Clinical Research Directory

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)