Clinical Study to Assess the Efficacy and Safety of Olaparib in Chinese Patients with Metastatic Castration-Resistant Prostate Cancer Who Have Failed Prior Treatment with a New Hormonal Agent and Have BRCA1/2 Mutations

Study identifier:D081LC00002

ClinicalTrials.gov identifier:NCT05457257

EudraCT identifier:N/A

CTIS identifier:N/A

Recruitment Complete

Official Title

A Randomized, Open-label Study to Assess the Efficacy and Safety of Olaparib Versus Enzalutamide or Abiraterone Acetate in Chinese Men with Metastatic Castration-Resistant Prostate Cancer Who Have Failed Prior Treatment with a New Hormonal Agent and Have BRCA1/2 Mutations (PROfound-CN)

Medical condition

metastatic castration-resistant prostate cancer

Phase

Phase 4

Healthy volunteers

No

Study drug

olaparib, enzalutamide, abiraterone acetate, Prednisone

Sex

Male

Actual Enrollment

43

Study type

Interventional

Age

18 Years - n/a

Date

Study Start Date: 29 Jul 2022
Estimated Primary Completion Date: 02 Sept 2024
Estimated Study Completion Date: 30 Sept 2025

Study design

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

Verification:

Verified 01 Aug 2024 by AstraZeneca

Sponsors

AstraZeneca

Collaborators

Merck Sharp & Dohme Corp.,a subsidiary of Merck & Co, Inc., Foundation Medicine, Inc., Myriad Genetics, Inc.

Inclusion and exclusion criteria