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

NCT03732820 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 895

Last updated 2026-01-29

Study results available
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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.

Conditions

Interventions

DRUG

abiraterone acetate

1000 milligrams (mg) once daily

DRUG

olaparib

300 mg (2 x 150 milligrams (mg) tablets) twice daily

Sponsors & Collaborators

Principal Investigators

  • Fred Saad, MD · University of Montreal Hospital Center

  • Noel Clarke, M.D. · Christie Hospital Foundation Trust

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
99 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-10-31
Primary Completion
2021-07-30
Completion
2026-04-27
FDA Drug
Yes

Countries

  • United States
  • Australia
  • Belgium
  • Brazil
  • Canada
  • Chile
  • Czechia
  • France
  • Germany
  • Italy
  • Japan
  • Netherlands
  • Slovakia
  • South Korea
  • Spain
  • Turkey (Türkiye)
  • United Kingdom

Study Locations

More Related Trials

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 NCT03732820 on ClinicalTrials.gov