ExosomeDx in MRI-negative Men With High PSA

Inclusion criteria

To be eligible to participate in this study, an individual must meet all the following criteria;

• Willingness to participate and provide signed and dated informed consent form
• Male (sex)
• Age ≥ 18 years
• PSA screen-eligible, per investigator discretion

• 45-75 years of age for average risk
• 40-75 years of age for high risk
• PSA ≥ 2.0 ng/mL and ≤ 10.0 ng/mL
• MRI PIRADS score of 1 or 2
• ECOG 0-1
• Must have a negative urine culture prior to biopsy
• No prior prostate biopsies within the last 5 years (biopsy-naïve)
• Willingness to undergo a prostate biopsy as part of the diagnostic work-up
• Digital rectal exam with no palpable nodules

Exclusion criteria

An individual who meets any of the following criteria will be excluded from participation in this study;

• Prior or current histologic or pathologic confirmed diagnosis of prostate cancer
• Prior transrectal ultrasound within the last 5 years
• Any prior cancer diagnosis within the last 5 years
• On immunosuppression or predefined immunosuppressed state
• A known coagulopathy predisposition to bleeding
• Diagnoses of any uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that, in the opinion of the investigator, would limit compliance with study requirements
• Cognitive inability or psychiatric conditions that preclude informed decision making or compliance with study requirements (per investigator discretion)