European urology oncology · 2026
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.
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Soares Andrey, Gillessen Silke, Choudhury Ananya, Saad Fred, Gallardo Enrique, Loriot Yohann, McDermott Raymond S, Rodriguez-Vida Alejo, Velho Pedro Isaacsson, Nolè Franco, Cruz Felipe Melo, Roumeguère Thierry André, Daugaard Gedske, Yamamura Rosely, Poncet Coralie, Coens Corneel, Fournier Béatrice, Tombal Bertrand F
Аннотация
DESIGN, SETTING, AND PARTICIPANTS: 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.
INTERVENTION: Enzalutamide 160 mg daily alone or combined with six-monthly injections of radium-223 (55 kBq/kg).
OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS: 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.
RESULTS AND LIMITATIONS: 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.
CONCLUSIONS: 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.
INTERVENTION: Enzalutamide 160 mg daily alone or combined with six-monthly injections of radium-223 (55 kBq/kg).
OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS: 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.
RESULTS AND LIMITATIONS: 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.
CONCLUSIONS: 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.