Prostate Cancer
Conditions
Keywords
elastography, ultrasound, prostate, cancer screening
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).
Interventions
OTHERFleet Enema
Since a probe will be introduced into the participant's rectal area, participants will be instructed to give themself one regular Fleet enema.
DEVICEAixplorer® ShearWave Elastography (SWE™)
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.
DIAGNOSTIC_TESTPre-surgery Ultrasound
The ultrasound procedure referenced above will be performed at the participant's pre-op visit one to two weeks before their surgery.
PROCEDUREProstatectomy
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.
Sponsors
H. Lee Moffitt Cancer Center and Research Institute
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Outcome results
None listed