PEACE-3 trial demonstrates significant overall survival benefit in patients with metastatic castration-resistant prostate cancer with bone metastases

Brussels, Belgium – The final results from the pivotal Phase III PEACE-3 trial demonstrated that first-line treatment with the androgen receptor inhibitor (ARI) enzalutamide in combination with radium-223 dichloride resulted in a significant overall survival (OS) benefit, reducing the risk of death by 24% versus enzalutamide alone in men with metastatic castration-resistant prostate cancer (mCRPC) and bone metastases. These data will be presented in an oral session at the American Society of Clinical Oncology Genitourinary Cancers Symposium (ASCO GU) 2026 (Oral abstract #15; February 26, 2026. 8:15 – 8:25 AM PST) and published simultaneously in Annals of Oncology.

“Despite recent advances in prostate cancer care, many men with mCRPC and bone metastases continue to face a poor prognosis and a high risk of disease progression,” said Enrique Gallardo, MD, Parc Tauli Hospital Universitari, Sabadell, Spain and Principal Investigator of the EORTC 1333/PEACE-3 trial. “Results from PEACE-3 show that starting with enzalutamide in combination with radium-223, which targets both the cancer and the bone metastases, may help patients live longer while supporting treatment strategies that prioritize bone health, an important consideration in helping men preserve function and retain their independence for longer.”

At the time of the final OS analysis, men receiving enzalutamide in combination with radium‑223 demonstrated a statistically significant improvement in OS compared to those receiving enzalutamide alone, with a 24% reduction in risk of death (hazard ratio (HR)=0.76, 95% CI 0.60-0.96, p=0.0096) . Median OS was 38.2 months with enzalutamide plus radium‑223 versus 32.6 months with enzalutamide alone. The OS benefit was generally consistent across most predefined subgroups.

These final OS results build on the primary analysis, published in Annals of Oncology in 2025, which showed a significant improvement in radiological progression-free survival (rPFS) with the combination versus enzalutamide alone (19.4 vs. 16.4 months respectively; HR 0.69; 95% CI 0.54–0.87; p=0.0009).

“PEACE-3 is a strong example of how academic cooperative research can help advance progress for complex diseases such as metastatic prostate cancer,” Denis Lacombe, Chief Executive Officer, European Organization for Research and Treatment of Cancer (EORTC). “These Phase III data provide important insights for clinicians and underline the value of international collaboration in generating evidence that supports clinical decision-making.”

“These new PEACE-3 data reinforce Bayer’s leadership and long‑term commitment to advancing prostate cancer care through differentiated, targeted therapies,” said Christine Roth, Executive Vice President, Global Product Strategy and Commercialization and Member of the Pharmaceuticals Leadership Team at Bayer. “By advancing combination approaches, we are building a growing prostate cancer portfolio designed to address the most pressing unmet medical needs and bring hope to patients across different stages of the disease. We look forward to engaging with the U.S. FDA and the EMA to bring radium-223 dichloride in combination with enzalutamide to men with mCPRC.”

Radium-223 dichloride is approved under the brand name Xofigo® in more than 50 countries for the treatment of patients with mCRPC, who have symptomatic bone metastases and no known visceral metastatic disease.

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

About PEACE-3 (EORTC GUCG-1333)

The PEACE-3 trial is an international, randomised, open-label, Phase III trial designed to investigate the efficacy and safety of XOFIGO in combination with enzalutamide in patients with mCRPC and bone metastases. A total of 446 asymptomatic or mildly symptomatic patients (Brief Pain Inventory WP24 score <4) with mCRPC and ≥2 bone metastases were randomized 1:1 to receive enzalutamide 160 mg once daily alone or in combination with six intravenous injections of radium‑223 dichloride (55 kBq/kg every four weeks).

The primary endpoint was radiological progression-free survival (rPFS) by investigator assessment. Key secondary endpoints included overall survival (OS), time to subsequent systemic treatment, pain progression, and symptomatic skeletal event.

This trial was a collaboration with several cancer cooperative groups: the European Organisation for Research and Treatment of Cancer (EORTC), Clinical Trial Ireland (CTI), the Canadian Urological Oncology Group (CUOG), the Latin American Cooperative Oncology Group (LACOG), and French UNICANCER Urogenital Tumor Study Group (GETUG).

About EORTC

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.

Contact

Caroline Moulins
Head of Communications
caroline.moulins@eortc.org