Feasibility Study of Ultrasound Elastography Detecting Prostate Cancer
Primary Purpose
Prostate Cancer
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Fleet Enema
Aixplorer® ShearWave Elastography (SWE™)
Pre-surgery Ultrasound
Prostatectomy
Sponsored by
About this trial
This is an interventional diagnostic trial for Prostate Cancer focused on measuring elastography, ultrasound, prostate, cancer screening
Eligibility Criteria
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.
Sites / Locations
- H. Lee Moffitt Cancer Center and Research Institute
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Pre-surgery Ultrasound
Arm Description
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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT03077126
First Posted
March 2, 2017
Last Updated
March 9, 2017
Sponsor
H. Lee Moffitt Cancer Center and Research Institute
1. Study Identification
Unique Protocol Identification Number
NCT03077126
Brief Title
Feasibility Study of Ultrasound Elastography Detecting Prostate Cancer
Official Title
Feasibility Study of Ultrasound Elastography Detecting Prostate Cancer: A Pilot Study
Study Type
Interventional
2. Study Status
Record Verification Date
March 2017
Overall Recruitment Status
Completed
Study Start Date
April 11, 2013 (Actual)
Primary Completion Date
June 29, 2015 (Actual)
Study Completion Date
September 18, 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
H. Lee Moffitt Cancer Center and Research Institute
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer
Keywords
elastography, ultrasound, prostate, cancer screening
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Pre-surgery Ultrasound
Arm Type
Other
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Fleet Enema
Other Intervention Name(s)
enema
Intervention Description
Since a probe will be introduced into the participant's rectal area, participants will be instructed to give themself one regular Fleet enema.
Intervention Type
Device
Intervention Name(s)
Aixplorer® ShearWave Elastography (SWE™)
Other Intervention Name(s)
ultrasound device, probe
Intervention Description
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.
Intervention Type
Diagnostic Test
Intervention Name(s)
Pre-surgery Ultrasound
Other Intervention Name(s)
Aixplorer® ShearWave Elastography (SWE™), ultrasound elastography
Intervention Description
The ultrasound procedure referenced above will be performed at the participant's pre-op visit one to two weeks before their surgery.
Intervention Type
Procedure
Intervention Name(s)
Prostatectomy
Other Intervention Name(s)
prostate surgery
Intervention Description
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.
Primary Outcome Measure Information:
Title
Rate of Correlation Between Ultrasound Results and Pathology Results
Description
Investigators will correlate the pathology findings from the radical prostatectomy specimen with the data recorded from USE.
Time Frame
6 months
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Julio Pow-Sang, M.D.
Organizational Affiliation
H. Lee Moffitt Cancer Center and Research Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
H. Lee Moffitt Cancer Center and Research Institute
City
Tampa
State/Province
Florida
ZIP/Postal Code
33612
Country
United States
12. IPD Sharing Statement
Links:
URL
https://moffitt.org/clinical-trials-research/
Description
Moffitt Cancer Center Clinical Trials website
Learn more about this trial
Feasibility Study of Ultrasound Elastography Detecting Prostate Cancer
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