[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"high-risk-prostate-carcinoma\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:high-risk-prostate-carcinoma":26},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,4,0,[8,41,69,97],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":30,"startDateStruct":33,"completionDateStruct":35,"leadSponsor":37,"locationsCount":40},"100545616","phase-2-hyperpolarized-hp-13c-pyruvate-magnetic-resonance-imaging-mri-for-response-monitoring-to-neoadjuvant-abiraterone-100545616",false,"NCT06384222","Hyperpolarized (HP) 13C Pyruvate Magnetic Resonance Imaging (MRI) for Response Monitoring to Neoadjuvant Abiraterone","Hyperpolarized (HP) 13C Pyruvate Magnetic Resonance Imaging (MRI) as a Response Monitoring Tool in Patients With High-Risk Prostate Cancer Receiving Neoadjuvant Therapy","Inclusion Criteria:\n\n1. Greater than or equal to 18 years of age\n2. Histologically confirmed adenocarcinoma of the prostate with archival biopsy tissue (collected within 12 months of cycle 1 day 1 of treatment) available for genomic profiling.\n\n   a. Tumor tissue does not need to be retrieved but rather identified and available upon later request for future pathologic review and possible correlative studies.\n3. High-risk disease defined as meeting 1 or more of the 3 following criteria:\n\n   1. Gleason grade group \\>=4; or\n   2. Pelvic node involvement by conventional imaging or PSMA PET imaging (cN1); or\n   3. Tumor stage T3 or higher (i.e. tumor extension outside of the prostate, or spread to tissues near the prostate other than the seminal vesicles, such as the bladder or wall of the pelvis) as determined by conventional imaging (including prostate MRI), transrectal ultrasound or PSMA PET imaging.\n4. No evidence of distant metastatic disease as determined by PSMA PET\u002FCT or PET\u002FMR. Nodal disease below the iliac bifurcation (clinical stage N1) is not an exclusion.\n5. Participants must be planning to undergo radical prostatectomy (RP) with or without pelvic lymph node dissection and considered surgically resectable by urologic evaluation at the time of study entry. Adjuvant therapy following RP will be allowed per treating provider discretion.\n6. Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2.\n7. Demonstrates adequate organ function as defined below:\n\n   1. Absolute neutrophil count (ANC) \\>=1,500\u002Fmicroliter (mcL).\n   2. Platelets \\>=100,000\u002FmcL, independent of transfusions\u002Fgrowth factors within 3 months of treatment start.\n   3. Total bilirubin within normal institutional limits, unless elevated due to Gilbert's syndrome and direct bilirubin is within normal limits.\n   4. Aspartate aminotransferase (AST)\u002Fserum glutamic-oxaloacetic transaminase (SGOT) \\\u003C=3 X institutional upper limit of normal.\n   5. Alanine aminotransferase (ALT)\u002Fserum glutamic-pyruvic transaminase (SGPT) \\\u003C=3 X institutional upper limit of normal.\n   6. Estimated creatinine clearance \\>=40 mL\u002Fmin (by the Cockcroft Gault equation).\n8. Ability to understand and the willingness to sign a written informed consent document.\n9. Human immunodeficiency virus (HIV)-infected individuals on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial.\n10. For participants with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated.\n11. Individuals with a history of hepatitis C virus (HCV) infection must have been treated and cured. For individuals with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load.\n12. Individuals with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial.\n13. Abiraterone may cause fetal harm when administered to a pregnant woman. The effects of hyperpolarized \\[1-13C\\]pyruvate on the developing human fetus are unknown. For this reason, men treated or enrolled on this protocol must agree to use adequate contraception prior to the study, for the duration of study participation and for 8 weeks after last administration of study treatment.\n\nExclusion Criteria:\n\n1. Participants unwilling or unable to undergo MR imaging, including patients with contraindications to MRI, such as cardiac pacemakers or non-compatible intracranial vascular clips.\n2. Participants who cannot tolerate or have contra-indications to endorectal coil insertion; for example, patients with a prior abdominoperineal resection of the rectum or latex allergy. The use of an endorectal coil may be waived at the discretion of the Principal Investigator upon review of available imaging with radiology, in which case this exclusion criteria will not apply.\n3. Participants with contra-indications to injection of gadolinium contrast; for example, participants with prior documented allergy or those with inadequate renal function.\n4. Metallic hip implant or any other metallic implant or device that distorts local magnetic field and compromises the quality of MR imaging.\n5. Poorly controlled hypertension, with blood pressure at study entry \\>160 mmHg systolic or \\>100 mmHg diastolic.\n6. Congestive heart failure with New York Heart Association (NYHA) status \\>=2.\n7. A history of clinically significant EKG abnormalities, including QT prolongation, a family history of prolonged QT interval syndrome, or myocardial infarction within 6 months of study entry.\n8. Has received prior prostate cancer therapy.\n\n   a. Prior 5-alpha reductase inhibitors (e.g. finasteride, dutasteride) allowed if discontinued at least 3 weeks prior to first dose.\n9. Is currently receiving any other investigational agent(s) or has participated in a study of an investigational product and received study treatment or used an investigational device within 2 weeks of the first dose of treatment.\n10. Concurrent use of strong CYP3A4 inhibitors (e.g., ketoconazole, itraconazole,clarithromycin, atazanavir, nefazodone, saquinavir, telithromycin, ritonavir, indinavir, nelfinavir, voriconazole) or inducers (e.g., phenytoin, carbamazepine, rifampin, rifabutin, rifapentine, phenobarbital).","ALL","18 Years",{"count":19,"type":20},32,"ESTIMATED","INTERVENTIONAL",[23],"PHASE2","This study will evaluate the use of hyperpolarized 13C MRI (HP 13C MRI) and the HP-derived 13C pyruvate-to-lactate conversion rate constant (kPL) as an early response biomarker in men with treatment-naïve, high-risk, localized or locally advanced prostate cancer receiving neoadjuvant therapy.",[26,27],"High Risk Prostate Carcinoma","Prostate Cancer","RECRUITING","2025-12-27",{"date":31,"type":32},"2025-12-30","ACTUAL",{"date":34,"type":32},"2024-12-09",{"date":36,"type":20},"2027-09-30",{"name":38,"class":39},"Ivan de Kouchkovsky, MD","OTHER",1,{"id":42,"slug":43,"hasResults":11,"nctId":44,"briefTitle":45,"officialTitle":46,"acronym":47,"eligibilityCriteria":48,"healthyVolunteers":11,"sex":49,"minAge":17,"maxAge":50,"enrollmentInfo":51,"targetDuration":4,"studyType":21,"phases":53,"briefSummary":55,"conditions":56,"keywords":57,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":59,"lastUpdatePostDateStruct":60,"startDateStruct":62,"completionDateStruct":64,"leadSponsor":66,"locationsCount":68},"100564191","phase-3-study-evaluating-the-efficacy-and-safety-of-darolutamide-and-stereotactic-dose-escalated-radiotherapy-in-patients-with-localized-prostate-cancer-and-high-risk-features-of-relapse-100564191","NCT06625970","Study Evaluating the Efficacy and Safety of Darolutamide and Stereotactic Dose Escalated Radiotherapy in Patients With Localized Prostate Cancer and High-risk Features of Relapse","A Randomized Phase III Trial With a Factorial Design Evaluating the Efficacy and Safety of Darolutamide and Stereotactic Dose Escalated Radiotherapy in Patients With Localized Prostate Cancer and High-risk Features of Relapse, From the Prostate Cancer Consortium in Europe (PEACE)","PEACE 7","Inclusion Criteria:\n\n1. Signed a written informed consent form prior to any trial specific procedures\n\n   Note: In case of physical incapacitation, a trusted representative of their choice, which is not the investigator or sponsor, can sign on the behalf of the patients\n2. Men, 18 years ≤ Age ≤ 80 years\n3. ECOG performance status of 0 or 1\n4. No significant co-morbidities that might prevent long-term follow-up\n5. Histologically confirmed adenocarcinoma of the prostate\n6. Meet at least 2 of the following criteria from NCCN classification:\n\n   * Gleason score ≥8\n   * T3 or T4 disease (T3 defined by MRI is acceptable)\n   * Prostate-specific antigen ≥20 ng\u002FmL\n7. Prostate size on MRI \\\u003C100 cc\n8. Absolute neutrophil count ≥ 1.5 x 10⁹\u002FL\n9. Platelet count ≥100 x 10⁹\u002FL\n10. Haemoglobin ≥90 g\u002FL (in absence of red blood cell transfusion within 4 weeks prior to randomization)\n11. Hepatic function: serum alanine aminotransferase (ALT) and\u002For aspartate transaminase (AST) ≤2.5 x upper limit of normal (ULN), total bilirubin ≤1.5 x ULN\n12. Creatinine ≤2.0 x ULN\n13. Sexually active patients must agree to use an effective contraceptive method while on treatment and for 1 week after the final dose of investigational product\n14. Patient must be affiliated to a Social Security System or in possession of equivalent private health insurance (according to local regulations for participation in clinical trials)\n15. Patient must be willing and able to comply with the protocol for the duration of the trial including undergoing treatment and scheduled visits, and examinations including follow-up\n\nExclusion Criteria:\n\n1. Clinically or radiologically detectable metastasis, including no evidence of pelvic lymph node metastasis on next generation imaging (PSMA PET\u002FCT), nor enlarged pelvic lymph nodes (≥1 cm in small diameter) on MRI Note: Patients with infra-centimetric nodal disease (\\\u003C1 cm in small diameter) on conventional imaging and equivocal hyperfixation on next generation imaging may be included\n2. Recent history of TURP or prostate enucleation (less than 6 months) Note: patients with severe obstructive symptoms (defined as International Prostate Symptom Score (IPSS) ≥20) should be carefully evaluated to rule out the need for TURP\u002FProstate enucleation\n3. Prior treatment for prostate cancer, including prostatectomy, except lymph node dissection (patients with PN- disease only can be accrued) or ADT (started more than 6 weeks before randomization)\n4. Patient with other known concurrent severe and\u002For uncontrolled concurrent medical disease or infection (such as active viral hepatitis, active human immunodeficiency virus (HIV) or chronic liver disease) or co-morbidity, which could compromise participation in the study\n5. Cardiac disease such as uncontrolled hypertension (systolic BP ≥160 mmHg or diastolic BP ≥95 mmHg; 3 consecutive measures taken 5 minutes apart), stroke, congestive cardiac failure, ventricular arrhythmias, active ischemic heart disease, myocardial infarction within one year, coronary\u002Fperipheral artery bypass graft, LVEF \\> grade 2\n6. Uncontrolled diabetes mellitus\n7. Current active hepatic or biliary disease (with exception of subjects with Gilbert's syndrome, asymptomatic gallstones, stable chronic liver disease per investigator assessment)\n8. Gastrointestinal disorder or procedure, which expects to interfere significantly with absorption of study treatment. Severe GI disorders precluding pelvic irradiation\n9. Known severely impaired lung function (spirometry and DLCO 70% or less of normal and O2 saturation of 88% or less at rest on room air)\n10. Other prior malignancy within the last 3 years, except basal cell skin cancer\n11. Known hypersensitivity to the study treatment or any of its ingredients.\n12. Physical or psychological condition or any condition that in the opinion of the investigator would impair the patients' ability to comply with the study procedures\n13. Previous treatment for prostate cancer (surgery or radiotherapy) or previous pelvic irradiation that would make prostate\u002Fpelvis radiotherapy impossible\n14. Concomitant prohibited treatment. Concurrent or planned treatment with strong inhibitors or strong inducers of cytochrome P450 3A4\u002F5. A one-week washout period is necessary for patients who are already on these treatments\n15. Prior treatment with second generation androgen receptor (AR) inhibitors, other investigational AR inhibitors, or CYP17 enzyme inhibitor\n16. Use of oestrogens or 5-α reductase inhibitors or AR inhibitors\n17. Acute toxicities of prior treatments and procedures not resolved to grade ≤1 or baseline before randomization\n18. Prior chemotherapy or immunotherapy for prostate cancer\n19. Major surgery within 28 days before randomization\n20. Participation in another therapeutic trial within 30 days prior to inclusion\n21. Persons deprived of their liberty or under protective custody or guardianship\n22. Patients unwilling or unable to comply with the medical follow-up required by the trial because of geographic, familial, social, or psychological reasons","MALE","80 Years",{"count":52,"type":20},700,[54],"PHASE3","PEACE 7 is an international, multicenter, randomized, open-label phase III study that aims at evaluating the efficacy and safety of darolutamide and of stereotactic dose escalated prostate radiotherapy in patients with localised prostate cancer and high-risk features of relapse (defined as patients with at least 2 high-risk criteria from National Comprehensive Cancer Network (NCCN) classification) using a factorial (2x2) design.\n\nThe primary objective of this study is to assess the efficacy of darolutamide and of a stereotactic dose escalated radiotherapy targeting prostate in combination with ADT and pelvic nodal radiotherapy in terms of metastasis-free survival (MSF).\n\nPatients will be randomized (1:1:1:1) to receive either:\n\n* Arm A (Standard arm): ADT + conventional fractionated or moderately hypo-fractionated prostate radiotherapy including pelvic nodal radiotherapy\n* Arm B (Experimental arm): ADT + conventional fractionated or moderately hypo-fractionated prostate radiotherapy including pelvic nodal radiotherapy + darolutamide\n* Arm C (Experimental arm): ADT + conventional fractionated or moderately hypo-fractionated pelvic nodal radiotherapy + Prostate SBRT\n* Arm D (Experimental arm): ADT + conventional fractionated or moderately hypo-fractionated pelvic nodal radiotherapy + Prostate SBRT + darolutamide\n\nPatient will receive systemic treatments (ADT and\u002For darolutamide) during 2 years where visits on site are planned at D45, D90, D180 and then every 3 months for checkups and follow prostate specific antigen (PSA) level.\n\nMetastasis-free survival (MFS) is defined as the time interval from randomization to the date of the appearance of metastasis (on next generation imaging) or death (from any cause), whichever occurs first. Radiographic evaluation will be carried out at the time of biochemical failure (Phoenix criteria) or in case of clinical suspicion. After biochemical failure (Phoenix criteria) radiographic evaluation on next generation imaging (prostate-specific membrane antigen (PSMA) positron emission tomography (PET) scan (any European Medicines Agency (EMA) approved PSMA tracer)) will be performed every 6 months until a metastatic site of relapse is identified and will be repeated at each subsequent PSA progression.",[26,27],[58],"HPRC, PSMA-PET, Prostate Cancer, High-Risk","2025-06-21",{"date":61,"type":32},"2025-06-26",{"date":63,"type":32},"2025-04-10",{"date":65,"type":20},"2045-10",{"name":67,"class":39},"UNICANCER",6,{"id":70,"slug":71,"hasResults":11,"nctId":72,"briefTitle":73,"officialTitle":74,"acronym":75,"eligibilityCriteria":76,"healthyVolunteers":11,"sex":49,"minAge":17,"maxAge":4,"enrollmentInfo":77,"targetDuration":4,"studyType":21,"phases":79,"briefSummary":81,"conditions":82,"keywords":83,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":88,"lastUpdatePostDateStruct":89,"startDateStruct":91,"completionDateStruct":93,"leadSponsor":95,"locationsCount":40},"100531787","towards-optimal-treatment-for-high-risk-prostate-cancer-100531787","NCT06204341","Towards Optimal Treatment for High Risk Prostate Cancer","Towards Optimal Treatment for High Risk Prostate Cancer; Stereotactic Pelvic Radiotherapy with Focal Boost to the Primary Tumour","HYPOPRIME","Inclusion Criteria:\n\n* Men (aged ≥18 years of age) diagnosed within 6 months before inclusion with high risk prostate cancer:\n\n  * T3 based on digital rectal examination AND\u002FOR\n  * Grade \\>= 4 AND\u002FOR\n  * PSA \\>=20 ug\u002FL\n* Indication for elective lymph node irradiation (based on current clinical guidelines) OR N1 on imaging (with a maximum of 4 suspect lymph nodes)\n\nExclusion Criteria:\n\n* Prior pelvic radiotherapy\n* TransUrethral Resection of the Prostate (TURP) \\\u003C 3 months ago\n* Prostatectomy or other primary treatment for prostate cancer (e.g. HIFU, cryotherapy, etc)\n* contraindications to MRI\n* no visible lesion on MRI in prostate for boost\n* no PSMA-PET scan\n* inflammatory bowel disease\n* metastatic disease (M1)\n* PSA \\>50\n* unsuitable for SBRT or WPRT\n* medical history of cancer other than basal cell carcinoma of the skin",{"count":78,"type":20},207,[80],"NA","The goal of this clinical trial is to combine several optimized treatments of high risk prostate cancer. The main question to answer is: is it safe to combine these optimized treatments.\n\n* patients will be irradiated on the prostate and (elective) lymph nodes more concentrated but with fewer hospital visits (hypofractionation)\n* the tumor will get a higher dose\n* androgen deprivation therapy will be reduced as much al possible preventing side effects\n\nResearchers will compare oncological outcome and toxicity.",[26],[84,85,86,87],"hypo fractionation","elective lymph node irradiation","focal boost","androgen deprivation therapy reduction","2024-09-10",{"date":90,"type":32},"2024-09-19",{"date":92,"type":32},"2024-01-02",{"date":94,"type":20},"2032-12-18",{"name":96,"class":39},"Haaglanden Medical Centre",{"id":98,"slug":99,"hasResults":11,"nctId":100,"briefTitle":101,"officialTitle":101,"acronym":102,"eligibilityCriteria":103,"healthyVolunteers":11,"sex":49,"minAge":104,"maxAge":4,"enrollmentInfo":105,"targetDuration":4,"studyType":21,"phases":107,"briefSummary":108,"conditions":109,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":110,"lastUpdatePostDateStruct":111,"startDateStruct":113,"completionDateStruct":115,"leadSponsor":117,"locationsCount":40},"100551569","phase-2-safety-of-dose-escalation-in-definitive-hypofractionated-radiation-therapy-and-hormone-therapy-with-spaceoar-tm-for-patients-with-high---risk-localized-prostate-cancer-desar-h-100551569","NCT06461793","Safety of Dose Escalation in Definitive Hypofractionated Radiation Therapy and Hormone Therapy With SpaceOAR TM for Patients With High - Risk Localized Prostate Cancer (DESAR-H)","DESAR-H","Inclusion Criteria:\n\n1. Histopathologically confirmed prostate adenocarcinoma within 6 months of study enrollment\n2. Patients with prostate cancer at high risk or above (c T3a-T4 or grade group 4-5 or PSA \\> 20 n g\u002FmL) )\n3. Patients who have undergone or are scheduled to undergo hormone therapy for high-risk prostate cancer\n4. Adults over 20 years of age\n5. Whole body performance ECOG 0-1\n6. SpaceOAR Patients who consented to the procedure and study\n\nExclusion Criteria:\n\n1. prostate removal surgery, Patients with a history of lower pelvic surgery including rectal cancer surgery\n2. primary cancer Patients with posterior extracapsular extension\n3. Medically biodegradable substances such as bleeding predisposition Patients for whom infusion is not appropriate\n4. Patients with a history of previous pelvic radiation therapy\n5. Patients with lymph node metastasis or distant metastasis","20 Years",{"count":106,"type":20},33,[23],"Dose increase after injection of biodegradable material A safety study of high-risk prostate cancer patients who underwent low-fractionation curative radiation therapy and hormone therapy",[26],"2024-06-19",{"date":112,"type":32},"2024-06-21",{"date":114,"type":32},"2023-09-12",{"date":116,"type":20},"2033-12-31",{"name":118,"class":39},"Samsung Medical Center"]