Evidence map›Paper›PMID 40742002›Full record

Trial reportBJU international2025

Transcriptome profiling of prostatic tumours from ENACT trial patients with or without enzalutamide.

Nicole Handa, Neal D Shore, Matthew R Cooperberg, Elai Davicioni, Xin Zhao, Dina Elsouda, Yang Liu, James A Proudfoot, Gaston Kuperman, David Russell and 3 more

Registry-linked trialAbstract readClinical Trial, Phase IIMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in BJU international, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02799745 (A Randomized Study of Enzalutamide in Patients With Localized Prostate Cancer Undergoing Active Surveillance), which is not on this map. Not yet cited in PubMed.

0numbers the graph read from it
0cells of the map it votes in
0citing 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.

NCT02799745 phase2completednot on this map

A Randomized Study of Enzalutamide in Patients With Localized Prostate Cancer Undergoing Active Surveillance (ENACT)

TypeinterventionalSponsorAstellas Pharma Global Development, Inc.Ran2016 to 2020Enrolled227ConditionsProstate CancerArmsEnzalutamide, Active Surveillance
3 · Its place in the literature

Who cites it

0 citing papers in PubMed.

No citing paper in PubMed yet.

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

13 authors.

Nicole HandaNorthwestern University Feinberg School of Medicine, Chicago, IL, USA.ORCID 0000-0002-0700-7200
Neal D ShoreCarolina Urologic Research Center, Myrtle Beach, SC, USA.
Matthew R CooperbergUrology and Epidemiology & Biostatistics, UCSF Helen Diller Comprehensive Cancer Center, San Francisco, CA, USA.ORCID 0000-0003-4339-6685
Elai DavicioniVeracyte, Inc., San Francisco, CA, USA.
Xin ZhaoVeracyte, Inc., San Francisco, CA, USA.
Dina ElsoudaAstellas Pharma Inc., Northbrook, IL, USA.
Yang LiuVeracyte, Inc., San Francisco, CA, USA.
James A ProudfootVeracyte, Inc., San Francisco, CA, USA.
Gaston KupermanAstellas Pharma Inc., Northbrook, IL, USA.
David RussellPfizer Inc., New York, NY, USA.
Kenneth K IwataAstellas Pharma Inc., Northbrook, IL, USA.
Edward M SchaefferNorthwestern University Feinberg School of Medicine, Chicago, IL, USA.
Ashley RossNorthwestern University Feinberg School of Medicine, Chicago, IL, USA.

Funding

Astellas PharmaPfizer Inc
6 · The paper itself

Abstract

objectivesTo evaluate the longitudinal transcriptomic changes that occurred over time in patients from the ENACT trial (ClinicalTrials.gov identifier: NCT02799745). ENACT evaluated patients with low- or intermediate-risk prostate cancer, comparing the efficacy and safety of enzalutamide plus active surveillance (AS) to AS alone. PATIENTS AND

methodsGene-expression profiling was conducted using the Decipher Genomic Resource for Intelligent Discovery (GRID) platform (Veracyte, Inc.) on 131 patient samples (enzalutamide plus AS: n = 57; AS alone: n = 74) collected at screening, Year 1, and Year 2. Pre-defined GRID signatures were analysed for associations with biological and clinical features, including immune activity, treatment sensitivity, metastatic risk, and molecular subtypes. Statistical analyses utilised Cox proportional hazards models and logistic/linear regression, while longitudinal changes were evaluated using linear mixed-effects models.

resultsAt Year 1, patients treated with enzalutamide plus AS showed significant transcriptomic changes, such as downregulation of androgen-receptor signalling and immune-suppressor signatures, alongside upregulation of immune-activated and basal-like markers. Many of these transcriptomic alterations, including immune-related changes, were transient and reverted to baseline levels at Year 2 after enzalutamide treatment cessation.

conclusionThis exploratory biomarker analysis highlights transcriptomic changes in patients undergoing AS and those treated with enzalutamide, providing insights into molecular disease progression on surveillance and the effects of transient exposure to enzalutamide. The observed immune modulation during enzalutamide treatment suggests opportunities to explore immunotherapy strategies.

Indexed as

Antineoplastic AgentsGene Expression ProfilingPhenylthiohydantoinProstatic NeoplasmsWatchful WaitingAgedBenzamidesHumansMaleMiddle AgedNitrilesTranscriptomeAntineoplastic AgentsBenzamidesenzalutamideNitrilesPhenylthiohydantoinactive surveillanceandrogen receptorbiomarkersenzalutamidegene‐expression profilingprostate cancer

Identifiers

PMID40742002
PMCPMC12522525

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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.