Urology of Virginia Case Series

This trial will enroll nine men with an indication for a prostate biopsy. The primary objective of the study is to provide guidance to clinicians who will be using the ExactVu system on the appearance of suspicious foci, and the difference between the appearance of these foci in LR-TRUS, mpMRI and transrectal micro-ultrasound images. The study is being conducted based on the hypothesis that a series of same-subject comparisons will clearly demonstrate the differences in appearance between the modalities. Procedures in the study are: * obtain informed consent for the subject * image the subject using mpMRI according to the PI-RADS v2 protocol, and obtain radiologist's report * perform biopsy procedure using micro-ultrasound (this may be conducted in a separate subject visit) * prepare biopsy specimens for pathology * record all procedure details in a case report form, including pathology and mpMRI reports The primary endpoint will be a standardized description using keywords of each biopsy sample region. These descriptions will be recorded during the blinded readings after the procedure to avoid added procedure time and will be used to compare appearance between the modalities. Secondary endpoints are the pathological result of each biopsy sample (Gleason Score and percentage of cancer in sample), and risk score identified on imaging. Both of these values are per-sample, with 12 systematic samples per subject plus any additional targeted samples warranted by standard of care.