Treatment of High-Risk Biochemically Recurrent Prostate Cancer With Enzalutamide in Combination With Leuprolide: Secondary End Points From the EMBARK Trial

作者：Neal D. Shore, Martin Gleave, Ugo De Giorgi, Antti Rannikko, Christopher Pieczonka, Swetha Sridharan, Klaus Brasso, Henry H. Woo, Antonio Gómez‐Caamaño, Jeff Saranchuk, Luke T. Nordquist, Ubirajara Ferreira, Yiyun Tang, Brad Rosbrook, Gabriel P. Haas, Matt Rosales, Fabian Zohren, Jamal Tarazi, Stephen J. Freedland · 发表于：The Journal of Urology · 年份：2025 · DOI：10.1097/ju.0000000000004890 · 被引用次数：1 · 研究领域：Prostate Cancer Treatment and Research、Prostate Cancer Diagnosis and Treatment、Cancer, Lipids, and Metabolism

PURPOSE: The primary analysis of EMBARK reported improved metastasis-free survival for enzalutamide plus leuprolide (enzalutamide combination) vs leuprolide plus placebo (leuprolide alone) in patients with high-risk biochemical recurrence while maintaining quality of life. Here, we present secondary efficacy end points for enzalutamide combination vs leuprolide alone. MATERIALS AND METHODS: values. RESULTS: Enzalutamide combination vs leuprolide alone was associated with increased 5-year probabilities (95% CI) for remaining free of distant metastasis (91.0% [87.1-93.7] vs 81.5% [76.3-85.7]), resumption of any hormonal therapy after treatment suspension (14.9% [10.8-19.6] vs 7.8% [4.4-12.3]), castration resistance (96.6% [93.9-98.1] vs 67.8% [62.4-72.6]), symptomatic progression (70.9% [65.5-75.6] vs 53.3% [47.6-58.6]), and first symptomatic skeletal event (97.8% [95.4-98.9] vs 91.5% [87.8-94.1]). Time to confirmed clinically meaningful deterioration of hormonal treatment-related symptoms favored leuprolide alone vs enzalutamide combination, although the median difference was small (0.03 months). CONCLUSIONS: Combined with the primary findings from EMBARK, data from non-key secondary efficacy end points strengthen support for enzalutamide combination as a new standard of care for patients with high-risk biochemical recurrence. CLINICAL TRIAL REGISTRATION NUMBER: NCT02319837.