Evidence map›Paper›PMID 33683939›Full record

Trial reportThe Journal of urology2021

Results of a Randomized Phase II Trial of Intense Androgen Deprivation Therapy prior to Radical Prostatectomy in Men with High-Risk Localized Prostate Cancer.

Rana R McKay, Wanling Xie, Huihui Ye, Fiona M Fennessy, Zhenwei Zhang, Rosina Lis, Carla Calagua, Dana Rathkopf, Vincent P Laudone, Glenn J Bubley and 12 more

Registry-linked trialOpen access · greenAbstract readClinical Trial, Phase IIMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in The Journal of urology, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02903368 (Phase II Randomized Study Of Neoadjuvant And Adjuvant Abiraterone Acetate + Apalutamide For Intermediate-High Risk Prostate Cancer Undergoing Prostatectomy), which is not on this map. Cited by 48 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
48citing papers in PubMed, 3 pooled it
7.2field-weighted citation impact, top 2% 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.

NCT02903368 phase2completednot on this map

Phase II Randomized Study Of Neoadjuvant And Adjuvant Abiraterone Acetate + Apalutamide For Intermediate-High Risk Prostate Cancer Undergoing Prostatectomy

TypeinterventionalSponsorDana-Farber Cancer InstituteRan2016 to 2024Enrolled118ConditionsProstate CancerArmsApalutamide, Leuprolide, Prednisone, Abiraterone Acetate
3 · Its place in the literature

Who cites it

48 citing papers in PubMed, 3 syntheses or guidelines pooled it, 71 citations in OpenAlex.

  1. Pooled it
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  7. 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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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

22 authors at 6 institutions in 1 country.

Rana R McKayUniversity of California San Diego, La Jolla, California.
Wanling XieDana-Farber Cancer Institute, Boston, Massachusetts.
Huihui YeUniversity of California Los Angeles, Los Angeles, California.
Fiona M FennessyDana-Farber Cancer Institute, Boston, Massachusetts.
Zhenwei ZhangDana-Farber Cancer Institute, Boston, Massachusetts.
Rosina LisDana-Farber Cancer Institute, Boston, Massachusetts.
Carla CalaguaUniversity of California Los Angeles, Los Angeles, California.
Dana RathkopfMemorial Sloan Kettering Cancer Center, New York, New York.
Vincent P LaudoneMemorial Sloan Kettering Cancer Center, New York, New York.
Glenn J BubleyBeth Israel Deaconess Medical Center, Boston, Massachusetts.
David J EinsteinBeth Israel Deaconess Medical Center, Boston, Massachusetts.
Peter K ChangBeth Israel Deaconess Medical Center, Boston, Massachusetts.
Andrew A WagnerBeth Israel Deaconess Medical Center, Boston, Massachusetts.
J Kellogg ParsonsUniversity of California San Diego, La Jolla, California.
Mark A PrestonDana-Farber Cancer Institute, Boston, Massachusetts.
Kerry KilbridgeDana-Farber Cancer Institute, Boston, Massachusetts.
Steven L ChangDana-Farber Cancer Institute, Boston, Massachusetts.
Atish D ChoudhuryDana-Farber Cancer Institute, Boston, Massachusetts.
Mark M PomerantzDana-Farber Cancer Institute, Boston, Massachusetts.
Quoc-Dien TrinhDana-Farber Cancer Institute, Boston, Massachusetts.
Adam S KibelDana-Farber Cancer Institute, Boston, Massachusetts.
Mary-Ellen TaplinDana-Farber Cancer Institute, Boston, Massachusetts.
Dana-Farber Cancer Institute · USBeth Israel Deaconess Medical Center · USMemorial Sloan Kettering Cancer Center · USUniversity of California, San Diego · USGTx (United States) · USUniversity of California, Los Angeles · US

Funding

X-RAY CRYSTALLOGRAPHYP30CA008748 · NCI · SLOAN-KETTERING INSTITUTE FOR CANCER RES · PI Hongbiao Carl Lekaye · 1985 to 2026
$347.4M
UCLA SPORE IN PROSTATE CANCERP50CA092131 · NCI · UNIVERSITY OF CALIFORNIA LOS ANGELES · PI REITER, ROBERT E · 2002 to 2023
$42.6M
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 P30 CA008748NCI NIH HHS P50 CA090381NCI NIH HHS P50 CA092131
6 · The paper itself

Abstract

purposeThis multicenter randomized phase 2 trial investigates the impact of intense androgen deprivation on radical prostatectomy pathologic response and radiographic and tissue biomarkers in localized prostate cancer (NCT02903368). MATERIALS AND

methodsEligible patients had a Gleason score ≥4+3=7, prostate specific antigen >20 ng/mL or T3 disease and lymph nodes <20 mm. In Part 1, patients were randomized 1:1 to apalutamide, abiraterone acetate, prednisone and leuprolide (AAPL) or abiraterone, prednisone, leuprolide (APL) for 6 cycles (1 cycle=28 days) followed by radical prostatectomy. Surgical specimens underwent central review. The primary end point was the rate of pathologic complete response or minimum residual disease (minimum residual disease, tumor ≤5 mm). Secondary end points included prostate specific antigen response, positive margin rate and safety. Magnetic resonance imaging and tissue biomarkers of pathologic outcomes were explored.

resultsThe study enrolled 118 patients at 4 sites. Median age was 61 years and 94% of patients had high-risk disease. The combined pathologic complete response or minimum residual disease rate was 22% in the AAPL arm and 20% in the APL arm (difference: 1.5%; 1-sided 95% CI -11%, 14%; 1-sided p=0.4). No new safety signals were observed. There was low concordance and correlation between posttherapy magnetic resonance imaging assessed and pathologically assessed tumor volume. PTEN-loss, ERG positivity and presence of intraductal carcinoma were associated with extensive residual tumor.

conclusionsIntense neoadjuvant hormone therapy in high-risk prostate cancer resulted in favorable pathologic responses (tumor

Indexed as

ProstatectomyAbiraterone AcetateAgedAntineoplastic AgentsAntineoplastic Agents, HormonalCombined Modality TherapyDrug Therapy, CombinationHumansLeuprolideMaleMiddle AgedPrednisonePreoperative PeriodProstatic NeoplasmsRisk AssessmentThiohydantoinsAbiraterone AcetateAntineoplastic AgentsAntineoplastic Agents, HormonalapalutamideLeuprolidePrednisoneThiohydantoinsabiraterone acetateneoadjuvant therapyprostatectomy

Identifiers

PMID33683939
PMCPMC9807004
OpenAlexW3134592109

What OpenQuestion holds

Textmetadata
LicenceTDM
Read underepoch 390

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.