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Completed No phase listed Observational Accepts healthy volunteers

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

ClinicalTrials.gov ID: NCT03031418

Public ClinicalTrials.gov record NCT03031418. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Jul 22, 2026, 3:53 PM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

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

Study identification

NCT ID
NCT03031418
Recruitment status
Completed
Study type
Observational
Phase
Not listed
Lead sponsor
Exosome Diagnostics, Inc.
Industry
Enrollment
532 participants

Conditions and interventions

Interventions

  • ExoDx Prostate Intelliscore Diagnostic Test

Diagnostic Test

Eligibility (public fields only)

Age range
50 Years and older
Sex
Male
Healthy volunteers
Accepts healthy volunteers

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Aug 31, 2016
Primary completion
Aug 31, 2018
Completion
Aug 31, 2018
Last update posted
Dec 28, 2020

2016 – 2018

United States locations

U.S. sites
18
U.S. states
11
U.S. cities
15
Facility City State ZIP Site status
21st Century Oncology Fort Myers Florida 33907
Mount Sinai Medical Center of Florida Miami Florida 33140
Southeastern Urology Associates Macon Georgia 31217
Johns Hopkins University Baltimore Maryland 21287
Walter Reed National Military Medical CPDR Bethesda Maryland 20889
Comprehensive Urology Royal Oak Michigan 48073
Five Valley Urology Missoula Montana 59808
Premier Urology Group Edison New Jersey 08837
Urologic Research and Consulting LLC Englewood New Jersey 07631
Delaware Valley Urology Voorhees Township New Jersey 08043
Manhattan Medical Research New York New York 10016
NYU Urology Associates New York New York 10016
Icahn School of Medicine at Mount Sinai New York New York 10029
Columbia University Medical Center New York New York 10032
Associated Urologists of North Carolina Raleigh North Carolina 27612
Carolina Urologic Research Center Myrtle Beach South Carolina 29572
UT Health Science Center San Antonio Texas 78229
Urology of Virginia Virginia Beach Virginia 23462

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT03031418, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Dec 28, 2020 · Synced Jul 22, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT03031418 live on ClinicalTrials.gov.

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