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).
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
5
All biopsies will be completed in the outpatient setting in the ambulatory operating room prior to routine prostate brachytherapy under general anesthesia. Patients will be prepped in a dorsal lithotomy position with insertion of a Foley catheter. The perineum will be shaved as needed, and cleansed with antiseptic solution, and the scrotum will be elevated with a towel roll to expose the perineum.
An MRI (magnetic resonance imaging) is a scan that uses radio waves and a strong magnetic field to provide images of internal organs and tissues. This is not part of the study but will have been done per standard treatment. An MRI will occur at the screening visit and last visit of the study.
Case Comprehensive Cancer Center
Cleveland, Ohio, United States
Number of Participants Who Had Biopsies With True Positives Between Biopsy Tissue and Intraprostatic MRI
Number of participants who had biopsies with true positives between biopsy tissue and intraprostatic MRI (sensitivity of the intraprostatic MRI)
Time frame: Within 15 days of screening
Number of Biopsies With True Negatives Between Biopsy Tissue and Intraprostatic MRI
Number of biopsies with true negatives between biopsy tissue and intraprostatic MRI (specificity of the intraprostatic MRI)
Time frame: Within 15 days of screening
Number of Biopsies With False Positives Between Biopsy Tissue and Intraprostatic MRI
Number of biopsies with false positives between biopsy tissue and intraprostatic MRI (positive predictive values of MRI)
Time frame: Within 15 days of screening
Number of Biopsies With False Negatives Between Biopsy Tissue and Intraprostatic MRI
Number of biopsies with false negatives between biopsy tissue and intraprostatic MRI (negative predictive values of MRI)
Time frame: Within 15 days of screening
Number of Participants With Infections Within 30 Days
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 .
Time frame: Up to 30 days post biopsy
Number of Hospitalizations Within 30 Days
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 .
Time frame: Up to 30 days post biopsy
Number of Participants Who Had Successful Completion of Transperineal Biopsy Procedure
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
Time frame: Up to 15 days after screening
Dosimetric Coverage of Brachytherapy Implant Described by Mean V100 (% Volume)
Post-operative radiation dose coverage reported as volumes of prostate receiving a percentage of the prescribed dose, described by mean V100 (% volume)
Time frame: Up to 15 days after screening
Dosimetric Coverage of Brachytherapy Implant Described by Mean D90 (% Rx)
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)
Time frame: Up to 15 days after screening
Dosimetric Coverage of Targeted Lesion Described by Mean V100 (% Volume)
post-operative radiation dose coverage reported as volumes of targeted lesion receiving a percentage of the prescribed dose, described by mean V100 (% Volume)
Time frame: Up to 15 days after screening
Dosimetric Coverage of Targeted Lesion Described by Mean D90 (%Rx)
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)
Time frame: Up to 15 days after screening
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