Pilot Study Evaluating the Role of Histopathology Correlation in Treatment Planning

Case Comprehensive Cancer Center (Case CCC)

Status: Completed

Conditions: Prostate Cancer

Treatments: Device: Uronav guided biopsy; Device: Magnetic resonance imaging

Study type: Interventional

Funder types: Other

Identifiers

NCT02681614

CASE10814

Details and patient eligibility

About

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.

Enrollment: 5 patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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5 participants in 1 patient group

Uronav

Experimental group

Description:

Participants will undergo a Uronav guided biopsy with Magnetic Resonance Imaging confirmation. All biopsies will be completed in the outpatient setting in the ambulatory OR prior to routine prostate brachytherapy under general anesthesia.

Treatment:

Device: Magnetic resonance imaging

Device: Uronav guided biopsy