Phase III Radium 223 mCRPC-PEACE III (PEACE III)

Official Title

A Randomized Multicenter 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 Measures :

  • radiological progression-free survival

Radiological progression free survival (rPFS1) is defined according to the recommendations of the "Prostate-Cancer clinical trials Working Group" version 2 and referred to as the "PCWG2"; for the setting "delay/prevent" progression.

An event of progression according to their definition is either of:

  • Objective progression of the disease according to RECIST criteria for soft tissue lesions with the additional requirement that progression at the first follow-up assessment be confirmed by a second scan ≥ 6 weeks apart
  • Appearance of ≥ 2 new bone lesions (see chapter 6 for clinical examinations required) and for the first follow-up assessment only, a confirmatory scan performed ≥ 6 weeks later that shows a minimum of two or more additional new lesions

Secondary Outcome Measures :

  • 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