# 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: 2026-09-22
- Also known as: AMPLITUDE
- 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
- Outcomes: Breast Cancer Gene (BRCA) Subgroup: Radiographic Progression-free Survival (rPFS) Assessed by Investigator: BRCA Subgroup: Placebo With Abiraterone Acetate Plus Prednisone 25.99 months vs BRCA Subgroup: Niraparib With Abiraterone Acetate Plus Prednisone, HR 0.515; HRR Effector Subgroup: Radiographic Progression-free Survival (rPFS) Assessed by Investigator: HRR Effector Subgroup: Placebo With Abiraterone Acetate Plus Prednisone 27.56 months vs HRR Effector Subgroup: Niraparib With Abiraterone Acetate Plus Prednisone, HR 0.571; All HRR: Radiographic Progression-free Survival (rPFS) Assessed by Investigator: Placebo With Abiraterone Acetate Plus Prednisone 29.54 months vs Niraparib With Abiraterone Acetate Plus Prednisone, HR 0.625

## Sources

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

## Connected records

- cancers: [Metastatic hormone-sensitive prostate cancer](https://onco.cc/cancers/prostate-mhspc/), [Prostate cancer](https://onco.cc/cancers/prostate/)
- technologies: [Androgen deprivation & AR pathway inhibitors](https://onco.cc/technologies/androgen-deprivation/), [PARP inhibitors](https://onco.cc/technologies/parp-inhibitor/)
- 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/)
- key papers: [Niraparib and abiraterone acetate plus prednisone for HRR-deficient metastatic castration-sensitive prostate cancer: a randomized phase 3 trial](https://onco.cc/key-papers/paper-nct04497844-nat-med-2025/)

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