# 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)

Source: https://onco.cc/trials/nct04497844/  
OnCo record `nct04497844` (Trial). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

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.

## Fields

- Kind: Trial
- Status: active
- Last checked: 2026-09-16
- Tags: pipeline; ctgov-ingest
- Registry id: 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
- Enrolled: 696

## Sources

- ClinicalTrials.gov NCT04497844: https://clinicaltrials.gov/study/NCT04497844

## Connected records

- cancers: [Prostate cancer](https://onco.cc/cancers/prostate/)
- drugs: [Abiraterone acetate](https://onco.cc/drugs/abiraterone/), [Niraparib](https://onco.cc/drugs/niraparib/), [Prednisone](https://onco.cc/drugs/prednisone/)
- companies: [Johnson & Johnson](https://onco.cc/companies/johnson-johnson/)

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