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).
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.
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.
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There are 17 Locations for this study
Fort Myers Florida, 33907, United States
Miami Florida, 33140, United States
Macon Georgia, 31217, United States
Baltimore Maryland, 21287, United States
Bethesda Maryland, 20889, United States
Royal Oak Michigan, 48073, United States
Missoula Montana, 59808, United States
Edison New Jersey, 08837, United States
Englewood New Jersey, 07631, United States
Voorhees New Jersey, 08043, United States
New York New York, 10016, United States
New York New York, 10016, United States
New York New York, 10029, United States
New York New York, 10032, United States
Raleigh North Carolina, 27612, United States
Myrtle Beach South Carolina, 29572, United States
San Antonio Texas, 78229, United States
Virginia Beach Virginia, 23462, United States
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