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

Study identifier:D081SC00001Sub

ClinicalTrials.gov identifier:NCT05171816

EudraCT identifier:N/A

CTIS identifier:N/A

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

108

Study type

Interventional

Age

18 Years - 99 Years

Date

Study Start Date: 24 Jun 2021
Primary Completion Date: 22 Jan 2024
Estimated Study Completion Date: 28 Apr 2026

Study design

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

Verification:

Verified 01 Sept 2024 by AstraZeneca

Sponsors

AstraZeneca

Collaborators

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

Inclusion and exclusion criteria