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

Completed · Phase 3

Conditions studied: Metastatic Castration Resistant Prostate Cancer

In brief

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.

Key facts

Study ID

NCT02975934

Run by

pharmaand GmbH

People needed

405

Starts

2017-06-13

Expected to finish

2024-08-08

Last updated by the study team

2025-07-25

Who can join

Age: 18 and older. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Mayo Clinic - Arizona — Phoenix, Arizona, United States
• Arizona Oncology Associates - USOR — Tucson, Arizona, United States
• University of Southern California — Beverly Hills, California, United States
• Alliance Research Centers — Laguna Hills, California, United States
• VA Greater Los Angeles Healthcare System — Los Angeles, California, United States
• San Bernardino Urological Associates — San Bernardino, California, United States
• Sharp Memorial Hospital — San Diego, California, United States
• Pacific Hematology Oncology Associates — San Francisco, California, United States
• San Francisco VA Health Care System — San Francisco, California, United States
• UCSF Helen Diller Family Comprehensive Cancer Center — San Francisco, California, United States
• St. Joseph Heritage Healthcare — Santa Rosa, California, United States
• Kaiser Permanente, Northern CA — Vallejo, California, United States
• Rocky Mountain Cancer Centers — Aurora, Colorado, United States
• Yale University School of Medicine — New Haven, Connecticut, United States
• Medical Oncology Hematology Consultants - USOR — Newark, Delaware, United States
• Boca Raton Community Hospital, Inc. — Boca Raton, Florida, United States
• University of Florida Health Cancer Center — Orlando, Florida, United States
• Atlanta Urological Group — Atlanta, Georgia, United States
• Kaiser Permanente Medical Group — Honolulu, Hawaii, United States
• Ochsner Medical Center — New Orleans, Louisiana, United States
• University of Maryland Greenebaum Cancer Center — Baltimore, Maryland, United States
• Walter Reed National Military Medical Center — Bethesda, Maryland, United States
• Maryland Oncology Hematology P.A. — Columbia, Maryland, United States
• Massachusetts General Hospital — Boston, Massachusetts, United States
• University of Alabama at Birmingham — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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