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

• Status: Recruiting
• Trial end date: 2022-04-01
• Target enrollment: 0
• Participant gender: Male

Summary

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Clovis Oncology, Inc.
• Collaborator: Foundation Medicine
• Treatments: Abiraterone Acetate; Docetaxel; Rucaparib

Criteria

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