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

The 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. We evalu...

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Published in:	The Journal of urology Vol. 192; no. 4; p. 1081
Main Authors:	Partin, Alan W, Van Neste, Leander, Klein, Eric A, Marks, Leonard S, Gee, Jason R, Troyer, Dean A, Rieger-Christ, Kimberly, Jones, J Stephen, Magi-Galluzzi, Cristina, Mangold, Leslie A, Trock, Bruce J, Lance, Raymond S, Bigley, Joseph W, Van Criekinge, Wim, Epstein, Jonathan I
Format:	Journal Article
Language:	English
Published:	United States 01.10.2014
Subjects:	Biopsy - methods DNA Methylation DNA, Neoplasm - genetics Epigenesis, Genetic Epigenomics - methods Follow-Up Studies Genes, APC Glutathione S-Transferase pi - biosynthesis Glutathione S-Transferase pi - genetics Humans Male Polymerase Chain Reaction Predictive Value of Tests Prognosis Prostate - metabolism Prostate - pathology Prostatic Neoplasms - genetics Prostatic Neoplasms - metabolism Prostatic Neoplasms - pathology Tumor Suppressor Proteins - biosynthesis Tumor Suppressor Proteins - genetics Unnecessary Procedures - utilization biopsy epigenomics prostate methylation prostatic neoplasms
ISSN:	1527-3792, 1527-3792
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Abstract	The 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. We 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. The 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). The 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.
AbstractList	The 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. We 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. The 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). The 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. The 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.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.We 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.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.The 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).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).The 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.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.
Author	Klein, Eric A Rieger-Christ, Kimberly Marks, Leonard S Partin, Alan W Mangold, Leslie A Troyer, Dean A Van Neste, Leander Epstein, Jonathan I Gee, Jason R Trock, Bruce J Van Criekinge, Wim Jones, J Stephen Magi-Galluzzi, Cristina Lance, Raymond S Bigley, Joseph W
Author_xml	– sequence: 1 givenname: Alan W surname: Partin fullname: Partin, Alan W email: apartin@jhmi.edu organization: James Buchanan Brady Urological Institute, The Johns Hopkins University School of Medicine, Baltimore, Maryland. Electronic address: apartin@jhmi.edu – sequence: 2 givenname: Leander surname: Van Neste fullname: Van Neste, Leander organization: Department of Pathology, GROW School for Oncology and Developmental Biology, Maastricht University Medical Center, Maastricht, The Netherlands; MDxHealth, Inc., Irvine, California – sequence: 3 givenname: Eric A surname: Klein fullname: Klein, Eric A organization: Glickman Urological Institute, Cleveland Clinic, Cleveland, Ohio – sequence: 4 givenname: Leonard S surname: Marks fullname: Marks, Leonard S organization: Department of Urology, University of California-Los Angeles, Los Angeles, California – sequence: 5 givenname: Jason R surname: Gee fullname: Gee, Jason R organization: Lahey Hospital and Medical Center, Burlington, Massachusetts – sequence: 6 givenname: Dean A surname: Troyer fullname: Troyer, Dean A organization: Leroy T. Canoles Jr. Cancer Research Center, East Virginia Medical School, Norfolk, Virginia – sequence: 7 givenname: Kimberly surname: Rieger-Christ fullname: Rieger-Christ, Kimberly organization: Lahey Hospital and Medical Center, Burlington, Massachusetts – sequence: 8 givenname: J Stephen surname: Jones fullname: Jones, J Stephen organization: Glickman Urological Institute, Cleveland Clinic, Cleveland, Ohio – sequence: 9 givenname: Cristina surname: Magi-Galluzzi fullname: Magi-Galluzzi, Cristina organization: Glickman Urological Institute, Cleveland Clinic, Cleveland, Ohio – sequence: 10 givenname: Leslie A surname: Mangold fullname: Mangold, Leslie A organization: James Buchanan Brady Urological Institute, The Johns Hopkins University School of Medicine, Baltimore, Maryland – sequence: 11 givenname: Bruce J surname: Trock fullname: Trock, Bruce J organization: James Buchanan Brady Urological Institute, The Johns Hopkins University School of Medicine, Baltimore, Maryland – sequence: 12 givenname: Raymond S surname: Lance fullname: Lance, Raymond S organization: Leroy T. Canoles Jr. Cancer Research Center, East Virginia Medical School, Norfolk, Virginia – sequence: 13 givenname: Joseph W surname: Bigley fullname: Bigley, Joseph W organization: MDxHealth, Inc., Irvine, California – sequence: 14 givenname: Wim surname: Van Criekinge fullname: Van Criekinge, Wim email: wim.vancriekinge@mdxhealth.com organization: MDxHealth, Inc., Irvine, California; Laboratory of Bioinformatics and Computational Genomics, Ghent University, Ghent, Belgium. Electronic address: wim.vancriekinge@mdxhealth.com – sequence: 15 givenname: Jonathan I surname: Epstein fullname: Epstein, Jonathan I organization: James Buchanan Brady Urological Institute, The Johns Hopkins University School of Medicine, Baltimore, Maryland
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Copyright	Copyright © 2014 American Urological Association Education and Research, Inc. Published by Elsevier Inc. All rights reserved.
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SubjectTerms	Biopsy - methods DNA Methylation DNA, Neoplasm - genetics Epigenesis, Genetic Epigenomics - methods Follow-Up Studies Genes, APC Glutathione S-Transferase pi - biosynthesis Glutathione S-Transferase pi - genetics Humans Male Polymerase Chain Reaction Predictive Value of Tests Prognosis Prostate - metabolism Prostate - pathology Prostatic Neoplasms - genetics Prostatic Neoplasms - metabolism Prostatic Neoplasms - pathology Tumor Suppressor Proteins - biosynthesis Tumor Suppressor Proteins - genetics Unnecessary Procedures - utilization
Title	Clinical validation of an epigenetic assay to predict negative histopathological results in repeat prostate biopsies
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