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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Summary: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.
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ISSN:1527-3792
1527-3792
DOI:10.1016/j.juro.2014.04.013