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Biomarkers for Early Detection of Clinically Relevant Prostate Cancer: A Multi-Institutional Validation Trial

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Technical Report,30 Sep 2014,29 Sep 2015

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Cleveland Clinic Foundation Cleveland United States

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For men diagnosed with early stage prostate cancer a critical need exists for molecular assays that accurately distinguish aggressive prostate cancer from those cancers that will not cause harm if left untreated. In this project, we are assessing three different panels of established molecular biomarkers for their ability to distinguish aggressive cancers from indolent cancers. We have established agreements with three commercial companies to analyze their biomarker platforms in our multi-center, prospectively accrued prostate cancer active surveillance cohort the Canary Prostate Active Surveillance Study PASS. We are in the process of evaluating these three biomarker panels in tissue, blood, and urine samples with well annotated clinical and pathologic data collected as part of PASS. We are conducting rigorous statistical evaluation to demonstrate the utility and performance of biomarkers in clinical practice to predict aggressive disease. The accuracy of each biomarker for predicting short- and long-term progression will be characterized with time dependent receiver operating characteristic curves. The successful clinical validation of biomarkers that offer substantially improved predictive and prognostic accuracy should bring extraordinary potential to improve the care of prostate cancer patients.

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