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

NCT03031418 | Completed

• 1 other identifier: ECT2016-001
• Study Type: observational
• Target: 532
• Locations: 1 country
• Sites: 18

Brief 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

Outcome Measures

Primary Outcomes (1)

• Confirm performance of the ExoDx Prostate IntelliScore

  Confirm performance of the ExoDx Prostate IntelliScore utilizing a designated collection vessel for men presenting for their initial prostate biopsy with an elevated prostate-specific antigen (2-10 ng/mL).

  6 months

Study Arms (2)

Cohort 1

Enroll up to 500 patients to confirm performance of ExoDx Prostate IntelliScore (EPI) for men scheduled for initial biopsy. The treating physician will collect a urine sample from from a consented subject to test before their scheduled prostate biopsy (during your established clinic visit).

Cohort 2

Enroll up to 500 patients to evaluate how the results of the urine test influences the decision process for determining whether to perform a prostate biopsy. The treating physician will collect a urine sample for testing and 2 weeks later discuss whether to perform a prostate biopsy with the subject knowing the results of the urine test and comparing them to the overall consensus report from Cohort 1 as well as other clinical factors the treating physician would otherwise use to determine whether they should have a prostate biopsy.

Diagnostic Test: ExoDx Prostate Intelliscore

Interventions

ExoDx Prostate Intelliscore DIAGNOSTIC_TEST

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.

Also known as: EPI

Cohort 2

Eligibility Criteria

• Age: 50 Years+
• Gender Eligibility Details: Must be male to screen for prostate cancer
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Male, 50+ years of age with a clinical suspicion for prostate cancer based in part on an elevated Prostate-specific antigen (limit range: 2.0 - 10 ng/ mL), and or suspicious DRE, without the clinical history of a prior negative biopsy.

You may qualify if:

• 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

You may not qualify if:

• 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.
• No known hepatitis (all types) and/or HIV documented in patient's medical record.
• Patients with history of concurrent renal/bladder tumors.

Sponsors & Collaborators

• Exosome Diagnostics, Inc.: lead

Study Sites (18)

21st Century Oncology

Fort Myers, Florida, 33907, United States

Location

Mount Sinai Medical Center of Florida

Miami, Florida, 33140, United States

Location

Southeastern Urology Associates

Macon, Georgia, 31217, United States

Location

Johns Hopkins University

Baltimore, Maryland, 21287, United States

Location

Walter Reed National Military Medical CPDR

Bethesda, Maryland, 20889, United States

Location

Comprehensive Urology

Royal Oak, Michigan, 48073, United States

Location

Five Valley Urology

Missoula, Montana, 59808, United States

Location

Premier Urology Group

Edison, New Jersey, 08837, United States

Location

Urologic Research and Consulting LLC

Englewood, New Jersey, 07631, United States

Location

Delaware Valley Urology

Voorhees Township, New Jersey, 08043, United States

Location

Manhattan Medical Research

New York, New York, 10016, United States

Location

NYU Urology Associates

New York, New York, 10016, United States

Location

Icahn School of Medicine at Mount Sinai

New York, New York, 10029, United States

Location

Columbia University Medical Center

New York, New York, 10032, United States

Location

Associated Urologists of North Carolina

Raleigh, North Carolina, 27612, United States

Location

Carolina Urologic Research Center

Myrtle Beach, South Carolina, 29572, United States

Location

UT Health Science Center

San Antonio, Texas, 78229, United States

Location

Urology of Virginia

Virginia Beach, Virginia, 23462, United States

Location

Related Publications (3)

• Donovan MJ, Noerholm M, Bentink S, Belzer S, Skog J, O'Neill V, Cochran JS, Brown GA. A molecular signature of PCA3 and ERG exosomal RNA from non-DRE urine is predictive of initial prostate biopsy result. Prostate Cancer Prostatic Dis. 2015 Dec;18(4):370-5. doi: 10.1038/pcan.2015.40. Epub 2015 Sep 8.

  PMID: 26345389 RESULT

• Kretschmer A, Tutrone R, Alter J, Berg E, Fischer C, Kumar S, Torkler P, Tadigotla V, Donovan M, Sant G, Skog J, Noerholm M. Pre-diagnosis urine exosomal RNA (ExoDx EPI score) is associated with post-prostatectomy pathology outcome. World J Urol. 2022 Apr;40(4):983-989. doi: 10.1007/s00345-022-03937-0. Epub 2022 Jan 27.

  PMID: 35084544 DERIVED

• McKiernan J, Donovan MJ, Margolis E, Partin A, Carter B, Brown G, Torkler P, Noerholm M, Skog J, Shore N, Andriole G, Thompson I, Carroll P. A Prospective Adaptive Utility Trial to Validate Performance of a Novel Urine Exosome Gene Expression Assay to Predict High-grade Prostate Cancer in Patients with Prostate-specific Antigen 2-10ng/ml at Initial Biopsy. Eur Urol. 2018 Dec;74(6):731-738. doi: 10.1016/j.eururo.2018.08.019. Epub 2018 Sep 17.

  PMID: 30237023 DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

Random first catch urine sample \> 20mL

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Officials

• Roger Tun

  Exosome Diagnostics, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 23, 2017
• First Posted: January 25, 2017
• Study Start: September 1, 2016
• Primary Completion: September 1, 2018
• Study Completion: September 1, 2018
• Last Updated: December 29, 2020

Record last verified: 2020-12

Locations

US (18)