Carboplatin or Olaparib for BRcA Deficient Prostate Cancer
Status:
Recruiting
Trial end date:
2025-08-29
Target enrollment:
Participant gender:
Summary
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 BRCA1, BRCA2 or PALB2 inactivating DNA 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.