ClariCore System Used in Transrectal Ultrasound Guided Prostate Biopsy for Real-Time Tissue Evaluation

Inclusion Criteria: * Males \> 22 years old * Patient scheduled for TRUS-guided prostate biopsy based on standard of care urologic requirements to assess for tissue malignancy (abnormal Digital Rectum Examination, Prostate Specific Antigen kinetics, age, ethnicity, family history, etc.) * Enrolling physician must have expectation that prostate dimensions will meet minimum prostate volume and height requirements that will be evaluated at start of biopsy procedure (i.e., Prostate volume \> 20cc and height at least 22mm) * Patient signs an Institutional Review Board approved, Informed Consent form to participate in the study prior to any study mandated determinations or procedure Exclusion Criteria: * Any anatomical or co-morbidity contraindications to TRUS prostate biopsy * Acute painful perianal disorder (i.e. rectal abscess) * Symptomatic, acute prostatitis * Surgical absence of a rectum or the presence of a rectal fistula * Patient has systemic infection or evidence of any surgical site infection (superficial or organ space), including active urinary tract infection * Previous prostate intervention \[Transurethral Prostatectomy (TURP) (bipolar, monopolar, laser)\], Transurethral Microwave Thermotherapy (TUMT), High-Intensity Focused Ultrasound (HIFU), Cryo, Rezum, Urolift\], not including previous prostate biopsy * Current use of blood thinning agents for medical comorbidity which prohibits the cessation of use as typically required per standard of care (SOC) or history o…