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

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.