drugset / Trial / NCT02194842
Phase III Radium 223 mCRPC-PEACE III
Phase 3
Active not recruiting
446 enrolled
European Organisation for Research and Treatment of Cancer - EORTC
Astellas Pharma Europe Ltd. · collabBayer · collabCanadian Urologic Oncology Group · collabCancer Trials Ireland · collabLatin American Cooperative Oncology Group · collabUNICANCER · collab
RandomizedParallel-groupOpen-labelTreatment
Summary
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
Timeline
- Start
- 2015-10
- Primary completion
- 2024-02-19
- Completion
- 2028-12
Outcome
Met primary endpoint
release “The EORTC PEACE III study evaluating radium-223 dichloride (Xofigo™) in combination with enzalutamide met its primary endpoint of improved and demonstrated overall survival (OS).” bayer.com ↗
release “PEACE-3 is the first randomized Phase III study to demonstrate a statistically significant improvement in both radiological progression-free survival and OS” bayer.com ↗
Publications
- Tombal B, Saad F, Gallardo E, Soares A, Loriot Y, McDermott R, Briers E, Lagstrom M, Coens C, Poncet C, Fournier B, Gillessen S. A plain language summary of the EORTC 1333/PEACE-3 study of enzalutamide alone vs enzalutamide plus radium-223 in patients with metastatic castrationresistant prostate cancer (mCRPC) and bone metastases. Future Oncol. 2025 Dec;21(30):3845-3858. doi: 10.1080/14796694.2025.2592722. Epub 2025 Nov 28.
- Gillessen S, Tombal B, Turco F, Choudhury A, Rodriguez-Vida A, Gallardo E, Velho PI, Nole F, Cruz F, Loriot Y, McDermott R, Roumeguere T, Daugaard G, Yamamura R, Bompas E, Maroto P, Polo MH, da Trindade KM, Preto DD, Skoneczna I, Lecouvet F, Coens C, Fournier B, Saad F. Decrease in Fracture Rate with Mandatory Bone-protecting Agents in the EORTC 1333/PEACE-3 Trial Comparing Radium-223 Combined with Enzalutamide Versus Enzalutamide Alone: A Safety Analysis. Eur Urol. 2025 Mar;87(3):285-288. doi: 10.1016/j.eururo.2024.11.027. Epub 2025 Jan 17.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | RADIUM | Small molecule | 0.055 mbq/kg | — |
| Background | Enzalutamide | Other / unclassified | 160 mg | — |