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Protocol # 19-241


Active, not recruiting


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.


  • Castration-Resistant Prostatic Cancer


  • Niraparib
  • Abiraterone Acetate
  • Prednisone
  • Placebo
  • New Formulation of Niraparib and Abiraterone Acetate (AA)


Phase 3

Study Type


Further Study Details

Primary Outcome:

  • Cohort 1 and 3: Radiographic Progression Free Survival (rPFS)

Secondary Outcome:

  • Cohort 1: Overall survival (OS)
  • Cohort 1: Time to Symptomatic Progression
  • Cohort 1: Time to Initiation of Cytotoxic Chemotherapy
  • Cohort 1: Observed Plasma Concentrations of Niraparib
  • Cohort 1: Observed Trough Plasma Concentrations of Abiraterone
  • Cohort 1: Number of Participants with Treatment-Emergent Adverse events (TEAEs)
  • Cohort 1: Number of Participants with Treatment-Emergent Adverse events by Severity
  • Cohort 1: Number of Participants with Laboratory Abnormalities as Measure of Safety



Study Start Date

January 25, 2019


  • Gender:     Male
  • Minimum age:     18 Years
  • Maximum age:     N/A
  • Healthy volunteers:     No


Janssen Research & Development, LLC


Janssen Research & Development, LLC

Official title

A Phase 3 Randomized, Placebo-controlled, Double-blind Study of Niraparib in Combination With Abiraterone Acetate and Prednisone Versus Abiraterone Acetate and Prednisone in Subjects With Metastatic Prostate Cancer Identifier



Source: Through our founding membership in the Dana-Farber/Harvard Cancer Center, an NCI-designated Comprehensive Cancer Center, these clinical trials are conducted at the Massachusetts General Hospital Cancer Center and may be available at other partner institutions.