A Study of Rucaparib Versus Physician's Choice of Therapy in Patients With Metastatic Castration-resistant Prostate Cancer and Homologous Recombination Gene Deficiency

Official Title

TRITON3: A Multicentre, Randomized, Open Label Phase 3 Study of Rucaparib Versus Physician's Choice of Therapy for Patients With Metastatic Castration Resistant Prostate Cancer Associated With Homologous Recombination Deficiency

Summary:

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 versus treatment with physician's choice of abiraterone acetate, enzalutamide, or docetaxel.

Trial Description

Primary Outcome:

• Radiographic Progression-free Survival (rPFS)

• Objective Response Rate (ORR)
• Duration of Response (DOR)
• Time to Prostate Specific Antigen (PSA) Progression
• PSA Response
• Change in Patient-reported Outcome (PRO)
• Clinical Benefit Rate (CBR), defined as the percentage of patients with a complete response (CR), partial response (PR), and stable disease (SD) according to modified RECIST Version 1.1 with no progression in bone per PCWG3 criteria
• Overall Survival
• Trough plasma PK (Cmin) of rucaparib based on sparse sampling
• Number of participants with Adverse Events (AEs) as a measure of safety and tolerability

View this trial on ClinicalTrials.gov