Prostate Cancer Clinical Trial

Clinical Evaluation of the ‘ExoDx Prostate IntelliScore’ (EPI)

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).

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Full 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.

View Eligibility Criteria

Eligibility Criteria

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.

Study is for people with:

Prostate Cancer

Estimated Enrollment:

532

Study ID:

NCT03031418

Recruitment Status:

Completed

Sponsor:

Exosome Diagnostics, Inc.

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There are 17 Locations for this study

See Locations Near You

21st Century Oncology
Fort Myers Florida, 33907, United States
Mount Sinai Medical Center of Florida
Miami Florida, 33140, United States
Southeastern Urology Associates
Macon Georgia, 31217, United States
Johns Hopkins University
Baltimore Maryland, 21287, United States
Walter Reed National Military Medical CPDR
Bethesda Maryland, 20889, United States
Comprehensive Urology
Royal Oak Michigan, 48073, United States
Five Valley Urology
Missoula Montana, 59808, United States
Premier Urology Group
Edison New Jersey, 08837, United States
Urologic Research and Consulting LLC
Englewood New Jersey, 07631, United States
Delaware Valley Urology
Voorhees New Jersey, 08043, United States
Manhattan Medical Research
New York New York, 10016, United States
NYU Urology Associates
New York New York, 10016, United States
Icahn School of Medicine at Mount Sinai
New York New York, 10029, United States
Columbia University Medical Center
New York New York, 10032, United States
Associated Urologists of North Carolina
Raleigh North Carolina, 27612, United States
Carolina Urologic Research Center
Myrtle Beach South Carolina, 29572, United States
UT Health Science Center
San Antonio Texas, 78229, United States
Urology of Virginia
Virginia Beach Virginia, 23462, United States

How clear is this clinincal trial information?

Study is for people with:

Prostate Cancer

Estimated Enrollment:

532

Study ID:

NCT03031418

Recruitment Status:

Completed

Sponsor:


Exosome Diagnostics, Inc.

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