[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100635271":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":32,"centralContacts":36,"locations":45,"responsibleParty":59,"collaborators":61,"id":65,"slug":66,"hasResults":67,"nctId":68,"briefTitle":69,"officialTitle":70,"acronym":26,"eligibilityCriteria":71,"healthyVolunteers":67,"sex":72,"minAge":73,"maxAge":26,"enrollmentInfo":74,"targetDuration":26,"studyType":77,"phases":78,"briefSummary":80,"conditions":81,"keywords":26,"overallStatus":83,"whyStopped":26,"lastUpdateSubmitDate":84,"lastUpdatePostDateStruct":85,"startDateStruct":88,"completionDateStruct":90,"leadSponsor":92,"locationsCount":93},{"fullName":5,"class":6},"Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Arm A (EBRT + 6 mo ADT + 177Lu-PSMA-617)","EXPERIMENTAL","Participants will receive EBRT + 6 mo ADT + 177Lu-PSMA-617",[13],"Drug: EBRT + 6 mo ADT + 177Lu-PSMA-617",{"label":15,"type":16,"description":17,"interventionNames":18},"Arm B (EBRT + 24 mo ADT)","ACTIVE_COMPARATOR","Participants will receive EBRT + 24 mo ADT",[19],"Radiation: EBRT + 24 mo ADT",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DRUG","EBRT + 6 mo ADT + 177Lu-PSMA-617","In Arm A, 177Lu-PSMA-617 will be given as intravenous infusion every 6 weeks, up to 4 cycles. Cycle 1 Day 1 (C1D1) of 177Lu-PSMA-617 will start at least 2 weeks after ADT, and EBRT will start at least 2 weeks after C1D1.",[9],null,{"type":28,"name":29,"description":30,"armGroupLabels":31,"otherNames":26},"RADIATION","EBRT + 24 mo ADT","In Arm B, EBRT will start 3-7 weeks after Day 1 of ADT.",[15],[33],{"name":34,"affiliation":5,"role":35},"Ana Kiess","PRINCIPAL_INVESTIGATOR",[37,41],{"name":34,"role":38,"phone":39,"phoneExt":26,"email":40},"CONTACT","443-287-7528","akiess1@jhmi.edu",{"name":42,"role":38,"phone":43,"phoneExt":26,"email":44},"Ryan Manuel","410-955-4261","rmanuel5@jhmi.edu",[46],{"facility":47,"status":26,"city":48,"state":49,"zip":50,"country":51,"countryCode":52,"cosmosGeoPoint":53,"geoPoint":58,"contacts":26},"Johns Hopkins University","Baltimore","Maryland","21287","United States","US",{"type":54,"coordinates":55},"Point",[56,57],-76.61219,39.29038,{"lat":57,"lon":56},{"type":60,"investigatorFullName":26,"investigatorTitle":26,"investigatorAffiliation":26,"oldNameTitle":26,"oldOrganization":26},"SPONSOR",[62],{"name":63,"class":64},"Novartis Pharmaceuticals","INDUSTRY","100635271","phase-2-psma-high-ebrt-psma617-adt-vs-ebrt-adt-100635271",false,"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.","MALE","18 Years",{"count":75,"type":76},60,"ESTIMATED","INTERVENTIONAL",[79],"PHASE2","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.",[82],"High-Risk Localized Prostate Cancer","NOT_YET_RECRUITING","2026-06-22",{"date":86,"type":87},"2026-06-24","ACTUAL",{"date":89,"type":76},"2026-07",{"date":91,"type":76},"2033-07",{"name":5,"class":6},1]