Decision Impact Trial of the ExoDx Prostate (IntelliScore)

A Prospective, Randomized Blinded, Shared Decision Impact Trial of the ExoDx Prostate (IntelliScore), EPI Test, in Men Presenting for Initial Biopsy.

The purpose of this research study is to investigate the utility of a validated urine test which predicts the likelihood of high grade prostate cancer on an initial prostate biopsy.

Primary Objective(s)

1. Evaluate performance of the ExoDx Prostate(IntelliScore) (EPI) to reduce the number of initial prostate biopsies by greater than or equal to 15% for men with an elevated Prostate-Specific Antigen 2-10ng/mL presenting for a biopsy in consultation with their urologist.
2. Compare performance of both the ExoDx Prostate(IntelliScore) 15.6 and 20 cut-points with respect to the biopsy decision process.
3. Assess physician satisfaction with the ExoDx Prostate(IntelliScore) report including test result presentation, graphics and interpretation.
4. Assess urologist / patient satisfaction for ease of understanding test results and role on biopsy decision process.

Secondary Objectives

1. Determine the medical economic impact of the ExoDx Prostate(IntelliScore) test in the prostate biopsy decision process.
2. Correlation of the ExoDx Prostate(IntelliScore) score with the actual biopsy result by utilizing the Receiver Operating Characteristic of the Area Under Curve for discriminating high-grade (greater than or equal to Gleason Score 7, International Society of Urological Pathology 2 and 3) from low-grade (Gleason Score 6, International Society of Urological Pathology 1) and benign disease on initial prostate needle biopsy.

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.
• Known hepatitis (all types) and/or HIV documented in patient's medical record.
• Patients with history of concurrent renal/bladder tumors.