Last updated on February 2019

Clinical Evaluation of the 'ExoDx Prostate IntelliScore' (EPI)

Brief description of study

The purpose of this research study is investigate a new and validated urine test which predicts the likelihood of high grade prostate cancer on an initial prostate biopsy The current protocol has two objectives; one is to further assess and evaluate the performance of the urine test in men already scheduled for initial prostate needle biopsy (cohort (group) 1) and two, to evaluate how the results of the urine test influences the decision process for determining whether to perform a prostate biopsy (cohort (group) 2).

Detailed Study Description

Primary Objective(s)

  • Confirm performance of the ExoDx Prostate (IntelliScore) (EPI) utilizing a designated collection vessel for men presenting for their initial prostate biopsy with an elevated Prostate-specific antigen (2-10 ng/mL).
  • Evaluate impact of the confirmed ExoDx Prostate (IntelliScore) on the decision to perform an initial prostate biopsy for men presenting with an elevated Prostate-specific antigen (2-10 ng/mL).

Secondary and Exploratory Objectives

  • Assess physician satisfaction with the ExoIntelliScore Prostate report including test result presentation, graphics and interpretation.
  • Assess patient satisfaction for ease of understanding test results and role on decision process to have a biopsy.
  • Determine the medical economic impact of the ExoIntelliScore Prostate in the prostate biopsy decision process.
  • Correlation of the ExoIntelliScore Prostate score with the actual biopsy result.

Clinical Study Identifier: NCT03031418

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Icahn School of Medicine at Mount Sinai

New York, NY United States
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Manhattan Medical Research

New York, NY United States
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NYU Urology Associates

New York, NY United States
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