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Decision Impact Trial of the ExoDx Prostate (IntelliScore)

NCT03235687 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 1000

Last updated 2022-05-06

No results posted yet for this study

Summary

The purpose of this research study is to investigate the utility of a validated urine test which predicts the likelihood of high grade prostate cancer on an initial prostate biopsy.

Conditions

  • Cancer of the 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.

Sponsors & Collaborators

  • CareFirst BlueCross BlueShield

    collaborator UNKNOWN

  • Chesapeake Urology Research Associates

    collaborator OTHER

  • Exosome Diagnostics, Inc.

    lead INDUSTRY

Principal Investigators

  • Roger Tun · Exosome Diagnostics, Inc.

  • Ronald F Tutrone, MD · Chesapeake Urology Research Associates

Study Design

Allocation
RANDOMIZED
Purpose
SCREENING
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
50 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-07-19
Primary Completion
2018-09-01
Completion
2023-09-29

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03235687 on ClinicalTrials.gov