Pilot Study Evaluating the Role of Histopathology Correlation in Treatment Planning

Not Applicable

Completed

Conditions: Prostate Cancer

Interventions: Device: Uronav guided biopsy
Device: Magnetic resonance imaging

Registration Number: NCT02681614

Lead Sponsor: Case Comprehensive Cancer Center

Brief 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).

Detailed 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.

Recruitment & Eligibility

Status: COMPLETED

Sex: Male

Target Recruitment: 5

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.

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Uronav	Uronav guided biopsy	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.
Uronav	Magnetic resonance imaging	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.

Primary Outcome Measures

Name	Time	Method
Number of Biopsies With False Positives Between Biopsy Tissue and Intraprostatic MRI	Within 15 days of screening	Number of biopsies with false positives between biopsy tissue and intraprostatic MRI (positive predictive values of MRI)
Number of Participants Who Had Biopsies With True Positives Between Biopsy Tissue and Intraprostatic MRI	Within 15 days of screening	Number of participants who had biopsies with true positives between biopsy tissue and intraprostatic MRI (sensitivity of the intraprostatic MRI)
Number of Biopsies With True Negatives Between Biopsy Tissue and Intraprostatic MRI	Within 15 days of screening	Number of biopsies with true negatives between biopsy tissue and intraprostatic MRI (specificity of the intraprostatic MRI)
Number of Biopsies With False Negatives Between Biopsy Tissue and Intraprostatic MRI	Within 15 days of screening	Number of biopsies with false negatives between biopsy tissue and intraprostatic MRI (negative predictive values of MRI)

Secondary Outcome Measures

Name	Time	Method
Number of Participants With Infections Within 30 Days	Up to 30 days post biopsy	The infection rate within 30 days due to the procedure will be collected for expected acute events and these data will be used for reporting the study results for specific aim 2 evaluation the transperineal use of Uronav to determine if the transperineal biopsy approach results in a reduced rate of infection compared to standard transrectal biopsies .
Dosimetric Coverage of Brachytherapy Implant Described by Mean V100 (% Volume)	Up to 15 days after screening	Post-operative radiation dose coverage reported as volumes of prostate receiving a percentage of the prescribed dose, described by mean V100 (% volume)
Dosimetric Coverage of Targeted Lesion Described by Mean D90 (%Rx)	Up to 15 days after screening	Dosimetric coverage of target lesion described by mean D90 (% Rx), which refers to the main dose in the hottest 90% of the targeted lesion volume (given as a percent of the RX dose)
Number of Hospitalizations Within 30 Days	Up to 30 days post biopsy	The hospitalization rate within 30 days due to the procedure will be collected for expected acute events and these data will be used for reporting the study results for specific aim 2 evaluation the transperineal use of Uronav to determine if the transperineal biopsy approach results in a reduced rate of hospitalization compared to standard transrectal biopsies .
Dosimetric Coverage of Brachytherapy Implant Described by Mean D90 (% Rx)	Up to 15 days after screening	Dosimetric coverage of brachytherapy implant described by mean D90 (% Rx), which refers to the main dose in the hottest 90% of the post-implant prostate volume (given as a percent of the RX dose)
Number of Participants Who Had Successful Completion of Transperineal Biopsy Procedure	Up to 15 days after screening	The study will be to report the incidence of successful completion of the transperineal biopsy procedure using the Uronav system which is provided by Philips Medical as part of the support for this study
Dosimetric Coverage of Targeted Lesion Described by Mean V100 (% Volume)	Up to 15 days after screening	post-operative radiation dose coverage reported as volumes of targeted lesion receiving a percentage of the prescribed dose, described by mean V100 (% Volume)