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).
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT03031418.
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.
Trial PhaseNo phase specified
Trial TypeNot provided by clinicaltrials.gov
Lead OrganizationExosome Diagnostics, Inc.
