Pilot Study Evaluating the Role of Histopathology Correlation in Treatment Planning

Study Objectives

Specific Aim 1: Evaluate final pathology post-operatively for histopathology confirmation of
multiparametric MRI targets detected during treatment planning. This will be accomplished by
using transperineal biopsies obtained prior to interstitial brachytherapy during the
procedure, while under anesthetic just prior to the placement of the brachytherapy needles
and sources.

Specific Aim 2: Evaluate the ability of the Uronav system in a transperineal setting to guide
biopsy needle placement using the electromagnetic guidance system and transperineal
ultrasound probe stabilization device and stepper.

Inclusion Criteria:

- Patients must have histopathology confirmed prostate cancer that is Gleason score
≤7(4+3) clinical stage ≤ T2bN0M0 with a Prostate-specific antigen (PSA) below 15
ng/mL.

- Patients must have MRI findings reporting intraprostatic lesions suspicious for
malignancy.

- Patient must not have had any prior treatment for prostate cancer

- Eastern Cooperative Oncology Group (ECOG) Performance status ≤ 2

- Subjects must have an International Prostate Symptom Score of ≤ 15.

- Subjects must have the ability to understand and the willingness to sign a written
informed consent document.

Exclusion Criteria:

- Gleason score of ≥ 8(4+4)

- PSA ≥ 15 ng/mL.

- Clinical stage >T2b or evidence of nodal

- Patients who are on anticoagulants or high dose aspirin therapy that cannot be safely
stopped for greater than 10 days prior to treatment should be excluded to limit
increased risk for urinary obstruction.

- Patients with 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 would limit
compliance with study requirements.

- HIV-positive patients on combination antiretroviral therapy are ineligible because of
the unlikely risk of prostate cancer being life threatening in this population.