Safety and Efficacy Study of Enzalutamide in Patients With Nonmetastatic Castration-Resistant Prostate Cancer

Official Title

A Multinational, Phase 3, Randomized, Double Blind, Placebo Controlled, Efficacy and Safety Study of Enzalutamide in Patients With Nonmetastatic Castration Resistant Prostate Cancer

Summary:

The purpose of this study is to assess the safety and efficacy of enzalutamide in patients with non metastatic prostate cancer.

Trial Description

Primary Outcome:

  • Metastasis Free Survival (MFS)
Secondary Outcome:
  • Overall Survival (OS)
  • Time to Pain Progression
  • Time to Opiate Use for Prostate Cancer Pain
  • Time to First Use of Cytotoxic Chemotherapy
  • Time to First Use of New Antineoplastic Therapy
  • Time to Prostate-Specific Antigen (PSA) Progression
  • FACT-P Global Score
  • Quality of Life as assessed by EQ-5D-5L and QLQ-PR25

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