EORTC Announces Final Overall Survival Results from the PEACE-3 Trial

The European Organisation for Research and Treatment of Cancer (EORTC) is pleased to announce that the EORTC 1333/PEACE-3 trial has reached its final overall survival (OS) endpoint at the time of the final database lock on September 19, 2025.

The EORTC 1333/PEACE-3 study is a randomized, open-label, multicentre phase III trial conducted in collaboration with Clinical Trial Ireland (CTI), the Canadian Urological Oncology Group (CUOG), the Latin American Cooperative Oncology Group (LACOG), and the French group GETUG/UNICANCER. A total of 446 asymptomatic or mildly symptomatic patients (Brief Pain Inventory score < 4) with metastatic castration-resistant prostate cancer (mCRPC) and ≥2 bone metastases were randomized 1:1 to receive either enzalutamide (160 mg daily) alone or enzalutamide plus six intravenous injections of radium-223 (55 kBq/kg every four weeks).

In the primary analysis, published in Annals of Oncology, the addition of six cycles of radium-223 to enzalutamide significantly improved the primary endpoint radiological progression-free survival (rPFS) from 16.4 months (95% CI 13.8–19.2) to 19.4 months (95% CI 17.1–25.3) (hazard ratio [HR] 0.69; 95% CI 0.54–0.87; p = 0.0009)¹, and an interim analysis at 80% of events that suggested an OS advantage for combining enzalutamide and Ra223.

The final overall survival analysis now confirms that the addition of six cycles of radium-223 to enzalutamide significantly prolongs overall survival, thereby reinforcing the findings of the interim analysis reported at the time of the primary publication.

Comprehensive results will be presented soon.

This trial is supported by an investigator driven clinical trial agreement from Bayer HealthCare Pharmaceuticals Inc. and Astellas Pharma Europe.

The European Organisation for Research and Treatment of Cancer (EORTC) is a non-governmental, non-profit organisation, which unites clinical cancer research experts, throughout Europe, to define better treatments for cancer patients to prolong survival and improve quality of life. Spanning from translational to large, prospective, multi-centre, phase III clinical trials that evaluate new therapies and treatment strategies as well as patient quality of life, its activities are coordinated from EORTC Headquarters, a unique international clinical research infrastructure, based in Brussels, Belgium.