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.

Summary:

The objective of this randomized phase III open label trial is to assess if upfront combination of enzalutamide and Ra223 improves radiological progression-free survival compared to enzalutamide single agent in asymptomatic or mildly symptomatic castration resistant prostate cancer 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
  • Time from entry to initiation of next systemic therapy
  • Treatments elected after first disease progression
  • Second progression-free survival in sequential regimen
  • Pain
  • Time to pain progression
  • Occurence of adverse events
  • Time to use of opioid analgesics
  • Quality of Life

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