Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Case Comprehensive Cancer Center
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.
Age
18–any
Sex
MALE
Healthy volunteers
Not accepted
You may be eligible if
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.
You may not be if
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.
