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      CLINICAL EVALUATION OF AN EPIGENETIC ASSAY TO PREDICT MISSED CANCER IN PROSTATE BIOPSY SPECIMENS

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          Abstract

          Approximately 1 million prostate biopsies are performed yearly in the United States, with only ~25% resulting in prostate cancer diagnosis. However, ~40% of men receive multiple biopsies for fear of cancer being missed. DNA hypermethylation is ideally suited for early disease detection and could be used to prevent unnecessary biopsies. Men with low-risk epigenetic signatures may forego subsequent biopsy and potential complications. A meta-analysis of two validation studies was conducted to gain additional insight into the benefits for patient risk stratification. In the Methylation Analysis to Locate Occult Cancer (MATLOC) study a negative predictive value of 90% was obtained, which represents a significant improvement over standard of care. This was confirmed in the Detection of Cancer Using Methylated Events in Negative Tissue (DOCUMENT) study (88% negative predictive value), which was designed to validate the performance in an independent cohort. The epigenetic assay, in combination with other known risk factors, may help reduce unnecessary repeat prostate biopsies and identify men at highest risk of harboring occult high-grade prostate cancer.

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          Author and article information

          Contributors
          Journal
          Trans Am Clin Climatol Assoc
          Trans. Am. Clin. Climatol. Assoc
          TACCA
          Transactions of the American Clinical and Climatological Association
          American Clinical and Climatological Association
          0065-7778
          2016
          : 127
          : 313-327
          Affiliations
          BALTIMORE, MARYLAND
          Author notes
          Correspondence and reprint requests: Alan W. Partin, MD, PhD, James Buchanan Brady Urological Institute, The Johns Hopkins University, School of Medicine, 600 N. Wolfe St., Baltimore, MD 21287 apartin@ 123456jhmi.edu
          Article
          PMC5216473 PMC5216473 5216473
          5216473
          28066067
          © 2016 The American Clinical and Climatological Association
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