This phase III trial is trying to determine how effective an oral therapy (niraparib) is in combination with a hormone therapy and a steroid (abiraterone acetate and prednisone, AA-P) in patients with metastatic prostate cancer.
This trial is treating patients with prostate cancer.
This is a systemic therapy trial.
You may be able to join this trial if:
- Your cancer has spread to other parts of the body.
You may be excluded from this trial if:
- You have a certain disease or psychological condition.
- You have been diagnosed with a prior or secondary type of cancer.
- You have had certain treatments, surgical procedures or drugs.
Clinical trials have complex eligibility criteria - talk to your doctor about your interest in this trial.
Clinical Summary Read More
Trial Identifiers
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Scientific 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
Commercial Sponsor
Janssen-Cilag Pty Ltd
Summary
Participants will be randomised into one of two treating Arms. In one Arm, participants will receive 200mg oral niraparib in combination with 1000mg oral abiraterone acetate and 10mg oral prednisone daily in each 28 day cycle. In the second Arm, participants will receive an oral placebo in combination with 1000mg oral abiraterone acetate and 10mg prednisone daily in each 28 day cycle.
Recruiting Hospitals Read More