Evidence map›Paper›PMID 40140551›Full record

Trial reportProstate cancer and prostatic diseases2026

Enzalutamide in patients with high-risk biochemically recurrent prostate cancer according to the European Association of Urology definition: a post hoc analysis of EMBARK.

Ugo De Giorgi, Stephen J Freedland, Antti Rannikko, Miguel Ramirez-Backhaus, Arnauld Villers, Jamal Tarazi, Yiyun Tang, Gabriel P Haas, Matt Rosales, Neal D Shore

Registry-linked trialAbstract readRandomized Controlled Trial
In one paragraph

Trial report in Prostate cancer and prostatic diseases, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. 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 5 papers.

0numbers the graph read from it
0cells of the map it votes in
5citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

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.

2 · The registry

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.

NCT02319837 phase3active not recruitingnot on this map

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

TypeinterventionalSponsorPfizerRan2014 to 2026Enrolled1,068ConditionsHormone Sensitive Prostate Cancer, Prostate Cancer, Cancer of the ProstateArmsEnzalutamide, Placebo (No longer applicable in Open Label study period), Leuprolide Open Label
3 · Its place in the literature

Who cites it

5 citing papers in PubMed.

  1. Article
  2. Article
  3. Article
  4. Review
  5. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

10 authors.

Ugo De GiorgiIRCCS Istituto Romagnolo per lo Studio dei Tumori (IRST) Dino Amadori, Meldola, Italy.
Stephen J FreedlandDepartment of Urology, Samuel Oschin Comprehensive Cancer Institute, Cedars-Sinai Medical Center, Los Angeles, CA, USA.ORCID http://orcid.org/0000-0002-8104-6419
Antti RannikkoDepartment of Urology and Research Program in Systems Oncology, University of Helsinki, Helsinki, Finland.ORCID http://orcid.org/0000-0002-4261-3484
Miguel Ramirez-BackhausServicio de Urología, Fundación Instituto Valenciano de Oncología, Valencia, Spain.
Arnauld VillersDepartment of Urology, Claude Huriez Hospital, CHU Lille, University of Lille, Lille, France.
Jamal TaraziGlobal Product Development, Pfizer Inc., La Jolla, CA, USA.
Yiyun TangPfizer Inc., South San Francisco, CA, USA.
Gabriel P HaasGlobal Product Development, Astellas Pharma Inc., Northbrook, IL, USA.
Matt RosalesGlobal Product Development, Astellas Pharma Inc., Northbrook, IL, USA.
Neal D ShoreCarolina Urologic Research Center, Myrtle Beach, SC, USA. nshore@auclinics.com.ORCID http://orcid.org/0000-0001-5767-0548

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

High-risk biochemical recurrence (BCR) definition varies across clinical studies/practice guidelines. We evaluated metastasis-free survival (MFS) by blinded, independent, central review and safety in EMBARK (NCT02319837) patients defined as high-risk BCR per European Association of Urology (EAU) criteria. Patients post-radical prostatectomy (prostatic-specific antigen doubling time ≤9 months) or post-radiation therapy with a Gleason score > 7, were considered EAU high-risk. MFS improved with enzalutamide + leuprolide (HR 0.37, 95% CI 0.25‒0.57) and enzalutamide monotherapy (HR 0.57, 95% CI 0.39‒0.83) versus leuprolide alone. MFS and safety for enzalutamide ± leuprolide versus leuprolide alone were similar in EMBARK patients with EAU-consistent or protocol-defined high-risk BCR. Clinical trial registration number: NCT02319837.

Indexed as

Antineoplastic Combined Chemotherapy ProtocolsNeoplasm Recurrence, LocalPhenylthiohydantoinProstatic NeoplasmsAgedBenzamidesHumansLeuprolideMaleMiddle AgedNeoplasm GradingNitrilesProstatectomyProstate-Specific AntigenBenzamidesenzalutamideLeuprolideNitrilesPhenylthiohydantoinProstate-Specific Antigen

Identifiers

PMID40140551
PMCPMC12909104

What OpenQuestion holds

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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.