A Study of Rucaparib Versus Physician's Choice of Therapy in Participants With Metastatic Castration-resistant Prostate Cancer and Homologous Recombination Gene Deficiency
NCT02975934 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 405
Last updated 2025-07-25
Summary
The purpose of this study is to determine how participants with metastatic castration-resistant prostate cancer, and evidence of a homologous recombination gene deficiency, respond to treatment with rucaparib versus treatment with physician's choice of abiraterone acetate, enzalutamide, or docetaxel.
Conditions
- Metastatic Castration Resistant Prostate Cancer
Interventions
- DRUG
-
Rucaparib
Rucaparib will be administered daily.
- DRUG
-
Abiraterone acetate or Enzalutamide or Docetaxel
Abiraterone acetate and enzalutamide will be administered daily. Docetaxel will be administered every 3 weeks.
Sponsors & Collaborators
- collaborator INDUSTRY
-
pharmaand GmbH
lead INDUSTRY
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- MALE
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2017-06-13
- Primary Completion
- 2022-08-25
- Completion
- 2024-08-08
- FDA Drug
- Yes
Countries
- United States
- Australia
- Belgium
- Canada
- Denmark
- France
- Germany
- Ireland
- Israel
- Italy
- Spain
- United Kingdom
Study Locations
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