A Study of Rucaparib Versus Physician's Choice of Therapy in Participants With Metastatic Castration-resistant Prostate Cancer and Homologous Recombination Gene Deficiency
Purpose
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.
Condition
- Metastatic Castration Resistant Prostate Cancer
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Genders
- Male
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Be 18 years old at the time the informed consent is signed - Have a histologically or cytologically confirmed adenocarcinoma or poorly differentiated carcinoma of the prostate that is metastatic - Be surgically or medically castrated, with serum testosterone levels of ≤ 50 ng/dL (1.73 nM) - Be eligible for treatment with physician's choice of comparator treatment (abiraterone acetate, enzalutamide or docetaxel) - Experienced disease progression after having received 1 prior next generation androgen receptor-targeted therapy - Have a deleterious mutation in a BRCA1/2 or ATM gene
Exclusion Criteria
- Active second malignancy, with the exception of curatively treated non melanoma skin cancer, carcinoma in situ, or superficial bladder cancer - Prior treatment with any PARP inhibitor - Prior treatment with chemotherapy for metastatic castration-resistant prostate cancer - Symptomatic and/or untreated central nervous system metastases - Pre-existing duodenal stent and/or any gastrointestinal disorder or defect that would, in the opinion of the investigator, interfere with absorption of study drug
Study Design
- Phase
- Phase 3
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Treatment
- Masking
- None (Open Label)
Arm Groups
Arm | Description | Assigned Intervention |
---|---|---|
Experimental Rucaparib |
Oral rucaparib (monotherapy). |
|
Active Comparator Abiraterone acetate or Enzalutamide or Docetaxel |
Oral abiraterone acetate (monotherapy, given in combination with prednisone). Oral enzalutamide (monotherapy). Intravenous docetaxel (monotherapy, given in combination with prednisone or prednisolone). |
|
More Details
- Status
- Active, not recruiting
- Sponsor
- pharmaand GmbH