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 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

• 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

View this trial on ClinicalTrials.gov