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.


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

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Canadian Cancer Society

These resources are provided in partnership with the Canadian Cancer Society