A Study of Rucaparib in Patients With Metastatic Castration-resistant Prostate Cancer and Homologous Recombination Gene Deficiency

Completed · Phase 2

Conditions studied: Metastatic Castration Resistant Prostate Cancer

In brief

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.

Key facts

Study ID

NCT02952534

Run by

pharmaand GmbH

People needed

277

Starts

2017-02-15

Expected to finish

2021-07-27

Last updated by the study team

2023-06-09

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 form is signed
• Have a histologically or cytologically confirmed adenocarcinoma or poorly differentiated carcinoma of the prostate
• Be surgically or medically castrated, with serum testosterone levels of ≤ 50 ng/dL (1.73 nM)
• Experienced disease progression after having received at least 1 but no more than 2 prior next-generation androgen receptor-targeted therapies, and 1 prior taxane-based chemotherapy, for castration-resistant disease
• Have a deleterious mutation in BRCA1/2 or ATM, or molecular evidence of other homologous recombination deficiency

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, mitoxantrone, cyclophosphamide or any platinum-based chemotherapy
• 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 rucaparib

Where it is running

• Mayo Clinc — Phoenix, Arizona, United States
• Arizona Oncology Associates — Tucson, Arizona, United States
• Alliance Research Centers — Laguna Hills, California, United States
• VA Greater Los Angeles Healthcare System — Los Angeles, California, United States
• University of Southern California — Los Angeles, California, United States
• Stanford University — Palo Alto, 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
• Redwood Regional Medical Group — Santa Rosa, California, United States
• Kaiser Permanente Medical Center (Vallejo) — Vallejo, California, United States
• Rocky Mountain Cancer Centers — Aurora, Colorado, United States
• Yale School of Medicine — New Haven, Connecticut, United States
• 4701 Ogletown Stanton Rd. — Newark, Delaware, United States
• Georgetown University Medical Center — Washington D.C., District of Columbia, United States
• Boca Raton Community Hospital, Inc. — Boca Raton, Florida, United States
• Florida Cancer Specialists — Fort Myers, Florida, United States
• University of Florida Health Cancer Center — Orlando, Florida, United States
• Moffitt Cancer Center — Tampa, Florida, United States
• Atlanta Urological Group — Atlanta, Georgia, United States
• University of Chicago Comprehensive Cancer Center — Chicago, Illinois, United States
• Ochsner Medical Center — New Orleans, Louisiana, United States
• University of Maryland Greenebaum Cancer Center — Baltimore, Maryland, United States
• University of Alabama at Birmingham — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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