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

Completed

Conditions studied: Cancer of Prostate

In brief

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).

Key facts

Study ID

NCT03031418

Run by

Exosome Diagnostics, Inc.

People needed

532

Starts

2016-09-01

Expected to finish

2018-09-01

Last updated by the study team

2020-12-29

Who can join

Age: 50 and older. Sex: male. Healthy volunteers: accepted.

You may qualify if…

• 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

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.

Where it is running

• 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 Township, 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

Full record on ClinicalTrials.gov

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