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A Study of Niraparib in Combination With Abiraterone Acetate and Prednisone Versus Abiraterone Acetate and Prednisone for Treatment of Participants With Metastatic Prostate Cancer

NCT03748641 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 765

Last updated 2026-05-08

Study results available
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Summary

The purpose of this study is to evaluate the effectiveness of niraparib in combination with abiraterone acetate plus prednisone (AAP) compared to AAP and placebo.

Conditions

  • Castration-Resistant Prostatic Cancer

Interventions

DRUG

Niraparib

Participants will receive niraparib 200 mg capsules or tablets once daily.

DRUG

Abiraterone Acetate

Participants will receive AA 1000 mg tablets once daily.

DRUG

Prednisone

Participants will receive prednisone 10 mg tablets daily.

DRUG

Placebo

Participants will receive matching placebo once daily.

DRUG

New Formulation of Niraparib and Abiraterone Acetate (AA)

Participants will receive a new formulation of niraparib 200 mg and AA 1000 mg tablets 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
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-01-25
Primary Completion
2021-10-08
Completion
2027-02-27
FDA Drug
Yes

Countries

  • United States
  • Argentina
  • Australia
  • Belgium
  • Brazil
  • Bulgaria
  • Canada
  • China
  • Czechia
  • France
  • Germany
  • Hungary
  • Israel
  • Italy
  • Malaysia
  • Mexico
  • Netherlands
  • Poland
  • Portugal
  • Puerto Rico
  • Russia
  • South Africa
  • South Korea
  • Spain
  • Sweden
  • Taiwan
  • 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 NCT03748641 on ClinicalTrials.gov