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

CompletedOBSERVATIONAL
Enrollment

532

Participants

Timeline

Start Date

September 1, 2016

Primary Completion Date

September 1, 2018

Study Completion Date

September 1, 2018

Conditions
Cancer of Prostate
Interventions
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.

Trial Locations (18)

10016

Manhattan Medical Research, New York

NYU Urology Associates, New York

10029

Icahn School of Medicine at Mount Sinai, New York

10032

Columbia University Medical Center, New York

20889

Walter Reed National Military Medical CPDR, Bethesda

21287

Johns Hopkins University, Baltimore

23462

Urology of Virginia, Virginia Beach

27612

Associated Urologists of North Carolina, Raleigh

29572

Carolina Urologic Research Center, Myrtle Beach

31217

Southeastern Urology Associates, Macon

33140

Mount Sinai Medical Center of Florida, Miami

33907

21st Century Oncology, Fort Myers

48073

Comprehensive Urology, Royal Oak

59808

Five Valley Urology, Missoula

78229

UT Health Science Center, San Antonio

08837

Premier Urology Group, Edison

07631

Urologic Research and Consulting LLC, Englewood

08043

Delaware Valley Urology, Voorhees Township

Sponsors
All Listed Sponsors
lead

Exosome Diagnostics, Inc.

INDUSTRY