[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"high-risk-localized-prostate-cancer\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:high-risk-localized-prostate-cancer":77},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,41,64],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":30,"startDateStruct":33,"completionDateStruct":35,"leadSponsor":37,"locationsCount":40},"100627589","phase-2-a-study-to-learn-how-well-a-combination-of-darolutamide-and-androgen-deprivation-therapy-adt-works-as-a-treatment-before-surgery-for-men-who-have-high-risk-localized-prostate-cancer-100627589",false,"NCT07450599","A Study to Learn How Well a Combination of Darolutamide and Androgen Deprivation Therapy (ADT) Works as a Treatment Before Surgery for Men Who Have High-risk Localized Prostate Cancer.","CHINANEO: A China Phase 2, Open-Label, Randomized, Multicenter Study to Investigate the Efficacy and Safety of Darolutamide + ADT as Neo-Adjuvant Treatment for 12 Weeks vs 24 Weeks in Treatment-Naïve Participants Who Have Planned for Radical Prostatectomy (RP) With High-Risk Localized Prostate Cancer","CHINANEO","Inclusion Criteria:\n\n* Participants must be 18 years or older at the time of signing the informed consent.\n* Darolutamide-naïve participants who are with localized prostate adenocarcinoma who plan to receive radical prostatectomy (RP) and defined as high risk with National Comprehensive Cancer Network (NCCN) criteria (version 1.2025).\n* No evidence of distant metastasis based on computed tomography (CT), magnetic resonance imaging (MRI), and whole body bone scan (WBBS) within 42 days prior to start of study treatment.\n* Candidate for RP with pelvic lymph node dissection (PLND) or extended PLND (ePLND) as per the investigator.\n* Participants must have at least one of the following features according to NCCN definition of high-risk:\n\n  * Biopsy Gleason score ≥8, and\u002For\n  * Prostate-specific antigen (PSA) \\>20 ng\u002FmL measured during Screening and prior to randomization, or\n  * Clinical stage ≥ T3a.\n* Participants with pelvic lymph node involvement (N1) can be included.\n* Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1.\n\nExclusion Criteria:\n\n* Prostate cancer with known neuroendocrine (NE) differentiation or small cell features.\n* Evidence of metastatic disease. Minimum imaging requirements to exclude metastatic disease are diagnostic quality imaging of the chest, pelvis, and the abdomen (CT or MRI with intravenous \\[IV\\] contrast), and WBBS. Nodal disease below the iliac bifurcation (clinical stage N1) is not an exclusion.\n* Intolerant to darolutamide or androgen deprivation therapy (ADT) treatment.\n* History of\n\n  * Loss of consciousness or transient ischemic attack or stroke within 6 months prior to randomization, or\n  * Significant cardiovascular disease within 6 months prior to randomization.\n  * Any contraindications for RP.\n* Uncontrolled or treatment-resistant hypertension.\n* History of another malignancy within 5 years prior to randomization.","MALE","18 Years",{"count":20,"type":21},250,"ESTIMATED","INTERVENTIONAL",[24],"PHASE2","Researchers are looking for a better way to treat men who have high-risk localized prostate cancer, which refers to a type of prostate cancer that is still confined to the prostate gland but has certain characteristics that make it more likely to grow and spread.\n\nThe study treatment darolutamide plus androgen deprivation therapy (ADT) is under development as treatment before surgery for men who have high-risk localized prostate cancer. Darolutamide works by blocking the attachment of androgen hormones to androgen receptors in cancer cells, thereby blocking cancer progression and growth. ADT is an established treatment that is used to lower the amount of androgen hormones (e.g., testosterone) in the body.\n\nThe main purpose of this study is to learn how the cancer responds to the two different treatment durations (12 weeks or 24 weeks) of darolutamide combined with ADT used before the men undergo surgery to remove the prostate. For this, the researchers will compare the percentage of participants who either achieve complete response to the treatment (where no cancer cells are found) or with condition of minimal residual disease after the treatment (where only a small amount of cancer cells remains).\n\nThe study participants will be randomly (by chance) assigned to one of two treatment groups. Depending on the group, they will receive darolutamide tablets by mouth plus ADT administered under the skin for either 12 weeks or 24 weeks. No more than 30 days after the end of the treatments, study participants will be performed with surgery to remove the prostate.\n\nEach participant will be in the study for approximately 29 to 32 months, including a screening phase of up to 28 days, 12 weeks or 24 weeks of treatment depending on the treatment groups, followed by the surgery no more than 30 days after the treatment, and a follow up phase of up to 2 years after the surgery.\n\n2 visits to the study site are planned during the screening phase, followed by 3 to 6 visits (every 28 days) during treatment. The treatment period ends with a visit within 7 days after the last dose of treatment.\n\nDuring the study, the doctors and their study team will:\n\n* take blood and urine samples\n* check the participants' health parameters\n* do physical examinations\n* check if the participants' cancer has grown and\u002For spread using CT (computed tomography) or MRI (magnetic resonance imaging) and, if needed, bone scan\n* take tumor samples\n* ask the participants questions about how they are feeling and what adverse events they are having.\n\nAn adverse event is any medical problem that a participant has during a study. Doctors keep track of all adverse events, irrespective if they think it is related or not to the study treatments.\n\nAbout 30 days after the last dose of treatment, 5 weeks after the surgery and every 12 weeks thereafter, the study doctors and their team will check the participants' health and any changes in cancer. This follow-up period ends 2 years after the surgery.",[27],"High-Risk Localized Prostate Cancer","RECRUITING","2026-06-23",{"date":31,"type":32},"2026-06-24","ACTUAL",{"date":34,"type":32},"2026-04-27",{"date":36,"type":21},"2030-10-15",{"name":38,"class":39},"Bayer","INDUSTRY",23,{"id":42,"slug":43,"hasResults":11,"nctId":44,"briefTitle":45,"officialTitle":46,"acronym":4,"eligibilityCriteria":47,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":48,"targetDuration":4,"studyType":22,"phases":50,"briefSummary":51,"conditions":52,"keywords":4,"overallStatus":53,"whyStopped":4,"lastUpdateSubmitDate":54,"lastUpdatePostDateStruct":55,"startDateStruct":56,"completionDateStruct":58,"leadSponsor":60,"locationsCount":63},"100635271","phase-2-psma-high-ebrt-psma617-adt-vs-ebrt-adt-100635271","NCT07550517","PSMA-High: EBRT\u002F PSMA617\u002F ADT vs. EBRT\u002F ADT","A Phase II Non-blinded Randomized Study Comparing External Beam Radiotherapy (EBRT), 177Lu-PSMA-617, and Short Term Androgen Deprivation Therapy (ADT) Versus EBRT and Long Term ADT in Men With High Risk Localized Prostate Cancer","Inclusion Criteria:\n\n* Patient must have high-risk prostate cancer (HRPC) defined by presence of exactly one high-risk feature: cT3a OR Grade Group 4 or 5 OR PSA \\> 20 ng\u002FmL.\n* Histologic confirmation of adenocarcinoma of the prostate.\n* Patient must have localized HRPC defined by conventional imaging (no N1 disease by CT or MRI). Patients with or without intra-pelvic nodal metastases by PSMA-PET may be included as long as not enlarged \\>10mm short axis by conventional CT size criteria.\n* Patients must have PSMA-PET (68Ga-PSMA-11 or 18F-DCFPyL) with prostate tumor SUVmax \\> 10.\n* Patient must qualify for definitive treatment of prostate cancer including EBRT as well as ADT (up to 45 days of prior ADT is allotted).\n* Patient must be ≥ 18 years of age.\n* Patient must have a life expectancy ≥ 24 months.\n* Patient must have an Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2.\n* Adequate bone marrow reserve and organ function as demonstrated by complete blood count and chemistry panel completed within the prior 6 weeks demonstrating:\n\n  1. Platelet count of \\>100 x109\u002FL\n  2. White blood cell (WBC) count \\> 3,000\u002FmL\n  3. Neutrophil count of \\> 1,500\u002FmL\n  4. Hemoglobin ≥ 10 g\u002FdL\n  5. Estimated glomerular filtration rate (eGFR) \\> 50 mL\u002Fmin based upon Chronic Kidney Disease-Epidemiology Collaboration (CKD-EPI) equation. Due to safety concerns relating to renal clearance and toxicity of 177Lu-PSMA-617, patients with estimated GFR between 50 - 60 mL\u002Fmin will require a 99mTc-TPA GFR test and only patients with non-obstructive pathology will be included in the study.\n  6. Total bilirubin \\\u003C 3 x ULN (except if confirmed history of Gilbert's disease)\n  7. Serum albumin \\> 30 g\u002FL\n  8. Aspartate aminotransferase (AST) \\\u003C 3 times the ULN\n* For male patients with partners of childbearing potential, agreement to use barrier contraceptive method (condom) and to continue its use for 6 months from receiving the last dose of 177Lu-PSMA-617.\n* Patient must have the ability to understand and the willingness to sign a written informed consent document.\n\nExclusion Criteria:\n\n* Presence of a very high-risk feature: cT3b to T4 OR primary pattern 5 OR 2 to 3 high-risk features OR \\>4 cores with Grade Group 4 or 5.\n* Any prior pharmacotherapy (with the exception of up to 45 days of ADT prior to randomization), radiation therapy, or surgery as treatment for prostate cancer. Any prior radiopharmaceutical therapy.\n* Any prior radiation to the pelvis.\n* Presence of N1 or M1 disease by conventional imaging (CT, MRI, and\u002For bone scan) or M1 disease by PSMA-PET (68Ga-PSMA-11 or 18F-DCFPyL). Lymph nodes with short axis \\> 8 mm by CT will be considered N1 by conventional imaging.\n* Castration-resistant prostate cancer (CRPC).\n* Patient receiving any other investigational agents.\n* Patient is participating in a concurrent treatment protocol involving radiotherapy, surgery, or systemic anti-cancer agents.\n* Inadequate bone marrow reserve and organ function as detailed in 5.1.10.\n* Unable to lie flat during or tolerate PET\u002FMRI, PET\u002FCT or EBRT.\n* Concurrent serious medical condition that, in the opinion of the Investigator, would impair study participation.\n* Contraindication to receiving pelvic radiation, including history of or active inflammatory bowel disorders.\n* Refusal to sign informed consent.",{"count":49,"type":21},60,[24],"This research is being done to find out if the study drug, 177Lu-PSMA-617, given before and during standard of care External Beam Radiation Therapy (EBRT) treatment, with a shorter course of Androgen Deprivation Therapy (ADT) (6 months) is (1) safe and effective compared to standard of care alone, and (2) can reduce the side effects caused by long-term (24 months) ADT in men with high risk localized prostate cancer.",[27],"NOT_YET_RECRUITING","2026-06-22",{"date":31,"type":32},{"date":57,"type":21},"2026-07",{"date":59,"type":21},"2033-07",{"name":61,"class":62},"Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins","OTHER",1,{"id":65,"slug":66,"hasResults":11,"nctId":67,"briefTitle":68,"officialTitle":68,"acronym":69,"eligibilityCriteria":70,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":71,"targetDuration":73,"studyType":74,"phases":4,"briefSummary":75,"conditions":76,"keywords":4,"overallStatus":53,"whyStopped":4,"lastUpdateSubmitDate":79,"lastUpdatePostDateStruct":80,"startDateStruct":82,"completionDateStruct":84,"leadSponsor":86,"locationsCount":4},"100636058","prospective-prostate-cancer-infrastructure-100636058","NCT07560748","Prospective Prostate Cancer Infrastructure","ProPCI","Inclusion Criteria:\n\n* Diagnosis of either: high-risk localized prostate cancer (any of the following: PSA \\> 20 ng\u002FmL, ISUP Grade Group 4 or 5, or clinical stage ≥ T2c); or metastatic prostate cancer confirmed by imaging (CT, bone scintigraphy, PSMA PET\u002FCT, or (whole-body) MRI in combination with tumor markers (PSA)), or by biopsy of a metastatic lesion histopathologically deemed to be of prostatic origin.\n* Prostate adenocarcinoma (our main focus). We will allow the inclusion of adenocarcinoma with mixed small- or large-cell neuroendocrine prostate\n* Age ≥ 18 years at the time of inclusion.\n* Written informed consent\n* Able to understand one of the following languages sufficiently: Dutch, English, Arabic or Turkish.\n\nExclusion Criteria:\n\n* Not currently living in the Netherlands.",{"count":72,"type":21},700,"48 Months","OBSERVATIONAL","The goal of this observational study is to collect detailed long-term real-world data and biomaterials from men with high-risk localized prostate cancer and synchronous metastatic hormone-sensitive prostate cancer. This will help to better understand how these patients are treated in daily practice, how treatments affect quality of life, and facilitate biomarker discovery. The infrastructure is also designed to enable future cohort multiple randomized controlled trials.",[77,78],"High Risk Localized Prostate Cancer","Synchronous Metastatic Hormone-Sensitive Prostate Cancer","2026-04-28",{"date":81,"type":32},"2026-05-01",{"date":83,"type":21},"2026-05",{"date":85,"type":21},"2030-05",{"name":87,"class":62},"Radboud University Medical Center"]