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

Cancer of Prostate Clinical Trial

Official title:

Clinical Evaluation of the 'ExoDx Prostate IntelliScore' in Men Presenting for Initial Biopsy; Additional Confirmation Study Including Impact on Decision-making and Health Economics.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03031418
• Other study ID #: ECT2016-001
• Status: Completed
• Start date: September 1, 2016
• Est. completion date: September 1, 2018

Study information

• Verified date: December 2020
• Source: Exosome Diagnostics, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

Description:

Primary Objective(s)

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

• Evaluate impact of the confirmed ExoDx Prostate (IntelliScore) on the decision to perform an initial prostate biopsy for men presenting with an elevated Prostate-specific antigen (2-10 ng/mL).

Secondary and Exploratory Objectives

• Assess physician satisfaction with the ExoIntelliScore Prostate report including test result presentation, graphics and interpretation.

• Assess patient satisfaction for ease of understanding test results and role on decision process to have a biopsy.

• Determine the medical economic impact of the ExoIntelliScore Prostate in the prostate biopsy decision process.

• Correlation of the ExoIntelliScore Prostate score with the actual biopsy result.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 532
• Est. completion date: September 1, 2018
• Est. primary completion date: September 1, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 50 Years and older

Eligibility

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.

• No known hepatitis (all types) and/or HIV documented in patient's medical record.

• Patients with history of concurrent renal/bladder tumors.

Related Conditions & MeSH terms

• Cancer of Prostate
• Prostatic Neoplasms

Intervention

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.

Locations

Country	Name	City	State
United States	Johns Hopkins University	Baltimore	Maryland
United States	Walter Reed National Military Medical CPDR	Bethesda	Maryland
United States	Premier Urology Group	Edison	New Jersey
United States	Urologic Research and Consulting LLC	Englewood	New Jersey
United States	21st Century Oncology	Fort Myers	Florida
United States	Southeastern Urology Associates	Macon	Georgia
United States	Mount Sinai Medical Center of Florida	Miami	Florida
United States	Five Valley Urology	Missoula	Montana
United States	Carolina Urologic Research Center	Myrtle Beach	South Carolina
United States	Columbia University Medical Center	New York	New York
United States	Icahn School of Medicine at Mount Sinai	New York	New York
United States	Manhattan Medical Research	New York	New York
United States	NYU Urology Associates	New York	New York
United States	Associated Urologists of North Carolina	Raleigh	North Carolina
United States	Comprehensive Urology	Royal Oak	Michigan
United States	UT Health Science Center	San Antonio	Texas
United States	Urology of Virginia	Virginia Beach	Virginia
United States	Delaware Valley Urology	Voorhees	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
Exosome Diagnostics, Inc.

Country where clinical trial is conducted

United States, 

References & Publications (1)

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- — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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