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Study · Randomized controlled trial · 2026

1 result

Improved Survival with Enzalutamide in Biochemically Recurrent Prostate Cancer.

Shore ND, Luz MA, De Giorgi U, Gleave M, Gotto GT, Pieczonka CM, Haas GP, Kim CS, Ramirez-Backhaus M, Rannikko A, Kalac M, Sridharan S and 8 more

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Rosales M, Tang Y, Tutrone RF Jr, Venugopal B, Villers A, Woo HH, Wang F, Freedland SJ

The New England journal of medicine19 Oct 2025Cited by 34 (Europe PMC)

Summary

The text of this summary is not shown here, because the article license does not allow reuse. Read it at the source (opens in a new tab)

Text rights: Publisher copyright. Results still quote short attributed sentences.

Results from this study1

1 result from studies that gave the peptide. 1 result from people.

  1. 01HumanRandomized controlled trialEfficacy outcome

    In high-risk recurrent prostate cancer, overall survival did not differ significantly between leuprolide alone and enzalutamide monotherapy (P = 0.19).

    In plain wordsIn patients with high-risk recurrent prostate cancer, overall survival did not differ significantly between leuprolide alone and enzalutamide monotherapy.

    Peptide
    Leuprolide
    Outcome
    No significant changeOverall survival
    Study

    n: not reported in source

    Comparator
    Enzalutamide monotherapy
    Analysis
    Secondary
    Outcome group
    Mortality · Cancer
    Studied dose
    Dose not stated

    Measurements

    8-year survival
    69.5%
    leuprolide alone
    95% CI lower
    64%
    leuprolide alone survival
    95% CI upper
    74.3%
    leuprolide alone survival
    8-year survival
    73.1%
    enzalutamide monotherapy
    95% CI lower
    67.6%
    monotherapy survival
    95% CI upper
    77.9%
    monotherapy survival
    Hazard ratio
    0.83
    monotherapy versus leuprolide
    95% CI lower
    0.63
    hazard ratio

    2 more measurements in the study.

    Source sentences

    Summary
    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).
    3 context sentences
    Summary · context
    and 69.5% (95% CI, 64.0 to 74.3) in the leuprolide-alone group
    Summary · context
    Overall survival was an alpha-controlled, key secondary end point.
    Summary · context
    We 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).

AI wrote and checked these results. AI can make mistakes, so check important results against the source.

Registered trials1

Trials this study reports on, or that list this study as a reference. Registry data from ClinicalTrials.gov.

1 trial · 1 ongoing · 1 with posted results · source ClinicalTrials.gov (opens in a new tab)

Active, not recruitingPhase 3Results postedNCT02319837

Safety and Efficacy Study of Enzalutamide Plus Leuprolide in Patients With Nonmetastatic Prostate Cancer (EMBARK)

Pfizern = 1,06817 Dec 2014 to est. 30 Jul 2027

Hormone Sensitive Prostate Cancer · Prostate Cancer · Cancer of the Prostate

Trial pageClinicalTrials.govUpdated 26 Oct 2026

Version history

PepBank keeps every version of the data on this study. Status changes from Retraction Watch, Europe PMC and Crossref are listed with their source.

  1. Version 2Current

    28 Oct 2026, 02:03 UTC

    Study results updated

  2. Version 1

    27 Oct 2026, 16:37 UTC

    First added · source update from Europe PMC

Subjects

Terms as the source lists them.

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