Spots Global Cancer Trial Database for Clinical Evaluation of the 'ExoDx Prostate IntelliScore' (EPI)
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Trial Identification
Brief Title: Clinical Evaluation of the 'ExoDx Prostate IntelliScore' (EPI)
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.
Study ID: NCT03031418
Conditions
Interventions
Study Description
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).
Detailed 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.
Keywords
Eligibility
Minimum Age: 50 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: MALE
Healthy Volunteers: Yes
Locations
21st Century Oncology, Fort Myers, Florida, United States
Mount Sinai Medical Center of Florida, Miami, Florida, United States
Southeastern Urology Associates, Macon, Georgia, United States
Johns Hopkins University, Baltimore, Maryland, United States
Walter Reed National Military Medical CPDR, Bethesda, Maryland, United States
Comprehensive Urology, Royal Oak, Michigan, United States
Five Valley Urology, Missoula, Montana, United States
Premier Urology Group, Edison, New Jersey, United States
Urologic Research and Consulting LLC, Englewood, New Jersey, United States
Delaware Valley Urology, Voorhees, New Jersey, United States
Manhattan Medical Research, New York, New York, United States
NYU Urology Associates, New York, New York, United States
Icahn School of Medicine at Mount Sinai, New York, New York, United States
Columbia University Medical Center, New York, New York, United States
Associated Urologists of North Carolina, Raleigh, North Carolina, United States
Carolina Urologic Research Center, Myrtle Beach, South Carolina, United States
UT Health Science Center, San Antonio, Texas, United States
Urology of Virginia, Virginia Beach, Virginia, United States
Contact Details
Name: Roger Tun
Affiliation: Exosome Diagnostics, Inc.
Role: STUDY_DIRECTOR
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