{"entity":{"id":"nct04497844","kind":"trial","name":"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)","aka":["AMPLITUDE"],"tldr":"A phase 3 trial of Abiraterone acetate, Niraparib and Prednisone in prostate cancer, run by Janssen Research & Development, LLC, active and no longer recruiting.","summary":"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) is a phase 3 interventional study registered as NCT04497844 by Janssen Research & Development, LLC, with 696 participants enrolled, started 2020-09-23 and due to reach its primary completion in 2025-01-07. Interventions recorded: Niraparib+ Abiraterone acetate fixed dose combination (FDC), Abiraterone acetate (AA), Prednisone, Placebo FDC and Placebo AA. Results have been posted on the registry.","status":"active","asOf":"2026-09-22","links":[{"label":"ClinicalTrials.gov NCT04497844","url":"https://clinicaltrials.gov/study/NCT04497844"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["prostate","prostate-mhspc"],"sections":[],"technologies":["androgen-deprivation","parp-inhibitor"],"targets":[],"drugs":["abiraterone","niraparib","prednisone"],"companies":["johnson-johnson"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":["paper-nct04497844-nat-med-2025"],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT04497844","phase":"3","setting":"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)","sponsor":"Janssen Research & Development, LLC","started":"2020-09-23","startedType":"actual","yearReported":2026,"enrolled":696,"enrolledBasis":"registry","outcomes":[{"endpoint":"Breast Cancer Gene (BRCA) Subgroup: Radiographic Progression-free Survival (rPFS) Assessed by Investigator","primary":true,"unit":"months","arms":[{"name":"BRCA Subgroup: Placebo With Abiraterone Acetate Plus Prednisone","n":196,"value":25.99,"note":"95% CI 22.11 to 41.17; Figures from the ClinicalTrials.gov results section (first posted 2026-01-22), not from a publication"},{"name":"BRCA Subgroup: Niraparib With Abiraterone Acetate Plus Prednisone","n":191,"note":"Median and the upper limit of the 95% confidence interval (CI) were not estimable due to an insufficient number of participants with events."}],"hr":0.515,"ci":[0.37,0.717],"p":"<0.0001","source":"https://clinicaltrials.gov/study/NCT04497844?tab=results"},{"endpoint":"HRR Effector Subgroup: Radiographic Progression-free Survival (rPFS) Assessed by Investigator","primary":true,"unit":"months","arms":[{"name":"HRR Effector Subgroup: Placebo With Abiraterone Acetate Plus Prednisone","n":226,"value":27.56,"note":"95% CI 25.59 to NA; Figures from the ClinicalTrials.gov results section (first posted 2026-01-22), not from a publication"},{"name":"HRR Effector Subgroup: Niraparib With Abiraterone Acetate Plus Prednisone","n":230,"note":"Median and the upper limit of the 95% CI were not estimable due to an insufficient number of participants with events."}],"hr":0.571,"ci":[0.421,0.774],"p":"0.0003","source":"https://clinicaltrials.gov/study/NCT04497844?tab=results"},{"endpoint":"All HRR: Radiographic Progression-free Survival (rPFS) Assessed by Investigator","primary":true,"unit":"months","arms":[{"name":"Placebo With Abiraterone Acetate Plus Prednisone","n":348,"value":29.54,"note":"95% CI 25.82 to NA; Figures from the ClinicalTrials.gov results section (first posted 2026-01-22), not from a publication"},{"name":"Niraparib With Abiraterone Acetate Plus Prednisone","n":348,"note":"Median and the upper limit of the 95% CI were not estimable due to an insufficient number of participants with events."}],"hr":0.625,"ci":[0.49,0.799],"p":"0.0001","source":"https://clinicaltrials.gov/study/NCT04497844?tab=results"}]},"route":"/trials/nct04497844/","neighbours":{"cancer":[{"id":"prostate-mhspc","kind":"cancer","name":"Metastatic hormone-sensitive prostate cancer","route":"/cancers/prostate-mhspc/"},{"id":"prostate","kind":"cancer","name":"Prostate cancer","route":"/cancers/prostate/"}],"technology":[{"id":"androgen-deprivation","kind":"technology","name":"Androgen deprivation & AR pathway inhibitors","route":"/technologies/androgen-deprivation/"},{"id":"parp-inhibitor","kind":"technology","name":"PARP inhibitors","route":"/technologies/parp-inhibitor/"}],"drug":[{"id":"abiraterone","kind":"drug","name":"Abiraterone acetate","route":"/drugs/abiraterone/"},{"id":"niraparib","kind":"drug","name":"Niraparib","route":"/drugs/niraparib/"},{"id":"prednisone","kind":"drug","name":"Prednisone","route":"/drugs/prednisone/"}],"company":[{"id":"johnson-johnson","kind":"company","name":"Johnson & Johnson","route":"/companies/johnson-johnson/"}],"paper":[{"id":"paper-nct04497844-nat-med-2025","kind":"paper","name":"Niraparib and abiraterone acetate plus prednisone for HRR-deficient metastatic castration-sensitive prostate cancer: a randomized phase 3 trial","route":"/key-papers/paper-nct04497844-nat-med-2025/"}]}}