Phase III Radium 223 mCRPC-PEACE III

Official Title

A Randomized Multicentre Phase III Trial Comparing Enzalutamide vs. a Combination of Ra223 and Enzalutamide in Asymptomatic or Mildly Symptomatic Castration Resistant Prostate Cancer Patients Metastatic to Bone.


The primary objective of the trial is to assess if upfront combination of enzalutamide and Ra223 improves radiological progression-free survival (rPFS1) compared to enzalutamide single agent in CRPC patients metastatic to bone

Trial Description

Primary Outcome:

  • radiological progression-free survival
Secondary Outcome:
  • Overall survival
  • prostate cancer specific survival
  • First symptomatic skeletal event
  • Time and incidence of first skeletal progression-free survival
  • Time from entry to initiation of next systemic anti-neoplastic therapy
  • Treatments elected after first disease progression
  • Second progression-free survival in sequential regimen
  • Patient self-rate scale assessing the pain associated to prostate cancer
  • Time to pain progression
  • Occurence of adverse events
  • Time to opiate use for cancer-related pain
  • Patient self-rate scale assessing the Quality of Life
  • rate of skeletal fractures

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Canadian Cancer Society

These resources are provided in partnership with the Canadian Cancer Society