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

  • STATUS
    Not Recruiting
  • participants needed
    1000
  • sponsor
    Exosome Diagnostics, Inc.
Updated on 26 January 2021
Manhattan Medical Research (7.0 mi away) Contact
prostate specific antigen
biopsy of prostate

Summary

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).

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.

Details
Condition Malignant neoplasm of prostate
Treatment ExoDx Prostate Intelliscore
Clinical Study IdentifierNCT03031418
SponsorExosome Diagnostics, Inc.
Last Modified on26 January 2021

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