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Active Not Recruiting
NCT03748641
A Study of Niraparib in Combination With Abiraterone Acetate and Prednisone Versus Abiraterone Acetate and Prednisone for Treatment of Participants With Metastatic Prostate Cancer
Conditions: Castration-Resistant Prostatic Cancer
Sex: Male
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: PHASE3
Enrollment: 765
Sponsor: Janssen Research & Development, LLC
Location: Urology Centers Of Alabama Homewood Alabama
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.
Eligibility Criteria
Inclusion Criteria:
* HRR gene alteration (as identified by the sponsor's required assays) as follows:
1. Cohort 1: positive for HRR gene alteration
2. Cohort 2: not positive for DRD (that is, HRR gene alteration)
3. Cohort 3: eligible by HRR status
* Metastatic disease documented by positive bone scan or metastatic lesions on computed tomography (CT) or magnetic resonance imaging (MRI)
* Metastatic prostate cancer in the setting of castrate levels of testosterone less than or equal to (\
Source: ClinicalTrials.gov (NCT03748641). StuddyBuddy aggregates publicly available trial information.
