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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)

NCT04497844 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 696

Last updated 2026-05-11

Study results available
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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

DRUG

Niraparib

Participants will receive Niraparib 200 mg once daily.

DRUG

Abiraterone acetate (AA)

Participants will receive AA 1000 mg once daily.

DRUG

Prednisone

Participants will receive prednisone 5 mg once daily.

DRUG

Placebo for Niraparib

Participants will receive matching placebo for Niraparib once daily.

Sponsors & Collaborators

  • Janssen Research & Development, LLC

    lead INDUSTRY

Principal Investigators

  • Janssen Research & Development, LLC Clinical Trial · Janssen Research & Development, LLC

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-09-23
Primary Completion
2025-01-07
Completion
2027-11-01
FDA Drug
Yes

Countries

  • United States
  • Argentina
  • Australia
  • Belarus
  • Belgium
  • Brazil
  • Bulgaria
  • Canada
  • China
  • Czechia
  • Denmark
  • France
  • Germany
  • Hungary
  • Israel
  • Italy
  • Malaysia
  • Mexico
  • Netherlands
  • New Zealand
  • Poland
  • Portugal
  • Puerto Rico
  • Russia
  • South Africa
  • South Korea
  • Spain
  • Sweden
  • Taiwan
  • Thailand
  • Turkey (Türkiye)
  • Ukraine
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04497844 on ClinicalTrials.gov