{"id":"177lu-psma","safety":{"commonSideEffects":[{"rate":null,"effect":"Hematologic toxicity (anemia, thrombocytopenia, leukopenia)"},{"rate":null,"effect":"Xerostomia (dry mouth)"},{"rate":null,"effect":"Nausea"},{"rate":null,"effect":"Fatigue"},{"rate":null,"effect":"Kidney toxicity"}]},"_chembl":null,"_dailymed":null,"mechanism":{"_ai_source":"anthropic-haiku","explanation":"The drug consists of lutetium-177 (a therapeutic radioisotope) conjugated to a ligand that binds with high affinity to PSMA, a transmembrane protein overexpressed on prostate cancer cells. Once bound, the radioisotope delivers localized radiation to kill cancer cells while minimizing exposure to healthy tissue. This targeted approach is particularly effective in metastatic castration-resistant prostate cancer.","oneSentence":"177Lu-PSMA is a radioligand therapy that delivers lutetium-177, a beta-emitting radioisotope, directly to prostate-specific membrane antigen (PSMA) on cancer cells, causing targeted cell death.","_ai_confidence":"medium"},"_scrapedAt":"2026-03-28T02:25:12.397Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Metastatic castration-resistant prostate cancer (mCRPC) with PSMA expression"}]},"trialDetails":[{"nctId":"NCT04663997","phase":"PHASE2","title":"177 LuPSMA-617 vs Docetaxel in Metastatic Castration Resistant and PSMA-Positive Prostate Cancer","status":"ACTIVE_NOT_RECRUITING","sponsor":"Canadian Cancer Trials Group","startDate":"2021-08-11","conditions":"Prostate Cancer","enrollment":200},{"nctId":"NCT06526299","phase":"PHASE2","title":"Low PSMA SUV Boost (LPS-Boost): Intensified 177Lu-PSMA-617 Treatment for Patients With 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Patients With Compromised Renal and/or Bone Marrow Function","status":"NOT_YET_RECRUITING","sponsor":"M.D. Anderson Cancer Center","startDate":"2026-08-13","conditions":"Lu-177 PSMA","enrollment":25},{"nctId":"NCT06216249","phase":"PHASE2","title":"Phase 2 Randomized Trial of Flexible Dosing Schedule of 177Lu-PSMA-617 for the Treatment of Metastatic Castration-Resistant Prostate Cancer (FLEX-MRT)","status":"RECRUITING","sponsor":"Jonsson Comprehensive Cancer Center","startDate":"2024-08-01","conditions":"Prostate Carcinoma, Stage IVB Prostate Cancer American Joint Committee on Cancer (AJCC) v8","enrollment":90},{"nctId":"NCT06004661","phase":"PHASE2","title":"Study of Lutetium (177Lu) Vipivotide Tetraxetan in mCRPC Participants With Moderately and Severely Impaired and With Normal Renal Function","status":"RECRUITING","sponsor":"Novartis Pharmaceuticals","startDate":"2024-04-04","conditions":"Metastatic Castration-Resistant Prostate Cancer 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v8","enrollment":15},{"nctId":"NCT07370597","phase":"","title":"LUtetium-177 DOsimetry as a Predictive Biomarker of Response in Metastatic Prostate Cancer Patients Treated With PSMA Radioligand THerapy.","status":"RECRUITING","sponsor":"Jules Bordet Institute","startDate":"2026-02-01","conditions":"Prostate Cancer (Adenocarcinoma)","enrollment":110},{"nctId":"NCT06322576","phase":"PHASE2","title":"177Lu-PSMA (177Lu-PNT2002) in PSMA-Positive Adenoid Cystic Carcinoma","status":"TERMINATED","sponsor":"Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins","startDate":"2025-02-10","conditions":"Adenoid Cystic Carcinoma","enrollment":1},{"nctId":"NCT04647526","phase":"PHASE3","title":"Study Evaluating mCRPC Treatment Using PSMA [Lu-177]-PNT2002 Therapy After Second-line Hormonal Treatment","status":"ACTIVE_NOT_RECRUITING","sponsor":"POINT Biopharma, a wholly owned subsidiary of Eli Lilly and Company","startDate":"2021-02-25","conditions":"Metastatic Castration-Resistant Prostate 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Prostate Cancer","enrollment":58},{"nctId":"NCT07316686","phase":"PHASE1","title":"Phase I Study of Docetaxel and 177-Lutetium-PSMA-I&T in First-Line Treatment for Patients With Metastatic Castration-Resistant Prostate Adenocarcinoma","status":"NOT_YET_RECRUITING","sponsor":"Instituto do Cancer do Estado de São Paulo","startDate":"2026-01","conditions":"Prostate Cancer (Adenocarcinoma)","enrollment":18},{"nctId":"NCT06450548","phase":"NA","title":"Dynamic 68Ga-PSMA and 18F-FDG PET/CT Analysis Prior to 177Lu-PSMA","status":"RECRUITING","sponsor":"Centre Henri Becquerel","startDate":"2025-03-05","conditions":"Prostate Cancer Metastatic","enrollment":60},{"nctId":"NCT06531499","phase":"PHASE1","title":"A Study of Radiation Dosimetry, Safety, and Tolerability of Extended Lutetium (177Lu) Vipivotide Tetraxetan Treatment in Chemo-naïve Adults With Metastatic Castration-resistant Prostate Cancer: RADIOpharmaceutical DOSimetry Evaluation (RADIODOSE) Study","status":"RECRUITING","sponsor":"Novartis Pharmaceuticals","startDate":"2024-11-11","conditions":"Metastatic Castration-Resistant Prostate Cancer","enrollment":106},{"nctId":"NCT06084338","phase":"PHASE2","title":"Randomized Phase II Trial of Targeted Radiation With no Castration for Mcrpc","status":"RECRUITING","sponsor":"VA Office of Research and Development","startDate":"2023-12-14","conditions":"Prostate Cancer","enrollment":60},{"nctId":"NCT07310355","phase":"PHASE1, PHASE2","title":"68Ga-PSMA-0057 and 177Lu-PSMA-0057 in Patients With PSMA-Positive Metastatic Castration-Resistant Prostate Cancer","status":"NOT_YET_RECRUITING","sponsor":"Chengdu StarRay Therapeutics Co., Ltd","startDate":"2025-12-30","conditions":"Metastatic Castration-resistant Prostate Cancer (mCRPC)","enrollment":49},{"nctId":"NCT06881823","phase":"PHASE1, PHASE2","title":"Study to Assess [177Lu]Lu-PSMA-R2 (AAA602) and [225Ac]Ac-PSMA-R2 (AAA802) in Participants With PSMA-positive HRLPC","status":"WITHDRAWN","sponsor":"Novartis Pharmaceuticals","startDate":"2026-06-29","conditions":"Prostate Cancer","enrollment":""},{"nctId":"NCT06828263","phase":"","title":"Prospective Evaluation of Imaging Response Biomarkers During [177Lu]Lu-PSMA in Metastatic Castration-resistant Prostate Cancer","status":"RECRUITING","sponsor":"University Hospital, Grenoble","startDate":"2023-08-01","conditions":"Prostate Cancer Metastatic Disease","enrollment":130},{"nctId":"NCT05983198","phase":"PHASE1, PHASE2","title":"Phase I/II Study of [225Ac]Ac-PSMA-R2 in PSMA-positive Prostate Cancer, With/Without Prior 177Lu-PSMA RLT","status":"ACTIVE_NOT_RECRUITING","sponsor":"Novartis Pharmaceuticals","startDate":"2023-11-07","conditions":"Prostate Cancer","enrollment":29},{"nctId":"NCT07150715","phase":"PHASE2","title":"Alpha-Emitting Radionuclide or Beta-Emitting Radionuclide With Metastasis-Directed Stereotactic Body Radiotherapy for the Treatment of Recurrent, Oligometastatic Prostate Adenocarcinoma","status":"RECRUITING","sponsor":"Jonsson Comprehensive Cancer Center","startDate":"2025-12-12","conditions":"Oligometastatic Prostate Adenocarcinoma, Recurrent Prostate Adenocarcinoma","enrollment":107},{"nctId":"NCT05162573","phase":"PHASE1","title":"EBRT + Lu-PSMA for N1M0 Prostate Cancer","status":"COMPLETED","sponsor":"The Netherlands Cancer Institute","startDate":"2021-12-20","conditions":"Prostatic Neoplasm","enrollment":14},{"nctId":"NCT06105918","phase":"PHASE1","title":"Radioligand Therapy After PSMA PET Guided External Beam Radiotherapy for Treating Post-Prostatectomy Patients With Biochemically Recurrent Prostate Cancer","status":"ACTIVE_NOT_RECRUITING","sponsor":"Emory University","startDate":"2023-11-29","conditions":"Biochemically Recurrent Prostate Carcinoma, Prostate Adenocarcinoma","enrollment":6},{"nctId":"NCT05867615","phase":"PHASE2","title":"Radiometabolic Therapy With 177Lu PSMA in PSMA PET/CT Positive Advanced/Metastatic Tumours:","status":"ACTIVE_NOT_RECRUITING","sponsor":"Istituto Romagnolo per lo Studio dei Tumori Dino Amadori IRST S.r.l. IRCCS","startDate":"2023-05-25","conditions":"Cancer","enrollment":83},{"nctId":"NCT05893381","phase":"PHASE2","title":"Lu-PSMA and Stereotactic Radiotherapy Versus Radiotherapy Alone for Prostate Cancer (LUST)","status":"RECRUITING","sponsor":"Istituto Romagnolo per lo Studio dei Tumori Dino Amadori IRST S.r.l. IRCCS","startDate":"2023-06-27","conditions":"Prostate Cancer","enrollment":70},{"nctId":"NCT07054346","phase":"PHASE1","title":"Comparison of 177Lu-PSMA-617 and 225Ac-PSMA-617","status":"RECRUITING","sponsor":"Thomas Hope","startDate":"2025-07-08","conditions":"Prostate Cancer, Prostate Cancer (Diagnosis), High-risk Prostate Cancer","enrollment":45},{"nctId":"NCT06200558","phase":"","title":"ARON-3 Study: International Multicentric Retrospective Study to Collect Global Experiences in the Treatment of Patients With Metastatic PCa","status":"RECRUITING","sponsor":"Hospital of Macerata","startDate":"2024-01-31","conditions":"Prostate Cancer","enrollment":534},{"nctId":"NCT06574880","phase":"PHASE1, PHASE2","title":"STereotActic Body Radiotherapy and 177Lutetium PSMA in Locally Advanced Prostate Cancer","status":"RECRUITING","sponsor":"Angela Y. Jia, MD PhD","startDate":"2025-05-13","conditions":"Malignant Neoplasm of Prostate, Locally Advanced Prostate Cancer","enrollment":45},{"nctId":"NCT05079698","phase":"PHASE1","title":"A Study of Stereotactic Body Radiotherapy and 177Lu-PSMA-617 for the Treatment of Prostate Cancer","status":"RECRUITING","sponsor":"Memorial Sloan Kettering Cancer Center","startDate":"2021-10-01","conditions":"Prostate Cancer","enrollment":27},{"nctId":"NCT07223034","phase":"PHASE1","title":"A Study of 177Lu-PSMA-617 in People With Gliomas","status":"RECRUITING","sponsor":"Memorial Sloan Kettering Cancer Center","startDate":"2025-10-27","conditions":"Glioma, Diffuse Astrocytoma, IDH-Wildtype (Grade 2-4), Glioblastoma, IDH-wildtype","enrollment":20},{"nctId":"NCT07200830","phase":"PHASE3","title":"Testing Different Dosing Schedules of the Anti-cancer Drug, Lutetium 177Lu PSMA RLT and Its Effect on Patients With Advanced Prostate Cancer, RECIPROCAL Trial","status":"NOT_YET_RECRUITING","sponsor":"Alliance for Clinical Trials in Oncology","startDate":"2025-10-08","conditions":"Metastatic Castration-Resistant Prostate Carcinoma, Metastatic Prostate Adenocarcinoma, Stage IVB Prostate Cancer AJCC v8","enrollment":1524},{"nctId":"NCT06320067","phase":"PHASE3","title":"A Randomised Controlled Platform Trial Testing Treatments in Metastatic Hormone Sensitive Prostate Cancer","status":"RECRUITING","sponsor":"University College, London","startDate":"2024-06-11","conditions":"Prostate Cancer Metastatic","enrollment":3360},{"nctId":"NCT05113537","phase":"PHASE1, PHASE2","title":"Abemaciclib Before 177Lu-PSMA-617 for the Treatment of Metastatic Castrate Resistant Prostate Cancer","status":"RECRUITING","sponsor":"Vadim S Koshkin","startDate":"2022-07-08","conditions":"Castration-Resistant Prostate Carcinoma, Metastatic Prostate Adenocarcinoma, Stage IV Prostate Cancer AJCC v8","enrollment":30},{"nctId":"NCT03042468","phase":"PHASE1, PHASE2","title":"Phase I Dose-escalation Study of Fractionated 177Lu-PSMA-617 for Progressive Metastatic CRPC","status":"ACTIVE_NOT_RECRUITING","sponsor":"Weill Medical College of Cornell University","startDate":"2016-12","conditions":"Prostate Cancer","enrollment":50},{"nctId":"NCT05230251","phase":"PHASE1, PHASE2","title":"Radioligand fOr locAl raDiorecurrent proStaTe cancER","status":"COMPLETED","sponsor":"Glenn Bauman","startDate":"2022-03-17","conditions":"Prostate Cancer","enrollment":3},{"nctId":"NCT06200103","phase":"PHASE2","title":"Schedule De-Escalation of 177Lu-PSMA-617 for the Treatment of Metastatic Castrate Resistant Prostate Cancer","status":"RECRUITING","sponsor":"Mayo Clinic","startDate":"2024-05-03","conditions":"Castration-Resistant Prostate Carcinoma, Stage IVB Prostate Cancer AJCC v8","enrollment":236},{"nctId":"NCT06943495","phase":"PHASE1","title":"Personalized vs. Fixed-Activity 177Lu-PSMA-617 Radiopharmaceutical Therapy (PRODIGY-2)","status":"RECRUITING","sponsor":"Jean-Mathieu 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