{"commentary":{"count":3,"free_build_floor":8,"listing_floor":3,"by_channel":{"x_thread":3},"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":false},"name":"PROTEUS","nct_id":"NCT03767244","offer":{"currency":"USD","how":"Order at https://www.erudio.com/contact?report=proteus-nct03767244. 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":750,"size":"focused","size_rule":"Focused: 1–12 commentary sources"},"registry":{"acronym":"PROTEUS","arms":[{"description":"Participants will receive androgen deprivation therapy (ADT) plus oral administration of apalutamide 240 milligram (mg) (4 tablets of 60 mg each) daily in each cycle (each cycle of 28 days). Participants will receive six cycles of treatment, followed by radical prostatectomy (RP) with pelvic lymph node dissection (pLND), followed by an additional six cycles of treatment. A Long-Term Extension (LTE) may be initiated at sponsor's discretion after completion of the primary endpoint analysis.","label":"Apalutamide + ADT","type":"EXPERIMENTAL"},{"description":"Participants will receive ADT with oral administration of matching placebo treatment daily in each cycle (each cycle of 28 days). Participants will receive six cycles of placebo treatment, followed by RP with pLND, followed by an additional six cycles of placebo treatment. A LTE may be initiated at sponsor's discretion after completion of the primary endpoint analysis.","label":"Placebo + ADT","type":"EXPERIMENTAL"}],"collaborators":[],"completion_date":{"date":"2028-10-13","type":"ESTIMATED"},"conditions":["Prostatic Neoplasms"],"enrollment":{"count":2517,"type":"ACTUAL"},"has_results":false,"interventions":[{"name":"Apalutamide","type":"DRUG"},{"name":"Androgen Deprivation Therapy (ADT)","type":"DRUG"},{"name":"Placebo","type":"DRUG"}],"last_update":"2026-09-25","lead_sponsor":"Janssen Research & Development, LLC","official_title":"A Randomized, Double-blind, Placebo-controlled, Phase 3 Study of Apalutamide in Subjects With High-risk, Localized or Locally Advanced Prostate Cancer Who Are Candidates for Radical Prostatectomy","overall_status":"ACTIVE_NOT_RECRUITING","phases":["PHASE3"],"primary_completion_date":{"date":"2026-12-01","type":"ESTIMATED"},"primary_outcomes":[{"measure":"Percentage of Participants with Pathologic complete response (pCR)","timeFrame":"Approximately 4 years"},{"measure":"Metastasis-Free Survival (MFS)","timeFrame":"Up to 7 years and 5 months"}],"references":[{"citation":"Taplin ME, Gleave M, Shore ND, Lopez-Gitlitz A, Kretschmer A, Efstathiou E, Nguyen PL, Damiao R, Kamoto T, Ross A, Briganti A, Hadaschik BA, Heidenreich A, Juarez Soto A, Ye H, Gotto G, Rooney B, Tian SK, Wetherhold L, Miladinovic B, McCarthy SA, Evans CP, Kibel AS; PROTEUS Investigators. Perioperative Apalutamide in High-Risk Localized Prostate Cancer. N Engl J Med. 2026 Aug 6;395(6):546-560. doi: 10.1056/NEJMoa2603878. Epub 2026 May 31.","pmid":"42223077","type":"DERIVED"},{"citation":"Ravi P, Kwak L, Xie W, Kelleher K, Acosta AM, McKay RR, Kibel AS, Taplin ME. Neoadjuvant Novel Hormonal Therapy Followed by Prostatectomy versus Up-Front Prostatectomy for High-Risk Prostate Cancer: A Comparative Analysis. J Urol. 2022 Oct;208(4):838-845. doi: 10.1097/JU.0000000000002803. Epub 2022 Sep 9.","pmid":"36082554","type":"DERIVED"}],"start_date":{"date":"2019-06-11","type":"ACTUAL"},"study_type":"INTERVENTIONAL","title":"A Study of Apalutamide in Participants With High-Risk, Localized or Locally Advanced Prostate Cancer Who Are Candidates for Radical Prostatectomy","url":"https://clinicaltrials.gov/study/NCT03767244"},"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/proteus-nct03767244"}