A Study of Enzalutamide Plus Androgen Deprivation Therapy (ADT) Versus Placebo Plus ADT in Patients With Metastatic Hormone Sensitive Prostate Cancer (mHSPC)

Official Title

A Multinational, Phase 3, Randomized, Double-blind, Placebo-controlled Efficacy and Safety Study of Enzalutamide Plus Androgen Deprivation Therapy (ADT) Versus Placebo Plus ADT in Patients With Metastatic Hormone Sensitive Prostate Cancer (mHSPC)

Summary:

The purpose of this study is to evaluate the efficacy of enzalutamide plus androgen deprivation therapy (ADT) as measured by radiographic progression-free survival (rPFS) based on central review. The study will also evaluate the safety of enzalutamide plus ADT in mHSPC.

Trial Description

Primary Outcome:

  • Radiographic progression-free survival (rPFS)
Secondary Outcome:
  • Overall survival (OS)
  • Time to first symptomatic skeletal event (SSE)
  • Time to castration resistance
  • Time to deterioration of quality of life (QoL)
  • Time to initiation of a new antineoplastic therapy
  • Time to PSA progression
  • PSA undetectable rate
  • Objective response rate
  • Time to pain progression

View this trial on ClinicalTrials.gov

Interested in this trial?

Print this page and take it to your doctor to discuss your eligibilty and treatment options. Only your doctor can refer you to a clinical trial.

Resources

Canadian Cancer Society

These resources are provided in partnership with the Canadian Cancer Society