Active — Not RecruitingPhase 3

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

United States765 participantsStarted 2019-01-25

Plain-language 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.

Who can participate

Age range18 Years

SexMALE

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Inclusion criteria

✓. Cohort 1: positive for HRR gene alteration
✓. Cohort 2: not positive for DRD (that is, HRR gene alteration)
✓. Cohort 3: eligible by HRR status

What they're measuring

Cohort 1: Radiographic Progression-Free Survival (rPFS) as Assessed by Blinded Independent Central Review (BICR)

Timeframe: Up to 32 months

Cohort 1 Breast Cancer Gene (BRCA) Subgroup: Radiographic Progression-Free Survival (rPFS) as Assessed by Blinded Independent Central Review (BICR)

Timeframe: Up to 32 months

Trial details

NCT IDNCT03748641

SponsorJanssen Research & Development, LLC

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2021-10-08

Results submitted2023-09-08

View on ClinicalTrials.gov More Castration-Resistant Prostatic Cancer trials