Trial reportThe New England journal of medicine2026
Improved Survival with Enzalutamide in Biochemically Recurrent Prostate Cancer.
Trial report in The New England journal of medicine, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 23 papers, 1 of them a synthesis that pooled it.
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
PEACE-9 - ESCALATE-RT: A Phase III Randomized Study in Patients With High-risk PSA Relapse After Local Therapy Treated With Enzalutamide Plus Androgen Deprivation Therapy and Comparing MDT ± Pelvic Radiotherapy Versus no Further Treatment
Who cites it
23 citing papers in PubMed, 1 synthesis or guideline pooled it.
- Hormone therapy use and duration with postoperative radiotherapy for recurrent prostate cancer: an individual patient data meta-analysis.Lancet (London, England) · 2026Pooled it
- Overall Survival of Patients With PSA-Recurrent Prostate Cancer: Long-Term Analysis of a Randomized Phase 2 Trial of pTVG-HP DNA Vaccine Versus Placebo.Clinical genitourinary cancer · 2026Trial
- Enzalutamide Monotherapy for the Treatment of Prostate Cancer With High-Risk Biochemical Recurrence: EMBARK Secondary End Points.The Journal of urology · 2026Trial
- Androgen receptor pathway inhibitor intensification in non-metastatic hormone-sensitive prostate cancer: current evidence and clinical implications.Clinical & translational oncology : official publication of the Federation of Spanish Oncology Societies and of the National Cancer Institute of Mexico · 2026Review
- Real-World Treatment Patterns for Patients with High-Risk Biochemically Recurrent Nonmetastatic Castration‑Sensitive Prostate Cancer.Advances in therapy · 2026Article
- Criteria Clinicians Use to Classify Patients as High Risk in Biochemically Recurrent Nonmetastatic Castration‑Sensitive Prostate Cancer.Advances in therapy · 2026Article
- Insights from EMBARK: guiding clinical care and trial design.Translational andrology and urology · 2026Article
- Reprogramming the Evolution of High-Risk Prostate Cancer: Multidisciplinary Strategies to Delay Castration Resistance.Journal of clinical medicine · 2026Review
- An argument not to EMBARK on systemic therapy for biochemical recurrence of prostate cancer.Translational andrology and urology · 2026Article
- 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
- [Oligometastatic hormone-sensitive prostate cancer: when can less be more?]Urologie (Heidelberg, Germany) · 2026Review
- Hydrogen peroxide self-supplied nanozyme system for synergistic prostate cancer therapy via ferroptosis/pyroptosis and CaJournal of nanobiotechnology · 2026Article
- Clinical advances and practice updates in genitourinary cancers: a 2025 review from the multidisciplinary Spanish 'Cambados annual meeting'.Clinical & translational oncology : official publication of the Federation of Spanish Oncology Societies and of the National Cancer Institute of Mexico · 2026Review
- 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
- EMBARK in biochemically recurrent prostate cancer: a journey for some but not most.The oncologist · 2026Article
- Progression-Free Survival versus Overall Survival in Patients with PSA-Recurrent Prostate Cancer: Long-Term Analysis of a Randomized Phase 2 Trial of pTVG-HP versus Placebo.Research square · 2026Article
- Personalized intensification of treatment for hormone-sensitive prostate cancer.Nature reviews. Clinical oncology · 2026Review
- Re: Amar U. Kishan, Luca F. Valle, Holly Wilhalme, et al.European urology open science · 2026Article
- PSMA-Based Radiopharmaceuticals in Prostate Cancer Theranostics: Imaging, Clinical Advances, and Future Directions.Cancers · 2026Review
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Authors and funding
20 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundIn the phase 3 EMBARK trial, enzalutamide plus leuprolide and enzalutamide monotherapy were associated with longer metastasis-free survival than leuprolide alone among patients with biochemically recurrent prostate cancer. The final analysis of overall survival has not been reported.
methodsWe randomly assigned patients with prostate cancer who had high-risk biochemical recurrence in a 1:1:1 ratio to receive enzalutamide plus leuprolide (the combination group), leuprolide alone (the leuprolide-alone group), or enzalutamide monotherapy (the monotherapy group). The primary end point was metastasis-free survival, assessed in the combination group as compared with the leuprolide-alone group. Overall survival was an alpha-controlled, key secondary end point. Updated results for prespecified secondary end points, including the time to first use of new antineoplastic therapy and the time to the first symptomatic skeletal event, were summarized descriptively, as was progression-free survival with the first subsequent therapy, an exploratory end point.
resultsThe 8-year overall survival was 78.9% (95% confidence interval [CI], 73.9 to 83.1) in the combination group and 69.5% (95% CI, 64.0 to 74.3) in the leuprolide-alone group; the hazard ratio for death was 0.60 (95% CI, 0.44 to 0.80; P<0.001). The 8-year overall survival with monotherapy was 73.1% (95% CI, 67.6 to 77.9), which did not differ significantly from that with leuprolide alone (hazard ratio, 0.83; 95% CI, 0.63 to 1.10; P = 0.19). In the descriptive updates for prespecified secondary end points, results were similar to those previously reported. Safety findings were consistent with those in the primary analysis of metastasis-free survival.
conclusionsOverall survival was significantly longer with the combination of enzalutamide and leuprolide than with leuprolide alone among patients with prostate cancer with high-risk biochemical recurrence. Enzalutamide monotherapy was not superior to leuprolide alone in the analysis of overall survival. (Funded by Pfizer and Astellas Pharma; EMBARK ClinicalTrials.gov number, NCT02319837.).
Indexed as
Identifiers
41124201What OpenQuestion holds
Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.