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:
  • Time to Prostate-Specific Antigen (PSA) Progression
  • Time to First Use of New Antineoplastic Therapy
  • Overall Survival (OS)
  • Time to First Use of Cytotoxic Chemotherapy
  • FACT-P Global Score
  • Quality of Life as assessed by EQ-5D-5L and QLQ-PR25
  • Time to chemotherapy-free disease specific survival
  • Time to chemotherapy-free survival
  • Time to pain progression
  • Safety as assessed by percentage of patients with any Adverse Event (AE), AE leading to Study Drug Discontinuation, AE leading to death, Serious Adverse Event (SAE), AE related to study drug, SAE related to study drug
  • PSA response rates

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