Evidence map›Paper›PMID 30811282›Full record

Trial reportJournal of clinical oncology : official journal of the American Society of Clinical Oncology2019

Evaluation of Intense Androgen Deprivation Before Prostatectomy: A Randomized Phase II Trial of Enzalutamide and Leuprolide With or Without Abiraterone.

Rana R McKay, Huihui Ye, Wanling Xie, Rosina Lis, Carla Calagua, Zhenwei Zhang, Quoc-Dien Trinh, Steven L Chang, Lauren C Harshman, Ashley E Ross and 9 more

Open access · greenAbstract readClinical Trial, Phase IIComparative StudyMulticenter Study
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Journal of clinical oncology : official journal of the American Society of Clinical Oncology, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 68 papers, 4 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
68citing papers in PubMed, 4 pooled it
17.6field-weighted citation impact, top 1% of its field
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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

68 citing papers in PubMed, 4 syntheses or guidelines pooled it, 158 citations in OpenAlex.

  1. Pooled it
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  4. Pooled it
  5. Trial
  6. Accelerating Drug Development in Hormone-Naïve Prostate Cancer through Multimodal Therapy Strategies: The MetaCURE Phase 2 Randomized Clinical Trial.Clinical cancer research : an official journal of the American Association for Cancer Research · 2026
    Trial
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  9. Loss ofJCO precision oncology · 2021
    Trial
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  14. 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 · 2026
    Review
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8 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

19 authors at 6 institutions in 1 country.

Rana R McKay1 University of California, San Diego, San Diego, CA.
Huihui Ye3 Beth Israel Deaconess Medical Center, Boston, MA.
Wanling Xie2 Dana-Farber Cancer Institute and Brigham and Women's Hospital, Boston, MA.
Rosina Lis2 Dana-Farber Cancer Institute and Brigham and Women's Hospital, Boston, MA.
Carla Calagua3 Beth Israel Deaconess Medical Center, Boston, MA.
Zhenwei Zhang2 Dana-Farber Cancer Institute and Brigham and Women's Hospital, Boston, MA.
Quoc-Dien Trinh2 Dana-Farber Cancer Institute and Brigham and Women's Hospital, Boston, MA.
Steven L Chang2 Dana-Farber Cancer Institute and Brigham and Women's Hospital, Boston, MA.
Lauren C Harshman2 Dana-Farber Cancer Institute and Brigham and Women's Hospital, Boston, MA.
Ashley E Ross4 Johns Hopkins Hospital, Baltimore, MD.
Kenneth J Pienta4 Johns Hopkins Hospital, Baltimore, MD.
Daniel W Lin5 University of Washington, Seattle, WA.
William J Ellis5 University of Washington, Seattle, WA.
Bruce Montgomery5 University of Washington, Seattle, WA.
Peter Chang3 Beth Israel Deaconess Medical Center, Boston, MA.
Andrew A Wagner3 Beth Israel Deaconess Medical Center, Boston, MA.
Glenn J Bubley3 Beth Israel Deaconess Medical Center, Boston, MA.
Adam S Kibel2 Dana-Farber Cancer Institute and Brigham and Women's Hospital, Boston, MA.
Mary-Ellen Taplin2 Dana-Farber Cancer Institute and Brigham and Women's Hospital, Boston, MA.
Beth Israel Deaconess Medical Center · USBrigham and Women's Hospital · USDana-Farber Brigham Cancer Center · USUniversity of Washington · USDana-Farber Cancer Institute · USJohns Hopkins Hospital · US

Funding

Tumor and Circulating Markers as Links Between Obesity and Lethal Prostate CanceP50CA090381 · NCI · DANA-FARBER CANCER INSTITUTE · PI KANTOFF, PHILIP W · 2002 to 2017
$36.2M
NCI NIH HHS P50 CA090381
6 · The paper itself

Abstract

purposePatients with locally advanced prostate cancer have an increased risk of cancer recurrence and mortality. In this phase II trial, we evaluate neoadjuvant enzalutamide and leuprolide (EL) with or without abiraterone and prednisone (ELAP) before radical prostatectomy (RP) in men with locally advanced prostate cancer. PATIENTS AND

methodsEligible patients had a biopsy Gleason score of 4 + 3 = 7 or greater, prostate-specific antigen (PSA) greater than 20 ng/mL, or T3 disease (by prostate magnetic resonance imaging). Lymph nodes were required to be smaller than 20 mm. Patients were randomly assigned 2:1 to ELAP or EL for 24 weeks followed by RP. All specimens underwent central pathology review. The primary end point was pathologic complete response or minimal residual disease (residual tumor ≤ 5 mm). Secondary end points were PSA, surgical staging, positive margins, and safety. Biomarkers associated with pathologic outcomes were explored.

resultsSeventy-five patients were enrolled at four centers. Most patients had high-risk disease by National Comprehensive Cancer Network criteria (n = 65; 87%). The pathologic complete response or minimal residual disease rate was 30% (n = 15 of 50) in ELAP-treated patients and 16% (n = four of 25) in EL-treated patients (two-sided P = .263). Rates of ypT3 disease, positive margins, and positive lymph nodes were similar between arms. Treatment was well-tolerated. Residual tumors in the two arms showed comparable levels of ERG, PTEN, androgen receptor PSA, and glucocorticoid receptor expression. Tumor ERG positivity and PTEN loss were associated with more extensive residual tumors at RP.

conclusionNeoadjuvant hormone therapy followed by RP in locally advanced prostate cancer resulted in favorable pathologic responses in some patients, with a trend toward improved pathologic outcomes with ELAP. Longer follow-up is necessary to evaluate the impact of therapy on recurrence rates. The potential association of ERG and PTEN alterations with worse outcomes warrants additional investigation.

Indexed as

Neoadjuvant TherapyProstatectomyAdenocarcinomaAdultAgedAndrogen AntagonistsAndrostenesAntineoplastic Combined Chemotherapy ProtocolsBenzamidesChemotherapy, AdjuvantHumansKallikreinsLeuprolideMagnetic Resonance ImagingMaleMiddle AgedabirateroneAndrogen AntagonistsAndrostenesBenzamidesenzalutamideKallikreinsKLK3 protein, humanLeuprolideNitrilesPhenylthiohydantoinPrednisoneProstate-Specific Antigen

Identifiers

PMID30811282
PMCPMC7051849
OpenAlexW2916580364

What OpenQuestion holds

Textmetadata
Read underepoch 390

Registered trials

None linked

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.