NCT03031418

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

Clinical Evaluation of the 'ExoDx Prostate IntelliScore' in Men Presenting for Initial Biopsy; Additional Confirmation Study Including Impact on Decision-making and Health Economics.

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 532 (actual)
• Sponsor: Exosome Diagnostics, Inc. · Industry
• Sex: Male
• Age: 50 Years
• Healthy volunteers: Accepted

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).

Detailed 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.

Conditions

• Cancer of Prostate

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	ExoDx Prostate Intelliscore	ExoDx Prostate (IntelliScore) is a non-invasive, urinary 3-gene expression validated test in which the results of the assay are adjunctive to the ordering physician's clinical judgment and work-up of the patient in the determination of whether a prostate needle biopsy is necessary. The ExoDx Prostate (IntelliScore) was clinically validated to discriminate patients with higher grade prostate cancer from those with more indolent lower grade cancer and benign disease.

Timeline

• Start date: 2016-09-01
• Primary completion: 2018-09-01
• Completion: 2018-09-01
• First posted: 2017-01-25
• Last updated: 2020-12-29

Locations

18 sites across 1 country: United States