Clinical Evaluation of ExoDx Prostate(IntelliScore) in Men Presenting for Initial Prostate Biopsy

Clinical Evaluation of ExoDx™ Prostate(IntelliScore) in Men Presenting for Initial Prostate Biopsy

The study described here is being conducted to prospectively confirm the performance of the ExoDx Prostate gene expression assay in patients presenting for an initial prostate biopsy and support of CE-marking the test for a European Union Launch.

Inclusion Criteria:

• Clinical suspicion for prostate cancer
• Elevated Prostate-specific Antigen between 2.0-10 ng/ mL
• Scheduled for a initial prostate biopsy

Exclusion Criteria:

• 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 (BPH) or lower urinary track symptoms within 6 months of study enrollment.
• Known hepatitis status (all types) and/or HIV documented in patient's medical record.
• Patients with history of concurrent renal/bladder tumors.
• Prior MRI used in the decision to biopsy