An Efficacy and Safety Study of Niraparib in Men With Metastatic Castration-Resistant Prostate Cancer and DNA-Repair Anomalies

Official Title

A Phase 2 Efficacy and Safety Study of Niraparib in Men With Metastatic Castration-Resistant Prostate Cancer and DNA-Repair Anomalies

Summary:

The purpose of this study is to assess the efficacy, safety, and pharmacokinetics of niraparib in men with metastatic castration resistant prostate cancer (mCRPC) and deoxyribonucleic acid (DNA) repair anomalies.

Trial Description

Primary Outcome:

  • Objective Response Rate (ORR)
Secondary Outcome:
  • Overall Survival (OS)
  • Radiographic Progression-Free Survival (rPFS)
  • Time to Prostate Specific Antigen (PSA) Progression
  • Time to Symptomatic Skeletal Event (SSE)
  • Number of Participants With Adverse Events as a Measure of Safety and Tolerability
  • Duration of Objective Response
  • Circulating Tumour Cells (CTC) Response
This is a multicentre and open-label (participants and researchers are aware of the treatment that participants are receiving) study that consists of 4 phases; a Prescreening Phase for biomarker evaluation only, a Screening Phase, a Treatment Phase (Cycle 1 Day 1 and will continue until the study drug is discontinued), and a Follow-up Phase (every 3 months after end of treatment visit). Participants will be monitored for safety during the study period, and up to 30 days after the last dose of study drug.

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