Feasibility Study of Ultrasound Elastography Detecting Prostate Cancer

Not Applicable

Completed

• Conditions: Prostate Cancer
• Interventions: Other: Fleet Enema; Device: Aixplorer® ShearWave Elastography (SWE™); Diagnostic Test: Pre-surgery Ultrasound; Procedure: Prostatectomy

• Registration Number: NCT03077126
• Lead Sponsor: H. Lee Moffitt Cancer Center and Research Institute

Brief Summary

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

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).

Study Timeline

• Study Start: 2013-04-11
• Primary Completion: 2015-06-29
• Study Completion: 2015-09-18
• Status Verified: 2017-03
• Study First Submitted: 2017-03-02
• Study First Submitted QC: 2017-03-06
• Last Update Submitted: 2017-03-09
• Study First Posted: 2017-03-10
• Last Update Posted: 2017-03-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 10

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Pre-surgery Ultrasound	Prostatectomy	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.
Pre-surgery Ultrasound	Fleet Enema	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.
Pre-surgery Ultrasound	Aixplorer® ShearWave Elastography (SWE™)	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.
Pre-surgery Ultrasound	Pre-surgery Ultrasound	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.

Primary Outcome Measures

Name	Time	Method
Rate of Correlation Between Ultrasound Results and Pathology Results	6 months	Investigators will correlate the pathology findings from the radical prostatectomy specimen with the data recorded from USE.

Trial Locations

Locations (1)

H. Lee Moffitt Cancer Center and Research Institute; 🇺🇸 Tampa, Florida, United States