[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"prostate-neoplasm\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:prostate-neoplasm":26},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,16,0,[8,43,78,104,126,148,188,246,273,308,337,384,412,450,473,498],{"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":27,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":31,"lastUpdatePostDateStruct":32,"startDateStruct":35,"completionDateStruct":37,"leadSponsor":39,"locationsCount":42},"100053561","prospective-study-of-ultrahypofractionated-proton-beam-therapy-for-localized-prostate-cancer-100053561",false,"NCT07699705","Prospective Study of Ultrahypofractionated Proton Beam Therapy for Localized Prostate Cancer","Prospective Cohort Study for Identifying Factors Predicting Long-term Outcomes of Prostate Cancer Patients Who Received Ultrahypofractionated Proton Beam Therapy","Inclusion Criteria:\n\n* Histologically confirmed localized adenocarcinoma of the prostate.\n* No evidence of distant metastasis (M0).\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0-2.\n* Eligible to receive definitive image-guided ultrahypofractionated pencil beam scanning proton beam therapy according to the study protocol.\n* Ability to complete study questionnaires and comply with scheduled follow-up assessments.\n* Provision of written informed consent before study enrollment.\n\nExclusion Criteria:\n\n* Residual or recurrent prostate cancer following prior radical prostatectomy.\n* Previous pelvic radiotherapy.\n* Evidence of distant metastatic disease.\n* Active malignancy within the previous 1 year, except adequately treated basal cell carcinoma or squamous cell carcinoma of the skin, carcinoma in situ of the cervix, or completely resected T1N0M0 malignancies.\n* Uncontrolled psychiatric illness, severe traumatic brain injury, chronic alcohol or substance dependence, or other medical conditions that, in the investigator's judgment, would preclude safe participation or adequate follow-up.\n* Inability or unwillingness to provide written informed consent or comply with study procedures.","MALE","19 Years",{"count":19,"type":20},50,"ESTIMATED","INTERVENTIONAL",[23],"NA","The goal of this prospective observational cohort study is to evaluate the long-term efficacy and safety of ultrahypofractionated proton beam therapy in patients with localized prostate cancer and to identify clinical and treatment-related factors associated with oncologic outcomes and treatment-related toxicity.\n\nThe main questions it aims to answer are:\n\nWhat are the long-term biochemical recurrence-free survival, clinical progression-free survival, overall survival, and acute and late treatment-related toxicity outcomes following ultrahypofractionated proton beam therapy? Which clinical characteristics, treatment planning parameters, and patient-reported outcomes are predictive of long-term oncologic outcomes and treatment-related toxicity?\n\nParticipants will:\n\nReceive protocol-based ultrahypofractionated proton beam therapy (35-40 Gy\\[RBE\\] in 5 fractions).\n\nUndergo routine clinical evaluation, laboratory testing including prostate-specific antigen (PSA), and imaging studies according to the institutional follow-up schedule.\n\nComplete patient-reported outcome questionnaires (EPIC-CP and Visual Analog Scale \\[VAS\\]) before treatment and during follow-up.\n\nBe followed prospectively to assess biochemical recurrence, clinical progression, survival outcomes, and acute and late treatment-related toxicities.",[26],"Prostate Neoplasm",[28,29],"prostate neoplasm","proton therapy","RECRUITING","2026-07-09",{"date":33,"type":34},"2026-07-13","ACTUAL",{"date":36,"type":34},"2024-11-04",{"date":38,"type":20},"2034-12-31",{"name":40,"class":41},"National Cancer Center, Korea","OTHER_GOV",1,{"id":44,"slug":45,"hasResults":11,"nctId":46,"briefTitle":47,"officialTitle":48,"acronym":49,"eligibilityCriteria":50,"healthyVolunteers":11,"sex":51,"minAge":52,"maxAge":4,"enrollmentInfo":53,"targetDuration":4,"studyType":21,"phases":55,"briefSummary":57,"conditions":58,"keywords":65,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":67,"lastUpdatePostDateStruct":68,"startDateStruct":70,"completionDateStruct":72,"leadSponsor":74,"locationsCount":77},"100601754","phase-1-a-study-of-ly4257496-in-participants-with-cancer-omniray-100601754","NCT07114601","A Study of LY4257496 in Participants With Cancer (OMNIRAY)","A Phase 1a\u002Fb Multicenter, Open-Label Trial to Evaluate Safety, Tolerability, and Dosimetry of LY4257496, a GRPR-Targeted Radioligand Therapy, in Adults With GRPR-Positive Advanced Solid Tumors (OMNIRAY)","OMNIRAY","Inclusion Criteria:\n\n* Must have histologically or cytologically proven diagnosis of locally advanced, unresectable, or metastatic cancer.\n* Must be assessed by computed tomography (CT)\u002Fmagnetic resonance imaging (MRI) to confirm at least 1 of the following:\n\n  * At least 1 measurable target lesion per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1\n  * If only bone lesions are present without a soft-tissue component, a bone scan or MRI must confirm at least 2 detectable lesions considered to represent active metastases\n* Must have GRPR-positive disease, defined by investigator assessment of GRPR imaging.\n* Must have the following histologically or cytologically confirmed diagnosis:\n\n  * Estrogen receptor (ER+)\u002Fhuman epidermal growth factor receptor 2 (HER2-) breast cancer\n  * ER+\u002FHER2+ breast cancer\n  * Esophageal squamous cell carcinoma\n  * Adenocarcinoma of the stomach, gastroesophageal junction, or esophagus\n  * Colorectal carcinoma\n  * Metastatic castration-resistant prostate cancer\n  * Endometrial carcinoma. Carcinosarcoma is eligible. Uterine leiomyosarcoma, adenosarcoma, or endometrial stromal sarcoma is not eligible.\n  * Low-grade papillary serous ovarian cancer\n  * Other non-Central Nervous System (CNS) primary GRPR-positive solid tumors (Cohorts A1 dose escalation and D1 dose expansion only)\n* For participants with breast cancer diagnosis, where possible, ER and HER2 status should be assessed from the most recent tissue biopsy taken at the time of presentation with recurrent or metastatic disease.\n\n  * To fulfill the requirement for ER+ disease by local testing, a tumor must express the ER immunohistochemistry, as defined in the relevant American Society of Clinical Oncology (ASCO)\u002FCollege of American Pathologists (CAP) guidelines.\n  * HER2 status should be determined by local testing, as defined in the relevant ASCO\u002FCAP Guidelines.\n* Must have an Eastern Cooperative Oncology Group (ECOG) performance status of less than or equal to 1.\n* Must be able to comply with outpatient treatment, laboratory monitoring, imaging, and required clinic visits for the duration of trial participation.\n\nExclusion Criteria:\n\n* Phase 1a (Cohort A1 and A2) only: Previously received radiopharmaceutical or radioligand therapy. For participants with prostate cancer, prior ¹⁷⁷Lu-prostate-specific membrane antigen (PSMA) is permitted.\n* Has a history of ongoing acute pancreatitis within 1 year of screening.\n* Previously received any prior hemi-body or whole-body radiotherapy, or prior external beam radiation therapy (EBRT) to greater than 25% of the bone marrow.\n* A bone superscan, defined as a bone scan that demonstrates markedly increased skeletal radioisotope uptake relative to soft tissues in association with absent or faint genitourinary tract activity.\n* Has evidence of ongoing and untreated urinary tract obstruction or unmanageable urinary incontinence.\n* Have known active hepatitis B virus (HBV). Exception: Individuals with chronic HBV if they:\n\n  * Have positive HBsAg\n  * Are on suppressive antiviral therapy, as allowed per local regulations prior to C1D1\n  * Remain on the same antiviral treatment throughout study, and should follow local standards for continuation of therapy after completion of trial therapy.\n  * Have undetectable HBV DNA ≤14 days of C1D1.\n* Have known active hepatitis C virus (HCV). Exception: Individuals previously treated for HCV if they:\n\n  * Completed curative antiviral therapy.\n  * Have an HCV viral load below the limit of quantification ≤14 days of C1D1 and.\n  * Are positive for anti-HCV antibodies and negative for HCV ribonucleic acid (RNA) before randomization.\n* Have untreated human immunodeficiency virus (HIV) infection. Exception: Individuals who have well-controlled HIV infection\u002Fdisease and they:\n\n  * Are on a stable and permitted antiretroviral therapy (ART) regimen without changes in drug or dose, for at least 4 weeks prior to C1D1\n  * Have a viral load of \\\u003C400 copies\u002FmL ≤14 days of C1D1.\n  * Have a CD4+ T-cell count ≥350 cells\u002FmL ≤14 days of C1D1.\n  * Have not had an opportunistic infection within the past 12 months.\n* Has an active second malignancy unless in remission with life expectancy greater than 2 years.\n* Has known hypersensitivity to any component or excipient of LY4257496.","ALL","18 Years",{"count":54,"type":20},421,[56],"PHASE1","The main purpose of this study is to evaluate safety, tolerability, and efficacy of LY4257496 alone and as part of relevant standard of care (SOC) combination therapy in participants with Gastrin-releasing Peptide Receptor (GRPR)-positive advanced cancer, including but not limited to breast, colorectal, prostate, endometrial, esophageal, gastroesophageal (GE) junction, and gastric cancer. The study will also evaluate the safety, tolerability, and efficacy of LY4257529 to identify cancer with high levels of a protein called GRPR. This is a 2-part study. Participation could last up to 36 weeks or until your tumor progresses.",[59,60,26,61,62,63,64],"Breast Neoplasms","Colorectal Neoplasms","Endometrial Neoplasms","Neoplasm Metastasis","Stomach Neoplasms","Esophageal Neoplasms",[66],"GRPR-positive","2026-06-19",{"date":69,"type":34},"2026-06-23",{"date":71,"type":34},"2025-08-06",{"date":73,"type":20},"2035-04",{"name":75,"class":76},"Eli Lilly and Company","INDUSTRY",32,{"id":79,"slug":80,"hasResults":11,"nctId":81,"briefTitle":82,"officialTitle":83,"acronym":4,"eligibilityCriteria":84,"healthyVolunteers":11,"sex":16,"minAge":52,"maxAge":4,"enrollmentInfo":85,"targetDuration":4,"studyType":21,"phases":87,"briefSummary":88,"conditions":89,"keywords":92,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":94,"lastUpdatePostDateStruct":95,"startDateStruct":97,"completionDateStruct":99,"leadSponsor":101,"locationsCount":42},"100493839","mri-risk-maps-for-prostate-cancer-diagnosis-using-targeted-biopsy-100493839","NCT05710380","MRI Risk Maps for Prostate Cancer Diagnosis Using Targeted Biopsy","Magnetic Resonance Imaging (MRI) Derived Quantitative Risk Maps for Prostate Cancer Diagnosis Using Targeted Biopsy","Inclusion Criteria:\n\n* Patients with known or suspected prostate cancer who have been referred for a diagnostic magnetic resonance imaging (MRI) exam of the prostate, to be followed by an MRI-guided fusion biopsy of the prostate.\n* Voluntary written informed consent before the MRI examination.\n\nExclusion Criteria:\n\n* Subjects incapable of giving informed written consent.\n* Subjects who cannot adhere to the experimental protocols for any reason, or have an inability to communicate with the researcher;\n* Subjects with psychiatric disorders that affect their ability to consent for themselves will be excluded and not the entire population of patients with psychiatric disorders.\n* Prisoners.\n* Minor children (under the age of 18 years old).\n* Patients with previous treatments (surgery, radiation, focal ablation, hormone or other chemotherapy) for prostate cancer.",{"count":86,"type":20},180,[23],"Doctors leading this study hope to learn about a software that researchers at the University of Chicago have developed to help analyze radiographic images (different techniques for taking images that allow doctors to visualize the body's internal structures) of the prostate. Participation in this research will last about 12 months. There is a one-time MRI and 1-2 biopsies and then the investigator would like to follow the participant's progress.",[90,91,26],"Prostate Cancer","Prostate Adenocarcinoma",[93],"prostate cancer","2026-04-22",{"date":96,"type":34},"2026-04-27",{"date":98,"type":34},"2023-04-26",{"date":100,"type":20},"2026-05-01",{"name":102,"class":103},"University of Chicago","OTHER",{"id":105,"slug":106,"hasResults":11,"nctId":107,"briefTitle":108,"officialTitle":108,"acronym":4,"eligibilityCriteria":109,"healthyVolunteers":110,"sex":51,"minAge":52,"maxAge":4,"enrollmentInfo":111,"targetDuration":4,"studyType":113,"phases":4,"briefSummary":114,"conditions":115,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":116,"lastUpdatePostDateStruct":117,"startDateStruct":119,"completionDateStruct":121,"leadSponsor":123,"locationsCount":125},"100540342","improvements-in-dynamic-contrast-enhanced-mr-angiography-and-perfusion-and-non-contrast-mri-100540342","NCT06315595","Improvements in Dynamic Contrast-Enhanced MR Angiography and Perfusion and Non-Contrast MRI","Inclusion Criteria:\n\n* Adults\n\nExclusion Criteria:\n\n* Standard exclusion criteria for clinical MRI; e.g. cardiac pacemaker, claustrophobia, an implanted device that has been determined to be MR conditional at 1.5T but not at 3T, anticipated considerable susceptibility artifact from hip prosthesis, etc.",true,{"count":112,"type":20},1000,"OBSERVATIONAL","This study evaluates if technical improvements in MRI can be used to provide improved performance contrast-enhanced MRI as used for angiography and perfusion as well as in non-contrast MRI.",[26],"2026-04-14",{"date":118,"type":34},"2026-04-17",{"date":120,"type":34},"2015-09-30",{"date":122,"type":20},"2030-09-30",{"name":124,"class":103},"Mayo Clinic",2,{"id":127,"slug":128,"hasResults":11,"nctId":129,"briefTitle":130,"officialTitle":131,"acronym":4,"eligibilityCriteria":132,"healthyVolunteers":11,"sex":16,"minAge":52,"maxAge":4,"enrollmentInfo":133,"targetDuration":4,"studyType":21,"phases":135,"briefSummary":137,"conditions":138,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":139,"lastUpdatePostDateStruct":140,"startDateStruct":142,"completionDateStruct":144,"leadSponsor":146,"locationsCount":42},"100318369","phase-1-safety-and-efficacy-of-21-gy-23-gy-and-25-gy-for-high-dose-rate-hdr-prostate-brachytherapy-100318369","NCT03424850","Safety and Efficacy of 21 Gy, 23 Gy and 25 Gy for High Dose Rate (HDR) Prostate Brachytherapy","A Phase I\u002FII Dose-escalation Study Evaluating the Safety and Efficacy of 21 Gy, 23 Gy and 25 Gy for High Dose Rate (HDR) Prostate Brachytherapy","Inclusion Criteria:\n\n* Histologically or cytologically confirmed diagnosis of early stage prostate cancer.\n* Must be considered either low-risk (T1-T2a, Gleason ≤ 6, PSA \\\u003C 10 ng\u002FmL) or favorable intermediate-risk (Gleason 3 +4 = 7, percentage of positive biopsy cores \\\u003C 50%, no more than one NCCN intermediate risk factor).\n* Prior androgen deprivation therapy is allowed and may have been initiated up to 6 months prior to the date of the HDR implant. The complete duration of androgen deprivation therapy can range from 4 months to 36 months provided it has been initiated no more than 6 months prior to the date of the HDR implant.\n* At least 18 years of age.\n* ECOG performance status ≤ 2\n* Able to understand and willing to sign an IRB approved written informed consent document (or that of legally authorized representative, if applicable).\n\nExclusion Criteria:\n\n* Prior radiation therapy to the prostate or lower pelvis encompassing the prostate.\n* A history of other malignancy ≤ 5 years previous with the exception of basal cell or squamous cell carcinoma of the skin which were treated with local resection only.\n* Currently receiving any other investigational agents.\n* Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, or cardiac arrhythmia.\n* Unable to undergo general, spinal or local anesthesia.\n* Prior TURP with a sufficiently large defect that would compromise the integrity of the implant per clinician's assessment.",{"count":134,"type":20},36,[56,136],"PHASE2","The purpose of this research study is to learn more about the outcomes and early and late side effects of treating early stage prostate cancer with high dose rate brachytherapy.",[90,26],"2026-03-10",{"date":141,"type":34},"2026-03-11",{"date":143,"type":34},"2018-02-27",{"date":145,"type":20},"2030-02-28",{"name":147,"class":103},"Washington University School of Medicine",{"id":149,"slug":150,"hasResults":11,"nctId":151,"briefTitle":152,"officialTitle":153,"acronym":154,"eligibilityCriteria":155,"healthyVolunteers":11,"sex":16,"minAge":156,"maxAge":4,"enrollmentInfo":157,"targetDuration":4,"studyType":21,"phases":159,"briefSummary":160,"conditions":161,"keywords":178,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":179,"lastUpdatePostDateStruct":180,"startDateStruct":182,"completionDateStruct":184,"leadSponsor":186,"locationsCount":42},"100589690","phase-2-proof-of-concept-trial-to-assess-the-efficacy-and-safety-of-fezolinetant-in-improving-vasomotor-symptoms-in-men-with-prostate-cancer-undergoing-androgen-deprivation-therapy-100589690","NCT06957691","Proof-of-Concept Trial to Assess the Efficacy and Safety of Fezolinetant in Improving Vasomotor Symptoms in Men With Prostate Cancer Undergoing Androgen Deprivation Therapy","Proof-of-Concept Trial to Assess the Efficacy and Safety of Fezolinetant in Improving Vasomotor Symptoms in Men With Prostate Cancer Undergoing Androgen Deprivation Therapy (Fezo-ADT Trial)","Fezo-ADT","Inclusion Criteria:\n\n* Male sex\n* Age 40 years and older\n* Diagnosis of prostate cancer\n* Androgen deprivation therapy\n* Presence of 5 or more moderate-to-severe hot flashes per day or 35 or more moderate-to-severe hot flashes per week\n* Ability to sign the inform consent\n* Willing to use reliable methods of contraception if partner is of childbearing age\n* Ability to record hot flashes electronically\n\nExclusion Criteria:\n\n* Use of abiraterone acetate\n* Use of docetaxel and other chemotherapeutic agents\n* Liver cirrhosis\n* Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) above the upper limit of normal\n* Total bilirubin above the upper limit of normal\n* Glomerular filtration rate \\\u003C 30 mL\u002Fmin\n* Use of selective serotonin reuptake inhibitors, serotonin-norepinephrine reuptake inhibitors, tricyclic antidepressants, sedatives, or hypnotics\n* Use of over-the-counter hormonal agents or herbal compounds\n* Current use of CYP1A2 inhibitors\n* Ingestion of alcohol within 2 weeks prior to the baseline visit\n* Inability to abstain from alcohol use during the study period.","40 Years",{"count":158,"type":20},60,[136],"The goal of this clinical trial is to learn if fezolinetant can treat hot flashes (vasomotor symptoms) in men with prostate cancer undergoing androgen deprivation therapy.\n\nThe main questions it aims to answer are:\n\n* Does fezolinetant improve the frequency and severity of hot flashes?\n* Does fezolinetant cause any harm to the liver?\n* Does fezolinetant improve quality of life, sleep quality, fatigue, mood, sexual function, and metabolic parameters?\n\nResearchers will compare how people respond to fezolinetant versus a placebo, which does not contain any active medicine.\n\nParticipants will:\n\n* Take fezolinetant or a placebo every day for 4 weeks\n* Visit the clinic once every 2 weeks for checkups and tests\n* Keep a diary of the number of times and intensity that they experience hot flashes",[90,162,163,164,165,26,91,166,167,168,169,170,171,172,173,174,175,176,177],"Prostate Cancer (Adenocarcinoma)","Prostate Cancer Metastatic Disease","Prostate Cancer Recurrent","Prostate Carcinoma","Prostate Cancer With Bone Metastasis","Vasomotor Disturbance","Vasomotor Symptoms","Vasomotor Symptoms (VMS)","Vasomotor Symptoms as a Sex Hormone-dependent Disorder in Women and Men","Vasomotor Symptoms; Hot Flashes","Androgen Deprivation Therapy","Androgen Ablative Therapy of Advanced Hormone-dependent Prostate Carcinoma","Androgen-deprivation Therapy","Hot Flashes","Hot Flushes","Hot Flushes and\u002For Sweats",[172,175,176,90,168],"2026-03-05",{"date":181,"type":34},"2026-03-09",{"date":183,"type":34},"2026-01-14",{"date":185,"type":20},"2028-12-31",{"name":187,"class":103},"Shehzad Basaria, M.D.",{"id":189,"slug":190,"hasResults":11,"nctId":191,"briefTitle":192,"officialTitle":193,"acronym":194,"eligibilityCriteria":195,"healthyVolunteers":11,"sex":51,"minAge":52,"maxAge":4,"enrollmentInfo":196,"targetDuration":198,"studyType":113,"phases":4,"briefSummary":199,"conditions":200,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":237,"lastUpdatePostDateStruct":238,"startDateStruct":239,"completionDateStruct":241,"leadSponsor":243,"locationsCount":245},"100368284","the-momentum-study-the-multiple-outcome-evaluation-of-radiation-therapy-using-the-mr-linac-study-100368284","NCT04075305","The MOMENTUM Study: The Multiple Outcome Evaluation of Radiation Therapy Using the MR-Linac Study","The Multiple Outcome Evaluation of Radiation Therapy Using the MR-Linac Study","MOMENTUM","Inclusion Criteria:\n\n* Patient is to undergo or has completed imaging or treatment procedures on an MR-Linac;\n* Patient provides written, informed consent;\n* Patient is 18 years old or older.\n\nExclusion Criteria:\n\n* MRI exclusion criteria, including\n* MRI contraindications as per usual clinical care, such as (possible) pregnancy; claustrophobia and metal or electronic implants not compatible with MRI.",{"count":197,"type":20},8000,"2 Years","The Multi-OutcoMe EvaluatioN of radiation Therapy Using the Unity MR-Linac Study (MOMENTUM) is a multi-institutional, international registry facilitating evidenced based implementation of the Unity MR-Linac technology and further technical development of the MR-Linac system with the ultimate purpose to improve patients' survival, local, and regional tumor control and quality of life.",[201,202,90,203,204,205,206,207,26,208,209,210,211,212,213,214,215,216,217,218,219,220,221,222,223,224,225,226,227,228,229,230,231,232,233,234,235,236],"Oncology","Breast Cancer","Gynecologic Cancer","Brain Tumor","Brain Cancer","Gynecologic Tumor","Prostate Tumor","Breast Tumor","Radiation Toxicity","Quality of Life","Rectal Cancer","Rectal Tumor","Rectal Neoplasms","Lung Cancer","Lung Tumor","Lung Neoplasm","Esophageal Cancer","Esophagus Cancer","Esophageal Tumor","Esophageal Neoplasm","Esophagus Tumor","Esophagus Neoplasm","Pancreatic Cancer","Pancreatic Tumor","Pancreatic Neoplasms","Head and Neck Cancer","Head and Neck Neoplasms","Head and Neck Tumor","Tumor","Neoplasms","Bladder Cancer","Bladder Neoplasm","Liver Cancer","Liver Neoplasms","Liver Metastases","Oligometastases","2026-03-03",{"date":179,"type":34},{"date":240,"type":34},"2019-02-01",{"date":242,"type":20},"2030-08-01",{"name":244,"class":103},"UMC Utrecht",18,{"id":247,"slug":248,"hasResults":11,"nctId":249,"briefTitle":250,"officialTitle":250,"acronym":4,"eligibilityCriteria":251,"healthyVolunteers":110,"sex":16,"minAge":52,"maxAge":252,"enrollmentInfo":253,"targetDuration":4,"studyType":113,"phases":4,"briefSummary":255,"conditions":256,"keywords":259,"overallStatus":262,"whyStopped":4,"lastUpdateSubmitDate":263,"lastUpdatePostDateStruct":264,"startDateStruct":266,"completionDateStruct":268,"leadSponsor":270,"locationsCount":272},"100611313","application-of-quantum-detection-driven-artificial-intelligence-algorithms-for-single-molecule-cfdna-characterization-in-the-early-diagnosis-of-prostate-cancer-100611313","NCT07238959","Application of Quantum Detection-Driven Artificial Intelligence Algorithms for Single-Molecule cfDNA Characterization in the Early Diagnosis of Prostate Cancer","Inclusion Criteria:\n\n1. Male, aged 18-80 years;\n2. PSA \\> 4 ng\u002Fml;\n3. Patients meeting criteria for prostate biopsy:\n\n   * fPSA\u002FPSA \\\u003C 0.16 or PSA D \\> 0.15 or PSA V \\> 0.75; ② Positive digital rectal examination (DRE); ③ Imaging studies (ultrasound\u002FMRI) showing suspicious lesions.\n\nExclusion Criteria:\n\n1. Patients diagnosed with any malignant tumour within the past five years;\n2. Patients who have undergone transurethral resection or enucleation of the prostate;\n3. Patients who have previously received treatment for prostate cancer, including but not limited to endocrine therapy, targeted therapy, or immunotherapy;\n4. Patients on long-term anticoagulant or antiplatelet therapy (anticoagulants discontinued for less than one week);\n5. Patients who have received any form of tumour treatment prior to enrolment blood sampling, including surgery, radiotherapy\u002Fchemotherapy, endocrine therapy, targeted therapy, or immunotherapy;\n6. Concurrent severe systemic diseases deemed by the investigator likely to interfere with trial treatment, evaluation, or compliance, including serious respiratory, circulatory, neurological, psychiatric, gastrointestinal, endocrine, immunological, or urological disorders;\n7. Organ transplant recipients or individuals with prior non-autologous (allogeneic) bone marrow or stem cell transplantation;\n8. Subjects who have undergone blood transfusion within one month prior to blood sampling;\n9. Patients currently participating in other clinical trials, or who have participated in other clinical trials within the past year;\n10. Patients deemed unsuitable for this clinical trial by the investigator;\n11. Patients meeting any of the above criteria shall not be eligible for inclusion as subjects.","80 Years",{"count":254,"type":20},1100,"This research project aims to develop a novel blood testing method integrating cutting-edge quantum sensing and artificial intelligence technologies to achieve precise, non-invasive early diagnosis of prostate cancer. The research will employ quantum sensors to perform ultra-high-sensitivity measurements of circulating free DNA (cfDNA) in blood, thereby training a dedicated AI diagnostic model. The ultimate objective is to establish the diagnostic efficacy of this approach through clinical validation, providing clinicians with a novel diagnostic tool capable of significantly reducing unnecessary prostate biopsy procedures.",[257,258,26],"Benign Prostate Hypertrophy(BPH)","Prostate Cancer (Diagnosis)",[260,261],"Early diagnosis","cfDNA","NOT_YET_RECRUITING","2025-11-15",{"date":265,"type":34},"2025-11-20",{"date":267,"type":20},"2025-12",{"date":269,"type":20},"2027-12",{"name":271,"class":103},"Shanghai Changzheng Hospital",7,{"id":274,"slug":275,"hasResults":11,"nctId":276,"briefTitle":277,"officialTitle":278,"acronym":4,"eligibilityCriteria":279,"healthyVolunteers":11,"sex":16,"minAge":52,"maxAge":280,"enrollmentInfo":281,"targetDuration":4,"studyType":21,"phases":283,"briefSummary":284,"conditions":285,"keywords":290,"overallStatus":262,"whyStopped":4,"lastUpdateSubmitDate":299,"lastUpdatePostDateStruct":300,"startDateStruct":302,"completionDateStruct":304,"leadSponsor":306,"locationsCount":42},"100586479","robotic-prostatectomy-artificial-intelligence-low-pressure-pain-ralp-trial-100586479","NCT06915909","Robotic Prostatectomy Artificial Intelligence Low Pressure Pain (RALP) Trial","Robotic Prostatectomy Artificial Intelligence Low Pressure Pain Study Trial - \"The Monitoring of Patients Outcomes Intraoperatively and Perioperatively Using the Airseal and Stryker Insufflator Undergoing Robotic Assisted Laparoscopic Prostatectomy at a Pressure and Stability of Pneumoperitoneum of 8 mmHg\"","Inclusion Criteria:\n\n* Patient indicated for non-emergent robotic Prostatectomy surgery\n* Patients (or appropriate legal representatives) able to provide written informed consent to participate in the study\n* Males, aged 18 to 75 years\n* Have no significant psychopathology that could limit the subject's ability to understand the procedure, comply with medical, surgical, and\u002For behavioural recommendations and office visits\n* Are American Society of Anaesthesiologists (ASA) Class I, II, or III);\n\nExclusion Criteria:\n\n* Patient participation in a different investigational clinical study within 90 days before screening and for the duration of this trial (unless previously approved by the investigator and Sponsor);\n* Patients requiring any surgical procedure in addition to Prostatectomy and or \u002F Pelvic Lymph node dissection\n* Previous pelvic surgery or previous malabsobtion or restrictive procedures performed for the treatment of obesity\n* Inability to provide informed consent\n* Unable or unwilling to attend follow-up visits and examinations\n* Uncontrolled hypertension (=\u002F\\>Systolic: 180 mmHg\u002FDiastolic: 120 mmHg) and\u002For diabetes mellitus (Blood sugar level: \\>200 mg\u002FdL)\n* Patients who fall into American Society of Anesthesiologists (ASA) Class ≥ IV\n* History of chronic alcohol or drug abuse within 2 years of the screening visit\n* Chronic renal failure or on dialysis\n* Significant complicating medical history or immunocompromised\n* History or presence of pre-existing autoimmune connective tissue disease, e.g., systemic lupus erythematosus or scleroderma\n* Immunocompromised such as that resulting from chronic oral steroid use, chemotherapeutic agents, or immune deficiency disorders;\n* Any medical condition which precludes compliance with the study\n* Subjects with any other clinically significant unstable medical disorder, life threatening disease, or conditions that, in the opinion of the investigator, may jeopardize the subject's well-being and\u002For the soundness of this clinical study or which would contra-indicate a surgical procedure.\n* Previous or current history of being on regular analgesia \u002F pain killers","75 Years",{"count":282,"type":20},40,[23],"The 'Robotic Prostatectomy Artificial Intelligence Low Pressure Pain Study Trial' aims to assess the feasibility of being able to review operative outcomes such as pain when comparing two commonly used surgical devices for the removal of prostate cancers. The data collected will inform methodologies for future, larger, multi-center trials investigating pain in patients undergoing prostate cancer surgery.\n\nA robotic prostatectomy is a commonly performed surgery used to treat prostate cancer by removing the prostate gland. In order to perform the procedure, the surgeon must 'inflate' (technical term pneumoperitoneum) the patients abdomen with carbon dioxide gas using a device called an insufflator. Adequate 'inflation' of the abdomen ensures the surgeon can clearly visualise the prostate. Unfortunately, higher pressures of abdominal 'inflation' are a large contributor to intra and post-operative pain in patients having prostatectomies. The type of insufflator device used to maintain inflation pressures in the abdomen are thought to be a variable contributing to differing levels of intra and post-operative pain. Therefore, the purpose of this trial is to compare intra and post-operative pain when using two different insufflator devices when performing robotic prostatectomies. Both insufflators are already commonly used across multiple NHS Trusts.\n\n40 patients awaiting a robotic prostatectomy at the urology department at the Lister hospital, Stevenage, will be randomised to use either the Conventional Insufflator System (CIS) {Stryker PneumoClear Insufflator} or the AIRSEAL® Insufflation System (AIS) to 'inflate' their abdomens during their prostatectomies. Data relating to various intra and post-operative outcomes will be collected in the 30 days following the patient's operation. Outcomes include levels of intra and post-operative pain, medication use, procedure time, recovery room time, length of hospital stay, post operative nausea and vomiting and adverse events. This data can be analysed to identify trends in differences in outcomes between the AIS and CIS insufflators.",[162,286,287,288,26,289],"Prostate Cancer (Post Prostatectomy)","Prostate Cancer Surgery","Prostate Cancers","Prostatectomy",[93,291,292,293,294,295,296,297,298],"prostatectomy","robotic prostatectomy","post-operative pain","pain","Stryker PneumoClear insufflator","AirSeal Insufflation System","intra-operative pain","Medasense","2025-03-31",{"date":301,"type":34},"2025-04-08",{"date":303,"type":20},"2025-04-01",{"date":305,"type":20},"2025-07-01",{"name":307,"class":41},"East and North Hertfordshire NHS Trust",{"id":309,"slug":310,"hasResults":11,"nctId":311,"briefTitle":312,"officialTitle":312,"acronym":313,"eligibilityCriteria":314,"healthyVolunteers":11,"sex":16,"minAge":52,"maxAge":315,"enrollmentInfo":316,"targetDuration":4,"studyType":21,"phases":318,"briefSummary":320,"conditions":321,"keywords":324,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":328,"lastUpdatePostDateStruct":329,"startDateStruct":331,"completionDateStruct":333,"leadSponsor":335,"locationsCount":125},"100576414","phase-4-impact-of-using-the-airseal-system-with-ultra-low-pneumoperitoneum-in-patients-undergoing-robot-assisted-radical-prostatectomy-a-prospective-comparative-randomized-clinical-study-100576414","NCT06784986","Impact of Using the Airseal System With Ultra-low Pneumoperitoneum in Patients Undergoing Robot-assisted Radical Prostatectomy: A Prospective, Comparative, Randomized Clinical Study.","ARCO2","Inclusion Criteria:\n\n* Patients with prostate cancer who will undergo robotic prostatectomy;\n\nExclusion Criteria:\n\n* Patients over 65 and under 18 years of age;\n* Patients allergic to NSAIDs and\u002For Morphine and\u002For Tramadol;\n* Patients with chronic renal failure;\n* Patients with recurrence, metastasis and other existing neoplasms.","65 Years",{"count":317,"type":20},200,[319],"PHASE4","The AirSeal platform has been evaluated in urological surgeries, mainly in cases of malignant diseases 5,6. However, there is still a lack of data demonstrating the possible benefits of its use, which justifies the conduct of this research in order to aggregate such knowledge. Therefore, the objective of this prospective pilot study is to compare and evaluate the role of low-pressure pneumoperitoneum with the AirSeal system in patients with prostate cancer undergoing robot-assisted prostatectomy with those undergoing the procedure with the conventional insufflation system. We seek to provide more data on the use of AirSeal, which is associated with shorter operative times, shorter hospital stays and a lower probability of complications. In addition, we aim to ratify the effectiveness and cost-benefit of using the AirSeal system.",[165,26,322,323],"Pain Intensity Assessment","Quality of Life (QOL)",[325,326,327],"pneumoperitoneum","airseal","pneumoperitoneum in prostate neoplasm","2025-01-15",{"date":330,"type":34},"2025-01-20",{"date":332,"type":20},"2025-02",{"date":334,"type":20},"2026-02-15",{"name":336,"class":103},"Brazilian Institute of Robotic Surgery",{"id":338,"slug":339,"hasResults":11,"nctId":340,"briefTitle":341,"officialTitle":342,"acronym":343,"eligibilityCriteria":344,"healthyVolunteers":11,"sex":51,"minAge":52,"maxAge":4,"enrollmentInfo":345,"targetDuration":4,"studyType":21,"phases":346,"briefSummary":347,"conditions":348,"keywords":352,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":375,"lastUpdatePostDateStruct":376,"startDateStruct":378,"completionDateStruct":380,"leadSponsor":382,"locationsCount":125},"100564575","evaluating-the-impact-of-financial-navigation-on-financial-catastrophe-and-distress-for-cancer-care-100564575","NCT06630962","Evaluating the Impact of Financial Navigation on Financial Catastrophe and Distress for Cancer Care","Evaluating the Impact of Financial Navigation on Financial Catastrophe and Distress for Cancer Care: A Randomized Control Trial- COST-FIN","COST-FIN","Inclusion Criteria:\n\n* Age 18 years and older\n* Recently diagnosed with breast, colorectal or prostate cancer within 6 weeks of presentation at the study site\n* Have not received definitive chemotherapy, radiotherapy, or undergone major surgery (diagnostic or temporary interventions, such as excisional biopsy or temporary colostomy may still enroll)\n* Candidate for definitive cancer treatment\n\nExclusion Criteria:\n\n* Unable to provide consent\n* Has initiated definitive cancer treatment at the study site or elsewhere in the past\n* Only receiving best supportive care",{"count":317,"type":20},[23],"The goal of this study is to investigate the effectiveness of a structured financial navigation program in reducing financial catastrophe and financial distress for cancer patients in Nigeria.\n\nThe main study questions being investigated are:\n\n1. If a financial navigation program can effectively and significantly reduce financial catastrophe and distress for cancer patients in Nigeria?\n2. If a financial navigation program is financially sustainable and cost-effective for cancer centers in Nigeria?\n\nParticipants will be required to:\n\n1. Complete surveys about their demographics, clinical history, and socioeconomic status\n2. Complete questionnaires about their quality of life and psychological wellbeing\n3. Report all costs related to their cancer care\n\nInvestigators will compare participants in the financial navigation program and those not in the financial navigation program to identify potential differences in catastrophic health expenditure and financial distress.",[349,26,350,351],"Breast Neoplasm","Colon Neoplasm","Rectal Neoplasm",[353,354,355,349,26,350,351,356,357,358,359,360,361,362,363,364,365,366,367,368,369,370,371,372,373,374],"Financial Navigation","Financing Cancer Care","Nigeria","Health Insurance","Randomized Control Trial","Healthcare Cost","Health Expenditure","Financial Risk Sharing","Universal Health Insurance","National Health Insurance Scheme","Catastrophic Health Spending","Financial Distress","Sub-Saharan Africa","Health Plan Implementation","Global Health","Healthcare Economics and Organizations","Clinical Oncology","Cancer Care Facilities","Surgical Oncology","Global Burden of Disease","Social Determinants of Health","Health Impact Assessment","2024-10-04",{"date":377,"type":34},"2024-10-08",{"date":379,"type":34},"2024-07-15",{"date":381,"type":20},"2026-09",{"name":383,"class":103},"Northwestern University",{"id":385,"slug":386,"hasResults":11,"nctId":387,"briefTitle":388,"officialTitle":389,"acronym":390,"eligibilityCriteria":391,"healthyVolunteers":11,"sex":16,"minAge":392,"maxAge":280,"enrollmentInfo":393,"targetDuration":4,"studyType":21,"phases":395,"briefSummary":396,"conditions":397,"keywords":398,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":403,"lastUpdatePostDateStruct":404,"startDateStruct":406,"completionDateStruct":408,"leadSponsor":410,"locationsCount":42},"100348665","mri-targeted-biopsy-of-the-prostate-software-versus-visual-registration-in-the-accuracy-of-prostate-cancer-detection-100348665","NCT03819751","MRI-targeted Biopsy of the Prostate: Software Versus Visual Registration in the Accuracy of Prostate Cancer Detection","MRI-targeted Biopsy of the Prostate: a Prospective Comparison of Software-based Fusion Versus Visual (Cognitive) Registration in the Accuracy of Clinically Significant Prostate Cancer Detection","PROSOVI","Inclusion Criteria:\n\n* willing to participate in the study by giving written informed consent.\n* male subjects aged between 50 to 75 years.\n* with a clinical suspicion of PCa: elevated prostate specific antigen (PSA) levels in blood and\u002For abnormal digital rectal examination (DRE).\n* good health condition based on medical history, physical examination and vital sign measurements.\n* with target lesion on dedicated MRI of the prostate (PI-RADS 3 to 5).\n\nExclusion Criteria:\n\n* has a prior history of prostate cancer.\n* had prior prostate biopsy.\n* has a contra-indication for MRI (claustrophobia, non-compatible metallic implants).\n* has evidence of lymph nodes involvement on prostate MRI or abdominal CT\n* has evidence of bone metastasis on bone scan.\n* has a prior history of hip prosthesis, pelvic radiation therapy or androgen deprivation therapy\n* unable to perform transrectal ultrasound due to prior rectal surgery or active rectal diseases (rectitis, …)\n* has any condition, physical, mental, familial or sociological, that could impede compliance with the study protocol and further follow-up. This is not an absolute contra-indication, but should be discussed with patient prior to registration in the trial.","50 Years",{"count":394,"type":20},96,[23],"With the general acceptance of MRI and technical advances in biopsy technique of the prostate, new questions arise concerning the selection of patients, the approach, the appropriate technique, the lesions to target and the number of biopsies. The purpose of this study is to address these issues in men suspicious of having prostate cancer and without prior biopsies.",[90,26],[399,400,401,402],"prostatic neoplasms","biopsy","Multimodal Imaging","prostate","2024-07-02",{"date":405,"type":34},"2024-07-03",{"date":407,"type":34},"2019-03-18",{"date":409,"type":20},"2025-07",{"name":411,"class":103},"Universitaire Ziekenhuizen KU Leuven",{"id":413,"slug":414,"hasResults":11,"nctId":415,"briefTitle":416,"officialTitle":416,"acronym":417,"eligibilityCriteria":418,"healthyVolunteers":11,"sex":16,"minAge":52,"maxAge":252,"enrollmentInfo":419,"targetDuration":421,"studyType":113,"phases":4,"briefSummary":422,"conditions":423,"keywords":428,"overallStatus":262,"whyStopped":4,"lastUpdateSubmitDate":441,"lastUpdatePostDateStruct":442,"startDateStruct":444,"completionDateStruct":446,"leadSponsor":448,"locationsCount":4},"100549161","outcomes-of-local-treatment-for-oligometastatic-prostate-cancer-diagnosed-using-psma-pet-imaging-oligomet-study-100549161","NCT06430411","Outcomes of Local Treatment for Oligometastatic Prostate Cancer Diagnosed Using PSMA PET Imaging: OLIGOMET Study","OLIGOMET","Inclusion Criteria:\n\n* Oligometastatic prostate cancer diagnosed using PSMA PET defined as cM1a and\u002For cM1b with ≤5 osseous metastases and\u002For M1c with ≤3 lung lesions, with or without cN positivity.\n* Oligometastatic prostate cancer treated with primary local therapy such as radical prostatectomy or radiation therapy.\n* Any Gleason Score, any cT stage, any PSA\n\nExclusion Criteria:\n\n* Visceral metastases (apart from lungs).\n* Neoadjuvant therapy prior to first PSMA PET.\n* Non-metastatic prostate cancer.\n* Patients who did not undergo imaging before local treatment.",{"count":420,"type":20},500,"5 Years","PSMA-PET\u002FCT or PSMA-PET\u002FMRI are more accurate imaging modalities compared to CT\u002FBS; in approximately 10-20% of high-risk patients diagnosed using conventional imaging PSMA-PET up-stages the disease. Therefore a substantial proportion of high-risk patients previously considered as non-metastatic are expected to be diagnosed with oligometastatic disease. While standard treatment pathways exist for patients with non-metastatic or oligometastatic disease confirmed using conventional imaging, less is known about the optimal management of patients with oligometastatic prostate cancer on PSMA-PET.\n\nCurrently, data on the safety, effectiveness and oncologic outcomes of local therapies in oligometastatic patients diagnosed using PSMA-PET have been poorly reported so far. Thus, there is a need for a prospectively maintained database to collect real-world clinical data to produce high-quality research on the optimal management in oligometastatic prostate cancer who underwent PSMA-PET for primary staging and subsequent local therapy. This database will allow centers to retro- and prospectively collect data to facilitate analysis and assessment of the outcomes of oligometastatic patients managed with local therapy.",[424,425,90,26,426,427],"Prostate Cancer Metastatic","Prostate Cancer Metastatic to Bone","Oligometastatic Disease","Oligometastasis",[402,429,430,431,291,432,433,434,435,436,437,438,439,440],"oligometastatic","oligometastasis","oligomet","irradiation","abiraterone","enzalutamide","darolutamide","apalutamide","androgen deprivation therapy","ADT","docetaxel","PSMA PET","2024-05-24",{"date":443,"type":34},"2024-05-28",{"date":445,"type":20},"2024-05-31",{"date":447,"type":20},"2031-12-31",{"name":449,"class":103},"Medical University of Vienna",{"id":451,"slug":452,"hasResults":11,"nctId":453,"briefTitle":454,"officialTitle":455,"acronym":456,"eligibilityCriteria":457,"healthyVolunteers":11,"sex":16,"minAge":52,"maxAge":4,"enrollmentInfo":458,"targetDuration":4,"studyType":113,"phases":4,"briefSummary":460,"conditions":461,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":464,"lastUpdatePostDateStruct":465,"startDateStruct":467,"completionDateStruct":469,"leadSponsor":471,"locationsCount":42},"100538596","using-tissue-based-spatial-data-to-understand-how-obesity-related-tumor-metabolites-fuel-prostate-cancer-progression-100538596","NCT06292897","Using Tissue-based Spatial Data to Understand How Obesity-related Tumor Metabolites Fuel Prostate Cancer Progression","Integrating Tissue-based Spatial Information to Elucidate How Obesity-induced Tumour Metabolites Drive Prostate Cancer Progression","OBESITA'&PCa","Inclusion Criteria:\n\n* affected by prostate cancer\n\nExclusion Criteria:\n\n\\-",{"count":459,"type":20},25,"Evaluate the protein expression of lactate dehydrogenase enzyme (LDHA) and MCT-1\u002F-4 transporters, involved in lactate synthesis and transport, in prostate carcinoma tissues from severely overweight\u002Fobese (BMI \\> 27.5) and non-severely overweight\u002Fnormoweight (BMI \\\u003C 27.5) patients affected by prostate carcinoma.\n\nii. Characterize the immune infiltrate in the prostate carcinoma of the aforementioned patients.\n\niii. Assess the association between intra-tumoral lactate accumulation (using LDHA and MCT-4 protein expression levels as readouts) and alterations in the tumor immune microenvironment and\u002For deregulation of relevant oncogenic pathways.",[90,91,26,462,463],"Prostatic Neoplasm","Obesity","2024-02-27",{"date":466,"type":34},"2024-03-05",{"date":468,"type":34},"2023-03-20",{"date":470,"type":20},"2027-01-15",{"name":472,"class":103},"Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico",{"id":474,"slug":475,"hasResults":11,"nctId":476,"briefTitle":477,"officialTitle":477,"acronym":478,"eligibilityCriteria":479,"healthyVolunteers":11,"sex":16,"minAge":480,"maxAge":4,"enrollmentInfo":481,"targetDuration":4,"studyType":21,"phases":483,"briefSummary":484,"conditions":485,"keywords":486,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":488,"lastUpdatePostDateStruct":489,"startDateStruct":491,"completionDateStruct":493,"leadSponsor":495,"locationsCount":497},"100533244","effectiveness-of-focal-therapy-in-men-with-prostate-cancer-100533244","NCT06223295","Effectiveness of Focal Therapy in Men With Prostate Cancer","ENFORCE","Inclusion Criteria:\n\n* Gleason score of 7 (3 + 4 or 4 + 3; ISUP grade 2\u002F3)\n* PSA level of ≤ 20 ng\u002Fml\n* Clinical stage ≤ T2b disease\n* Life expectancy of ≥ 10 years\n* Men with a prostate size ≤ 5 cm in sagittal length and ≤ 6 cm in axial length\n* Fit, eligible, and normally destined for radical surgery or radiotherapy\n* No concomitant cancer\n* No previous treatment of their prostate\n* An understanding of the Dutch language sufficient to receive written and verbal information about the trial, its consent process and the study questionnaires\n\nExclusion Criteria:\n\n* Unfit for general anesthesia or radical surgery\n* Low volume low-risk disease (≤4mm Gleason score of ≤ 6 \u002F ISUP grade 1)\n* High-risk disease (Gleason score of ≥ 8 \u002F ISUP grade \\>3)\n* Clinical T3 disease (extracapsular PCa)\n* Men who have received previous active therapy for PCa.\n* Men with evidence of extraprostatic disease.\n* Men with an inability to tolerate a transrectal ultrasound.\n* Cardiac pacemaker\n* Metal implants\u002Fstents in the urethra or prostate.\n* ASA ≥4\n* Prostatic calcification\u002Fcysts that interfere with effective delivery of TULSA\u002FHIFU based on MRCT.\n* Men with renal impairment and a glomerular filtration rate (GFR) of \\\u003C 30 ml\u002Fminute\u002F1.73 m2.\n* Unable to give consent to participate in the trial, as judged by the attending clinicians","45 Years",{"count":482,"type":20},356,[23],"In the Netherlands, most men with prostate cancer (PCa) are treated with radical whole-gland treatment, i.e. prostatectomy or radiotherapy. The burden of complications such as incontinence and erectile dysfunction associated with radical treatment is considerable. A recent systematic review by our group has shown that focal therapy of PCa seems to reduce the burden of treatment side-effects in men with intermediate-risk disease, maintaining their quality of life without compromising oncological effectiveness. The costs of side effects that can be prevented are estimated at €5456 per patient, resulting in total expected cost savings of about €22 million per year in The Netherlands. Furthermore, exploration of the benefit-risk balance under patients showed that they are willing to sacrifice some survival for an improvement in quality of life (QoL).\n\nFocal therapy comprises a modern alternative to selectively treat a specific part of the prostate while preserving the rest of the gland. There is, however, a lack of high-quality evidence, and numerous papers therefore recommend to perform a multicenter randomized controlled trial (RCT). The RCT should have long-term follow-up, predefined assessment of cancer-specific and health-related QoL outcome measures, and economic evaluations to inform policymakers regarding cost-effectiveness. This RCT on focal therapy versus usual care is urgently needed to enable focal therapy to overgrow the experimental status, provide the evidence needed for guidelines, and make this available for selected patients who benefit from this strategy. Because of its promising results in other countries, focal therapy is increasingly requested by patients, but due to the lack of high-quality evidence, it is not reimbursed yet. This has been designated by both the PCa patient support group and physicians as a failure of both the market and the funding agencies. The investigators, therefore, aim to perform a high-quality multi-center RCT to provide the evidence needed to decide on reimbursement and implementation of focal therapy in patients with intermediate-risk, unilateral clinically localized PCa in the Netherlands.",[90,26],[28,487,93],"focal therapy","2024-02-15",{"date":490,"type":34},"2024-02-20",{"date":492,"type":34},"2024-02-01",{"date":494,"type":20},"2031-02",{"name":496,"class":103},"Radboud University Medical Center",5,{"id":499,"slug":500,"hasResults":11,"nctId":501,"briefTitle":502,"officialTitle":502,"acronym":503,"eligibilityCriteria":504,"healthyVolunteers":11,"sex":16,"minAge":52,"maxAge":505,"enrollmentInfo":506,"targetDuration":4,"studyType":21,"phases":508,"briefSummary":509,"conditions":510,"keywords":4,"overallStatus":262,"whyStopped":4,"lastUpdateSubmitDate":511,"lastUpdatePostDateStruct":512,"startDateStruct":514,"completionDateStruct":516,"leadSponsor":518,"locationsCount":125},"100467941","phase-2-addition-of-a-focal-boost-in-external-beam-radiotherapy-for-locally-advanced-prostate-cancer-by-online-adaptive-mr-guided-radiotherapy-100467941","NCT05373316","Addition of a Focal Boost in External Beam Radiotherapy for Locally Advanced Prostate Cancer by Online Adaptive MR-guided Radiotherapy","AFFIRM","Inclusion Criteria:\n\n* Men aged 18 years or older with histologically proven prostate carcinoma\n* Imaging stage T3b (as defined on mpMRI) N0M0\n* Intraprostatic lesion visible on MRI\n* Capable of giving informed consent\n\nExclusion Criteria:\n\n* History of radiotherapy to the pelvis or transurethral resection of the prostate (TURP)\n* Contraindications for MRI according to the guidelines of the local department of Radiology, inability to lay on a treatment table for 45-60 minutes or severe claustrophobia\n* Absence of pre-treatment PSMA PET CT\n* WHO performance score \\> 2\n* International Prostate Symptom Score ≥ 15\n* PSA \\> 30\n* Prostate volume \\>100c","100 Years",{"count":507,"type":20},95,[136],"The AFFIRM trial tests the safety and clinical feasibility of MR-guided hypofractionated focal boost radiotherapy for patients with locally advanced prostate cancer. External beam radiotherapy combined with androgen deprivation therapy is considered as the treatment of choice for patients with locally advanced non-metastatic prostate cancer with seminal vesicle invasion.The long-term results of the multicentre phase III study (FLAME trial) showed that addition of an isotoxic focal boost to the intraprostatic lesion improves biochemical disease free survival in intermediate to high-risk patients without impacting toxicity and quality of life.\n\nThis focal boost strategy is now proven for a conventional fractionation scheme (35 fractions). The current trend in radiotherapy for prostate cancer is (extreme) hypofractionation, reducing the number of fractions. For locally advanced prostate cancer, however, the data on extreme hypofractionation are scarce.",[90,26],"2022-11-03",{"date":513,"type":34},"2022-11-07",{"date":515,"type":20},"2022-12-01",{"date":517,"type":20},"2029-07-01",{"name":496,"class":103}]