A Study of Rucaparib Versus Physician's Choice of Therapy in Patients With Metastatic Castration-resistant Prostate Cancer and Homologous Recombination Gene Deficiency


The purpose of this study is to determine how patients 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.


  • Metastatic Castration Resistant Prostate Cancer


Eligible Ages
Over 18 Years
Eligible Genders
Accepts Healthy Volunteers

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 for castration-resistant disease - 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 3
Study Type
Intervention Model
Parallel Assignment
Primary Purpose
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Oral rucaparib (monotherapy).
  • Drug: Rucaparib
    Rucaparib will be administered daily.
    Other names:
    • CO-338
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).
  • Drug: Abiraterone acetate or Enzalutamide or Docetaxel
    Abiraterone acetate and enzalutamide will be administered daily. Docetaxel will be administered every 3 weeks.
    Other names:
    • Zytiga (abiraterone acetate) or Xtandi (enzalutamide) or Taxotere (docetaxel)

Recruiting Locations

University of Maryland Greenebaum Cancer Center
Baltimore, Maryland 21201

More Details

Clovis Oncology, Inc.

Study Contact

Clovis Oncology Clinical Trial Navigation Service
1-855-262-3040 (USA)