Abiraterone/Prednisone, Olaparib, or Abiraterone/Prednisone + Olaparib in Patients With Metastatic Castration-Resistant Prostate Cancer With DNA Repair Defects (NCT03012321)
BRCAAway: A Randomized Phase II Trial of Abiraterone, Olaparib, or Abiraterone + Olaparib in Patients With Metastatic Castration-Resistant Prostate Cancer With DNA Repair Defects
🩺 Plain-English Summary (8th-Grade Level)
This is a biomarker preselected, randomized, open-label, multicenter, phase II study in men with metastatic castration resistant prostate cancer (mCRPC). Patients with tumors that have ATM, BRCA1 and/or BRCA2 mutations/deletions/loss of heterozygosity will be randomized in a 1:1:1 fashion to each arm. Patients with mutations in noncanonical DNA repair genes including FANCA, PALB2, RAD51, ERCC3, MRE11, NBN, MLH3, CDK12, CHEK2, HDAC2, ATR, PMS2, GEN1, MSH2, MSH6, BRIP1, or FAM175A defects will be assigned to Arm IV with single agent olaparib.
Who can join: To join this study, participants generally need to meet the listed inclusion criteria (19 items) and avoid the listed exclusions (36 items).
Location: University of California Los Angeles — Los Angeles, California
Age range: 18 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistCheck every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).
Usually NOT eligible if any of the following apply:
- Exclusion Criteria:
- Prior exposure to CYP17 (other than ketoconazole) or PARP inhibitors for prostate cancer. Patients with prior exposure to ketoconazole are eligible.
- Prior chemotherapy for castration resistant disease. Chemotherapy given in the hormone-sensitive setting is permissible if stopped at least 4 weeks prior to registration. Note: Patients can receive a stable dose of bisphosphonates for bone metastases, including zoledronic acid, or denosumab before and during the study as deemed appropriate by the treating physician.
- Prior exposure to enzalutamide, ARN-509 or other investigational AR-directed therapy in the setting of mCRPC.
- Patients with a currently active second malignancy excluding non-melanomatous skin cancer or superficial transitional cell carcinoma. Note: Patients are not considered to have a "currently active" malignancy if they have completed all therapy and are now considered without evidence of disease for 1 year.
- Patients receiving any other investigational agents. Any prior investigational agents must be stopped at least 14 days (2 week washout) prior to registration.
- Patients who have received itraconazole, ketoconazole, or fluconazole within 3 weeks prior to registration or those who have not recovered (i.e., back to baseline or Grade 1) from AEs due to agents administered more than 3 weeks earlier.
- Patients with a history of active seizures (or a single confirmed seizure event) in the last 2 years from the time of registration.
- Patients with a history of pituitary or adrenal dysfunction or active or symptomatic viral hepatitis or chronic liver disease are not eligible.
- Patients with active brain metastases. A scan to confirm the absence of brain metastases is not required for asymptomatic patients.
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to olaparib or abiraterone.
- Patients considered a poor medical risk due to a serious, uncontrolled medical disorder, non-malignant systemic disease or active, uncontrolled infection. Examples include, but are not limited to, uncontrolled ventricular arrhythmia, recent (within 3 months) myocardial infarction, unstable spinal cord compression (untreated or unstable within at least 28 days prior to registration), superior vena cava syndrome, and extensive bilateral lung disease on HRCT scan or any psychiatric disorder that prohibits obtaining informed consent.
🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.
📍 All Participating Trial Locations (16 Sites)
- University of California Los Angeles — Los Angeles, California
- H. Lee Moffitt Cancer Center and Research Institute — Tampa, Florida
- Northwestern Medicine — Chicago, Illinois
- Rush University Cancer Center — Chicago, Illinois
- University of Chicago — Chicago, Illinois
- Kellogg Cancer Center - NorthShore University — Evanston, Illinois
- Indiana University/ Melvin and Bren Simon Cancer Center — Indianapolis, Indiana
- Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins — Baltimore, Maryland
- University of Michigan Health System — Ann Arbor, Michigan
- University of Michigan Rogel Cancer Center — Detroit, Michigan
- Washington University School of Medicine — St Louis, Missouri
- Rutgers Cancer Institute of New Jersey — New Brunswick, New Jersey
- Weill Cornell Medical College — New York, New York
- University of North Carolina at Chapel Hill — Chapel Hill, North Carolina
- Huntsman Cancer Institute - University of Utah — Salt Lake City, Utah
- University of Virginia — Charlottesville, Virginia
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
More studies in Prostate Cancer Metastatic Castration-Resistant
- External Beam and Radioligand Radiotherapy for mCRPC — Montreal, Quebec
Explore by condition: All Prostate Cancer Metastatic Castration-Resistant clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Review the official NIH record below to find the coordinating site.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.