Ultrasound-Based Imaging Using the Aixplorer System in Diagnosing Prostate Cancer in Patients Undergoing Biopsy

Study Overview
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Brief Summary
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This clinical trial studies an ultrasound-based imaging procedure called elastography using the Aixplorer system in diagnosing prostate cancer in patients undergoing biopsy. Ultrasound is a non-invasive imaging technique that uses high-frequency sound waves to produce images of internal structures. Elastography uses ultrasound imaging techniques to examine the stiffness or elasticity of a tissue and may enhance the detection of prostate cancer. It is not yet known whether elastography imaging using the Aixplorer system works better than standard ultrasound imaging in detecting prostate cancer.

Detailed Description
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PRIMARY OBJECTIVES: I. To evaluate the detection of prostate cancer with elastography using the Aixplorer scanner. SECONDARY OBJECTIVES: I. To obtain quantitative data on the elastic properties of normal and malignant tissue in the prostate of patients referred for ultrasound guided biopsy. II. To compare the Gleason grade of prostate cancers detected with elastography to the Gleason grade of tumors detected by conventional systematic biopsy.

Official Title
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Evaluation of the Aixplorer Ultrasound System for Evaluation of the Prostate

Conditions
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Prostate Carcinoma

Intervention / Treatment
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* Procedure: Shear Wave Elastography
* Procedure: Ultrasound Elasticity Imaging
* Procedure: Ultrasound-Guided Prostate Biopsy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Be scheduled for a clinically indicated biopsy of the prostate Agree to an ultrasound examination using the Aixplorer system Sign an institutional review board (IRB) approved informed consent prior to any study procedures Exclusion Criteria: • Recent prostate biopsy within 90 days

Ages Eligible for Study
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Minimum Age: 18 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: Diagnostic (elastography imaging using the Aixplorer system)<br>Patients undergo ultrasound-based elastography imaging using the Aixplorer system followed by standard of care ultrasound-guided prostate biopsy over approximately 25 minutes. | Procedure: Shear Wave Elastography<br>* Undergo ultrasound-based elastography imaging using the Aixplorer system<br>* Other names: Transient Elastography;Procedure: Ultrasound Elasticity Imaging<br>* Undergo ultrasound-based elastography imaging using the Aixplorer system<br>Procedure: Ultrasound-Guided Prostate Biopsy<br>* Undergo standard of care ultrasound-guided prostate biopsy<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Frequency of diagnosis of prostate cancer using elastography using the Aixplorer scanner | Will focus on comparing the frequency of diagnosis of prostate cancer between conventional systematic biopsy and targeted biopsy based upon abnormalities in gray scale imaging, Doppler imaging, and elastography. The main parameter of interest will be the ratio of the detection frequency with targeted biopsy versus that with systematic biopsy. The analyses will be based on methods for matched data in cohort studies and will use the appropriate estimate and variance for the relative risk. | At the time of prostate biopsy | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Gleason scores of the cores detected with targeted biopsy versus those of the cores of systematic biopsy | Analyses will be carried out via the Generalized Estimating Equations methods to account for clustering within patient (multiple cores per patient). | At the time of prostate biopsy |