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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

NCT05457257 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 43

Last updated 2026-04-21

Study results available
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Summary

The purpose of this study is to evaluate the efficacy and safety of Olaparib compared with standard of care (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.

Conditions

Interventions

DRUG

olaparib

300 mg (2x 150 mg tablets) twice daily

DRUG

enzalutamide

160 mg (4 x 40 mg capsules) once daily

DRUG

abiraterone acetate

1,000 mg (4 x 250 mg tablets) once daily

DRUG

Prednisone

5mg(5mg x 1 tablet) twice daily

Sponsors & Collaborators

Principal Investigators

  • Fangjian Zhou, M.D. · Sun Yat-Sen University Cancer Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-07-29
Primary Completion
2024-10-22
Completion
2026-12-31

Countries

  • China

Study Locations

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Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05457257 on ClinicalTrials.gov