Feasibility Study of Ultrasound Elastography Detecting Prostate Cancer

Study Overview
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Brief Summary
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The main purpose of this study is to determine the accuracy and feasibility (possibility) of Aixplorer® ShearWave Elastography (SWE™) Ultrasound System (made by SuperSonic Imagine, Inc.) for detecting prostate cancer in men undergoing radical prostatectomy.

Detailed Description
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The point estimate and its 95% confidence interval will be calculated using the exact binominal method. Identification of suspicious cancer tissue in a 12 prostate zone schema: Participants will undergo USE: Aixplorer® ShearWave Elastography (SWE™), (SuperSonic Imagine). Areas of the prostate with high suspicion for harboring cancer will be recorded in a 12 zone prostate schema. For study purposes the prostate will be divided into Zone 1(Left Lateral Base), Zone 2 (Left Base), Zone 3 (Right Base), Zone 4 (Right Lateral Base), Zone 5 (Left Lateral Mid), Zone 6 (Left Mid), Zone 7 (Right Mide), Zone 8 (Right Lateral Mid), Zone 9 (Left Lateral Apex), Zone 10 (Left Apex), Zone 11 (Right Apex), Zone 12 (Right Lateral Apex).

Official Title
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Feasibility Study of Ultrasound Elastography Detecting Prostate Cancer: A Pilot Study

Conditions
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Prostate Cancer

Intervention / Treatment
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* Other: Fleet Enema
* Device: Aixplorer® ShearWave Elastography (SWE™)
* Diagnostic Test: Pre-surgery Ultrasound
* Procedure: Prostatectomy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Men with prostate cancer who elect surgery as the primary treatment of their cancer and to be performed at the Moffitt Cancer Center. Biopsy confirmed prostate cancer with at least ten biopsies performed for diagnosis. Location of cancer specified in the pathology report. Pathology reviewed by Moffitt pathologist Exclusion Criteria: Less than ten biopsies obtained at time of diagnosis. Location of cancer not specified. Pathology not reviewed by Moffitt pathologist.

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 |
| --- | --- |
| Other: Pre-surgery Ultrasound<br>Aixplorer® ShearWave Elastography (SWE™) Ultrasound. Participants will undergo ultrasound prep with Fleet Enema and ultrasound procedure at their pre-op visit one to two weeks before their standard of care prostatectomy. | Other: Fleet Enema<br>* Since a probe will be introduced into the participant's rectal area, participants will be instructed to give themself one regular Fleet enema.<br>* Other names: enema;Device: Aixplorer® ShearWave Elastography (SWE™)<br>* Pre-surgery ultrasound: Aixplorer® ShearWave Elastography (SWE™) Ultrasound System (made by SuperSonic Imagine, Inc.). The device is used transrectally. This device (ultrasound system) has been cleared by the United States Food and Drug Administration (FDA) for the indication for use as described in this consent form.<br>* Other names: probe;Diagnostic Test: Pre-surgery Ultrasound<br>* The ultrasound procedure referenced above will be performed at the participant's pre-op visit one to two weeks before their surgery.<br>* Other names: ultrasound elastography;Procedure: Prostatectomy<br>* Participants will undergo radical prostatectomy as currently performed at our Moffitt Cancer Center. This procedure is performed under general anesthesia in the operating room. This is considered standard of care.<br>* Other names: prostate surgery;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of Correlation Between Ultrasound Results and Pathology Results | Investigators will correlate the pathology findings from the radical prostatectomy specimen with the data recorded from USE. | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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elastography, ultrasound, prostate, cancer screening