Predicting Location and Extent of Prostate Cancer Using Micro-Ultrasound Imaging

Study Overview
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Brief Summary
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The goal of this study is to use a clinical micro-ultrasound to systematically image the prostate before biopsy or surgery. The images from the ultrasound system will be saved and compared to other imaging modalities and pathology in order to develop better tools.

Official Title
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Predicting Location and Extent of Prostate Cancer Using Micro-Ultrasound Imaging

Conditions
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Prostate Cancer

Intervention / Treatment
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* Device: ExactVu


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Scheduled for MR-US fusion prostate biopsy or radical prostatectomy Agree to consent to the study Exclusion Criteria: Does not agree to consent.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 89 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ExactVu Imaging<br>EV29L transducer will be inserted in the subject's rectum. Cine sweeps will be performed to save images of: The entire prostate from posterior to anterior (may require 2 sweeps to cover base and apex) The peripheral zone using the highest zoom setting (30mm depth) on the system (may require 2 sweeps to cover base and apex). Analysis of these images will be performed after surgery but before prostatectomy | Device: ExactVu<br>* clinical micro-ultrasound, imaging Device, Manufacturer; Exact Imaging<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Diagnostic accuracy of micro-ultrasound biopsy and prostatectomy patients. | Rate of adequately identified (positive or negative) lesions of prostate cancer will be measured | From date of micro ultrasound exam until the date of Prostate biopsy data are obtained (average of 7 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Morphology of lesions detected by mirco-resolution ultrasound | Hausdoff distance between the ultrasound lesion and pathology lesions would be measured and reported in mm. | From date of micro ultrasound exam until the date of Prostate biopsy data are obtained (average of 7 days | 
| Volume from systematic and targeted cores | Volume of cancer from individual biopsy cores will be reported | From date of micro ultrasound exam until the date of Prostate biopsy data are obtained (average of 7 days | 
| Sensitivity of micro-ultrasound and multiparametric MRI | Sensitivity of micro-ultrasound and multiparametric MRI in the detection of lesions of prostate cancer will be reported | From date of micro ultrasound exam until the date of Prostate biopsy data are obtained (average of 7 days | 
| Measuring correlation between Prostatectomy pathology and imaging correlation | Perform a detailed pathologic and imaging correlation between findings on micro-ultrasound, MRI and final surgical histopathology in men who undergo prostatectomy. For prostatectomy specimens, Dice score will be computed, comparing the pixel-wise labels from the annotated pathology specimen to the annotations on multi-parametric magnetic resonance imaging (mpMRI) and micro-ultrasound (this is a unit-less coefficient).Hausdorff Distance, which will give us the greatest distance between the overlapping lesions, with units in millimeters will be reported | From date of micro ultrasound exam until the date of Prostate biopsy data are obtained (average of 7 days | 
| Specificity of micro-ultrasound and multiparametric MRI | Specificity of micro-ultrasound and multiparametric MRI in the detection of lesions of prostate cancer will be reported | From date of micro ultrasound exam until the date of Prostate biopsy data are obtained (average of 7 days | 
| Negative predictive values of high-resolution ultrasound and multiparametric MRI | Negative predictive values of high-resolution ultrasound and multiparametric MRI in the detection of lesions of prostate cancer will be reported | From date of micro ultrasound exam until the date of Prostate biopsy data are obtained (average of 7 days | 
| Positive predictive values of high-resolution ultrasound and multiparametric | Positive predictive values of high-resolution ultrasound and multiparametric MRI in the detection of lesions of prostate cancer will be reported | From date of micro ultrasound exam until the date of Prostate biopsy data are obtained (average of 7 days | 
| Location from systematic and targeted cores | Location of cancer from individual biopsy cores will be reported | From date of micro ultrasound exam until the date of Prostate biopsy data are obtained (average of 7 days |