Evidence map›Paper›PMID 24747657›Full record

Trial reportThe Journal of urology2014

Clinical validation of an epigenetic assay to predict negative histopathological results in repeat prostate biopsies.

Alan W Partin, Leander Van Neste, Eric A Klein, Leonard S Marks, Jason R Gee, Dean A Troyer, Kimberly Rieger-Christ, J Stephen Jones, Cristina Magi-Galluzzi, Leslie A Mangold and 5 more

Abstract readClinical TrialMulticenter Study
PubMed Full text at PMC Publisher
In one paragraph

Trial report in The Journal of urology, 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 112 papers, 4 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
112citing papers in PubMed, 4 pooled it
20.8field-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

112 citing papers in PubMed, 4 syntheses or guidelines pooled it, 223 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. NCCN Guidelines Insights: Prostate Cancer Early Detection, Version 2.2016.Journal of the National Comprehensive Cancer Network : JNCCN · 2016
    Guideline
  4. CLINICAL EVALUATION OF AN EPIGENETIC ASSAY TO PREDICT MISSED CANCER IN PROSTATE BIOPSY SPECIMENS.Transactions of the American Clinical and Climatological Association · 2016
    Pooled it
  5. Trial
  6. Trial
  7. Article
  8. Review
  9. Review
  10. Prostate Cancer: Etiology, Diagnosis, and Treatment.Serican journal of medicine · 2026
    Article
  11. Review
  12. Review
  13. Article
  14. Biomarkers in Localized Prostate Cancer: From Diagnosis to Treatment.International journal of molecular sciences · 2025
    Review
  15. Article
  16. Review
  17. Review
  18. Review
  19. Review
  20. Review

52 more citing papers are in PubMed but not listed here.

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

15 authors at 8 institutions in 3 countries.

Alan W PartinJames Buchanan Brady Urological Institute, The Johns Hopkins University School of Medicine, Baltimore, Maryland. Electronic address: apartin@jhmi.edu.
Leander Van NesteDepartment of Pathology, GROW School for Oncology and Developmental Biology, Maastricht University Medical Center, Maastricht, The Netherlands; MDxHealth, Inc., Irvine, California.
Eric A KleinGlickman Urological Institute, Cleveland Clinic, Cleveland, Ohio.
Leonard S MarksDepartment of Urology, University of California-Los Angeles, Los Angeles, California.
Jason R GeeLahey Hospital and Medical Center, Burlington, Massachusetts.
Dean A TroyerLeroy T. Canoles Jr. Cancer Research Center, East Virginia Medical School, Norfolk, Virginia.
Kimberly Rieger-ChristLahey Hospital and Medical Center, Burlington, Massachusetts.
J Stephen JonesGlickman Urological Institute, Cleveland Clinic, Cleveland, Ohio.
Cristina Magi-GalluzziGlickman Urological Institute, Cleveland Clinic, Cleveland, Ohio.
Leslie A MangoldJames Buchanan Brady Urological Institute, The Johns Hopkins University School of Medicine, Baltimore, Maryland.
Bruce J TrockJames Buchanan Brady Urological Institute, The Johns Hopkins University School of Medicine, Baltimore, Maryland.
Raymond S LanceLeroy T. Canoles Jr. Cancer Research Center, East Virginia Medical School, Norfolk, Virginia.
Joseph W BigleyMDxHealth, Inc., Irvine, California.
Wim Van CriekingeMDxHealth, Inc., Irvine, California; Laboratory of Bioinformatics and Computational Genomics, Ghent University, Ghent, Belgium. Electronic address: wim.vancriekinge@mdxhealth.com.
Jonathan I EpsteinJames Buchanan Brady Urological Institute, The Johns Hopkins University School of Medicine, Baltimore, Maryland.
Cleveland Clinic · USJohns Hopkins Medicine · USEastern Virginia Medical School · USLahey Medical Center · USGhent University · BEJohns Hopkins University · USMaastricht University · NLUniversity of California, Los Angeles · US

Funding

Translational Research Central ServicesP30CA006973 · NCI · JOHNS HOPKINS UNIVERSITY · PI WILLIAM George NELSON · 1985 to 2026
$208.6M
NCI NIH HHS P30 CA006973
6 · The paper itself

Abstract

purposeThe DOCUMENT multicenter trial in the United States validated the performance of an epigenetic test as an independent predictor of prostate cancer risk to guide decision making for repeat biopsy. Confirming an increased negative predictive value could help avoid unnecessary repeat biopsies. MATERIALS AND

methodsWe evaluated the archived, cancer negative prostate biopsy core tissue samples of 350 subjects from a total of 5 urological centers in the United States. All subjects underwent repeat biopsy within 24 months with a negative (controls) or positive (cases) histopathological result. Centralized blinded pathology evaluation of the 2 biopsy series was performed in all available subjects from each site. Biopsies were epigenetically profiled for GSTP1, APC and RASSF1 relative to the ACTB reference gene using quantitative methylation specific polymerase chain reaction. Predetermined analytical marker cutoffs were used to determine assay performance. Multivariate logistic regression was used to evaluate all risk factors.

resultsThe epigenetic assay resulted in a negative predictive value of 88% (95% CI 85-91). In multivariate models correcting for age, prostate specific antigen, digital rectal examination, first biopsy histopathological characteristics and race the test proved to be the most significant independent predictor of patient outcome (OR 2.69, 95% CI 1.60-4.51).

conclusionsThe DOCUMENT study validated that the epigenetic assay was a significant, independent predictor of prostate cancer detection in a repeat biopsy collected an average of 13 months after an initial negative result. Due to its 88% negative predictive value adding this epigenetic assay to other known risk factors may help decrease unnecessary repeat prostate biopsies.

Indexed as

Epigenesis, GeneticBiopsyDNA MethylationDNA, NeoplasmEpigenomicsFollow-Up StudiesGenes, APCGlutathione S-Transferase piHumansMalePolymerase Chain ReactionPredictive Value of TestsPrognosisProstateProstatic NeoplasmsTumor Suppressor ProteinsDNA, NeoplasmGlutathione S-Transferase piGSTP1 protein, humanRASSF1 protein, humanTumor Suppressor Proteinsbiopsyepigenomicsmethylationprostateprostatic neoplasms

Identifiers

PMID24747657
PMCPMC4337855
OpenAlexW2018483968

What OpenQuestion holds

Textmetadata
LicenceTDM
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.