Treatment of High-Risk Biochemically Recurrent Prostate Cancer With Enzalutamide in Combination With Leuprolide: Secondary End Points From the EMBARK Trial.
TL;DR
Combined with the primary findings from EMBARK, data from non-key secondary efficacy endpoints strengthen support for enzalutamide combination as a new standard of care for patients with high-risk BCR.
OpenAlex 토픽 ·
Prostate Cancer Treatment and Research
Prostate Cancer Diagnosis and Treatment
Cancer, Lipids, and Metabolism
Combined with the primary findings from EMBARK, data from non-key secondary efficacy endpoints strengthen support for enzalutamide combination as a new standard of care for patients with high-risk BCR
APA
Neal D. Shore, Martin Gleave, et al. (2026). Treatment of High-Risk Biochemically Recurrent Prostate Cancer With Enzalutamide in Combination With Leuprolide: Secondary End Points From the EMBARK Trial.. The Journal of urology, 215(5), 512-525. https://doi.org/10.1097/JU.0000000000004890
MLA
Neal D. Shore, et al.. "Treatment of High-Risk Biochemically Recurrent Prostate Cancer With Enzalutamide in Combination With Leuprolide: Secondary End Points From the EMBARK Trial.." The Journal of urology, vol. 215, no. 5, 2026, pp. 512-525.
PMID
41364813
Abstract
[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] EMBARK is a global, multicenter, randomized, controlled, phase 3 trial. Patients were randomized (1:1:1) to enzalutamide combination, leuprolide alone, or enzalutamide monotherapy. Non-key secondary end points reported herein include time to distant metastasis, resumption of any hormonal therapy, castration resistance, symptomatic progression, and first symptomatic skeletal event. Hormonal treatment-related symptoms were assessed using the Quality-of-Life Questionnaire-Prostate 25. Time-to-event end points were summarized using the Kaplan-Meier method, with nominal 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.
[MATERIALS AND METHODS] EMBARK is a global, multicenter, randomized, controlled, phase 3 trial. Patients were randomized (1:1:1) to enzalutamide combination, leuprolide alone, or enzalutamide monotherapy. Non-key secondary end points reported herein include time to distant metastasis, resumption of any hormonal therapy, castration resistance, symptomatic progression, and first symptomatic skeletal event. Hormonal treatment-related symptoms were assessed using the Quality-of-Life Questionnaire-Prostate 25. Time-to-event end points were summarized using the Kaplan-Meier method, with nominal 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.
MeSH Terms
Humans; Male; Leuprolide; Benzamides; Phenylthiohydantoin; Nitriles; Neoplasm Recurrence, Local; Aged; Antineoplastic Combined Chemotherapy Protocols; Middle Aged; Prostatic Neoplasms; Quality of Life; Prostate-Specific Antigen; Antineoplastic Agents, Hormonal; Double-Blind Method
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- Strategies to Mitigate Breast-related Adverse Events in Patients with High-risk Biochemically Recurrent Prostate Cancer Receiving Enzalutamide Monotherapy: Perspectives and Challenges.
- Real-world analysis of androgen receptor inhibitors in US patients with nonmetastatic castration-resistant prostate cancer: DEAR-EXT study.
- Enzalutamide with or without leuprolide in patients with high-risk biochemically recurrent prostate cancer: EMBARK post hoc analysis by age.
- Improved Survival with Enzalutamide in Biochemically Recurrent Prostate Cancer.