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