Study
| Phase 3, randomized, open-label, international trial (PEACE-3) |
| mCRPC with bone metastases, no visceral metastases, asymptomatic or mildly symptomatic |
| Enzalutamide 160 mg daily vs. Enzalutamide 160 mg daily + radium-223 55 kBq/kg IV every 4 wks for 6 cycles |
Efficacy
| rPFS: 16.4 mos vs. 19.4 mos (enzalutamide vs. enzalutamide + radium) (HR: 0.69 [0.54–0.87]) |
| OS: 35.0 mos vs. 42.3 mos (HR: 0.69 [0.52–0.90]) |
| 24-mo OS: 67.2% vs. 73.3% |
| TTNT: HR: 0.57 [0.44–0.75] |
Safety
| Grade ≥3 AEs: 55.8% vs. 65.6% (enzalutamide vs. enza + radium) => |
| Hypertension (34.4% vs. 33.5%), fatigue (1.8% vs. 5.5%), anemia (2.2% vs. 4.6%), neutropenia (0% vs. 4.6%) |
| Fracture incidence: 13.4% vs. 24.3% |
Ann Oncol 2025;35:in press
http://doi.org/10.1016/j.annonc.2025.05.011
Reviewed by Ulas D. Bayraktar, MD on Jun 2, 2025
