Decision Impact Trial of the ExoDx Prostate (IntelliScore)

May 3, 2022 updated by: Exosome Diagnostics, Inc.

A Prospective, Randomized Blinded, Shared Decision Impact Trial of the ExoDx Prostate (IntelliScore), EPI Test, in Men Presenting for Initial Biopsy.

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

Primary Objective(s)

  1. Evaluate performance of the ExoDx Prostate(IntelliScore) (EPI) to reduce the number of initial prostate biopsies by greater than or equal to 15% for men with an elevated Prostate-Specific Antigen 2-10ng/mL presenting for a biopsy in consultation with their urologist.
  2. Compare performance of both the ExoDx Prostate(IntelliScore) 15.6 and 20 cut-points with respect to the biopsy decision process.
  3. Assess physician satisfaction with the ExoDx Prostate(IntelliScore) report including test result presentation, graphics and interpretation.
  4. Assess urologist / patient satisfaction for ease of understanding test results and role on biopsy decision process.

Secondary Objectives

  1. Determine the medical economic impact of the ExoDx Prostate(IntelliScore) test in the prostate biopsy decision process.
  2. Correlation of the ExoDx Prostate(IntelliScore) score with the actual biopsy result by utilizing the Receiver Operating Characteristic of the Area Under Curve for discriminating high-grade (greater than or equal to Gleason Score 7, International Society of Urological Pathology 2 and 3) from low-grade (Gleason Score 6, International Society of Urological Pathology 1) and benign disease on initial prostate needle biopsy.

Study Type

Interventional

Enrollment (Anticipated)

1000

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Maryland
      • Towson, Maryland, United States, 21204
        • Chesapeake Urology Research Associates

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  • 50 years of age
  • Clinical suspicion for prostate cancer
  • Elevated Prostate-specific antigen between: 2.0 - 10 ng/ mL
  • No clinical history of a prior negative biopsy

Exclusion Criteria:

  • History of prior prostate biopsy.
  • Use of medications or hormones that are known to affect serum Prostate-specific antigen levels within 3-6 months of study enrollment.
  • Clinical symptoms of urinary tract infection (including prostatitis) at the time of enrollment.
  • History of prostate cancer.
  • History of invasive treatments for benign prostatic hypertrophy (Benign Prostatic Hyperplasia) or lower urinary track symptoms within 6 months of study enrollment.
  • Known hepatitis (all types) and/or HIV documented in patient's medical record.
  • Patients with history of concurrent renal/bladder tumors.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: SCREENING
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: TRIPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Cohort A
Patients randomized to Cohort A will receive ExoDx Prostate (IntelliScore) test results along with a post-ExoDx Prostate (IntelliScore) test result questionnaire to evaluate impact of test results in the biopsy decision process, utility, ease of understanding and work-flow implementation.
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.
Other Names:
  • EPI
NO_INTERVENTION: Cohort B
Patients randomized to Cohort B will proceed with conventional standard of care.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evaluate performance of the ExoDx Prostate(IntelliScore)
Time Frame: 6 Months
Evaluate performance of the ExoDx Prostate(IntelliScore) to reduce the number of initial prostate biopsies by greater than or equal to 15% for men with an elevated prostate specific antigen between 2-10ng/mL presenting for a biopsy in consultation with their urologist.
6 Months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Exosome Diagnostics, Inc.

Collaborators

Chesapeake Urology Research Associates
CareFirst BlueCross BlueShield

Investigators

  • Principal Investigator: Ronald F Tutrone, MD, Chesapeake Urology Research Associates

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

July 19, 2017

Primary Completion (ACTUAL)

September 1, 2018

Study Completion (ANTICIPATED)

September 29, 2023

Study Registration Dates

First Submitted

July 28, 2017

First Submitted That Met QC Criteria

July 28, 2017

First Posted (ACTUAL)

August 1, 2017

Study Record Updates

Last Update Posted (ACTUAL)

May 6, 2022

Last Update Submitted That Met QC Criteria

May 3, 2022

Last Verified

May 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ECT2017-002

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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