648","the-balance-study-black-and-mixed-mens-lived-experience-with-prostate-cancer-diversity-in-prostate-cancer-proms-study-100633648","NCT07529418","The BALANCE Study: BlAck and Mixed Men's Lived Experience With Prostate cANCEr-Diversity in Prostate Cancer PROMS Study","BlAck and Mixed Men's Lived Experience With Prostate cANCEr - Diversity in Prostate Cancer PROMS Study","BALANCE","Inclusion Criteria:\n\nIn order to be eligible to participate in this study, a subject must meet all of the following criteria:\n\n* Age ≥ 18 years;\n* Be of either:\n\n  * Black African ancestry; OR\n  * Black African-Caribbean ancestry; OR\n  * Mixed Black ancestry.\n* Diagnosed with PCa;\n* Assigned male at birth;\n* Participants with access to digital devices (smartphones, tablets, computers) or able to complete hardcopy versions of the survey;\n* Participants willing to participate and provide informed consent.\n\nExclusion Criteria:\n\nA potential subject who meets any of the following criteria will be excluded from participation in this study:\n\n* Participants having no diagnosis of PCa;\n* Participants unable to provide consent;\n* Participants assigned female at birth.",{"count":84,"type":22},800,"OBSERVATIONAL","The BALANCE study is a prospective Patient Reported Outcomes Measures (PROMs) study developed to look at the quality of life (QoL) of patients diagnosed with prostate cancer (PCa) in communities underrepresented in research, especially Black men of African, and Caribbean ancestry as well as men of Mixed ethnicity. This study will also investigate various PCa treatment types and their mental health impact on patients. There is a lack of research on PROMs in diverse populations. Collecting PROMs specifically from Black men and individuals with prostates who are receiving\u002Fhave received treatment for PCa is essential for understanding their unique post-treatment experiences. The insights are vital to addressing documented disparities, tailoring supportive care and ultimately providing equitable health outcomes.\n\nParticipants in this study will be asked to complete a questionnaire (either electronically or hardcopy) to share their insights following their PCa diagnosis.",[88],"Prostate Cancer","NOT_YET_RECRUITING","2026-04-08",{"date":66,"type":39},{"date":93,"type":22},"2026-05-05",{"date":95,"type":22},"2027-03",{"name":45,"class":46},{"id":98,"slug":99,"hasResults":12,"nctId":100,"briefTitle":101,"officialTitle":101,"acronym":102,"eligibilityCriteria":103,"healthyVolunteers":12,"sex":104,"minAge":19,"maxAge":4,"enrollmentInfo":105,"targetDuration":4,"studyType":85,"phases":4,"briefSummary":107,"conditions":108,"keywords":4,"overallStatus":89,"whyStopped":4,"lastUpdateSubmitDate":110,"lastUpdatePostDateStruct":111,"startDateStruct":113,"completionDateStruct":115,"leadSponsor":117,"locationsCount":4},"100546577","deployment-and-clinical-evaluation-of-an-ai-powered-digital-oncology-biomarker-tool-to-guide-treatment-in-tnbc-100546577","NCT06396754","Deployment and Clinical Evaluation of an AI-powered Digital Oncology Biomarker Tool to guidE Treatment in TNBC","AIDOBE","Inclusion Criteria:\n\n* Age ≥18 years\n* Confirmed diagnosis of triple negative breast cancer (non-metastatic)\n* Planned for neo-adjuvant systemic therapy\n* Written consent to generic Tissue for Research donation\n\nExclusion Criteria:\n\n* Patients declined consent for generic Tissue for Research donation","ALL",{"count":106,"type":22},50,"TILs have been shown to be predictive for response to neo-adjuvant chemotherapy in patients with TNBC in multiple studies (Level-1B evidence for clinical validity as per REMARK criteria). TNBC patients with excellent survival outcome and low incidence of metastasis can be identified using a manual TIL score.\n\nFurthermore, a fully end-to-end blinded evaluation of the same algorithm to be used in this study achieved \\>90% accuracy for predicting disease free survival (DFS) and overall survival (OS) in the pooled analysis of seven adjuvant phase-III TNBC trials.",[109],"Triple Negative Breast Cancer","2026-03-23",{"date":112,"type":39},"2026-03-27",{"date":114,"type":22},"2026-08-01",{"date":116,"type":22},"2027-07-31",{"name":45,"class":46},{"id":119,"slug":120,"hasResults":12,"nctId":121,"briefTitle":122,"officialTitle":123,"acronym":4,"eligibilityCriteria":124,"healthyVolunteers":12,"sex":104,"minAge":19,"maxAge":4,"enrollmentInfo":125,"targetDuration":4,"studyType":23,"phases":127,"briefSummary":128,"conditions":129,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":110,"lastUpdatePostDateStruct":131,"startDateStruct":132,"completionDateStruct":134,"leadSponsor":136,"locationsCount":137},"100358372","phase-2-kortuc-phase-ii---intra-tumoural-radiation-sensitizer-in-patients-with-locally-advancedrecurrent-breast-cancer-100358372","NCT03946202","KORTUC Phase II - Intra-tumoural Radiation Sensitizer in Patients With Locally Advanced\u002FRecurrent Breast Cancer","Randomised Phase II Trial Testing Efficacy of Intra-tumoural Hydrogen Peroxide as a Radiation Sensitiser in Patients With Locally Advanced\u002FRecurrent Breast Cancer","Inclusion Criteria:\n\n* Patient age 18 years and over\n* Primary locally advanced breast cancer, or locally recurrent breast cancer with\u002Fwithout metastases (metastases, if present, should be stable or oligometastatic)\n* Radical\u002Fhigh dose palliative radiotherapy required for lifetime control of local morbidities\n* Patient physically and mentally fit for radical\u002Fhigh dose palliative radiotherapy\n* Target tumour accessible for intra-tumoural injection\n* Patient suitable\u002Fcompliant with MR protocol\n* At least one tumour diameter ≥30 mm and ≤150 mm measurable by ultrasound or MR imaging\n* Patients with predicted life expectancy of 12 months or more\n* Negative pregnancy test before start of radiotherapy in women of child bearing potential and an ability\u002Fwillingness to protect against pregnancy from consent and for 3 months post-radiotherapy\n* Patient offers written informed consent\n\nExclusion Criteria:\n\n* Prior radiotherapy to the target area\n* Maximum diameter of target tumour \\\u003C30 mm or \\>150mm measurable by ultrasound or MR\n* Anatomical location and\u002For extent of disease difficult to access for safe intra-tumoural drug injections, for example by virtue of contiguous major blood vessels and\u002For brachial plexus\n* Concomitant chemotherapy or biological therapy except Herceptin, Pertuzumab and Denosumab (all endocrine therapies and bisphosphonates are allowed concomitantly; other cytotoxics and biological therapies apart from those mentioned above should be stopped 3 weeks prior to RT)\n* Pregnancy or nursing\n* Hypersensitivity to any of the KORTUC ingredients",{"count":126,"type":22},184,[25],"This is a study aimed at testing a commonly available and inexpensive chemical (hydrogen peroxide) for efficacy in sensitising large cancerous lumps in the breast to a standard course of radiotherapy in patients with locally advanced or recurrent breast cancer. Laboratory research and initial clinical trials in Japan suggest that 4 to 6 injections of a radiation sensitiser ('KORTUC') based on very dilute (0.5%) hydrogen peroxide injected into cancers under local anaesthetic twice a week during radiotherapy greatly increases the effectiveness of standard doses of radiotherapy alone. The side effects are limited to mild\u002Fmoderate discomfort at the injection site for up to 24 hours reported by Japanese breast cancer patients in whom this treatment has been tested. Complete tumour shrinkage in 70\u002F71 (98%) primary breast cancers up to 5 cm diameter have been reported by Japanese collaborators.",[130],"Breast Cancer",{"date":112,"type":39},{"date":133,"type":39},"2020-06-16",{"date":135,"type":22},"2028-06-30",{"name":45,"class":46},10,{"id":139,"slug":140,"hasResults":12,"nctId":141,"briefTitle":142,"officialTitle":143,"acronym":4,"eligibilityCriteria":144,"healthyVolunteers":145,"sex":56,"minAge":146,"maxAge":147,"enrollmentInfo":148,"targetDuration":4,"studyType":85,"phases":4,"briefSummary":150,"conditions":151,"keywords":152,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":157,"lastUpdatePostDateStruct":158,"startDateStruct":160,"completionDateStruct":162,"leadSponsor":164,"locationsCount":165},"100565003","the-i4i-prodict-study-evaluation-of-the-i4i-prodict-test-in-different-ethnic-groups-the-i4i-prodict-study-100565003","NCT06636526","The i4i PRODICT® Study: Evaluation of the i4i PRODICT® Test in Different Ethnic Groups (The i4i PRODICT® Study).","The i4i PRODICT® Study: Evaluation of the i4i PRODICT® Test in Different Ethnic Groups.","Inclusion Criteria:\n\n* People with a prostate\\* (PwP). \\*People with a prostate is defined as people born male.\n* Aged 40 to 55 years.\n* People of either (i) Black African\u002FBlack African-Caribbean; (ii) White European; or (iii) South Asian or East Asian ancestry. These are defined as individuals with 4 grandparents of the same ancestry.\n* Absence of any psychological, familial, sociological or geographical situation potentially hampering compliance with the study protocol and follow-up schedule.\n\nExclusion Criteria:\n\n* Previous diagnosis of prostate cancer.\n* People of mixed ancestry\n* Previous diagnosis of cancer with a life-expectancy of less than five years.\n* Negative prostate biopsy within one year before recruitment.\n* Any significant psychological conditions that may be worsened or exacerbated by participation in the study.",true,"40 Years","55 Years",{"count":149,"type":22},1000,"The i4i PRODICT® study has been developed to investigate the uptake and acceptability of the i4i PRODICT® test which combines both common and rare genetic changes (genetic variants) into one saliva-based DNA test to estimate a person's future risk of prostate cancer (PrCa) in people of varying ethnicities.",[88],[88,153,154,155,156],"Prostate cancer screening","Polygenic risk score","PSA","Genetic Predisposition","2026-02-02",{"date":159,"type":39},"2026-02-04",{"date":161,"type":39},"2025-06-02",{"date":163,"type":22},"2033-01-06",{"name":45,"class":46},3,{"id":167,"slug":168,"hasResults":12,"nctId":169,"briefTitle":170,"officialTitle":171,"acronym":172,"eligibilityCriteria":173,"healthyVolunteers":12,"sex":56,"minAge":19,"maxAge":4,"enrollmentInfo":174,"targetDuration":176,"studyType":85,"phases":4,"briefSummary":177,"conditions":178,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":157,"lastUpdatePostDateStruct":179,"startDateStruct":180,"completionDateStruct":182,"leadSponsor":184,"locationsCount":74},"100501531","the-active-surveillance-study-100501531","NCT05810467","The Active Surveillance Study","Active Surveillance Study for Prostate Cancer Management for Men at Higher Genetic Risk Compared With Men at No Known Higher Genetic Risk.","AS","Inclusion Criteria\n\n* Men ≥18 years old under the care of an Active Surveillance clinic.\n* Known diagnosis of PrCa, deemed suitable for Active surveillance at multi-disciplinary meeting (MDT).\n* Men at genetically higher PrCa risk who are either:\n\n  (1) Men of any ancestry with a positive family history of PrCa defined as:\n* Having a first degree relative (or second degree if through female line) with histologically or death certificate proven PrCa diagnosed at \\\u003C70 years\n* Having two relatives on the same side of the family with histologically or death certificate proven PrCa where at least one is diagnosed at \\\u003C70 years\n* Having three relatives on the same side of the family with histologically or death certificate proven PrCa diagnosed at any age\n\nOr (2) Men of Black African or Black African-Caribbean ancestry defined as:\n\n* Both parents and all 4 grandparents from that origin Or (3) Men of any ancestry with a pathogenic mutation in a gene thought to cause a higher risk of prostate cancer: (including BRCA1, BRCA2, ATM, PALB2, MLH1, MSH2, MSH6, CHEK2 and other DNA repair gene mutations as listed in appendix A) Or (4) Men of any ancestry with a high genetic risk (common and\u002For rare variants) for PrCa resulting in a RR of ≥2 of PrCa\n* Men of any ancestry with no known high risk genetic factors who have been diagnosed with low grade PrCa and deemed suitable for Active Surveillance at multi-disciplinary meeting (control group) as defined in the 4 criteria above.\n* Who performance status 0-2\n* Absence of any psychological, familial, sociological, or geographical situation potentially hampering compliance with the study protocol and follow-up schedule.\n\nExclusion Criteria\n\n* No PrCa diagnosis\n* PrCa diagnosis that is not deemed suitable for active surveillance at multi-disciplinary meeting\n* Any significant psychological conditions that may be worsened or exacerbated by participation in the study",{"count":175,"type":22},200,"5 Years","The Active Surveillance study is a prospective study developed to look at the association of biomarkers with PrCa presentation and progression among men on Active Surveillance and stratify it by their genetic risk. This study will also investigate the incidence and progression by differing genetic risks.",[88],{"date":159,"type":39},{"date":181,"type":39},"2023-08-22",{"date":183,"type":22},"2027-12",{"name":45,"class":46},{"id":186,"slug":187,"hasResults":12,"nctId":188,"briefTitle":189,"officialTitle":190,"acronym":191,"eligibilityCriteria":192,"healthyVolunteers":12,"sex":104,"minAge":193,"maxAge":4,"enrollmentInfo":194,"targetDuration":4,"studyType":23,"phases":196,"briefSummary":197,"conditions":198,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":201,"lastUpdatePostDateStruct":202,"startDateStruct":204,"completionDateStruct":206,"leadSponsor":208,"locationsCount":209},"100623021","phase-1-5g-pearl-paxalisib-in-malignant-brain-tumours-100623021","NCT07391215","5G-PEARL: Paxalisib in Malignant Brain Tumours","5G-PEARL: Paxalisib in Combination With Temozolomide in Patients With High Grade Malignant Brain Tumours Within the 5G Platform","5G-PEARL","Inclusion Criteria:\n\nPhase 1b front line mrd cohort:\n\n1. Patients with histologically confirmed advanced WHO Stage IV glioblastoma (per fourth edition 2016). Per the new 2021 fifth edition of WHO Classification of Tumours of the Central Nervous System, this will include:\n\n   • Glioblastoma, IDH-wildtype Grade 4\n2. Patients for Phase 1b will need to have consented to the Minderoo Precision Brain Tumour Programme and have whole genome, and transcriptome data available. Patients who have had NHS funded whole genome sequencing and have available frozen tissue stored can be recruited to the study in parallel to consenting to the Minderoo Precision Brain Tumour Programme to have transcriptome analysis done.\n3. Patients for the minimal residual disease (mrd) cohort will be eligible following completion of optimal surgery and Stupp based adjuvant chemoradiotherapy as long as they meet all other inclusion\u002Fexclusion criteria. Patients will need to commence Cycle 1 Day 1 of the study no later than 6 weeks from the completion of chemoradiotherapy. Patients who are radiologically progressing following chemo-radiotherapy will not be eligible.\n4. 16 years or over.\n5. Life expectancy of at least 12 weeks.\n6. World Health Organisation (WHO) performance status of 0-1.\n7. Neurologically stable (eg without a progression of neurological symptoms or requiring escalating doses of systemic steroid therapy within one week prior to cycle 1, day 1.\n8. Written (signed or dated) informed consent and be capable of co-operating with treatment and follow up.\n9. Haematological and biochemical indices within the ranges shown below. These measurements must be performed within one week prior to the first dose of either IMP.\n\n   Haemoglobin (Hb): ≥ 9.0 g\u002FdL Absolute neutrophil count: ≥1.5 x 10\\^9\u002FL Platelet count: ≥100 x 10\\^9\u002FL Coagulation: INR \\\u003C 1.5 and APTT \\\u003C1.5x if not anticoagulated INR stable \\> 7 days within intended therapeutic range if anticoagulated Bilirubin: ≤1.5 x ULN; participants with Gilbert's syndrome can enrol if conjugated bilirubin is within normal ranges.\n\n   Alanine aminotransferase (ALT) and aspartate aminotransferase (AST): \\\u003C3 x ULN Albumin: ≥ 28 g\u002FL Creatinine: \\\u003C1.5 x ULN Sodium: ≥130 mmol\u002FL Potassium, Calcium, Magnesium, phosphate: Within institution normal ranges (replacement is permitted) HbA1C (%): \\\u003C8.0 Urinary protein: \\\u003C 1+ on dipstick\n10. Female patients with reproductive potential must have a negative serum pregnancy test within 14 days prior to start of trial.\n11. Men and women of childbearing potential must agree to comply with the use of a highly effective method of contraception so as to avoid impregnating a partner or becoming pregnant, respectively, during the study, and for at least 180 days after the last dose of either investigational drug. Please, refer to section 4.1 of the Clinical Trials Facilitation and Coordination Group (CTCG) guidance for further details.\n\nExclusion Criteria:\n\nPhase 1b frontline mrd cohort:\n\n1. Receipt of treatment before the first dose of study drug (Cycle 1 Day 1) within an interval shorter than the following, as applicable:\n\n   * Bevacizumab during the prior 6 weeks\n   * Any investigational medicinal product since diagnosis.\n   * Tumour treating fields during the prior 6 weeks\n2. Prior immune checkpoint inhibitor therapy or vaccine therapy is not permitted. Prior use of any other immune-modulatory investigational agent must be discussed with sponsor team and CI.\n3. Ongoing Grade 2 or greater toxicities from pre-existing conditions or from previous treatments.\n4. Patients with carcinomatous meningitis, leptomeningeal spread of tumour, spread of tumour to the brain stem or spinal cord.\n5. Has evidence of recent intratumoural or peritumoural haemorrhage on baseline MRI. Patients with radiological findings that are stable on at least 2 consecutive MRI scans at least 3 weeks apart will be eligible.\n6. History of clinical relevant bleeding disorders, including significant GI bleeding within last 6 months.\n7. History of arterial thromboembolism.\n8. Recent (within 3 months) deep vein thrombosis or pulmonary embolism or other significant thromboembolism. Venous port of catheter thrombosis or superficial thrombosis are not considered significant. Patients with prior thrombosis (\\> 3 months ago) on stable anticoagulation are permitted to be enrolled.\n9. History of clinically significant cardiac disorders:\n\n   * Myocardial infarction, or New York Heart Association Class II to IV congestive heart failure, within 6 months of the first dose of study drug.\n   * Concurrent and clinically significant abnormalities on electrocardiogram (ECG) at Screening, including a corrected QT interval (QTcF \\>480ms).\n10. History of malabsorption syndrome or other conditions that may interfere with enteral absorption. Patients with a history of or active inflammatory bowel disease (eg Crohn's disease or ulcerative colitis). History of gastrointestinal perforation or fistulae.\n11. History of uncontrolled diabetes. Patients with controlled diabetes on therapy with HbA1C \\\u003C8% will be eligible.\n12. Has urine protein \\> 1g\u002F24 hours. Participants with \\>1+ on urine dipstick testing will undergo 24-hour urine collection for quantitative assessment of proteinuria.\n13. Has significant lung disease including pneumonitis, interstitial lung disease, idiopathic pulmonary fibrosis, cystic fibrosis, active tuberculosis, or history of opportunistic infections (including PCP or CMV pneumonia).\n14. Known to be serologically positive for hepatitis B, hepatitis C or human immunodeficiency virus (HIV).\n15. Steroid requirement for neurological symptom control of \\>3mg Dexamethasone per day (patients will allowed to enrol if they have been on a stable dose of steroids of equivalent or less than 3mg Dexamethasone for at least 5 days prior to Day 1 of Cycle 1).\n16. Has received a live vaccine within 30 days of planned start of study therapy. Note: inactive vaccines including COVID vaccines are allowed prior to 1 week of Day 1 of Cycle 1).\n17. Current active concurrent malignancy. Cancer survivors who have undergone potentially curative therapy for a prior malignancy, have no evidence of that disease recurrence for three years or more and are deemed at negligible risk of recurrence will be eligible.\n18. Is a participant or plans to participate on another interventional clinical trial while taking part in this Phase 1 study. Participation in an observational trial would be acceptable.\n19. Any other condition which in the investigator's opinion would not make the patient a good candidate for the clinical trial.\n20. Exposure to medications (with or without prescriptions), supplements, herbal remedies, or foods with potential for drug-drug interactions with study interventions within 14 days prior to the first dose of study intervention and during the course of therapy, including strong CYP3A4 inhibitors or inducers, due to potential drug-drug interactions with both paxalisib and temozolomide.\n21. Major surgery within 4 weeks (excluding placement of vascular access), minor surgery within 2 weeks.\n22. Live and attenuated vaccines are not permitted during or within 4 weeks prior to initiation of study treatment.\n\nInclusion and Exclusion criteria for Phase 2:\n\n1. This will be broadened following an assessment of the safety and tolerability seen in the Phase 1 to be more inclusive and reflective of the real-world population.\n2. Patients with any other CNS tumours will only be eligible for defined Phase 2 biomarker arms once a Phase 1b GO decision has been met. Specific eligibility criteria for these tumours will be defined following an amendment.","16 Years",{"count":195,"type":22},64,[60,25],"The purpose of this clinical trial is to evaluate the safety and tolerability of paxalisib in combination with temozolomide and to determine the preliminary antitumour activity of the combination therapy. In the Phase 1b of this study parallel biomarker defined arms will be opened in the front-line unmethylated MGMT setting, enrolling 10 patients onto each arm. These patients will be treated with paxalisib in combination with temozolomide (TMZ). The starting dose of paxalisib will be 45mg once a day (OD) with the option of increasing to 60 mg (30 mg BD) in Cycle 2. TMZ will be administered once daily by mouth on days 1 to 5 in a 28-day cycle, with a starting dose of 150mg\u002Fm2 during cycles 1 and 2, and subsequent dose escalation to 200mg\u002Fm2 at the start of cycle 3 if cycles 1 and 2 have been well tolerated with no significant toxicity.",[199,200],"Malignant Primary Gliomas","Glioblastoma Multiforme (GBM)","2026-01-29",{"date":203,"type":39},"2026-02-05",{"date":205,"type":22},"2026-01-19",{"date":207,"type":22},"2029-06-30",{"name":45,"class":46},1,{"id":211,"slug":212,"hasResults":12,"nctId":213,"briefTitle":214,"officialTitle":215,"acronym":216,"eligibilityCriteria":217,"healthyVolunteers":12,"sex":104,"minAge":193,"maxAge":4,"enrollmentInfo":218,"targetDuration":4,"studyType":23,"phases":220,"briefSummary":221,"conditions":222,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":205,"lastUpdatePostDateStruct":225,"startDateStruct":227,"completionDateStruct":229,"leadSponsor":231,"locationsCount":165},"100564521","phase-1-5g-ruby-avutometinib-and-defactinib-in-malignant-brain-tumours-100564521","NCT06630260","5G-RUBY: Avutometinib and Defactinib in Malignant Brain Tumours","A Phase 1\u002F2 Trial of the Doublet Combination of Avutometinib and Defactinib and as a Triplet in Combination With Temozolomide in Patients With High Grade Malignant Brain Tumours Within the 5G Platform","5G-RUBY","Inclusion Criteria for Phase 1b:\n\n1. Patients with histologically confirmed advanced WHO Stage IV glioblastoma (per fourth edition 2016). Per the new 2021 fifth edition of WHO Classification of Tumours of the Central Nervous System, this will include:\n\n   * Glioblastoma, IDH-wildtype Grade 4\n   * Astrocytoma, IDH-mutant, Grade 4 (lower Grade 2\u002F3 are not included)\n   * Diffuse hemispheric glioma, H3 G34 mutant Grade 4\n\n   Patients with any other CNS tumours will only be eligible for defined Phase 2 biomarker arms once a Phase 1b GO decision has been met. Specific eligibility criteria for these tumours will be defined following an amendment.\n2. Patients for Phase 1 will need to have consented to the Minderoo Precision Brain Tumour Programme and have available whole genome, and transcriptome data available.\n3. Patients for the relapsed cohorts will be eligible at first relapse following completion of optimal surgery, and Stupp based adjuvant chemo-radiotherapy (or equivalent). They will need to have measurable disease per RANO or evaluable disease.\n4. Patients for the front line minimal residual disease (mrd) cohort will be eligible following completion of optimal surgery and Stupp based adjuvant chemoradiotherapy as long as they meet all other inclusion\u002Fexclusion criteria.\n5. 16 years or over\n6. Life expectancy of at least 12 weeks.\n7. World Health Organisation (WHO) performance status of 0-1\n8. Neurologically stable (e.g., without a progression of neurological symptoms or requiring escalating doses of systemic steroid therapy within the last week)\n9. Written (signed or dated) informed consent and be capable of co-operating with treatment and follow up\n10. Haematological and biochemical indices within the ranges shown below. These measurements must be performed within one week prior to the first dose of either IMP\n\n    Haemoglobin (Hb): ≥ 9.0 g\u002FdL; Absolute neutrophil count: ≥1.5 x 10\\^9\u002FL; Platelet count: ≥100 x 10\\^9\u002FL; Coagulation: INR \\\u003C1.5 and APTT \\\u003C1.5x if not anticoagulated, INR stable \\> 7 days within intended therapeutic range if anticoagulated; Bilirubin: Within institution normal ranges; Alanine aminotransferase (ALT) and aspartate aminotransferase (AST): \\\u003C3 x ULN; Albumin: ≥ 28 g\u002FdL; Creatinine: \\\u003C1.5 x ULN; Sodium: ≥130 mmol\u002FL; Potassium, Calcium, Magnesium, phosphate: Within institution normal ranges (replacement is permitted); Urinary protein: \\\u003C 1+ on dipstick.\n11. Female patients with reproductive potential must have a negative serum pregnancy test within 14 days prior to start of trial.\n12. Men and women of childbearing potential must agree to comply with the use of a highly effective method of contraception to avoid impregnating a partner or becoming pregnant, respectively, during the study, and for at least 150 days after the last dose of either investigational drug.\n\nExclusion Criteria for Phase 1b:\n\n1. Receipt of treatment before the first dose of study drug (Cycle 1 Day 1) within an interval shorter than the following, as applicable:\n\n   * Cytotoxic chemotherapy during the prior 2 weeks or 6 weeks for nitrosoureas\n   * Bevacizumab during the prior 6 weeks\n   * Five half-lives of any small molecule investigational or licensed medicinal product.\n2. Prior immune checkpoint inhibitor therapy or vaccine therapy is not permitted. Prior use of any other immune-modulatory investigational agent must be discussed with sponsor team and CI. Prior use of BRAF or MEK inhibitors is not permitted.\n3. Ongoing Grade 2 or greater toxicities from pre-existing conditions or from previous treatments.\n4. Patients with carcinomatous meningitis, leptomeningeal spread of tumour, spread of tumour to the brain stem or spinal cord.\n5. Has evidence of recent intratumoural or peritumoural haemorrhage on baseline MRI. Patients with radiological findings that are stable on at least 2 consecutive MRI scans at least 3 weeks apart will be eligible.\n6. History of clinically relevant bleeding disorders, including significant GI bleeding within last 6 months.\n7. History of arterial thromboembolism.\n8. Recent (within 3 months) deep vein thrombosis or pulmonary embolism or another significant thromboembolism. Venous port of catheter thrombosis or superficial thrombosis are not considered significant. Patients with prior thrombosis (\\> 3 months ago) on stable anticoagulation are permitted to be enrolled. Patients on Warfarin will need to be converted onto low-molecular weight-based heparin therapy.\n9. History of clinically significant cardiac disorders:\n\n   * Myocardial infarction, or New York Heart Association Class II to IV congestive heart failure, within 6 months of the first dose of study drug\n   * Concurrent and clinically significant abnormalities on ECG at Screening, including a corrected QT interval (QTcF \\>460ms).\n10. History of malabsorption syndrome or other conditions that may interfere with enteral absorption. Patients with a history of or active inflammatory bowel disease (e.g., Crohn's disease or ulcerative colitis). Patients with acute or chronic pancreatitis. History of gastrointestinal perforation or fistulae. Patients with known Gilbert's syndrome will be excluded from this study.\n11. Concurrent ocular disorders:\n\n    1. Patients with history of glaucoma, history of retinal vein occlusion (RVO), predisposing factors for RVO, including uncontrolled hypertension, uncontrolled diabetes\n    2. Patient with history of retinal pathology or evidence of visible retinal pathology that is considered a risk factor for RVO, intraocular pressure \\> 21 mm Hg as measured by tonometry, or other significant ocular pathology, such as anatomical abnormalities that increase the risk for RVO.\n    3. Patients with a history of corneal erosion (instability of corneal epithelium), corneal degeneration, active or recurrent keratitis, and other forms of serious ocular surface inflammatory conditions.\n12. Has urine protein \\> 1g\u002F24 hours. Participants with \\>1+ on urine dipstick testing will undergo 24-hour urine collection for quantitative assessment of proteinuria.\n13. Has significant lung disease including pneumonitis, interstitial lung disease, idiopathic pulmonary fibrosis, cystic fibrosis, active tuberculosis, or history of opportunistic infections (including PCP or CMV pneumonia).\n14. Known to be serologically positive for hepatitis B, hepatitis C or human immunodeficiency virus (HIV).\n15. Steroid requirement for neurological symptom control of \\> 3mg Dexamethasone per day (patients will allowed to enrol if they have been on a stable dose of steroids of equivalent or less than 3mg Dexamethasone for at least 5 days prior to Day 1 of Cycle 1).\n16. Has received a live vaccine within 30 days of planned start of study therapy. Note: inactive vaccines including COVID vaccines are allowed prior to 1 week of Day 1 of Cycle 1).\n17. Current active concurrent malignancy. Cancer survivors who have undergone potentially curative therapy for a prior malignancy, have no evidence of that disease recurrence for three years or more and are deemed at negligible risk of recurrence will be eligible.\n18. Is a participant or plans to participate on another interventional clinical trial while taking part in this Phase 1 study. Participation in an observational trial would be acceptable.\n19. Exposure to medications (with or without prescriptions), supplements, herbal remedies, or foods with potential for drug-drug interactions with study interventions within 14 days prior to the first dose of study intervention and during the course of therapy, including:\n\n    1. Strong CYP3A4 inhibitors or inducers, due to potential drug-drug interactions with both avutometinib and defactinib.\n    2. Strong CYP2C9 inhibitors or inducers, due to potential drug-drug interactions with defactinib. Not applicable if and when patients randomized to avutometinib monotherapy.\n    3. Strong P-glycoprotein (P-gp) inhibitors or inducers, due to potential drug-drug interactions with both avutometinib and defactinib.\n    4. Strong breast cancer resistance protein (BCRP) inhibitors or inducers, due to potential drug-drug interactions with avutometinib.\n20. Major surgery within 4 weeks (excluding placement of vascular access), minor surgery within 2 weeks, or palliative radiotherapy within 1 week of the first dose of defactinib.\n21. Any other condition which in the investigator's opinion would not make the patient a good candidate for the clinical trial.",{"count":219,"type":22},182,[60,25],"The purpose of this clinical trial is to evaluate the safety and tolerability of avutometinib and defactinib and to determine the preliminary antitumour activity of avutometinib and defactinib administered at the recommended Phase 2 dose (RP2D). In the Phase 1b of this study parallel biomarker defined arms will be opened, initially in the relapsed GMB setting, enrolling 12 patients onto each arm. These patients will be treated with avutometinib and defactinib double therapy. Avutometinib will be administered orally at 3.2mg twice a week (e.g., on Monday \u002F Thursday or Tuesday \u002F Friday) with or without a meal. The total weekly dose of avutometinib is 6.4mg. Defactinib will be administered orally, at 200mg, twice a day within 30 min after a meal. The total daily dose of defactinib is 400mg.\n\nOnce a treatment in any biomarker arm has met the \"GO\" decision (≥3 successes\u002F12 patients) for relapsed GBM in Phase 1b, that arm can progress to Phase 2. The primary objective of Phase 2 is to determine the antitumour activity of investigational agents administered at the RP2D in patients with molecularly defined malignant brain tumours.",[200,223,224,199],"Glioblastoma Multiform (Grade IV Astrocytoma)","Diffuse Hemispheric Glioma, H3 G34-Mutant",{"date":226,"type":39},"2026-01-21",{"date":228,"type":39},"2024-11-15",{"date":230,"type":22},"2030-09-30",{"name":45,"class":46},{"id":233,"slug":234,"hasResults":12,"nctId":235,"briefTitle":236,"officialTitle":237,"acronym":238,"eligibilityCriteria":239,"healthyVolunteers":12,"sex":56,"minAge":19,"maxAge":4,"enrollmentInfo":240,"targetDuration":4,"studyType":85,"phases":4,"briefSummary":241,"conditions":242,"keywords":249,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":252,"lastUpdatePostDateStruct":253,"startDateStruct":255,"completionDateStruct":257,"leadSponsor":259,"locationsCount":209},"100446733","the-genpet-study---an-imaging-study-of-fch-pet-ct-in-men-with-prostate-cancer-and-a-dna-repair-gene-mutation-100446733","NCT05097274","The GENPET Study - An Imaging Study of FCH-PET-CT in Men With Prostate Cancer and a DNA Repair Gene Mutation.","An Imaging Study of FCH-PET-CT in Men With Prostate Cancer and a DNA Repair Gene Mutation (GENPET)","GENPET","Inclusion Criteria:\n\n* Confirmed pathogenic germline mutation in any of the following genes BRCA1, BRCA2, MSH2, MSH6, MLH1, PMS2, CHEK2, PALB2 or ATM.\n* Over the age of 18\n* Diagnosed with prostate cancer and at a time when staging imaging is clinically indicated; either:\n\n  * At a new diagnosis\n  * Biochemically progressing patients who were treated radically with surgery or radiotherapy (more than 6 months ago) and are currently not receiving hormonal treatment or chemotherapy\n  * Patients on active surveillance with a PSA doubling time of 6 months or less\n\nExclusion Criteria:\n\n* Diagnosis of other malignancy (excluding basal cell cancer\u002Fsquamous cell cancer of the skin) within five years of diagnosis\n* Known metastatic prostate cancer, both local and distant\n* Patients who have received any oncological treatment within the last six months\n* Patients on any investigational drug treatment\n* Patients on steroids\n* Known history of inflammatory\u002Finfective diseases (e.g. sarcoidosis, tuberculosis, inflammatory bowel disease)\n* Contraindications to having an MRI using the standard MRI checklist (e.g. pacemakers, aneurysm clips, claustrophobia)",{"count":106,"type":22},"The aim of the study is to determine if PET-CT imaging (using contrast recommended in clinical guidelines) is superior to combined bone scan and MRI\u002FCT of the abdomen \\& pelvis in detecting the increased incidence of metastasis (nodal\u002Fdistant outside the pelvis) in men with prostatic carcinoma with mutations in any of the following germline DNA repair genes BRCA1, BRCA2, MSH2, MSH6, MLH1, PMS2, CHEK2, PALB2, ATM.",[88,243,244,245,246,247,248],"BRCA Mutation","Mismatch Repair Gene Mutation","ATM Gene Mutation","HOXB13 Germline Mutation","CHEK2 Gene Mutation","PALB2 Gene Mutation",[250,251],"FCH-PET-CT","PSMA-PET-CT","2025-12-08",{"date":254,"type":39},"2025-12-16",{"date":256,"type":39},"2015-10-15",{"date":258,"type":22},"2032-12-31",{"name":45,"class":46},{"id":261,"slug":262,"hasResults":12,"nctId":263,"briefTitle":264,"officialTitle":265,"acronym":266,"eligibilityCriteria":267,"healthyVolunteers":12,"sex":56,"minAge":268,"maxAge":269,"enrollmentInfo":270,"targetDuration":4,"studyType":85,"phases":4,"briefSummary":272,"conditions":273,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":252,"lastUpdatePostDateStruct":274,"startDateStruct":275,"completionDateStruct":277,"leadSponsor":279,"locationsCount":209},"100421095","precision-medicine-in-the-prostate-cancer-care-pathway-100421095","NCT04763317","Precision Medicine in the Prostate Cancer Care Pathway","Precision Medicine in the Prostate Cancer Care Pathway: an Evaluation of Integrating Germline Genetic Testing Into the Management of Men at Risk of \u002F Living With Prostate Cancer","PMPRC","Inclusion Criteria:\n\nAffected cohort:\n\n1. Affected with PrCa \\\u003C 60 years or\n2. Affected with metastatic castration resistant PrCa (mCRPC) at any age or Aggressive PrCa Gleason 4+4 or higher \\\u003C70 years\n3. Affected with family history defined as three or more cases any age (FDR or SDR)\n\nUnaffected cohort: (This cohort is no longer recruiting, it has completed recruitment)\n\nAged \\>30 and with a family history defined as:\n\n1. FDR diagnosed \\\u003C 70\n2. 2 or more cases in First or Second Degree Relatives (FDR\u002FSDR) with one case diagnosed \\\u003C 70 years\n3. 3 or more cases at any age (on same side of family)\n\nExclusion Criteria:\n\n* • WHO performance status 4","30 Years","70 Years",{"count":271,"type":22},3000,"This study aims to evaluate the use of a prostate cancer specific predisposition genetic panel test in men with \u002F at high risk of prostate cancer. The genetic test will analyse men's DNA samples for the presence of mutations in rare genes as well as common genetic variation to provide men with information about their risk of prostate cancer. This study will evaluate the clinical impact of the test on risk assessment and clinical management in terms of screening and treatment.",[88,156],{"date":254,"type":39},{"date":276,"type":39},"2019-02-14",{"date":278,"type":22},"2034-12",{"name":45,"class":46},{"id":281,"slug":282,"hasResults":12,"nctId":283,"briefTitle":284,"officialTitle":285,"acronym":4,"eligibilityCriteria":286,"healthyVolunteers":12,"sex":56,"minAge":19,"maxAge":4,"enrollmentInfo":287,"targetDuration":4,"studyType":23,"phases":289,"briefSummary":290,"conditions":291,"keywords":293,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":297,"lastUpdatePostDateStruct":298,"startDateStruct":300,"completionDateStruct":302,"leadSponsor":304,"locationsCount":305},"100525822","phase-1-combination-study-of-antibiotics-with-enzalutamide-promize-100525822","NCT06126731","Combination Study of Antibiotics With Enzalutamide (PROMIZE)","PROMIZE: A Phase I\u002FII Trial to Assess the Safety, Tolerability and Preliminary Anti-tumour Activity of Oral Combination Antibiotic Therapy to Modulate the Microbiome in Combination With Enzalutamide With Metastatic Castration Resistant Prostate Cancer (mCRPC).","Inclusion Criteria:\n\n1. Histologically or cytologically proven metastatic castration-resistant prostate cancer or adenocarcinoma refractory to conventional treatment, or for which no conventional therapy exists or is declined by the patient.\n2. Documented prostate cancer progression as assessed by the investigator with RECIST (v1.1) and PCWG3 criteria with at least one of the following criteria:\n\n   1. Progression of soft tissue\u002Fvisceral disease by RECIST (v1.1) and\u002For,\n   2. Progression of bone disease by PCWG3 bone scan criteria and\u002For,\n   3. Progression of PSA by PCWG3 PSA criteria and\u002For\n   4. Clinical progression with worsening pain and need for palliative radiotherapy for bone metastases.\n3. Phase I: Patients that have progressed after at least 12 weeks of treatment with a NAAT within the previous 6 months Phase II: Patients that have progressed after at least 12 weeks of treatment with a NAAT within the previous 6 months (for combination treatment) or more than 6 months prior to trial entry (for enzalutamide alone resistance run-in).\n4. Previously progressed on at least one line of taxane chemotherapy (or not fit or not willing to receive a taxane).\n5. Ongoing androgen deprivation maintaining serum testosterone of less than 50 ng\u002FdL (less than 2.0 nM) is mandatory.\n6. Life expectancy of at least 12-weeks.\n7. Able to swallow tablets.\n8. Archival tumour tissue must be available for analyses.\n9. Willing to have pre- and post-treatment biopsies if biopsy is feasible.\n10. World Health Organisation (WHO) performance status of 0-2 (Appendix 1).\n11. Haematological and biochemical indices within the ranges shown below. These measurements must be performed within one week (Day -7 to Day 1) prior to the patient's first dose of IMP.\n\n    Haemoglobin (Hb): ≥ 9.0 g\u002FdL\n\n    Absolute neutrophil count: ≥ 1.5 x 109\u002FL\n\n    Platelet count: ≥ 75 x 109\u002FL\n\n    Serum bilirubin: ≤ 1.5 x upper limit of normal (ULN)\n\n    Alanine aminotransferase (ALT): ≤ 2.5 x (ULN) unless raised due to tumour in which case up to 5 x ULN is permissible\n\n    Aspartate aminotransferase (AST): ≤ 2.5 x (ULN) unless raised due to tumour in which case up to 5 x ULN is permissible\n\n    Serum creatinine \u002F calculated creatinine clearance: ≤ 1.5 x upper limit of normal (ULN) \u002F GFR ≥ 50 mL\u002Fmin (uncorrected value)\n\n    Serum albumin: \\>25 g\u002FL\n12. 18 years or over\n13. Written (signed and dated) informed consent and be capable of co-operating with treatment and follow-up\n14. Willing and able to comply with the study requirement including the collection of blood, fresh tumour biopsy, urine, rectal swab and stool samples.\n\nExclusion criteria:\n\n1. Surgery, radiotherapy, chemotherapy, or other anti-cancer therapy within 4-weeks prior to trial entry into the study (6 weeks for bicalutamide). The use of bisphosphonates or RANK ligand inhibitors in patients with known osteopenia or osteoporosis or bone metastases is permitted. Prior antiandrogenic treatment exclusions as follows:\n\n   * Patients receiving enzalutamide immediately preceding the trial will be able to continue on enzalutamide without washout.\n   * Prior flutamide treatment during previous 4-weeks. N.B. Patients whose PSA did not decline in response to antiandrogens given as a second line or later intervention will only require a 14-day washout;\n   * Prior bicalutamide (Casodex) and nilutimide (Nilandron) treatment during previous 6-weeks;\n   * Prior progesterone, medroxyprogesterone, progestins, cyproterone acetate, tamoxifen, and 5-alpha reductase inhibitors during previous 2-weeks (14-days).\n2. Ongoing toxic manifestations of previous treatments. Exceptions to this are alopecia or certain Grade 1 toxicities, which in the opinion of the Investigator and the DDU should not exclude the patient.\n3. Previous treatment with any systemic antibiotic within 12 weeks of study entry.\n4. Known hypersensitivity reaction or intolerance to any penicillin, amoxicillin, metronidazole, vancomycin, ciprofloxacin or enzalutamide.\n5. History of tendon disorder secondary to quinolones\n6. Use of drugs that are listed in the prohibited concomitant medications section including strong inducers and inhibitors of CYP450 (please refer to http:\u002F\u002Fmedicine.iupui.edu\u002Fclinpharm\u002Fddis\u002Ftable.aspx). Seville orange or grapefruit products and any herbal medications should be avoided for 4 weeks prior to starting trial treatment.\n7. Concurrent treatment with prohibited medications which include medications that causes ototoxicity, neurotoxicity, and nephrotoxicity.\n8. Known or suspected leptomeningeal metastases or untreated brain metastasis. Patients with brain metastases that have been treated and have been shown to be radiologically stable for more than 6 months may be considered for the trial.\n9. History of stroke, epilepsy or current excessive alcohol intake. History of clinically significant hearing loss including but not limited to congenital hearing loss, need for hearing aids, ongoing acute or chronic ear infection, history of tympanic membrane perforation, tinnitus, vertigo, Meniere disease, cerebrovascular ischemia.\n10. History of clinically significant hearing loss including but not limited to congenital hearing loss, need for hearing aids, ongoing acute or chronic ear infection, history of tympanic membrane perforation, tinnitus, vertigo, Meniere disease, cerebrovascular ischemia.\n11. Patients with partners of child-bearing potential (unless they agree to use a barrier method of contraception \\[condom plus spermicide\\] or to sexual abstinence effective from the first administration of any of the investigational agents, throughout the trial and for 6 months afterwards. Patients with partners of child-bearing potential must also be willing to ensure that their partner uses an effective method of contraception for the same duration for example, hormonal contraception, intrauterine device, diaphragm with spermicidal gel or sexual abstinence). Patients with pregnant or lactating partners must be advised to use barrier method contraception (for example, condom plus spermicidal gel) to prevent exposure of the foetus or neonate.\n\n    NB. Abstinence is only considered to be an acceptable method of contraception when this is in line with the preferred and usual lifestyle of the subject. Periodic abstinence (e.g., calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception\n12. Any condition that would increase enteral absorption in the opinion of the investigator, including but not limited to malabsorption syndromes, impaired GI motility, chronic pancreatitis, partial or complete gastric and\u002For bowel resections, history of clinically significant gastrointestinal bleeding in the last 6 months, history of mesenteric ischemia or bowel obstruction, chronic diarrhoea (≥Grade 2), inflammatory bowel disease (Crohn's disease, ulcerative colitis).\n13. At high medical risk because of non-malignant systemic disease including active uncontrolled infection.\n14. Clinically significant history of liver disease consistent with Child-Pugh Class B or C, including viral or other hepatitis, current alcohol abuse, or cirrhosis.\n15. Known to be serologically positive for hepatitis B, hepatitis C or human immunodeficiency virus (HIV).\n16. Any of the following cardiac criteria:\n\n    * Clinically important abnormalities including rhythm, conduction or ECG changes (left bundle branch block, third degree heart block).\n    * Factors predisposing to QT prolongation including congenital long QT syndrome; family history of prolonged QT syndrome, unexplained sudden death (under 40); concomitant medications known to prolong QT interval.\n    * Concurrent congestive heart failure, prior history of class III\u002F IV cardiac disease (New York Heart Association \\[NYHA\\] - refer to Appendix 5), prior history of cardiac ischaemia or prior history of cardiac arrhythmia.\n    * QTcF (corrected using Fredericia formula) of ≥460 ms.\n17. Prior bone marrow transplant or have had extensive radiotherapy to greater than 25% of bone marrow within eight weeks.\n18. Active or uncontrolled autoimmune disease requiring corticosteroid therapy or other forms of systemic immunosuppression.\n19. Patient is a participant or plans to participate in another interventional clinical trial, whilst taking part in this study. Participation in an observational trial would be acceptable.\n20. Any other condition which in the Investigator's opinion would not make the patient a good candidate for the clinical trial.\n21. Malignancy other than prostate cancer within 3-years of trial entry with the exception of adequately treated basal cell carcinoma. Cancer survivors, who have undergone potentially curative therapy for a prior malignancy must have no evidence of that disease for at least-3 years and be deemed at negligible risk for recurrence, are deemed eligible.\n22. Symptoms of COVID-19 and\u002For current documented COVID-19 infection.",{"count":288,"type":22},39,[60,25],"PROMIZE is an open-label, multi-centre, single-arm, Phase I\u002FII clinical trial, evaluating the safety, tolerability and anti-tumuor efficacy of an antibiotic combination and enzalutamide in patients with metastatic castration-resistant prostate cancer (mCRPC).",[292],"Metastatic Castration-Resistant Prostate Cancer (mCRPC)",[294,295,296],"Microbiome","Antibiotic","Enzalutamide","2025-11-19",{"date":299,"type":39},"2025-11-24",{"date":301,"type":39},"2023-11-02",{"date":303,"type":22},"2027-06-30",{"name":45,"class":46},2,{"id":307,"slug":308,"hasResults":12,"nctId":309,"briefTitle":310,"officialTitle":311,"acronym":312,"eligibilityCriteria":313,"healthyVolunteers":12,"sex":56,"minAge":19,"maxAge":4,"enrollmentInfo":314,"targetDuration":4,"studyType":85,"phases":4,"briefSummary":316,"conditions":317,"keywords":318,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":323,"lastUpdatePostDateStruct":324,"startDateStruct":326,"completionDateStruct":328,"leadSponsor":330,"locationsCount":209},"100263220","analysing-outcomes-after-prostate-cancer-diagnosis-and-treatment-in-carriers-of-rare-germline-mutations-100263220","NCT02705846","Analysing Outcomes After Prostate Cancer Diagnosis and Treatment in Carriers of Rare Germline Mutations","Analysing Outcomes After Prostate Cancer Diagnosis and Treatment in Carriers of Rare Germline Mutation in Cancer Predisposition Genes","GENPROS","Inclusion Criteria:\n\n* Men diagnosed with PCa are eligible if:\n* known carriers of germline mutations associated with PCa risk OR\n* known non-carriers of mutations in the genes above\n\nExclusion Criteria:\n\n* patients under 18 years of age\n* patients who are unable to give informed consent\n* patients who cannot be traced (\\\u003C6 months follow-up) or whose clinical data are not available\n* patients whose genetic status is unknown",{"count":315,"type":22},4260,"GENPROS aims to analyse the outcomes of patients with rare gene mutations in the cancer predisposition genes, BRCA1, BRCA2, HOXB13, and Lynch Syndrome, after a diagnosis of and treatment for prostate cancer (PCa). The study includes a cohort of gene mutation carriers with PCa matched with a control group of men with PCa who are known not to carry a mutation in the same gene. Clinical data regarding treatment and patient outcome will be collected retrospectively and prospectively. Archived tumour samples will also be collected for tumour profiling. A blood or saliva sample will be taken, if the participant consents to this part of the study, for genetic profiling to investigate any association of other inherited factors with PCa outcomes. Information obtained from this study will be of critical importance to support clinical trials investigating the most appropriate management of PCa in this group of patients at increased risk of prostate cancer.",[88],[319,320,321,322],"BRCA1","BRCA2","Lynch Syndrome","Genetic predisposition to Prostate cancer","2025-09-25",{"date":325,"type":39},"2025-09-26",{"date":327,"type":4},"2014-09",{"date":329,"type":22},"2035-12",{"name":45,"class":46},{"id":332,"slug":333,"hasResults":12,"nctId":334,"briefTitle":335,"officialTitle":336,"acronym":337,"eligibilityCriteria":338,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":339,"targetDuration":4,"studyType":23,"phases":341,"briefSummary":342,"conditions":343,"keywords":345,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":348,"lastUpdatePostDateStruct":349,"startDateStruct":351,"completionDateStruct":353,"leadSponsor":355,"locationsCount":165},"100591166","phase-1-investigating-idetrexed-and-olaparib-in-patients-with-ovarian-cancer-100591166","NCT06976892","Investigating Idetrexed and Olaparib in Patients With Ovarian Cancer","A Phase I\u002FIb Trial of Idetrexed (Alpha Folate Receptor Targeted Thymidylate Synthase Inhibitor) in Combination With Olaparib (a PARP Inhibitor) at Different Doses in Patients With Ovarian Cancer (IDOL)","IDOL","Inclusion Criteria:\n\n* Histologically or cytologically proven high grade serous ovarian cancer refractory to conventional treatment, or for which no conventional therapy exists or is declined by the patient.\n* Measurable (as defined by RECIST v1.1) or evaluable (based on tumour markers) disease.\n* Life expectancy of at least 12 weeks.\n* World Health Organisation (WHO) performance status of 0-1 (Appendix 1 of Protocol).\n* Haematological and biochemical indices within the ranges shown in Protocol section 4.1.1). These measurements must be performed within one week (Day -7 to Day 1) prior to the patient's first dose of IMP.\n\nNormal (no clinically significant abnormalities) 12-lead ECG, QTcF interval \\\u003C470 ms\n\n* Pulmonary function test FVC of \\>70%, DLCOc (DLCO corrected for Hb) of \\>60%.\n* 18 years or over.\n* Written (signed and dated) informed consent and be capable of co-operating with treatment and follow-up.\n* For dose expansion patients only, they must have medium to high α-folate receptor expression according to the Ventana FOLR1-2.1 IHC assay.\n\nExclusion Criteria:\n\n* Radiotherapy (except for palliative reasons), endocrine therapy, immunotherapy or chemotherapy during the previous four weeks (six weeks for nitrosoureas, Mitomycin-C) and 4 weeks for investigational medicinal products) before treatment.\n* Ongoing toxic manifestations of previous treatments. Exceptions to this are alopecia or certain Grade 1 toxicities, which in the opinion of the Investigator and the DDU should not exclude the patient.\n* Patients with new brain metastases. Patients with treated (surgically excised or irradiated) and stable brain metastases are eligible as long as the treatment was at least 4 weeks prior to initiation of study drug and brain MRI within 2 weeks of initiation of study drug is negative for new metastases.\n* Patients with pulmonary metastases.\n* History of thoracic radiation or other history likely to create pre-existing lung disease\n* Presence of significant clinical ascites and\u002For pleural effusions.\n* Female patients of child-bearing potential (or are already pregnant or lactating). However, those patients who have a negative serum or urine pregnancy test before enrolment and agree to use two forms of contraception (one effective form plus a barrier method) \\[oral, injected or implanted hormonal contraception and condom; intra-uterine device and condom; diaphragm with spermicidal gel and condom\\] or agree to sexual abstinence (see Protocol Section 16.5 - Appendix 5), effective from signing the consent form, throughout the trial and for six months afterwards are considered eligible.\n* Major thoracic or abdominal surgery from which the patient has not yet recovered.\n* Patients with sub-acute bowel obstruction.\n* Organ transplant patients.\n* At high medical risk because of non-malignant systemic disease including active uncontrolled infection.\n* Known to be serologically positive for hepatitis B, hepatitis C or human immunodeficiency virus (HIV).\n* Patients with history of QT prolongation, clinically significant VT, VF, heart block, MI within 1 year, CHF NYHA Class III or IV, unstable angina, angina within 6 months, or other evidence of clinically significant coronary artery disease\u002F\n* Is a participant or plans to participate in another interventional clinical trial, whilst taking part in this Phase I\u002FIb study of Idetrexed and Olaparib. Participation in an observational trial would be acceptable.\n* Inability to tolerate Olaparib.\n* Any other condition which in the Investigator's opinion would not make the patient a good candidate for the clinical trial.\n* Confirmed, current COVID-19 infection.",{"count":340,"type":22},33,[60],"Two drugs called Idetrexed and olaparib are being evaluated. Idetrexed is a type of drug called an \"aFR-targeted thymidylate synthase inhibitor\". Idetrexed has been designed to selectively target cancer cells that have a protein called folate receptor on the surface of cancer cells. Thymidylate synthase is key to cancer cells for creating new DNA when they multiply. Blocking the action of thymidylate synthase with a drug like Idetrexed may therefore stop cancers from growing by damaging DNA in cancer cells. Olaparib is a type of drug called a \"PARP inhibitor\". It prevents cells repairing DNA damage. This leads to cells dying. Combining Idetrexed and olaparib should increase the number of cancer cells dying, especially those cells that have a lot of folate receptors. Cancer cells with a high number of folate receptors should be targeted more than normal healthy cells.",[344],"High Grade Serous Ovarian Cancer",[30,346,347],"idetrexed","olaparib","2025-08-12",{"date":350,"type":39},"2025-08-13",{"date":352,"type":22},"2025-08",{"date":354,"type":22},"2029-12",{"name":45,"class":46},{"id":357,"slug":358,"hasResults":12,"nctId":359,"briefTitle":360,"officialTitle":360,"acronym":361,"eligibilityCriteria":362,"healthyVolunteers":12,"sex":104,"minAge":19,"maxAge":4,"enrollmentInfo":363,"targetDuration":4,"studyType":23,"phases":365,"briefSummary":366,"conditions":367,"keywords":371,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":379,"lastUpdatePostDateStruct":380,"startDateStruct":382,"completionDateStruct":384,"leadSponsor":386,"locationsCount":387},"100342612","phase-2-phoenix-ddranti-pd-l1-trial-a-pre-surgical-window-of-opportunity-and-post-surgical-adjuvant-biomarker-study-of-dna-damage-response-inhibition-with-or-without-anti-pd-l1-immunotherapy-in-patients-with-neoadjuvant-treatment-resistant-residual-triple-negative-breast-cancer-100342612","NCT03740893","PHOENIX DDR\u002FAnti-PD-L1 Trial: A Pre-surgical Window of Opportunity and Post-surgical Adjuvant Biomarker Study of DNA Damage Response Inhibition With or Without Anti-PD-L1 Immunotherapy in Patients With Neoadjuvant Treatment Resistant Residual Triple Negative Breast Cancer","PHOENIX","Inclusion Criteria for Trial Registration:\n\n1. Signed Informed Consent Form (ICF) for Trial Registration;\n2. Aged ≥18 years old;\n3. Histologically confirmed invasive triple negative breast cancer (TNBC). TNBC defined as ER negative, PgR negative (ER and PgR negative as defined by Allred score 0\u002F8, 1\u002F8 or 2\u002F8 or stain in \\\u003C1% of cancer cells) or PgR unavailable, and HER2 negative (immunohistochemistry 0\u002F1+ or negative in situ hybridization) as determined by local laboratory and recorded in the patients notes;\n4. Planned definitive surgical treatment after at least 6 cycles of neoadjuvant chemotherapy (NACT) Patients currently receiving SOC pembrolizumab, or having previously received SOC pembrolizumab but subsequently discontinued treatment, in combination with NACT are eligible for Trial Registration;\n5. Radiographically measurable tumour mass assessable for new distinct radio-opaque marker insertion and repeated biopsies on the NACT mid-assessment standard of care imaging modality;\n6. Eastern Oncology Cooperative Group (ECOG) performance status 0-1;\n7. Considered fit enough to have breast cancer surgery with curative intent;\n8. Considered fit to complete at least 2 weeks of pre-operative trial treatment in the WOP;\n9. Patients must be suitable for a mandatory pre-treatment baseline biopsy performed Day -1 or 1 of the window of opportunity (WOP) and a post-treatment biopsy performed on Day 14 of the WOP. Registered patients who are approached for Trial Entry will be required to consent to the pre- and post- WOP treatment biopsy. If it is deemed unsafe to proceed with biopsy upon Trial Entry the patient will not be eligible for participation in the trial.\n10. Patients with clinical stage II or III disease or clinical suspicion of metastatic disease must have staging studies to exclude metastatic disease if this is standard of care, and staging methods should be used as per standard of care (axillary lymph nodes or internal mammary node involvement will not be regarded as evidence of metastatic disease);\n11. Patients with previous invasive cancers (including breast cancer) are eligible if the treatment was completed \\>5 years prior to Trial Registration, and there is no evidence of recurrent disease;\n12. Absence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the trial protocol and follow-up schedule; those conditions should be discussed with the patient before Trial Registration;\n13. Patients must be a) surgically sterile (i.e. if female have undergone a hysterectomy, bilateral salpingectomy or bilateral oophorectomy; if male have undergone a bilateral orchidectomy); b) have a sterilised sole partner; or c) be post-menopausal; or d) must agree to practice total\u002Ftrue abstinence; or e) use a condom and one highly effective form of contraception in combination during the period of trial treatment and be willing to do so for a period of at least 6 months following the end of trial treatment. Please refer to Section 5.4 Lifestyle Guidance for the definition of total\u002Ftrue abstinence and a list of the permitted highly effective forms of contraception.\n\nPost-menopausal is defined by at least one of the following criteria:\n\n1. Amenorrhoeic for 1 year or more following cessation of exogenous hormonal treatments\n2. Luteinizing hormone (LH) and follicle stimulating hormone (FSH) levels in the post-menopausal range for the institution for women \\\u003C 50 years of age not using hormonal contraception or hormonal replacement therapy. Please note: in absence of amenorrhea for 1 year, a single LH and\u002For FSH measurement is insufficient.\n3. Radiation-induced oophorectomy with last menses \\>1 year ago\n4. Chemotherapy-induced menopause with \\>1 year interval since last menses\n5. Surgical sterilisation (hysterectomy, bilateral salpingectomy or bilateral oophorectomy)\n\nExclusion Criteria for Trial Registration:\n\n1. Definitive evidence of metastatic disease (axillary lymph nodes or internal mammary node involvement will not be regarded as evidence of metastatic disease) ;\n2. Patients with bilateral tumours.\n3. History of another primary malignancy within the last 5 years prior to Trial Registration, except for:\n\n   1. Adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease;\n   2. Adequately treated carcinoma in situ without evidence of disease;\n4. Patients with myelodysplastic syndrome (MDS)\u002Facute myeloid leukaemia (AML) or with features suggestive of MDS\u002FAML;\n5. Severe concurrent disease, infection or co-morbidity that, in the judgment of the local Investigator, would make the patient inappropriate for Trial Registration;\n6. Resting ECG indicating uncontrolled, potentially irreversible cardiac conditions, as judged by the investigator (e.g., unstable ischemia, uncontrolled symptomatic arrhythmia, congestive heart failure, QTcF prolongation \\>470 msec, electrolyte disturbances, etc.), or patients with congenital long QT syndrome;\n7. Patients unable to swallow orally administered medication;\n8. Patients receiving therapeutic anti-coagulation treatment (including warfarin and novel oral anti-coagulants).\n9. Patients with gastrointestinal disorder affecting absorption (e.g. gastrectomy, active peptic ulcer disease within last 3 months);\n10. History of seizure or any condition that may predispose to seizure.\n11. Other non-malignant systemic disease that would preclude trial treatment or would prevent required follow-up;\n12. Pregnant or breast-feeding;\n13. Prior exposure to PARP inhibitor, including olaparib, anti-PD-1 or anti-PDL1 immunotherapy (including durvalumab) except for pembrolizumab if received as standard of care in combination with neoadjuvant chemotherapy;\n14. Any other disease(s), psychiatric condition, metabolic dysfunction, or findings from a physical examination or clinical laboratory test result that in the investigators opinion would cause reasonable suspicion of a disease or condition, that contraindicates the use of trial treatment, that may increase the risk associated with trial participation, that may affect the interpretation of the results, or that would make this trial inappropriate for the patient;\n15. Patients with a known hypersensitivity to pembrolizumab, durvalumab or olaparib or any excipients of the products;\n16. Previous allogenic bone marrow transplant or double umbilical cord blood transplantation (dUCBT);\n17. Active infection including tuberculosis (TB) (clinical evaluation that includes clinical history, physical examination and radiographic findings, and TB testing in line with local practice), hepatitis B (HBV; known positive HBV surface antigen (HBsAg) result), hepatitis C (HCV), or human immunodeficiency virus (HIV; positive HIV 1\u002F2 antibodies). Patients with a past or resolved HBV infection (defined as the presence of hepatitis B core antibody \\[anti-HBc\\] and absence of HBsAg) are eligible. Patients positive for HCV antibody are eligible only if polymerase chain reaction is negative for HCV RNA;\n\nInclusion Criteria for Trial Entry:\n\n1. Signed Informed Consent Form (ICF) for Trial Entry;\n2. Residual disease is confirmed as at least one viable disease focus ≥1cm on trial-specific imaging performed at least 1 week following day 1 of the final cycle of NACT.\n3. Provision of acceptable archival diagnostic tumour tissue sample prior to Trial Entry as defined in the Investigator Laboratory Manual.\n4. Recovery from all acute adverse events of prior NACT or pembrolizumab to baseline or NCI CTCAE Grade ≤1, except for alopecia. Patients with irreversible toxicity not reasonably expected to be exacerbated by trial treatment may be included only after consultation with the CI or Coordinating Investigator.\n5. Patients must have adequate haematological, renal and hepatic function as defined by:\n\n   * Haemoglobin (Hb) ≥ 10 g\u002FdL (≥ 100 g\u002FL) with no blood transfusion in the past 28 days\n   * Absolute neutrophil count (ANC) ≥ 1500\u002Fmm3 (≥ 1.5 x 109\u002FL)\n   * Platelet count ≥100,000\u002Fmm3 (≥ 100 x 109\u002FL)\n   * Total bilirubin ≤ 1.5 x institutional upper limit of normal (ULN)\n   * Aspartate aminotransferase (AST) (Serum Glutamic Oxaloacetic Transaminase (SGOT)) \u002F Alanine aminotransferase (ALT) (Serum Glutamic Pyruvate Transaminase (SGPT)) ≤ 2.5 x institutional ULN\n   * Calculated creatinine clearance ≥51 mL\u002Fmin using the Cockcroft-Gault equation (please refer to Appendix 4) or based on a 24 hour urine test or another validated test as per local practice\n6. Women of childbearing potential must have a confirmed menstrual period and a negative urinary or serum pregnancy test prior to Trial Entry. This should be repeated as applicable to ensure a negative pregnancy test is performed on the day of planned trial treatment.\n7. Confirmation that all Trial Registration inclusion criteria listed in Section 5.3.1 remain satisfied.\n\nExclusion Criteria for Trial Entry:\n\n1. Patients considered a poor medical risk due to a serious, uncontrolled medical disorder, non-malignant systemic disease or active, uncontrolled infection. Examples include, but are not limited to, uncontrolled ventricular arrhythmia, recent (within 3 months) myocardial infarction, uncontrolled major seizure disorder, unstable spinal cord compression, superior vena cava syndrome, extensive interstitial bilateral lung disease on High Resolution Computed Tomography (HRCT) scan or any psychiatric disorder that prohibits obtaining informed consent.\n2. Major surgery (excluding minor procedures, e.g. placement of vascular access) within 2 weeks prior to Trial Entry. Patients must have recovered from any effects of any major surgery prior to commencing trial treatment.\n3. Use of any investigational agent within 30 days prior to commencing trial treatment.\n4. Concomitant use of known strong CYP3A inhibitors (e.g. itraconazole, telithromycin, clarithromycin, protease inhibitors boosted with ritonavir or cobicistat, indinavir, saquinavir, nelfinavir, boceprevir, telaprevir) or moderate CYP3A inhibitors (e.g. ciprofloxacin, erythromycin, diltiazem, fluconazole, verapamil). The required washout period prior to commencing trial treatment is 5 weeks;\n5. Concomitant use of known strong (e.g. phenobarbital, enzalutamide, phenytoin, rifampicin, rifabutin, rifapentine, carbamazepine, nevirapine and St John's Wort) or moderate (e.g. bosentan, efavirenz, modafinil) CYP3A inducers. The required washout period prior to commencing trial treatment is 5 weeks;\n6. Whole blood infusion within 28 days prior to trial entry (packed red blood cells and platelet transfusions are acceptable).\n7. Receipt of live attenuated vaccine within 30 days prior to commencing trial treatment.\n8. Confirmation that none of the Trial Registration exclusion criteria listed in Section 5.3.2 are met.",{"count":364,"type":22},119,[25],"PHOENIX is a window of opportunity (WOP), open-label, multi-centre, phase IIa trial comprising multiple non-comparative treatment cohorts with patient allocation via minimisation (cohorts A-D) or allocation according to HRD and germline BRCA1\u002F2 mutation status (cohorts E-G). The trial consists of two parts: a post-neoadjuvant treatment preoperative WOP component (PART 1); and a post-operative component (PART 2).\n\nCohorts A-D: To assess whether short exposure to a DDR inhibitor or anti-PD-L1 immunotherapy in a preoperative WOP in patients with post-NACT high risk residual disease, generates a signal of anti-tumour biological activity within residual disease tissue.\n\nCohort E: To assess whether short exposure to a DDR inhibitor with or without anti-PD-1 immunotherapy in a preoperative WOP in patients with non-HRD associated TNBC and post-neoadjuvant treatment high risk residual disease, generates a signal of anti-tumour biological activity within residual disease tissue.\n\nCohorts F \\& G: To assess whether short exposure to the DDR inhibitor olaparib with or without anti-PD-1 immunotherapy in a preoperative WOP in patients with HRD associated TNBC and post-neoadjuvant treatment high risk residual disease, generates a signal of anti-tumour biological activity within residual disease tissue.",[368,369,370],"Breast Neoplasm","Triple Negative Breast Cancer (TNBC)","HRD",[372,373,374,375,376,377,378],"AZD6738","Olaparib","Durvalumab","Window of opportunity","Triple negative breast cancer","Breast cancer","Homologous Repair Deficiency (HRD)","2025-08-05",{"date":381,"type":39},"2025-08-11",{"date":383,"type":39},"2019-10-15",{"date":385,"type":22},"2029-06",{"name":45,"class":46},6,{"id":389,"slug":390,"hasResults":12,"nctId":391,"briefTitle":392,"officialTitle":392,"acronym":393,"eligibilityCriteria":394,"healthyVolunteers":145,"sex":104,"minAge":19,"maxAge":4,"enrollmentInfo":395,"targetDuration":397,"studyType":85,"phases":4,"briefSummary":398,"conditions":399,"keywords":402,"overallStatus":89,"whyStopped":4,"lastUpdateSubmitDate":405,"lastUpdatePostDateStruct":406,"startDateStruct":408,"completionDateStruct":410,"leadSponsor":412,"locationsCount":4},"100600540","the-evaluation-of-sources-of-vibration-for-vibrational-shear-wave-elastography-100600540","NCT07098819","The eValuation of Sources of vIBRAtioN for Vibrational Shear Wave elasTography","VIBRANT","Inclusion Criteria:\n\n* Healthy adult volunteers\n\nExclusion Criteria:\n\n* Healthy volunteers who do not consider themselves to currently have normal neck mobility and feel able to lie supine with their neck supported for up to 90 minutes.\n* Volunteers who are receiving treatment for diseases of the thyroid, glands, or lymph nodes.",{"count":396,"type":22},15,"1 Day","Patients suffering with Head and Neck Cancer often must wait 3 months or more to know if their treatment has been effective, which can be very stressful. The investigators are developing an imaging tool that may be useful to help clinicians understand if patients need secondary treatment, surgery to remove lymph nodes in the neck, sooner. Evidence suggests that lymph nodes containing cancer are stiffer than normal lymph nodes.\n\nThe investigator's tool, vibrational shear wave elastography, measures the stiffness of tissue using shear waves. Gentle vibrations, like those of a mobile phone, applied to the skin surface can create shear waves in the body. The investigators use ultrasound imaging and an algorithm the investigators have developed to measure shear wave speed which is related to tissue stiffness. The algorithm is applied to ultrasound images using software we have written.\n\nTo help develop the software the investigators wish to explore different ways of creating shear waves in the neck and see how well the investigators can detect shear waves as they pass through tissues such as muscle, the thyroid and other glands in the neck. The investigators will recruit healthy volunteers to participate in this study. The investigators will use external vibrational sources gently placed against the neck in different positions to understand what the best approach to achieve the best measurement of tissue stiffness is. The investigators will also ask healthy volunteers to generate vibrations themselves using their vocal cords, a process called vocal fremitus. Participants will be asked utter 'aaa' sounds at different pitches, and the investigators will image the shear wave generated by the vibrating vocal cords. The investigators will also ask volunteers how comfortable they found the external vibrations and how easy or difficult they found it to utter and hold the sounds. This study is an exploratory benchmarking study of the software that will help the investigators develop our technique further, and design and build optimal equipment before testing it in patients.",[400,401],"Head and Neck Cancer (H&Amp;Amp;N)","Lymph Nodes",[403,404],"vibrational shear wave elastography","ultrasound imaging","2025-07-29",{"date":407,"type":39},"2025-08-01",{"date":409,"type":22},"2025-09-01",{"date":411,"type":22},"2026-07-30",{"name":45,"class":46},{"id":414,"slug":415,"hasResults":12,"nctId":416,"briefTitle":417,"officialTitle":417,"acronym":418,"eligibilityCriteria":419,"healthyVolunteers":145,"sex":56,"minAge":146,"maxAge":420,"enrollmentInfo":421,"targetDuration":4,"studyType":85,"phases":4,"briefSummary":423,"conditions":424,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":428,"lastUpdatePostDateStruct":429,"startDateStruct":431,"completionDateStruct":433,"leadSponsor":435,"locationsCount":209},"100250829","the-profile-study-germline-genetic-profiling-correlation-with-targeted-prostate-cancer-screening-and-treatment-100250829","NCT02543905","The PROFILE Study: Germline Genetic Profiling: Correlation With Targeted Prostate Cancer Screening and Treatment","PROFILE","Inclusion Criteria:\n\nEither:\n\n1. Men of any ethnicity with a positive family history of PrCa defined as:\n\n   * Men with a first degree relative (or second degree if through female line) with histologically or death certificate proven PrCa diagnosed at \\\u003C70 years\n   * Men with two relatives on the same side of the family with histologically or death certificate proven PrCa where at least one is diagnosed at \\\u003C70 years\n   * Men with three relatives on the same side of the family with histologically or death certificate proven PrCa diagnosed at any age\n\n   Or\n2. Men of black African or black African-Caribbean ancestry defined as:\n\n   Both parents and all 4 grandparents being of either black African or black African-Caribbean ancestry.\n\n   Or\n3. Men of any ethnicity with a genetic predisposition to having prostate cancer e.g., being known to have inherited a gene mutation that increases risk of prostate cancer (e.g. BRCA1, BRCA2, ATM, PALB2, MLH1, MSH2, MSH6, CHEK2 and other DNA repair gene mutations as listed in the study protocol); and\u002For being known to have a high polygenic risk score (PRS) (defined as being in the top tenth percentile prior to enrolment).\n\n   * Age 40- 69 years\n   * WHO performance status 0-2\n   * Absence of any psychological, familial, sociological or geographical situation potentially hampering compliance with the study protocol and follow up schedule.\n\nExclusion Criteria:\n\n* Previous cancer with a life expectancy of less than five years.\n* Previous PrCa\n* Negative biopsy within one year before recruitment\n* Co-morbidities making prostate biopsy risk unacceptable (anticoagulants or antiplatelet medication including Warfarin, Clopidogrel, Apixaban, Dabigatran or other NOAC (Novel Oral Anti-Coagulant); poorly controlled diabetes, cardiovascular\u002Frespiratory disease, immunosuppressive medication or splenectomy)\n* Men with body mass index (BMI) 40 and above.\n* Men with BMI 35 and above plus other co-morbidities.\n* Contraindications to having an MRI (non-MRI compliant pacemakers, aneurysm clips, metallic cardiac valve\u002Fstent, Ventriculo-Peritoneal (VP) shunt, cochlear implant, neurotransmitter, metallic foreign bodies in eye(s), other metalwork, claustrophobia)\n* Any significant psychological conditions that may be worsened or exacerbated by participation in the study","69 Years",{"count":422,"type":22},1600,"Prostate cancer is now the most common cancer in men in the Western world. In the United Kingdom (UK), there were over 52,000 new cases diagnosed in 2016-2018 and a lifetime risk of 1 in 8. Prostate cancer (PrCa) can run in some families and research studies have identified several genetic changes in Caucasian populations that are thought to increase the risk of developing prostate cancer. Other studies have shown that men from certain ethnic groups also have a higher risk of prostate cancer, and this includes men of black African or black African-Caribbean ancestry. This study aims to look at men with a higher risk of prostate cancer based on their ethnicity, family history and\u002For genetic predisposition to see whether any of these genetic changes are present in their DNA (genetic material) and whether this could be a helpful screening tool in prostate cancer screening programmes. It is thought that many genetic changes are involved in the development of prostate cancer and research is being carried out worldwide to identify these genetic changes. Some of these changes may cause a very slight increase in prostate cancer risk while others may cause a much larger increase in risk of developing prostate cancer. The investigators will invite (i) men of any ethnicity with a family history of prostate cancer; (ii) men of black African or black African-Caribbean ancestry; and (iii) men of any ethnicity with a known genetic predisposition to having prostate cancer (e.g., being known to have inherited a gene mutation that increases risk of prostate and\u002For being known to be in the top tenth percentile of the polygenic risk score (high PRS score prior to enrolment) for targeted prostate screening (Prostate Specific Antigen (PSA) testing, MRI and a biopsy of the prostate gland) and genetic profiling. The outcome of these prostate cancer screening investigations will be compared with the genetic profiles of those taking part in the study in order to look for certain genetic changes in the gene code that are thought to increase prostate cancer risk. This research will help us to determine what the role of such genetic profiling is in a prostate cancer screening programme and if it helps identify men at high prostate cancer risk.",[88,425,426,427],"Prostate Biopsy","Genetic Counselling","Genetic Markers","2025-07-24",{"date":430,"type":39},"2025-07-25",{"date":432,"type":39},"2015-03-09",{"date":434,"type":22},"2026-12-31",{"name":45,"class":46},{"id":437,"slug":438,"hasResults":12,"nctId":439,"briefTitle":440,"officialTitle":441,"acronym":442,"eligibilityCriteria":443,"healthyVolunteers":145,"sex":104,"minAge":19,"maxAge":4,"enrollmentInfo":444,"targetDuration":4,"studyType":85,"phases":4,"briefSummary":445,"conditions":446,"keywords":448,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":453,"lastUpdatePostDateStruct":454,"startDateStruct":456,"completionDateStruct":458,"leadSponsor":460,"locationsCount":209},"100591065","the-coherence-of-scatter-identification-and-exclusion-algorithm-study-100591065","NCT06975579","The COherence of Scatter Identification and Exclusion Algorithm Study","A Study of the COherence of Scatter Identification and Exclusion Algorithm: The COSIE Study","COSIE","Inclusion Criteria:\n\nHealthy Volunteers:\n\n* Healthy male or female adults (18 or above).\n* Volunteers must consider themselves fit and healthy.\n* RMH and\u002For ICR employees.\n\nPatients:\n\n* Patients undergoing liver MRI as part of clinical standard of care with evidence of steatosis on preceding MRI.\n* Aged 18 and above.\n\nExclusion Criteria:\n\nHealthy Volunteers:\n\n* Volunteers that are under investigation or planning to consult their GP to seek investigation for an undiagnosed condition, particularly regarding pelvic or abdominal disease or injury.\n* Healthy volunteers who do not have an NHS number or who are not registered with a GP will be excluded.\n\nPatients:\n\n• Severe liver fibrosis (fibrosis stage F4) or severe cirrhosis.",{"count":396,"type":22},"Non-alcoholic fatty liver disease (NAFLD) is currently the most common liver condition worldwide; approximately 55% of the world population will have NAFLD by 2040. NAFLD is an unwanted side effect of common cancer therapies, such as chemotherapy. Ultrasound can detect NAFLD via measurement of the backscatter coefficient (BSC). It is an attractive technique because of its low cost and availability, potentially enabling earlier detection of NAFLD in a larger population through screening. This approach has shown promise in detecting NAFLD but is limited by variability in measurement due to several factors. Measurement of the BSC requires assumptions about the nature of the tissue being measured; if these assumptions are incorrect, they can lead to inaccurate BSC measurements. To improve accuracy, an algorithm (COSIE) was developed to quantify the suitability of tissue for BSC analysis. The investigators believe COSIE will enable more reliable BSC measurements by selecting the optimal regions of tissue to measure. By measuring the BSC in the livers of healthy volunteers and patients with evidence of fatty liver, the algorithm can be evaluated against liver fat percentage values obtained from MRI imaging. This study will assess whether applying the COSIE algorithm enhances the reliability of BSC measurements, bringing them closer in quality to MRI imaging.",[447],"Steatohepatitis, Nonalcoholic",[449,450,451,452],"Liver ultrasound","backscatter coefficient","Non-alcoholic fatty liver disease","steatosis","2025-05-15",{"date":455,"type":39},"2025-05-16",{"date":457,"type":39},"2024-08-27",{"date":459,"type":22},"2025-06-30",{"name":45,"class":46},{"id":462,"slug":463,"hasResults":12,"nctId":464,"briefTitle":465,"officialTitle":466,"acronym":4,"eligibilityCriteria":467,"healthyVolunteers":145,"sex":104,"minAge":468,"maxAge":4,"enrollmentInfo":469,"targetDuration":4,"studyType":85,"phases":4,"briefSummary":471,"conditions":472,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":474,"lastUpdatePostDateStruct":475,"startDateStruct":477,"completionDateStruct":479,"leadSponsor":480,"locationsCount":209},"100283764","primer-development-of-daily-online-magnetic-resonance-imaging-for-magnetic-resonance-image-guided-radiotherapy-100283764","NCT02973828","PRIMER: Development of Daily Online Magnetic Resonance Imaging for Magnetic Resonance Image Guided Radiotherapy","Development of Daily Online Magnetic Resonance Imaging for Magnetic Resonance Image Guided Radiotherapy (MRIgRT)","Inclusion Criteria:\n\n* All volunteers must undergo and satisfy MRI safety screening\n* Non-patient volunteers must have no known (or suspected) significant medical condition and be 18 years of age\n* Patient volunteers must have histologically confirmed invasive carcinoma of the tumour\u002Ftarget sites listed in this protocol and be under the care of a Clinical Oncologist at the Royal Marsden NHS Foundation Trust or The Christie NHS Foundation Trust and patients be planned to receive radiotherapy to target site to be imaged\n* All volunteers must be willing and able to provide informed consent\u002Fassent for the study\n* Paediatric patient volunteers between the ages of 3 and 18 years, will have consent provided by his or her legal guardian who is 18 years of age\n* Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0-1\n\nExclusion Criteria:\n\nAny conditions that would be a contra-indication to MRI including:\n\n* Failure to satisfy the MRI safety screening\n* Implanted pacemakers and\u002For pacing wires\n* Cochlear implants\n* Programmable hydrocephalus shunts\n* Implanted neurostimulation systems\n* Implanted drug infusion pumps\n* Ferromagnetic implants And additional conditions that may place volunteers at increased risk from MRI procedures including:\n* Known susceptibility to seizures or migraines\n* Fever, reduced thermal regulatory capabilities or increased sensitivity to raised body temperature (for example pregnant women)","3 Years",{"count":470,"type":22},173,"In radiotherapy high-tech scans with x-rays (CT scans) are taken before and during treatment to locate the tumour and ensure the radiation is hitting the target.\n\nThese x-rays expose patients to additional radiation and the quality of these scans is often poor which makes it difficult to distinguish tumour from normal tissue and there may be uncertainty in the tumour position due to movement or shrinkage. To allow for these uncertainties a large margin around the tumour is also treated, but this means that large volumes of normal tissue also receive significant doses of radiation, which can result in early and late toxicity.\n\nMRI (magnetic resonance imaging) is better than CT scanning at being able to tell the difference between tumour and normal tissues and does not expose patients to additional radiation. A new machine called an MR Linac (or magnetic resonance imaging-guided linear accelerator) integrates high quality MRI with a state-of-the-art radiotherapy machine and the Institute of Cancer Research (ICR)\u002FThe Royal Marsden Hospital (RMH) are currently installation a prototype, which will be one of the first in the world. This revolutionary technology has the potential to change the way radiotherapy is delivered. We hope the improved precision and accuracy in hitting the target will mean reductions in margins around tumours and that this will lead to higher cure rates with significantly fewer side effects. Studies are required to simulate treatment on the MR Linac before it can be used in routine clinical practice and to conduct these studies, we need to obtain MRI scans on volunteers and patients who are currently undergoing treatment. This study will involve imaging with MRI in healthy volunteers as well as in patient volunteers before and during their standard course of radiotherapy to allow us to develop MRI sequences derived on the MR Linac for MR Linac-based research focusing on clinical application and establishment into a MR-CT and MR only workflow, treatment adaptation and quality assurance.",[473],"Adenocarcinoma","2025-05-01",{"date":476,"type":39},"2025-05-06",{"date":478,"type":39},"2017-10-17",{"date":434,"type":22},{"name":45,"class":46},{"id":482,"slug":483,"hasResults":12,"nctId":484,"briefTitle":485,"officialTitle":486,"acronym":487,"eligibilityCriteria":488,"healthyVolunteers":12,"sex":104,"minAge":193,"maxAge":4,"enrollmentInfo":489,"targetDuration":4,"studyType":23,"phases":491,"briefSummary":492,"conditions":493,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":494,"lastUpdatePostDateStruct":495,"startDateStruct":497,"completionDateStruct":499,"leadSponsor":501,"locationsCount":305},"100564673","phase-1-5g-emerald-amivantamab-in-malignant-brain-tumours-100564673","NCT06632236","5G-EMERALD: Amivantamab in Malignant Brain Tumours","5G-EMERALD: A Phase 1 Trial of Amivantamab in High Grade Malignant Brain Tumours Within the 5G Platform","5G-EMERALD","Inclusion Criteria for Phase 1b:\n\n1. Patients with histologically confirmed advanced WHO Stage IV glioblastoma (per fourth edition 2016). Per the new 2021 fifth edition of WHO Classification of Tumours of the Central Nervous System, this will include:\n\n   * Glioblastoma, IDH-wildtype Grade 4\n   * Astrocytoma, IDH-mutant, Grade 4 (lower Grade 2\u002F3 are not included)\n   * Diffuse hemispheric glioma, H3 G34 mutant Grade 4\n2. Patients for Phase 1 will need to have consented to the Minderoo Precision Brain Tumour Programme and have available whole genome, and transcriptome data available.\n3. Patients for the relapsed cohorts will be eligible at first relapse following completion of optimal surgery, and Stupp based adjuvant chemo-radiotherapy (or equivalent). They will need to have measurable disease per Response Assessment in Neuro-Oncology (RANO) or evaluable disease.\n4. Patients for the front line minimal residual disease (MRD) cohort will be eligible following completion of optimal surgery and Stupp based adjuvant chemoradiotherapy as long as they meet all other inclusion\u002Fexclusion criteria.\n5. 16 years or over.\n6. Life expectancy of at least 12 weeks.\n7. World Health Organisation (WHO) performance status of 0-1.\n8. Neurologically stable (e.g., without a progression of neurological symptoms or requiring escalating doses of systemic steroid therapy within the last week).\n9. Written (signed or dated) informed consent and be capable of co-operating with treatment and follow up.\n10. Haematological and biochemical indices within the ranges shown below. These measurements must be performed within one week prior to the first dose of either IMP:\n\n    Haemoglobin (Hb): ≥ 10.0 g\u002FdL Absolute neutrophil count: ≥ 1.5 x 10\\^9\u002FL Platelet count: ≥ 75 x 10\\^9\u002FL Coagulation: INR \\\u003C1.5 and APTT \\\u003C1.5x if not anticoagulated INR stable \\> 7 days within intended therapeutic range if anticoagulated Bilirubin: ≤ 1.5 x ULN; subjects with Gilbert's syndrome can enrol if conjugated bilirubin is within normal limits.\n\n    Alanine aminotransferase (ALT) and aspartate aminotransferase (AST): \\\u003C 3 x ULN Albumin: ≥ 28 g\u002FL Creatinine: \\\u003C1.5 x ULN and creatinine clearance \\> 45 ml\u002Fmin as measured or calculated based on Cockcroft-Gault formula Sodium: ≥ 130 mmol\u002FL Potassium, Calcium, Magnesium, phosphate: Within institution normal ranges (replacement is permitted) Urinary protein: \\\u003C 1+ on dipstick\n11. Female patients with reproductive potential must have a negative serum, or urine, pregnancy test at screening and within 72 hours of the first dose of study treatment and must agree to further serum or urine pregnancy tests during the study.\n12. A participant must be either of the following: a. not of childbearing potential, b. of child-bearing potential and practicing true abstinence during the entire period of the study, including up to 6 months after the last dose of the study treatment is given, or c. of childbearing potential and practicing 2 methods of contraception, including 1 highly effective user independent method and a second method, to avoid impregnating a partner or becoming pregnant, respectively. A participant must agree to continue contraception throughout the study, and for at least 6 months after the last dose of study treatment.\n\n    Please, refer to section 4.1 of CTFG guidance \"Recommendations related to contraception and pregnancy testing in clinical trials\" and to section 9.6 of the Master Protocol for further details.\n\n    Note: If the childbearing potential changes after start of the study (eg, participant of childbearing potential who is not heterosexually active becomes active, premenarchal participant experiences menarche) the participant must begin birth control, as described above.\n13. A participant must agree not to donate eggs (ova, oocytes) for the purposes of assisted reproduction during the study and for 6 months after receiving the last dose of study treatment.\n14. A participant must wear a condom when engaging in any activity that allows for passage of ejaculate to another person during the study and for 6 months after receiving the last dose of study treatment. A participant who is sexually active with a partner of childbearing potential must agree to use a condom with spermicidal foam\u002Fgel\u002Ffilm\u002Fcream\u002Fsuppository and their partner must also be practicing a highly effective method of contraception (ie, established use of oral, injected, or implanted hormonal methods of contraception; placement of an intrauterine device \\[IUD\\] or intrauterine hormone-releasing system \\[IUS\\]). If the participant is vasectomized, they must still use a condom (with or without spermicide) for prevention of passage of exposure through ejaculation, but their partner is not required to use contraception.\n15. A participant must agree not to donate sperm for the purpose of reproduction during the study and for a minimum of 6 months after receiving the last dose of study treatment.\n16. A participant must be willing and able to adhere to the lifestyle restrictions specified in this protocol.\n\nExclusion Criteria for Phase 1b:\n\n1. Receipt of treatment before the first dose of study drug (Cycle 1 Day 1) within an interval shorter than the following, as applicable:\n\n   * Cytotoxic chemotherapy during the prior 2 weeks or 6 weeks for nitrosoureas\n   * Bevacizumab during the prior 6 weeks\n   * Five half-lives of any small molecule investigational or licensed medicinal product.\n2. Prior immune checkpoint inhibitor therapy or vaccine therapy is not permitted. Prior EGFR-targeting therapy is not permitted. Prior use of any other immune-modulatory investigational agent must be discussed with sponsor team and CI.\n3. Ongoing Grade 2 or greater toxicities from pre-existing conditions or from previous treatments.\n4. Patients with carcinomatous meningitis, leptomeningeal spread of tumour, spread of tumour to the brain stem or spinal cord.\n5. Has evidence of recent intratumoural or peritumoural haemorrhage on baseline MRI. Patients with radiological findings that are stable on at least 2 consecutive MRI scans at least 3 weeks apart will be eligible.\n6. History of clinically relevant bleeding disorders, including significant gastrointestinal (GI) bleeding within last 6 months.\n7. Participant has active cardiovascular disease including, but not limited to:\n\n   * A medical history of deep venous thrombosis or pulmonary embolism within 1 month prior to first dose of study drug or any of the following within 6 months prior to first dose of study drug: myocardial infarction, unstable angina, stroke, transient ischemic attack, coronary\u002Fperipheral artery bypass graft, or any acute coronary syndrome. Clinically non-significant thrombosis such as non-obstructive catheter-associated thrombus, incidental or asymptomatic pulmonary embolism, are not exclusionary. Patients on Warfarin will need to be converted onto low-molecular weight-based heparin therapy.\n   * Participant has a significant genetic predisposition to venous thromboembolic (VTE) events such as Factor V Leiden.\n   * Participant has a prior history of VTE and is not on appropriate therapeutic anticoagulation as per National Comprehensive Cancer Network (NCCN) or local guidelines.\n   * Uncontrolled (persistent) hypertension: systolic blood pressure \\> 160 mm Hg; diastolic blood pressure \\> 100 mm Hg.\n   * Congestive heart failure (CHF), defined as New York Heart Association (NYHA) class III-IV or hospitalization for CHF (any NYHA class) within 6 months of first dose of the study drug.\n   * Concurrent and clinically significant abnormalities on ECG at Screening, including a corrected QT interval (QTcF \\> 460ms).\n8. History of malabsorption syndrome or other conditions that may interfere with enteral absorption. Patients with a history of or active inflammatory bowel disease (e.g., Crohn's disease or ulcerative colitis). Patients with acute or chronic pancreatitis. History of GI perforation or fistulae.\n9. Has urine protein \\> 1g\u002F24 hours. Participants with \\> 1+ on urine dipstick testing will undergo 24-hour urine collection for quantitative assessment of proteinuria.\n10. Has significant lung disease including pneumonitis, interstitial lung disease (including drug-induced or radiation ILD\u002Fpneumonitis), idiopathic pulmonary fibrosis, cystic fibrosis, active tuberculosis, or history of opportunistic infections (including PCP or Cytomegalovirus (CMV) pneumonia).\n11. Participant is serologically positive for hepatitis B surface antigen (HbsAg), Note: participants with a prior history of hepatitis B virus (HBV) demonstrated by positive hepatitis B core antibody are eligible if they have at Screening 1) a negative HBsAg and 2) a HBV DNA (viral load) below the lower limit of quantification, per local testing. Subjects with a positive HBsAg due to recent vaccination are eligible if HBV DNA (viral load) is below the lower limit of quantification, per local testing.\n12. Participant is serologically positive for hepatitis C antibody. Note: participants with a prior history of hepatitis C virus (HCV), who have completed antiviral treatment and have subsequently documented HCV RNA below the lower limit of quantification per local testing are eligible.\n13. Participant has other clinically active infectious liver disease.\n14. Participant is positive for human immunodeficiency virus (HIV), with 1 or more of the following:\n\n    * Receiving antiretroviral therapy (ART) that may interfere with study treatment (consult sponsor for review of medication prior to enrolment).\n    * CD4 count \\\u003C 350 at screening\n    * AIDS-defining opportunistic infection within 6 months of start of screening\n    * Not agreeing to start ART and be on ART \\> 4 weeks plus having HIV viral load \\\u003C 400 copies\u002FmL at end of 4-week period (to ensure ART is tolerated and HIV controlled).\n15. Participant has an uncontrolled illness, including but not limited to:\n\n    * Uncontrolled diabetes\n    * Ongoing or active infection (includes infection requiring treatment with antimicrobial therapy \\[participants will be required to complete antibiotics 1 week prior to starting study treatment\\] or diagnosed or suspected viral infection.\n    * active bleeding diathesis\n    * Impaired oxygenation requiring continuous oxygen supplementation\n    * Psychiatric illness, social situation, or any other circumstances that would limit compliance with study requirements\n    * Any ophthalmologic condition that is clinically unstable\n16. Steroid requirement for neurological symptom control of \\> 3mg Dexamethasone per day (patients will allowed to enrol if they have been on a stable dose of steroids of equivalent or less than 3mg Dexamethasone for at least 5 days prior to Day 1 of Cycle 1).\n17. Has received a live vaccine within 30 days of planned start of study therapy. Note: inactive vaccines including COVID vaccines are allowed prior to 1 week of Day 1 of Cycle 1).\n18. Concurrent or prior malignancy other than the disease under study. The following exceptions require consultation with the Chief Investigator:\n\n    1. Non-muscle invasive bladder cancer (NMIBC) treated within the last 24 months that is considered completely cured.\n    2. Skin cancer (non-melanoma or melanoma) treated within the last 24 months that is completely cured.\n    3. Non-invasive cervical cancer treated within the last 24 months that is considered completely cured.\n19. Is a participant or plans to participate on another interventional clinical trial while taking part in this Phase 1 study. Participation in an observational trial would be acceptable.\n20. A participant has major surgery excluding placement of vascular access or tumour biopsy, or had significant traumatic injury within 4 weeks before first dose of study drug or minor surgery within 2 weeks, or will not have fully recovered from surgery, or has surgery planned during the time the participant is expected to participate in the study. Note: Participants with planned surgical procedures to be conducted under local anaesthesia may participate.\n21. A participant has palliative radiotherapy within 1 week of the firs dose of study drug,\n22. Any other condition which in the investigator's opinion would not make the patient a good candidate for the clinical trial.",{"count":490,"type":22},12,[60],"The purpose of this clinical trial is to evaluate the safety and tolerability of amivantamab and to determine the preliminary antitumour activity of amivantamab administered at the recommended Phase 2 dose (RP2D). In the Phase 1b of this study a biomarker defined arm will be opened, initially in the relapsed GMB setting, enrolling 12 patients. These patients will be treated with amivantamab monotherapy. Amivantamab will be administered intravenously (IV) weekly for the first 4 weeks, then every 2 weeks thereafter until disease progression or unacceptable toxicity. The first dose will be given as a split infusion, 350 mg IV over 4 hours on cycle 1 day 1 and 1400 mg IV over 6 hours on cycle 1 day 2. Subsequent infusions are given at a dose of 1750 mg IV over 2-5 hours in cycle 1 and between 2-3 hours from cycle 2 onwards if the first dose was well-tolerated with no significant toxicity.\n\nProgression to Phase 2 is dependent on emergent data and funding.",[199,223,224,200],"2025-04-23",{"date":496,"type":39},"2025-04-25",{"date":498,"type":39},"2024-10-09",{"date":500,"type":22},"2027-03-05",{"name":45,"class":46},{"id":503,"slug":4,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":15,"acronym":16,"eligibilityCriteria":504,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":505,"targetDuration":4,"studyType":23,"phases":506,"briefSummary":507,"conditions":508,"keywords":509,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":510,"lastUpdatePostDateStruct":511,"startDateStruct":513,"completionDateStruct":514,"leadSponsor":515,"locationsCount":516},"100515337","Inclusion Criteria:\n\n1. Patients ≥ 18 years of age.\n2. Histologically confirmed epithelial ovarian, fallopian tube or primary peritoneal cancer.\n3. Radiological disease progression whilst on, or following, any prior PARP inhibitor therapy. The PARP inhibitor is required to have been the patient's last systemic therapy.\n4. Minimum duration of 6 months PARP inhibitor therapy as first line therapy or treatment for recurrent disease.\n5. ≤3 lesions of progressive disease.\n6. Each lesion to undergo SBRT \\\u003C4 cm axial diameter, and feasible for SBRT as discussed in the SOPRANO virtual MDT (vMDT) meeting.\n7. Measurable disease by RECIST criteria v1.1, which can be accurately assessed at baseline by CT or MRI. Patients with CA125 progression in the absence of measurable disease will NOT be eligible.\n8. No contra-indication to restarting a PARP inhibitor.\n9. Patients for whom surgery for recurrent disease is not planned.\n10. Adequate baseline organ function to allow SBRT to all relevant targets as deemed by the investigator.\n11. ECOG performance status of 0 or 1.\n12. Predicted life expectancy ≥ 6 months.\n13. Women of child-bearing potential who are confirmed NOT to be pregnant. This should be evidenced by a negative urine or serum pregnancy test within 72 hours prior to start of trial treatment. Patients will be considered to be not of child-bearing potential if they are:\n\n    1. Post-menopausal -- defined as aged more than 50 years and amenorrhoeic for at least 12 months following cessation of all exogenous hormonal treatments, OR women under 50 years old who have been amenorrhoeic for at least 12 months following cessation of all exogenous hormonal treatments and have serum follicle- stimulating hormone (FSH), luteinizing hormone (LH) and plasma oestradiol levels in the post-menopausal range for the institution.\n    2. Able to provide documentation of irreversible surgical sterilisation by hysterectomy, bilateral oophorectomy or bilateral salpingectomy but not tubal ligation.\n    3. Radiation or chemotherapy-induced oophorectomy or menopause with \\> 1 year since last menses.\n14. Willingness to commit to scheduled visits, treatments plans, laboratory tests and trial procedures.\n15. Histological tissue specimen (tissue block or 8-10 unstained slides) must be available prior to commencing SBRT (specimen can be the sample at diagnosis or taken at relapse or progression). Otherwise, a biopsy must be carried out to obtain sufficient tissue for translational analyses.\n16. Able to swallow, absorb and retain oral medication.\n17. Able to provide written, informed consent.\n\nExclusion Criteria:\n\n1. Co-morbidities which would preclude the safe use of SBRT.\n2. Progressing or newly diagnosed brain metastases identified at the time of trial entry, not amenable to radical surgery or stereotactic radiosurgery. Previously treated brain metastases (i.e. palliative radiotherapy or systemic therapy) which have remained clinically and radiologically stable for ≥ 6 months are permissible.\n3. Prior radiotherapy near the oligometastatic \u002F oligoprogressive lesion precluding ablative SBRT. Suitability of lesions for ablative SBRT as part of the trial defined in Section 6.1 of this document and will be determined by the SOPRANO virtual MDT.\n4. Treatment with any other investigational medicinal product (IMP) within the 4 weeks prior to trial entry.\n5. Pregnant or lactating women.\n6. Women of childbearing age and potential who are not willing to use a highly effective contraceptive measure.\n7. Any unresolved toxicities from prior therapy should be no greater than CTCAE Grade 1 with the exception of Grade 2 alopecia or chemo-induced neuropathy at trial entry.\n8. Clinical\u002Fradiological evidence of bowel obstruction (e.g. hospitalisation) or symptoms of sub-acute bowel obstruction within 6 weeks prior to trial entry.\n9. Any other malignancy which has been active or treated within the past 3 years, with the exception of non-melanoma skin cancer. If prior treatment for another malignancy has taken place, then confirmation of ovarian\u002Ffallopian tube\u002Fperitoneal cancer progression is required e.g. biopsy, and discussion with the trial Chief Investigator and SBRT Lead\n10. Judgment by the Investigator that the patient is unsuitable to participate in the trial and\u002For the patient is unlikely to comply with trial procedures, restrictions and requirements.",{"count":21,"type":22},[25],"SOPRANO is a multi-centre, randomised phase II trial which aims to assess the impact of Stereotactic radiotherapy (SBRT) and continuing treatment with a PARP inhibitor (PARPi) for patients with oligometastatic or oligoprogressive ovarian, fallopian tube and primary peritoneal carcinoma. SOPRANO will also establish the feasibility and acceptability of delivering SBRT in this setting.",[28],[30,31,32,33,34],"2025-04-17",{"date":512,"type":39},"2025-04-22",{"date":41,"type":39},{"date":303,"type":22},{"name":45,"class":46},5,{"id":518,"slug":519,"hasResults":12,"nctId":520,"briefTitle":521,"officialTitle":521,"acronym":522,"eligibilityCriteria":523,"healthyVolunteers":12,"sex":56,"minAge":19,"maxAge":4,"enrollmentInfo":524,"targetDuration":4,"studyType":23,"phases":525,"briefSummary":527,"conditions":528,"keywords":530,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":536,"lastUpdatePostDateStruct":537,"startDateStruct":539,"completionDateStruct":541,"leadSponsor":543,"locationsCount":544},"100232591","phase-3-international-penile-advanced-cancer-trial-international-rare-cancers-initiative-study-100232591","NCT02305654","International Penile Advanced Cancer Trial (International Rare Cancers Initiative Study)","InPACT","Inclusion Criteria:\n\n1. Written informed consent\n2. Measurable disease as determined by RECIST (version 1.1) criteria;\n3. Histologically-proven squamous cell carcinoma of the penis,\n4. Stage:\n\n   * any T, N1 (i.e. a palpable mobile unilateral inguinal lymph node), M0 or;\n   * any T, N2 (i.e. palpable mobile multiple or bilateral inguinal lymph nodes), M0 or;\n   * any T, N3 (i.e. fixed inguinal nodal mass or any pelvic lymphadenopathy), M0\n5. Performance Status ECOG 0, 1 or 2.\n\nExclusion Criteria:\n\n1. Pure verrucous carcinoma of the penis,\n2. Nonsquamous malignancy of the penis,\n3. Squamous carcinoma of the urethra,\n4. Stage M1,\n5. Previous chemotherapy or chemoradiotherapy,\n6. Concurrent malignancy (other than SCC or Basal Cell Carcinoma of non-penile skin) that has required surgical or non-surgical treatment in the last 3 years.",{"count":175,"type":22},[526],"PHASE3","This is an international phase III trial, with a Bayesian design, incorporating two sequential randomisations. It efficiently examines a series of questions that routinely arise in the sequencing of treatment. The study design has evolved from lengthy international consultation that has enabled us to build consensus over which questions arise from current knowledge and practice. It will enable potential randomisation for the majority of patients with inguinal lymph node metastases and will provide data to inform future clinical decisions.\n\nInPACT-neoadjuvant patients are stratified by disease burden as assessed by radiological criteria. Treatment options are then defined according to the disease burden strata. Treatment is allocated by randomisation. Patients may be allocated to one of three initial treatments:\n\nA. standard surgery (ILND); B. neoadjuvant chemotherapy followed by standard surgery (ILND); or C. neoadjuvant chemoradiotherapy followed by standard surgery (ILND).\n\nAfter ILND, patients are defined as being at low or high risk of recurrence based on histological interpretation of the ILND specimen. Patients at high risk of relapse are eligible for InPACT-pelvis, where they are randomised to either:\n\nP. prophylactic PLND Q. no prophylactic PLND",[529],"Squamous Cell Carcinoma of the Penis, Usual Type",[531,532,533,534,535],"Penis cancer","Chemotherapy","Chemoradiotherapy","Surgery","Phase III","2025-03-27",{"date":538,"type":39},"2025-04-02",{"date":540,"type":39},"2017-05-12",{"date":542,"type":22},"2027-11-30",{"name":45,"class":46},17,{"id":546,"slug":547,"hasResults":12,"nctId":548,"briefTitle":549,"officialTitle":550,"acronym":551,"eligibilityCriteria":552,"healthyVolunteers":12,"sex":56,"minAge":19,"maxAge":4,"enrollmentInfo":553,"targetDuration":4,"studyType":23,"phases":555,"briefSummary":556,"conditions":557,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":558,"lastUpdatePostDateStruct":559,"startDateStruct":561,"completionDateStruct":563,"leadSponsor":565,"locationsCount":21},"100486357","phase-3-a-trial-of-5-fraction-prostate-sbrt-versus-5-fraction-prostate-and-pelvic-nodal-sbrt-100486357","NCT05613023","A Trial of 5 Fraction Prostate SBRT Versus 5 Fraction Prostate and Pelvic Nodal SBRT","PACE-NODES. A Phase III Randomised Trial of 5 Fraction Prostate SBRT Versus 5 Fraction Prostate and Pelvic Nodal SBRT","PACE-NODES","Inclusion Criteria:\n\n1. Aged ≥ 18 years at randomisation\n2. Histopathological confirmation of prostate adenocarcinoma with Gleason\u002FISUP grade group scoring within twelve months of randomisation (unless otherwise discussed with the CI or co-Clinical Leads)\n3. Patients planned for 12-36 months androgen deprivation therapy\n4. High risk localised prostate cancer as defined by\n\n   * Gleason 8-10 (grade groups 4 and 5) and\u002For\n   * Stage T3a\u002Fb or T4 and\u002For\n   * PSA \\> 20ng\u002Fml (or \\>10 ng\u002Fml for patients on 5-alpha reductase inhibitors)\n5. Multi-parametric MRI of the pelvis- to include at least one functional MRI sequence in addition to T2W imaging within twelve months of randomisation\n6. Radiological staging to exclude metastatic disease, prior to starting ADT, with one of the following: PSMA PET-CT, fluciclovine\u002Fcholine PET-CT, whole-body MRI, bone scan, CT of chest, abdomen and pelvis (imaging method as per local practice\u002Fstandard of care).\n7. WHO performance status 0-2\n8. Ability of research subject to give written informed consent\n\nExclusion Criteria:\n\n1. N1 or M1 disease\n2. PSA \\>50ng\u002Fml (or \\>25ng\u002Fml for patients on 5-alpha reductase inhibitors), unless PET-CT imaging has been performed to confirm N0M0 disease\n3. Previous active treatment for prostate cancer\n4. Patients where SBRT is contraindicated: prior pelvic radiotherapy, inflammatory bowel disease, significant lower urinary tract symptoms N.B. where patient has repeated imaging showing bowel in close apposition to target volumes that would make pelvic radiotherapy highly unlikely to be deliverable should be excluded.\n5. Contraindications to fiducial marker insertion, where used- including clotting disorders, or patients at high risk when stopping anticoagulation or antiplatelet medications\n6. Bilateral hip prostheses or any other implants\u002Fhardware that would introduce substantial CT artefacts and would make pelvic node planning more difficult.\n7. Patients who have had chemotherapy within 6 weeks of the start of radiotherapy.\n8. Life expectancy \\\u003C 5 years",{"count":554,"type":22},1128,[526],"This study will compare the safety and efficacy of curative radiotherapy to the prostate and lymph glands given in 5 visits to that of prostate alone radiotherapy given in 5 visits, in men with high risk localised prostate cancer.",[88],"2024-09-04",{"date":560,"type":39},"2024-09-19",{"date":562,"type":39},"2022-09-09",{"date":564,"type":22},"2030-06",{"name":45,"class":46},{"id":567,"slug":568,"hasResults":12,"nctId":569,"briefTitle":570,"officialTitle":571,"acronym":572,"eligibilityCriteria":573,"healthyVolunteers":12,"sex":56,"minAge":19,"maxAge":4,"enrollmentInfo":574,"targetDuration":4,"studyType":85,"phases":4,"briefSummary":575,"conditions":576,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":577,"lastUpdatePostDateStruct":578,"startDateStruct":580,"completionDateStruct":582,"leadSponsor":584,"locationsCount":209},"100548667","microbiome-molecular-charaterisation-100548667","NCT06423976","Microbiome Molecular Charaterisation","Collection of Clinical Material From Patients With Prostate Cancer or Undergoing Investigation for Diagnostic or Follow up Purposes for Molecular Characterisation and Microbiome Analysis","MMC","Inclusion Criteria:\n\n1. Male \\>=18 years.\n2. Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 - 2.\n3. Undergoing investigation for diagnosis, or with a proven diagnosis of prostate cancer and undergoing further investigation or clinical trial participation.\n4. Patients with tumour deemed by the designated investigator as safely suitable for fresh biopsy AND who are medically fit (according to local practice) to undergo a biopsy or surgical procedure to acquire tumour tissue.\n5. Willing and able to comply with the requirements of the sample collection including fresh tumour biopsy.\n6. The subject is capable of understanding and complying with the protocol requirements and has given written informed consent.\n7. A record of PSA levels within last 3 months.\n\nExclusion Criteria:\n\n1. The presence of any haematological disorders, including coagulation disorders, which would be a contraindication if patient were to undergo a biopsy.\n2. Any psychiatric illness\u002Fsocial situations that would limit compliance with study requirements.\n3. Presence of any concurrent condition or situation, which, in the investigator's opinion, may put the patient at significant risk, may confound the study results, or may interfere significantly with the patient's participation in the study.",{"count":149,"type":22},"Preclinical models of prostate cancer have proved to be poorly predictive of the behaviour of the disease in patients. This protocol describes the acquisition of prostate cancer tissue or cells from patients with treatment naïve\u002Fhormone-sensitive and castration-resistant prostate cancer or patients undergoing diagnostic or follow up investigations. The knowledge gained will improve the investigators' understanding of the steps leading to the development of castration resistance and identify new molecular targets for treatment.\n\nThe human microbiome has been under investigation in a range of human diseases (i.e. metabolic disease\u002Fobesity, neurological disorders, cardiovascular disease, mental disorders, autoimmune disease, asthma and allergies) and cancer. The human microbiota can have direct (e.g. via direct genotoxicity, induction of chronic inflammation, etc.) and\u002For indirect (e.g. effects on tumour effects on tumour development or progression exerted through microbial communities that exist at a site distant to the tumour) effects on the disease. Emerging data supports the influence of the gut microbiota on the efficacy of anti-cancer treatments, including immunotherapy. To date, the impact of the gut microbiome on prostate cancer therapies is virtually unexplored. Based on the evidence to date, the investigators hypothesize that the gut flora may be altered by certain treatments for advanced prostate cancer, and that the composition of the microbiome in the gastrointestinal tract may be used to predict therapeutic efficacy or therapy-related toxicities; as well as prevent treatment toxicity and\u002For enhance treatment response.\n\nFurthermore, the purpose is to investigate the association between gut flora and treatment response and related toxicities\u002Fmorbidities in advanced prostate cancer.",[88],"2024-05-23",{"date":579,"type":39},"2024-05-24",{"date":581,"type":39},"2023-10-23",{"date":583,"type":22},"2038-10",{"name":45,"class":46},{"id":586,"slug":587,"hasResults":12,"nctId":588,"briefTitle":589,"officialTitle":590,"acronym":591,"eligibilityCriteria":592,"healthyVolunteers":12,"sex":104,"minAge":19,"maxAge":4,"enrollmentInfo":593,"targetDuration":4,"studyType":85,"phases":4,"briefSummary":595,"conditions":596,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":598,"lastUpdatePostDateStruct":599,"startDateStruct":601,"completionDateStruct":603,"leadSponsor":605,"locationsCount":209},"100513664","myeloma-novel-drug-discovery-ver-12-100513664","NCT05968417","Myeloma Novel Drug Discovery Ver 1.2","Investigation of the Activity of Novel Compounds for the Treatment of Myeloma and Mechanisms of Drug Resistance to Current Therapies","DISCO","Inclusion Criteria:\n\n1. Participants who have a diagnosis, or suspected diagnosis, of myeloma or related plasma cell disorder\n2. Participants who are undergoing a peripheral blood or bone marrow aspirate sampling for diagnostic, staging or follow-up purposes, before, whilst or after receiving anti-myeloma treatment\n3. Participants aged 18 years of age or above\n4. Participants willing to consent to an additional sample being taken at the time of their peripheral blood or bone marrow aspirate sampling\n\nExclusion Criteria:\n\n1. Participants unable to provide consent\n2. Participants with known active infectious diseases (e.g. HIV, Hepatitis B\u002FC, COVID) that pose a risk to the use of the sample in the laboratory",{"count":594,"type":22},250,"Myeloma is a bone marrow cancer with over 5000 patients diagnosed in the UK each year. Researchers are committed to improving understanding of myeloma and developing more effective treatments with fewer side effects in order to improve patient outcomes. In order to do this, researchers are collecting samples of blood and bone marrow to test the activity of potential new treatments in the laboratory and to understand what may be the cause of some treatments not working.",[597],"Multiple Myeloma","2023-08-01",{"date":600,"type":39},"2023-08-03",{"date":602,"type":39},"2020-07-22",{"date":604,"type":22},"2035-02-28",{"name":45,"class":46},""]