Prostate Cancer Clinical Trial
Pilot Study Evaluating the Role of Histopathology Correlation in Treatment Planning
Summary
This clinical research study tests the Uronav system. Patients with prostate cancer will be asked to take part in this study.
Uronav system is an investigational device that is used on this study to help place markers in the patient. These are called fiducial markers and they are placed in the patient to help plan radiation treatment. Radiation therapy treatment will be planned by the treating physician and will not be experimental or part of this research study.
This study will also test the similarities and differences of biopsy tissue structures and the findings from the intraprostatic MRI (internally guided MRI).
Full Description
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.
Eligibility Criteria
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.
Check Your Eligibility
Let’s see if you might be eligible for this study.
What is your age and gender ?
There is 1 Location for this study
Cleveland Ohio, 44106, United States
How clear is this clinincal trial information?

Please confirm you are a US based health care provider:
Yes, I am a health care Provider No, I am not a health care providerSign Up Now.
Take Control of Your Disease Journey.
Sign up now for expert patient guides, personalized treatment options, and cutting-edge insights that can help you push for the best care plan.