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Completed

NCT Number: NCT03077126

Feasibility Study of Ultrasound Elastography Detecting Prostate Cancer

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.

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Key information

Conditions

Prostate Cancer Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Neoplasms Neoplasms by Site Prostatic Diseases Prostatic Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

H. Lee Moffitt Cancer Center and Research Institute

Tampa, Florida, 33612, United States

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Fleet Enema

Other

Since a probe will be introduced into the participant's rectal area, participants will be instructed to give themself one regular Fleet enema.

Other names: enema

Aixplorer® ShearWave Elastography (SWE™)

Device

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.

Other names: ultrasound device, probe

Pre-surgery Ultrasound

Diagnostic Test

The ultrasound procedure referenced above will be performed at the participant's pre-op visit one to two weeks before their surgery.

Other names: Aixplorer® ShearWave Elastography (SWE™), ultrasound elastography

Prostatectomy

Procedure

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.

Other names: prostate surgery

Primary outcomes

  1. Rate of Correlation Between Ultrasound Results and Pathology Results

    Time frame: 6 months

    Investigators will correlate the pathology findings from the radical prostatectomy specimen with the data recorded from USE.

Sponsors and collaborators

Lead sponsor

H. Lee Moffitt Cancer Center and Research Institute

Other

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2015
Study completion
2015
First posted
Mar 10, 2017
Registry last updated
Mar 13, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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