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.

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

Trial Phase Phase III

Trial Type Treatment

Lead Organization
Clovis Oncology

• Primary ID CO-338-063
• Secondary IDs NCI-2017-01110, s16-02260
• Clinicaltrials.gov ID NCT02975934