ClariCore™ Biopsy System in Patients Undergoing Radical Retropubic Prostatectomy

The overall objective of this study is to acquire and analyze spectral data and correlative
tissue biopsy cores using the ClariCore System for the purpose of algorithm development.

The system algorithm will be trained to identify real-time in vivo 'Normal' versus
'Suspicious' prostate tissue. The 'Normal' or 'Suspicious' assignment will be based on the
optical signal principle component parameters of the measured signal when compared to a
threshold to be derived from pathologically known values of suspicious (or possibly
cancerous) and normal (or non-cancerous) measurements in prostate tissue.

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