At a glance
ClinicalIndex Comparison Record- ✓Male age >18 years
- ✓Diagnosis of prostate cancer (neuroendocrine differentiation allowed, but pure small-cell or pure high-grade neuroendocrine histology excluded)
- ✓Ongoing gonadal androgen deprivation therapy with GnRH analogues, antagonists, or orchiectomy
- ✓mCRPC with serum testosterone <50 ng/ml plus PSA progression, evaluable disease progression by modified RECIST 1.1, or bone disease progression
- ✕Currently receiving active therapy for other neoplastic disorder(s)
- ✕Concurrent enrollment in another clinical investigational drug or device study
- ✕Histologic evidence of small cell carcinoma (morphology alone)
- ✕Prior treatment with platinum, mitoxantrone, or PARP inhibitor for castration resistant prostate cancer
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
An Open-label, Multicenter Phase II Study to Compare the Efficacy of Carboplatin as First-line Followed by Second-line Olaparib Versus Olaparib as First-line Followed by Second-line Carboplatin in the Treatment of Patients With Castration Resistant Prostate Cancer Containing Homologous Recombination Deficiency
In Brief
A Phase 2 clinical trial evaluating Carboplatin and Olaparib for Metastatic Castrate Resistant Prostate Cancer and 2 related conditions. Currently recruiting, targeting 100 participants across 18 sites.
Signals
Detailed 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 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.
Study Details
Timeline
Interventions
Chemotherapy FDA approved drug used to treat: ovarian, lung, head and neck cancers. It is sometimes used in combination with other medications or off-label use to treat other metastatic cancers.
Olaparib is a targeted therapy drug that is used for mCRPC and is approved by the FDA for this use.