Alkaline Phosphatase and Prostate-specific Antigen Response in Metastatic Castration-resistant Prostate Cancer Treated with Enzalutamide Alone or in Combination with Radium-223: Ad Hoc Analysis of the PEACE-3 Consortium Trial.

Authors

Andrey Soares, Silke Gillessen, Ananya Choudhury, Fred Saad, Enrique Gallardo, Yohann Loriot, Raymond S McDermott, Alejo Rodriguez-Vida, Pedro Isaacsson Velho, Franco Nolè, Felipe Melo Cruz, Thierry André Roumeguère, Gedske Daugaard, Rosely Yamamura, Coralie Poncet, Corneel Coens, Béatrice Fournier, Bertrand F Tombal

Published in

European urology oncology. Aug 28, 2026. Epub Aug 28, 2026.

Abstract

Exploratory post hoc analysis of the international, randomised, open-label phase 3 PEACE-3 trial including 446 patients with asymptomatic or mildly symptomatic mCRPC and bone metastases. Overall, 441 and 436 patients were evaluable for ALP and PSA, respectively.
Enzalutamide 160 mg daily alone or combined with six-monthly injections of radium-223 (55 kBq/kg).
ALP response was defined as a ≥30% decline from baseline (ALP-30), and PSA response as a≥50% decline (PSA-50) or ≥90% decline (PSA-90). Confirmed responses required consecutive measurements ≥21 d apart. Time-to-event endpoints were analysed using Kaplan-Meier and Cox models.
At 6 months, confirmed ALP-30 response was 56.5% with the combination versus 50.8% with enzalutamide alone. Median time to confirmed ALP-30 response was 2.4 versus 3.7 months (hazard ratio [HR] 1.41, 95% confidence interval [CI] 1.12-1.78; p = 0.003), and time to ALP normalisation was 2.0 versus 4.5 months (HR 2.05, 95% CI 1.46-2.88; p < 0.001). Confirmed PSA-90 response at 6 months was 50.5% versus 34.1% (p = 0.001), with median time to confirmed PSA-90 response of 5.6 versus 22.1 months (HR 1.48, 95% CI 1.13-1.93; p = 0.004). Limitations include the exploratory post hoc design, the absence of multiplicity adjustment, and the lack of an analysis linking biomarker responses to clinical outcomes.
Adding radium-223 to enzalutamide was associated with faster and more frequent ALP and deep PSA responses. These findings support additional antitumour activity of radium-223 when combined with enzalutamide.

PMID:
42665513
Bibliographic data and abstract were imported from PubMed on 29 Aug 2026.

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