Evidence map›Paper›PMID 31176622›Full record

Trial reportEuropean urology2019

Clinical and Biological Characterisation of Localised High-risk Prostate Cancer: Results of a Randomised Preoperative Study of a Luteinising Hormone-releasing Hormone Agonist with or Without Abiraterone Acetate plus Prednisone.

Eleni Efstathiou, John W Davis, Louis Pisters, Weimin Li, Sijin Wen, Ryan P McMullin, Michael Gormley, Deborah Ricci, Mark Titus, Anh Hoang and 7 more

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

Trial report in European urology, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT06306612 (Systemic Therapy Combined With Cytoreductive Prostatectomy for the Treatment of de Novo Poly-metastatic Hormone Sensitive Prostate Cancer), which is not on this map. Cited by 37 papers, 4 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
37citing papers in PubMed, 4 pooled it
6.6field-weighted citation impact, top 3% 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.

NCT06306612 narecruitingnot on this mapstarted 2024, after this paper: background citation

Systemic Therapy Combined With Cytoreductive Prostatectomy for the Treatment of de Novo Poly-metastatic Hormone Sensitive Prostate Cancer: A Prospective, Open-label Randomized Controlled Trial

TypeinterventionalSponsorRenJi HospitalRan2024 to 2028Enrolled192ConditionsProstate CancerArmsSystemic Chemohormonal Therapy, Systemic Hormonal Therapy, Cytoreductive Prostatectomy, Postoperative Adjuvant Radiotherapy
3 · Its place in the literature

Who cites it

37 citing papers in PubMed, 4 syntheses or guidelines pooled it, 80 citations in OpenAlex.

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  9. Phase I/II Trial of Enzalutamide and Mifepristone, a Glucocorticoid Receptor Antagonist, for Metastatic Castration-Resistant Prostate Cancer.Clinical cancer research : an official journal of the American Association for Cancer Research · 2022
    Trial
  10. Loss ofJCO precision oncology · 2021
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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

17 authors at 3 institutions in 2 countries.

Eleni EfstathiouDepartment of Genitourinary Medical Oncology, David H. Koch Center for Applied Research of GU Cancers, The University of Texas MD Anderson Cancer Center, Houston, TX, USA; Department of Clinical Therapeutics, University of Athens, Athens, Greece. Electronic address: eefstathiou@mdanderson.org.
John W DavisDivision of Surgery, Department of Urology, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.
Louis PistersDivision of Surgery, Department of Urology, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.
Weimin LiJanssen Research & Development, Spring House, PA, USA.
Sijin WenDepartment of Biostatistics, West Virginia University School of Public Health, Morgantown, WV, USA.
Ryan P McMullinLabConnect LLC, Seattle, WA, USA.
Michael GormleyJanssen Research & Development, Spring House, PA, USA.
Deborah RicciJanssen Research & Development, Raritan, NJ, USA.
Mark TitusDepartment of Genitourinary Medical Oncology, David H. Koch Center for Applied Research of GU Cancers, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.
Anh HoangDepartment of Genitourinary Medical Oncology, David H. Koch Center for Applied Research of GU Cancers, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.
Amado J ZuritaDepartment of Genitourinary Medical Oncology, David H. Koch Center for Applied Research of GU Cancers, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.
NamPhuong TranClinical Research & Development, Janssen Research & Development, Los Angeles, CA, USA.
Weimin PengClinical Research & Development, Janssen Research & Development, Los Angeles, CA, USA.
Thian KheohDepartment of Biostatistics & Programming, Janssen Research & Development, San Diego, CA, USA.
Arturo MolinaOncology Science Innovation, Janssen Research & Development, Menlo Park, CA, USA.
Patricia TroncosoDivision of Pathology and Laboratory Medicine, Department of Pathology, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.
Christopher J LogothetisDepartment of Genitourinary Medical Oncology, David H. Koch Center for Applied Research of GU Cancers, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.
The University of Texas MD Anderson Cancer Center · USJanssen (United States) · USWest Virginia University · US

Funding

Tumor Evolution and Metastasis ProgramP30CA016672 · NCI · UNIVERSITY OF TX MD ANDERSON CAN CTR · PI Fabien Delerue · 1985 to 2026
$290.8M
West Virginia IDEA-CTRU54GM104942 · NIGMS · WEST VIRGINIA UNIVERSITY · PI Laura F. Gibson · 2012 to 2026
$81.0M
NCI NIH HHS P30 CA016672NIGMS NIH HHS U54 GM104942
6 · The paper itself

Abstract

Optimal therapeutic strategy remains an unmet need in localised high-risk prostate cancer (LHRPC). Androgen biosynthesis inhibition in the preoperative setting may improve outcomes. In this single-centre randomised trial, we looked at therapy outcomes of preoperative treatment with abiraterone acetate+prednisone (AAP)+luteinising hormone-releasing hormone agonist (LHRHa) or LHRHa alone followed by radical prostatectomy in 65 men. We did not see a significant difference of organ-confined carcinoma (p=0.27). However, tumour volume measures were significantly lower for AAP+LHRHa treatment (p≤0.001). Of note, lower tumour epithelium volume correlated with improved biochemical recurrence-free survival at ≥4-yr follow-up (p=0.0014). Tumours pretreated with AAP+LHRHa had lower proliferation and androgen signalling expression than LHRHa. On multivariate analysis, glucocorticoid receptor (GR) overexpression correlated with persistent tumours in AAP+LHRHa (p=0.018). The presence of nuclear androgen receptor splice variant (nARV7) correlated with persistent tumours in both arms. No new safety signals were observed. This is the first study investigating the role of preoperative AAP+LHRHa versus LHRHa alone in LHRPC. We report significant cytoreduction by tumour volume measures inversely correlating with biochemical relapse. Validation of these proposed tumour volume measures is planned. A potential role of GR in resistance to androgen biosynthesis inhibition warrants further study. PATIENT SUMMARY: This is the first study of abiraterone acetate plus leuprolide versus leuprolide alone in high-risk localised prostate cancer followed by prostatectomy. Patients in the combination arm had a significantly smaller tumour size.

Indexed as

Abiraterone AcetateAgedAntineoplastic AgentsDrug CombinationsGonadotropin-Releasing HormoneHumansMaleMiddle AgedPrednisonePreoperative PeriodProstatectomyProstatic NeoplasmsRisk AssessmentAbiraterone AcetateAntineoplastic AgentsDrug CombinationsGonadotropin-Releasing HormonePrednisoneAbiraterone acetateAndrogen deprivation therapyAndrogen receptorAndrogen receptor splice variantGlucocorticoid receptorHigh-risk localised prostate cancerNeoadjuvantPreoperativeRadical prostatectomyTumour volume

Identifiers

PMID31176622
PMCPMC7205516
OpenAlexW2948197666

What OpenQuestion holds

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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.