OncRef

Clinical Trial: NCT03732820

Study on Olaparib Plus Abiraterone as First-line Therapy in Men With Metastatic Castration-resistant Prostate Cancer

Status:

ACTIVE NOT RECRUITING

Phase:

Phase 3

Lead Sponsor:AstraZeneca
Information Provided By:AstraZeneca
Last Update Posted:2026-08-18

Study Overview

Brief Summary

The purpose of this study is to evaluate the efficacy and safety (including evaluating side effects) of combination of olaparib and abiraterone versus placebo and abiraterone in patients with metastatic castration-resistant prostate cancer (mCRPC) who have received no prior cytotoxic chemotherapy or new hormonal agents (NHAs) at metastatic castration-resistant prostate cancer (mCRPC) stage.

Official Title

A Randomised, Double-blind, Placebo-controlled, Multicentre Phase III Study of Olaparib Plus Abiraterone Relative to Placebo Plus Abiraterone as First-line Therapy in Men With Metastatic Castration-resistant Prostate Cancer (PROpel Study)

Conditions

Metastatic Castration-resistant Prostate Cancer

Intervention / Treatment

  • Drug: olaparib
  • Drug: abiraterone acetate

Other Study ID Numbers

  • D081SC00001
  • 2018-002011-10
  • 2018

Start Date (Actual)

2018-10-31

Primary Completion Date (Actual)

2021-07-30

Study Completion Date (Estimated)

2027-02-05

Enrollment (Actual)

895

Study Type

Interventional

Phase

Phase 3