ClariCoreâ„¢ Biopsy System in Patients Undergoing Radical Retropubic Prostatectomy

Inclusion Criteria:

Patient scheduled for radical retropubic prostatectomy
Prostate volume > 20cc and height at least 22mm (at the area(s) to be biopsied) as verified by ultrasound or MRI
Patient, or authorized representative signs a written Informed Consent form to participate in the study, prior to any study mandated determinations or procedure

Exclusion Criteria:

Patient opted for robotic (da Vinci robot) or laparoscopic surgery
Any condition, or history of illness or surgery that, in the opinion of the Investigator, might confound the results of the study or pose additional risks to the patient (e.g. significant cardiovascular conditions or allergies)
Patient has systemic infection or evidence of any surgical site infection (superficial or organ space), including active urinary tract infection
Bladder cancer (current or prior)
Actively taking blood thinning agents (with the exception of low dose aspirin {81 mg}, Plavix, Coumadin etc.) or severe medical comorbidity prohibiting halting of anticoagulation therapies or history of bleeding disorder (e.g. coagulopathy)
Any malignancy other than non-melanoma cell skin cancer, unless no evidence of disease for a minimum of 5 years
Hormone therapy for locally advanced disease (except patients on 5-alpha reductase inhibitors to reduce the size of the prostate)
Neo-adjuvant hormonal therapy
Salvage radical prostatectomy, i.e., patients having surgery due to failure of previous therapy (radiation, brachytherapy, cryotherapy, etc.)
Patient has compromised immune system or autoimmune disease (WBC < 4000 or > 20,000)
Patient is not likely to comply with the follow-up evaluation schedule
Patient is participating in a clinical trial of another investigational drug or device
Patient is mentally incompetent or a prisoner