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TRITON2: A Multicenter, Open-label Phase 2 Study of Rucaparib in Patients with Metastatic Castration-resistant Prostate Cancer Associated with Homologous Recombination Deficiency.
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.
Primary Objective: - To assess the efficacy of rucaparib based on the response rate in mCRPC patients with HRD who progressed on AR-targeted therapy (abiraterone acetate, enzalutamide, or investigational AR-targeted agent) and taxane-based chemotherapy in the castrationresistant setting Secondary Objectives: - To assess duration of response (DOR). - To assess radiologic PFS (rPFS). - To assess overall survival (OS). - To assess clinical benefit rate (CBR). - To assess PSA response >/= 50% (all participants). - To assess PSA response >/= 90% (all participants). - To assess time to PSA progression. - To characterize the steady-state pharmacokinetics (PK) of rucaparib in mCRPC patients. - To assess safety and tolerability. Exploratory Objectives: - To assess response in circulating tumor cells (CTCs). - To evaluate Patient-reported Outcome (PRO) using the EuroQol 5 dimensions questionnaire (EQ-5D), Functional Assessment of Cancer Therapy - Prostate (FACTP), analgesic drug score, and Brief Pain Inventory - Short Form (BPI-SF) instruments. - To assess changes in the molecular profile over time of matched pre and post-treatment tumor or plasma samples. - To assess concordance in HR gene mutation status in matched screening biopsy tissue, archival primary tumor tissue and plasma circulating tumor DNA (ctDNA). - To assess ctDNA as a molecular marker of response. - To assess CTC phenotype as a marker of response. - To assess time to first subsequent antineoplastic therapy. - To evaluate loss of heterozygosity (LOH) in metastatic disease site biopsy and archival primary tumor tissue samples. - To evaluate mechanisms of response and resistance in ctDNA and progression tumor tissue samples.