{"preliminary_commentary":{"by_channel":{"x_thread":3},"note":"Preliminary. Indexed podcasts, YouTube videos and X posts that name this trial so far. This is where a report starts, not where it ends: the build searches for more, so finished reports usually cover more than this."},"free_build":{"available":false},"commentary_summary":null,"drugs_tested":[["niraparib"]],"indication":"HRR-deficient metastatic castration-sensitive prostate cancer","name":"AMPLITUDE","nct_id":"NCT04497844","offer":{"currency":"USD","how":"Order at https://www.erudio.com/contact?report=amplitude-nct04497844. The price is an estimate of verified statements from the commentary indexed so far. Final coverage is set when the report is built. You never pay more than quoted: if the report is delivered at a smaller size, you pay that size's price, and anything paid above it is refunded. We build the report within 24 hours of confirming the order and deliver it when it passes our checks; if it cannot be built to our standard, nothing is charged.","price_rule":"Never more than quoted: the buyer pays the smaller of price_usd and the price the delivered edition is sold at.","price_usd":750,"size":"focused","size_rule":"Focused: 1–150 verified statements, estimated at 14 per indexed commentary source"},"registry":{"acronym":"AMPLITUDE","arms":[{"description":"Participants will receive the following in each 28-day treatment cycle: niraparib 200 milligrams (mg) + abiraterone acetate (AA) 1000 mg fixed dose combination (FDC) along with placebo for AA and prednisone 5 mg once daily.","label":"Niraparib with Abiraterone Acetate plus Prednisone (AAP)","type":"EXPERIMENTAL"},{"description":"Participants will receive the following in each 28-day treatment cycle: matching placebo for Niraparib+AA FDC along with AA 1000 mg and prednisone 5 mg once daily.","label":"Placebo for Niraparib + AA FDC plus AA and prednisone (AAP)","type":"ACTIVE_COMPARATOR"}],"collaborators":[],"completion_date":{"date":"2027-11-01","type":"ESTIMATED"},"conditions":["Prostatic Neoplasms"],"enrollment":{"count":696,"type":"ACTUAL"},"has_results":true,"interventions":[{"name":"Niraparib+ Abiraterone acetate fixed dose combination (FDC)","otherNames":[],"type":"COMBINATION_PRODUCT"},{"name":"Abiraterone acetate (AA)","otherNames":[],"type":"DRUG"},{"name":"Prednisone","otherNames":[],"type":"DRUG"},{"name":"Placebo FDC","otherNames":[],"type":"DRUG"},{"name":"Placebo AA","otherNames":[],"type":"DRUG"}],"last_update":"2026-11-04","lead_sponsor":"Janssen Research & Development, LLC","official_title":"A Phase 3 Randomized, Placebo-controlled, Double-blind Study of Niraparib in Combination With Abiraterone Acetate and Prednisone Versus Abiraterone Acetate and Prednisone for the Treatment of Participants With Deleterious Germline or Somatic Homologous Recombination Repair (HRR) Gene-Mutated Metastatic Castration-Sensitive Prostate Cancer (mCSPC)","overall_status":"ACTIVE_NOT_RECRUITING","phases":["PHASE3"],"primary_completion_date":{"date":"2025-01-07","type":"ACTUAL"},"primary_outcomes":[{"measure":"Breast Cancer Gene (BRCA) Subgroup: Radiographic Progression-free Survival (rPFS) Assessed by Investigator","timeFrame":"From date of randomization (Day -3 to Day 1) up to approximately 49 months"},{"measure":"HRR Effector Subgroup: Radiographic Progression-free Survival (rPFS) Assessed by Investigator","timeFrame":"From date of randomization (Day -3 to Day 1) up to approximately 49 months"},{"measure":"All HRR: Radiographic Progression-free Survival (rPFS) Assessed by Investigator","timeFrame":"From date of randomization (Day -3 to Day 1) up to approximately 49 months"}],"references":[{"citation":"Attard G, Agarwal N, Graff JN, Sandhu S, Efstathiou E, Ozguroglu M, Pereira de Santana Gomes AJ, Vianna K, Luo H, Gotto GT, Cheng HH, Kim W, Varela CR, Schaeffer D, Kramer K, Li S, Baron B, Shen F, Mundle SD, McCarthy SA, Olmos D, Chi KN, Rathkopf DE. Niraparib and abiraterone acetate plus prednisone for HRR-deficient metastatic castration-sensitive prostate cancer: a randomized phase 3 trial. Nat Med. 2025 Dec;31(12):4109-4118. doi: 10.1038/s41591-025-03961-8. Epub 2025 Oct 7.","pmid":"41057655","type":"DERIVED"}],"start_date":{"date":"2020-09-23","type":"ACTUAL"},"study_type":"INTERVENTIONAL","title":"A Study of Niraparib in Combination With Abiraterone Acetate and Prednisone Versus Abiraterone Acetate and Prednisone for the Treatment of Participants With Deleterious Germline or Somatic Homologous Recombination Repair (HRR) Gene-MutatedProstatic Neoplasms (mCSPC)","url":"https://clinicaltrials.gov/study/NCT04497844"},"report":null,"schema_id":"erudio.trial_listing","schema_version":"3.2","state":"listed","state_text":"No report yet. It can be ordered.","url":"https://www.erudio.com/trials/amplitude-nct04497844"}