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Enzalutamide Monotherapy Shows Higher Survival and Metastasis-Free Rates Versus Leuprolide in High-Risk Biochemical RecurrenceEnzalutamide shows better outcomes than leuprolide for high risk prostate cancer recurrence

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Key Takeaway
Consider enzalutamide monotherapy for high-risk biochemical recurrence showing improved survival and sexual health.

This Phase 3 randomized controlled trial assessed enzalutamide monotherapy versus leuprolide alone in patients with high-risk biochemical recurrence prostate cancer. The sample size and setting were not reported. Follow-up duration was 60.0 months.

Enzalutamide monotherapy showed higher 5-year probability rates compared to leuprolide alone across multiple endpoints. Overall survival was 89.5% versus 87.2% (95% CI: 85.6-92.4 vs 83.0-90.4). Time to remaining free from distant metastasis was 86.8% versus 81.5% (95% CI: 82.3-90.2 vs 76.3-85.7). Time to symptomatic progression was 66.6% versus 53.3% (95% CI: 61.2-71.4 vs 47.6-58.6). Time to first symptomatic skeletal event was 95.8% versus 91.5% (95% CI: 92.9-97.6 vs 87.8-94.1). Time to resumption of any hormonal therapy showed Leuprolide alone 7.8% versus Enzalutamide monotherapy 5.6% (95% CI: 4.4-12.3 vs 3.3-8.8). Sexual health quality of life was better preserved in enzalutamide monotherapy (HR 0.76; 95% CI: 0.62-0.94; p = .008).

Safety information including adverse events, serious adverse events, discontinuations, and tolerability was not reported. There were no limitations listed in the provided data. The primary outcome was not reported.

Practice relevance indicates secondary end point results support enzalutamide monotherapy as a potential option to improve efficacy and preserve sexual health versus leuprolide alone for patients with high-risk biochemical recurrence. The randomized controlled trial design supports causal inference.

This study looked at men with high-risk prostate cancer that returned after initial treatment. It was a randomized controlled trial comparing enzalutamide alone against leuprolide alone. The research followed patients for five years to see how long they lived and how the cancer behaved over time.

Results showed enzalutamide was associated with higher survival rates and less cancer spread to other parts of the body. Patients taking enzalutamide also stayed free from symptoms longer and had better sexual health scores. The chance of needing more hormone therapy was lower with enzalutamide compared to leuprolide.

Important details are missing from this report. The total number of patients and specific safety side effects were not shared. Because this is only an abstract, we do not have full information on how well the drugs were tolerated or if there were serious issues.

These findings suggest enzalutamide might be a strong option for this specific group. Still, doctors need to weigh the benefits against unknown safety data. Patients should discuss these results with their care team before making changes to their treatment plan.

What this means for you:
This trial suggests enzalutamide may work better than leuprolide for some prostate cancer outcomes, though safety details are missing.

Study Details

Study typeRct
EvidenceLevel 2
Follow-up60.0 mo
PublishedApr 2026
View Original Abstract ↓
PURPOSE: Primary 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 METHODS: Patients 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 values. RESULTS: Five-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; = .008). After discontinuation, most patients were subsequently treated with hormonal therapies in both groups. CONCLUSIONS: Secondary 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 REGISTRATION: ClinicalTrials.gov Identifier: NCT02319837.
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