A Study of Rucaparib in Patients With Metastatic Castration-resistant Prostate Cancer and Homologous Recombination Gene Deficiency

Official Title

TRITON2: A Multicentre, Open-label Phase 2 Study of Rucaparib in 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.

Trial Description

Primary Outcome:

  • Objective Response Rate (ORR)
  • Prostate Specific Antigen (PSA) Response
Secondary Outcome:
  • Duration of Response (DOR)
  • Radiologic Progression-free Survival (rPFS)
  • Overall Survival (OS)
  • Clinical Benefit Rate (CBR), defined as the percentage of patients with a complete response (CR), partial response (PR) or stable disease (SD) according to modified RECIST 1.1 with no progression in bone per PCWG3 criteria
  • Time to PSA Progression
  • Trough plasma PK (Cmin) of rucaparib based on sparse sampling
  • Safety and tolerability of rucaparib assessed by AEs reported; clinical laboratory investigations; Vital signs; 12-lead ECGs; Physical examinations; and ECOG performance status

View this trial on ClinicalTrials.gov

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Resources

Canadian Cancer Society

These resources are provided in partnership with the Canadian Cancer Society