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New accurate epigenetic test could eliminate unnecessary repeat biopsies for prostate cancer
Date:7/21/2014

New York, NY -- More than one million prostate biopsies are performed each year in the U.S. alone, including many repeat biopsies for fear of cancer missed. Therefore there is a need to develop diagnostic tests that will help avoid unnecessary repeat biopsies. Two independent trials have now validated the performance of an epigenetic test that could provide physicians with a better tool to help eliminate unnecessary repeat prostate biopsies, report investigators in The Journal of Urology.

In the previously reported independent MATLOC (Methylation Analysis To Locate Occult Cancer) trial, a multiplex epigenetic assay (ConfirmMDx for Prostate Cancer) profiling the APC, GSTP1 and RASSF1 genes demonstrated a negative predictive value of 90%. GSTP1 methylation is a specific biomarker for (prostate) cancer and this gene is methylated in up to 90% of prostate cancer cases. Additionally, APC and RASSF1 are important field effect markers and increase the diagnostic sensitivity of the assay.

A second multicenter study, DOCUMENT (Detection Of Cancer Using Methylated Events in Negative Tissue), has validated the performance of the epigenetic assay used in the MATLOC trial as an independent predictor of prostate cancer risk to guide decision making for repeat biopsy. In the DOCUMENT study patients with a negative biopsy were evaluated to identify those at low risk for harboring cancer missed, through biopsy sampling error, who could forego an unnecessary repeat biopsy. The validation study resulted in a negative predictive value of 88%.

"This epigenetic assay is a significant, independent predictor and has been shown to be the most valuable diagnostic aid of all evaluated risk factors in two independent trials," comments Alan W. Partin, MD, PhD, of the James Buchanan Brady Urological Institute, The Johns Hopkins University School of Medicine, Baltimore, Maryland. "Negative findings of this assay could be used to reduce concern over unsampled
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Contact: Linda Gruner
jumedia@elsevier.com
212-633-3923
Elsevier Health Sciences
Source:Eurekalert

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