Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.

NCT03031418 · ClinicalTrials.gov registry record

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

A clinical trial of Cancer Of Prostate, sponsored by Exosome Diagnostics.

Completed
Registry status
532
Enrollment target
18
Study locations

NCT03031418 is a study of Cancer Of Prostate that has completed, run by Exosome Diagnostics. The registered enrollment target is 532 participants, below the 1,863-participant average among 7 other Cancer Of Prostate trials with a reported enrollment target (71% lower). The trial reports 18 study locations across 11 states.

View on ClinicalTrials.gov ↗

View your shortlist →

The verdict

NCT03031418, a study of Cancer Of Prostate, has completed, sponsored by Exosome Diagnostics.

COMPLETED
Registry status
532 participants
Enrollment target
18
Study locations

Study 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).

Conditions Studied

Interventions

  • DIAGNOSTIC_TEST ExoDx Prostate Intelliscore

Study Locations (18)

New York

  • Manhattan Medical Research - New York
  • NYU Urology Associates - New York
  • Icahn School of Medicine at Mount Sinai - New York
  • Columbia University Medical Center - New York

New Jersey

  • Premier Urology Group - Edison
  • Urologic Research and Consulting LLC - Englewood
  • Delaware Valley Urology - Voorhees Township

Florida

  • 21st Century Oncology - Fort Myers
  • Mount Sinai Medical Center of Florida - Miami

Maryland

  • Johns Hopkins University - Baltimore
  • Walter Reed National Military Medical CPDR - Bethesda

Georgia

  • Southeastern Urology Associates - Macon

Michigan

  • Comprehensive Urology - Royal Oak

Montana

  • Five Valley Urology - Missoula

North Carolina

  • Associated Urologists of North Carolina - Raleigh

Trial Details

FieldValue
Enrollment Target 532 participants
Start Date 2016-09-01
Est. Completion 2018-09-01

Sponsor

Exosome Diagnostics

3 total trials

What the Registry Record Tells You About NCT03031418

The ClinicalTrials.gov registry entry for NCT03031418 describes a study currently listed as completed, categorized as an unspecified phase. The registered enrollment target is 532 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 1,863-participant average among 7 other Cancer Of Prostate trials with a reported enrollment target (71% lower). The listed sponsor is Exosome Diagnostics, which has 3 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Cancer Of Prostate appearing as the primary indexed condition, and to 1 intervention - of which ExoDx Prostate Intelliscore is the first listed.

NCT03031418 reports 18 study locations spanning 11 distinct geographic areas - top geographies include New York, New Jersey, Florida.

Frequently Asked Questions

What is clinical trial NCT03031418 about?

NCT03031418 is a clinical study titled "Clinical Evaluation of the 'ExoDx Prostate IntelliScore' (EPI)". 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 s...

What is the current status of trial NCT03031418?

This trial is currently completed. The enrollment target is 532 participants. The study started on 2016-09-01. Estimated completion is 2018-09-01.

What conditions does trial NCT03031418 study?

This clinical trial studies the following conditions: Cancer Of Prostate.

What interventions are being tested in trial NCT03031418?

The interventions under investigation include: ExoDx Prostate Intelliscore (DIAGNOSTIC_TEST).

Who is sponsoring clinical trial NCT03031418?

This trial is sponsored by Exosome Diagnostics, which has 3 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT03031418 being conducted?

This trial has 18 study locations across Florida, Georgia, Maryland, Michigan, Montana. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Similar trials for Cancer Of Prostate

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.