Condition: Metastatic Castrate Resistant Prostate Cancer · BARD1, BRCA1, BRCA2, BRIP1, CHEK1, FANCL, PALB2 · RAD51B, RAD51C, RAD51D, or RAD54L Mutations · Sponsor: VA Office of Research and Development
This is an unblinded, randomized clinical study comparing the efficacy of DNA damaging chemotherapy using carboplatin, to standard of care therapy for patients who have metastatic castrate resistant prostate cancer. This trial will use olaparib or carboplatin as initial therapy with crossover to the alternate or second-line drug after first progression for patients with tumors containing BARD1, BRCA1, BRCA2, BRIP1, CHEK1, FANCL, PALB2, RAD51B, RAD51C, RAD51D, or RAD54L inactivating mutations. Participants are randomized (1:1) and receive either carboplatin (AUC 5, IV) every 21 days, first or olaparib taken orally (300 mg), twice daily in 28 day cycles, until intolerance, complete response, or progression by Prostate Cancer Working Group 3 (PCWG3) criteria. Participants then crossover from the first-line therapy to the second-line therapy with the opposite study medication and receive treatment to intolerance or progression (whichever is first). Enrolled participants will be allowed to crossover to second line therapy if they continue to meet initial eligibility criteria, and at least three weeks have elapsed since last administration of either carboplatin or olaparib. Throughout the study, safety and tolerability will be assessed. Progression will be evaluated with bone scan, CT of the abdomen/pelvis, or MRI and PSA as per PCWG3 criteria.
This description comes directly from the study's public registry record.
Robert B Montgomery, MD · (206) 277-6878 · rbmontgo@uw.edu
Makayla L DeJong, BA · (206) 277-4527 · Makayla.Dejong@va.gov
Always discuss trial participation with your own doctor first.
| VA Greater Los Angeles Healthcare System, West Los Angeles, CA | West Los Angeles, California, United States | Recruiting |
| Rocky Mountain Regional VA Medical Center, Aurora, CO | Aurora, Colorado, United States | Recruiting |
| Washington DC VA Medical Center, Washington, DC | Washington D.C., District of Columbia, United States | Recruiting |
| Bay Pines VA Healthcare System, Pay Pines, FL | Bay Pines, Florida, United States | Terminated |
| Orlando VA Medical Center, Orlando, FL | Orlando, Florida, United States | Recruiting |
| Atlanta VA Medical and Rehab Center, Decatur, GA | Decatur, Georgia, United States | Recruiting |
| Boise VA Medical Center, Boise, ID | Boise, Idaho, United States | Recruiting |
| Jesse Brown VA Medical Center, Chicago, IL | Chicago, Illinois, United States | Terminated |
| VA Ann Arbor Healthcare System, Ann Arbor, MI | Ann Arbor, Michigan, United States | Recruiting |
| Minneapolis VA Health Care System, Minneapolis, MN | Minneapolis, Minnesota, United States | Recruiting |
| Kansas City VA Medical Center, Kansas City, MO | Kansas City, Missouri, United States | Recruiting |
| Manhattan Campus of the VA NY Harbor Healthcare System, New York, NY | New York, New York, United States | Recruiting |
+ 6 more locations — full list on the registry record.
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Source record: clinicaltrials.gov/study/NCT04038502