{"commentary":{"count":299,"free_build_floor":8,"listing_floor":3,"by_channel":{"x_thread":139,"youtube":85,"podcast":68,"x_video":7},"note":"Indexed podcasts, YouTube videos and X posts that name this trial. A report screens them, searches for more and cites what clinicians said when it is built."},"free_build":{"available":true,"how":"POST https://www.erudio.com/api/trial-requests with {\"nct_id\": \"NCT04720157\", \"email\": \"<work email>\"}. The person who owns that inbox must confirm by the emailed link; agents cannot confirm. The result is the report's public preview; the full report is still bought."},"name":"PSMAddition","nct_id":"NCT04720157","offer":{"currency":"USD","how":"Order at https://www.erudio.com/contact?report=psmaddition-nct04720157. The price is fixed at order. We build the report after the order and deliver it when it passes our checks; if it cannot be built to our standard, nothing is charged.","price_usd":1950,"size":"deep","size_rule":"Deep: 41+ commentary sources"},"registry":{"acronym":"PSMAddition","arms":[{"description":"Participant will receive 7.4 GBq (+/- 10%) 177Lu-PSMA-617, once every 6 weeks (+/- 1 week) for a planned 6 cycles, in addition to the Standard of Care (SOC); Androgen receptor-directed therapy (ARDT) + Androgen deprivation therapy (ADT) is considered as SOC and treatment will be administered per the physician's order","label":"177Lu-PSMA-617","type":"EXPERIMENTAL"},{"description":"For participants randomized to Standard of Care arm, ARDT +ADT is considered as SOC and treatment will be administered per the physician's order","label":"Standard of Care","type":"ACTIVE_COMPARATOR"}],"collaborators":["Alliance Foundation Trials, LLC.","RTOG Foundation, Inc."],"completion_date":{"date":"2027-02-11","type":"ESTIMATED"},"conditions":["Prostatic Neoplasms"],"enrollment":{"count":1140,"type":"ACTUAL"},"has_results":false,"interventions":[{"name":"177Lu-PSMA-617","type":"DRUG"},{"name":"68Ga-PSMA-11","type":"DRUG"},{"name":"ARDT","type":"DRUG"},{"name":"ADT","type":"DRUG"}],"last_update":"2026-06-08","lead_sponsor":"Novartis Pharmaceuticals","official_title":"An Open-label, Randomized, Phase III Study Comparing 177Lu-PSMA-617 in Combination With Standard of Care, Versus Standard of Care Alone, in Adult Male Patients With Metastatic Hormone Sensitive Prostate Cancer (mHSPC)","overall_status":"ACTIVE_NOT_RECRUITING","phases":["PHASE3"],"primary_completion_date":{"date":"2025-01-13","type":"ACTUAL"},"primary_outcomes":[{"measure":"Radiographic Progression Free Survival (rPFS)","timeFrame":"From date of randomization until date of radiographic progression or date of death from any cause, whichever comes first, assessed up to 50 months (estimated final OS analysis)"}],"references":[{"citation":"Tagawa ST, Sartor O, Piulats JM, Saad F, Fizazi K, Reid A, Beltran H, Kramer G, Mahammedi H, Eiber M, Gupta S, Castellano D, Hauke R, Kim H, Kwak C, Pang ST, Barthelemy P, Dai D, Lee JL, Nordquist L, Szmulewitz RZ, Wiechno P, Yovine A, Smith L, Bouillaud E, Sakharova O, Morris MJ; PSMAddition Investigators. [177Lu]Lu-PSMA-617 in patients with PSMA-positive metastatic androgen pathway modulator-naive/sensitive prostate cancer (PSMAddition): a phase 3 randomised, controlled trial. Lancet. 2026 Aug 6:S0140-6736(26)01092-5. doi: 10.1016/S0140-6736(26)01092-5. Online ahead of print.","pmid":"42561994","type":"DERIVED"}],"start_date":{"date":"2021-06-09","type":"ACTUAL"},"study_type":"INTERVENTIONAL","title":"An International Prospective Open-label, Randomized, Phase III Study Comparing 177Lu-PSMA-617 in Combination With Standard of Care (SoC), Versus SoC Alone, in Adult Male Patients With Metastatic Hormone Sensitive Prostate Cancer (mHSPC)","url":"https://clinicaltrials.gov/study/NCT04720157"},"report":null,"schema_id":"erudio.trial_listing","schema_version":"2.0","state":"listed","state_text":"No report yet. It can be ordered.","url":"https://www.erudio.com/trials/psmaddition-nct04720157"}