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-Mutated Metastatic Castration-Sensitive Prostate Cancer (mCSPC)

Study Summary

The purpose of the study is to determine if the combination of niraparib with Abiraterone Acetate (AA) plus prednisone compared with AA plus prednisone in participants with deleterious germline or somatic Homologous Recombination Repair (HRR) gene-mutated Metastatic Castration-Sensitive Prostate Cancer (mCSPC) provides superior efficacy in improving radiographic progression-free survival (rPFS).

Conditions

Metastatic Castration-sensitive Prostate Cancer

Interventions / Drugs

Niraparib Abiraterone acetate (AA)Prednisone Placebo for Niraparib

View on ClinicalTrials.gov ↗

Sponsor

Study Details

Enrollment696 participants

Primary Completion—

Lead SponsorJanssen Research & Development, LLC

Data Retrieved2026-04-11 02:55:31.550544+00:00

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