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

NCT03031418 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 532

Last updated 2020-12-29

No results posted yet for this 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

  • 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.

Sponsors & Collaborators

  • Exosome Diagnostics, Inc.

    lead INDUSTRY

Principal Investigators

  • Roger Tun · Exosome Diagnostics, Inc.

Eligibility

Min Age
50 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2016-09-01
Primary Completion
2018-09-01
Completion
2018-09-01

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 NCT03031418 on ClinicalTrials.gov