Feasibility Study of Ultrasound Elastography Detecting Prostate Cancer

H. Lee Moffitt Cancer Center and Research Institute

Status: Completed

Conditions: Prostate Cancer

Treatments: Diagnostic Test: Pre-surgery Ultrasound; Procedure: Prostatectomy; Device: Aixplorer® ShearWave Elastography (SWE™); Other: Fleet Enema

Study type: Interventional

Funder types: Other

Identifiers

NCT03077126

MCC-17294

Details and patient eligibility

About

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.

Full 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).

Enrollment: 10 patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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10 participants in 1 patient group

Pre-surgery Ultrasound

Other group

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.

Treatment:

Other: Fleet Enema

Device: Aixplorer® ShearWave Elastography (SWE™)

Procedure: Prostatectomy

Diagnostic Test: Pre-surgery Ultrasound