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

Study identifier:D081SC00001

ClinicalTrials.gov identifier:NCT03732820

EudraCT identifier:2018-002011-10

CTIS identifier:2024-511144-86-00

Recruitment Complete

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)

Medical condition

metastatic castration-resistant prostate cancer

Phase

Phase 3

Healthy volunteers

No

Study drug

olaparib, abiraterone acetate

Sex

Male

Actual Enrollment

895

Study type

Interventional

Age

18 Years - 99 Years

Date

Study Start Date: 31 Oct 2018
Primary Completion Date: 30 Jul 2021
Estimated Study Completion Date: 04 Nov 2024

Study design

Allocation: Randomized
Endpoint Classification: -
Intervention Model: Parallel Assignment
Masking: -
Primary Purpose: Treatment

Verification:

Verified 01 Jun 2024 by AstraZeneca

Sponsors

AstraZeneca

Collaborators

Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.

Inclusion and exclusion criteria