Trial reportThe Journal of urology2026
Enzalutamide Monotherapy for the Treatment of Prostate Cancer With High-Risk Biochemical Recurrence: EMBARK Secondary End Points.
Trial report in The Journal of urology, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. It is linked to trial NCT02319837 (A Phase 3, Randomized, Efficacy and Safety Study of Enzalutamide Plus Leuprolide, Enzalutamide Monotherapy, and Placebo Plus Leuprolide in Men With High-Risk Nonmetastatic Prostate Cancer Progressing After Definitive Therapy), which is not on this map. Cited by 3 papers.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
A Phase 3, Randomized, Efficacy and Safety Study of Enzalutamide Plus Leuprolide, Enzalutamide Monotherapy, and Placebo Plus Leuprolide in Men With High-Risk Nonmetastatic Prostate Cancer Progressing After Definitive Therapy
Who cites it
3 citing papers in PubMed.
- Redefining the standard of care for high-risk biochemical recurrence of prostate cancer after definitive therapy: insights from the EMBARK final analysis.Translational andrology and urology · 2026Article
- Enzalutamide in biochemically recurrent prostate cancer: key findings from subsequent analyses of EMBARK and their implications in clinical practice.Future oncology (London, England) · 2026Article
- Enzalutamide in biochemically recurrent prostate cancer: clinical implications from EMBARK for real-world practice.Future oncology (London, England) · 2026Article
Corrections and comments
- Erratum issued
Authors and funding
18 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
purposePrimary analysis of the phase 3 EMBARK trial reported efficacy and safety outcomes for enzalutamide monotherapy in patients with high-risk biochemical recurrence. Here, we report secondary end points for enzalutamide monotherapy vs leuprolide alone. MATERIALS AND
methodsPatients were randomized (1:1:1) to enzalutamide plus leuprolide, leuprolide alone, or enzalutamide monotherapy. Overall survival was a key secondary end point; non-key secondary end points were time to: distant metastasis, symptomatic progression, first symptomatic skeletal event, and resumption of any hormonal therapy. Sexual health was assessed using the Quality of Life Questionnaire-Prostate 25. Time-to-event end points were summarized using Kaplan-Meier methods with nominal
resultsFive-year probability rates (95% CI) for enzalutamide monotherapy vs leuprolide alone were: overall survival, 89.5% (85.6-92.4) vs 87.2% (83.0-90.4); time to remaining free from distant metastasis, 86.8% (82.3-90.2) vs 81.5% (76.3-85.7); symptomatic progression, 66.6% (61.2-71.4) vs 53.3% (47.6-58.6); and first symptomatic skeletal event, 95.8% (92.9-97.6) vs 91.5% (87.8-94.1). After treatment suspension, the 5-year probability rate (95% CI) of remaining free from resumption of any hormonal therapy for leuprolide alone vs enzalutamide monotherapy was 7.8% (4.4-12.3) vs 5.6% (3.3-8.8). Sexual health was better preserved in patients treated with enzalutamide monotherapy than leuprolide alone (HR 0.76; 95% CI: 0.62-0.94;
conclusionsSecondary end point results support enzalutamide monotherapy as a potential option to improve efficacy and preserve sexual health vs leuprolide alone for patients with high-risk biochemical recurrence.
trial registrationClinicalTrials.gov Identifier: NCT02319837.
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