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. (PEACE III)

NCT02194842 Phase 3 ACTIVE_NOT_RECRUITING

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

Details

Lead sponsor	European Organisation for Research and Treatment of Cancer - EORTC
Phase	Phase 3
Status	ACTIVE_NOT_RECRUITING
Enrolment	446
Start date	2015-10
Completion	2028-12

Conditions

• Prostate Cancer

Interventions

• Ra223
• Enzalutamide

Primary outcomes

• radiological progression-free survival — 46 months after first patient entry
  Radiological progression free survival (rPFS1) is defined according to the recommendations of the "Prostate-Cancer clinical trials Working Group" version 3 and referred to as the "PCWG3"; 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 1.1 criteria for soft tissue lesions * A skeletal radiological progression defined as the appearance of ≥ 2 new bone lesions and for the first follow-up assessment only (i.e., within 12 weeks ± 1 week, during the flare period), a confirmatory scan performed ≥ 6 weeks later that shows a minimum of two or more additional new lesions (2+2 criterion) In this protocol: PSA progression is not considered disease progression and should NOT trigger a change of treatment. The rPFS1 endpoint is subject to a retrospective Blinded Independent Central Review
• progression-free survival per Blinded Independent Central Review (PFS1B) — 96 months after first patient entry
  PFS1 per BICR will be defined and analyzed in the same manner as the primary endpoint rPFS1 by investigator assessment. The central reviewers will provide timepoint assessments of skeletal and nonskeletal progression and determinations of respective progression dates from which PFS1 per BICR will be calculated.

Countries

Belgium, Brazil, Canada, Denmark, France, Ireland, Italy, Norway, Poland, Spain, Switzerland, United Kingdom