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Lead
Exosome Diagnostics, Inc.
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.
Age
50–any
Sex
MALE
Healthy volunteers
Accepted
You may be eligible 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 be 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.
Clareo Health | Clinical Evaluation of the 'ExoDx Prostate IntelliScore' (EPI)
