Evaluation Ultrasound Elasticity/Tissue Strain-Hardening Imaging for Prostate Cancer Patients Undergoing Radical Prostatectomy

January 7, 2015 updated by: M.D. Anderson Cancer Center

A Pilot Trial Evaluation of Ultrasound Elasticity/Tissue Strain-Hardening Imaging for Prostate Cancer in Patients Undergoing Radical Prostatectomy

The primary objective is to perform a pilot trial evaluation of a novel prostate ultrasound imaging software utilizing tissue elasticity measurements to identify tumor foci among men who will undergo radical prostatectomy for localized prostate cancer.

As a secondary objective, investigators will compare elasticity measured tumor foci volume to the measured volume from radical prostatectomy pathologic examination.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

Study Imaging:

As part of routine care, ultrasound scanning is commonly used to find the cancerous areas of the prostate before the prostate is surgically removed. The ultrasound images are in black, white, and gray, and the dark areas may show prostate cancer.

In this study, standard ultrasound scanning will still be done, but researchers want to test another form of diagnostic imaging called tissue elastography.

Tissue elastography uses the same machine and probe as the ultrasound. The probe is gently pushed through the rectum and into the prostate gland (similar to a digital rectal exam). The ultrasound machine will use a special elastography software that is designed to scan the prostate for differences in how hard the tissue is. Prostate cancer tissue may be harder than surrounding tissue, and the images produced by tissue elastography are designed to show these differences in hardness of tissue.

Screening:

Before you can join this study, the study staff will review the results of your most recent prostate ultrasound and biopsy. This is a "screening" procedure to help the doctor decide if you are eligible to take part in this study.

Study Procedures:

If you are found to be eligible to take part in this study, tissue elastography imaging will be performed during your routine ultrasound before prostate surgery. The probe, once inserted, will be gently pressed against the prostate a few times in order to perform the tissue elastography. The routine ultrasound part of the procedure should take about 10 minutes, and the elastography should take about 10-15 minutes.

Length of Study Participation:

Your active participation in this study will be over after the tissue elastography imaging. The routine ultrasound will be the main decision-making exam. However, if the tissue elastography imaging shows something different and possibly related to your care, your doctor will be informed.

After the prostate is removed and the tissue results are available, researchers will compare the tissue results with the tissue elastography images. You will not receive the results of the tissue elastography imaging, as the imaging is being used for research only.

This is an investigational study. The ultrasound machine and probe that are used for the tissue elastography in this study are FDA approved for ultrasound scanning. Performing tissue elastography for prostate cancer detection is investigational. At this time and for this purpose, tissue elastography is only being performed in research.

Up to 60 patients will take part in this study. All will be enrolled at M. D. Anderson.

Study Type

Interventional

Enrollment (Actual)

13

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • Houston, Texas, United States, 77030
        • UT MD Anderson Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  1. Patients selected for radical prostatectomy (any technique) at MDACC
  2. Histologic diagnosis of prostate cancer, clinical stage cT1c-cT3b
  3. Serum prostate specific antigen less than 30 ng/ml.
  4. Any Gleason score
  5. Total prostate volume of 20-60 cc, measured by outside ultrasound or clinical examination at MDACC.
  6. Group 1: high volume disease. At least 3 positive cores containing cancer on one side of the prostate Group 2: low volume disease. Less than 50% tumor length in a single positive core on one side of the prostate

Exclusion Criteria:

  1. Prior radiation therapy to the pelvis
  2. Prior hormonal therapy within 3 months (including LH/RH agonists, estrogens, testosterone receptor blockade, finasteride, dutasteride)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Tissue Elastography Imaging
Using special elastography software, probe pressed gently against prostate during routine ultrasound before prostate surgery, 10-15 minutes process.
Procedure: Tissue Elastography Imaging
Using special elastography software, probe pressed gently against prostate during routine ultrasound before prostate surgery, 10-15 minutes process.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evaluation of diagnostic technique (using tissue elastography) for prostate cancer detection in men scheduled to undergo a radical prostatectomy
Time Frame: 2 Years
Pilot evaluation of novel prostate ultrasound imaging software utilizing tissue elasticity measurements to identify tumor foci among men who will undergo radical prostatectomy for localized prostate cancer. The methods of Bland and Altman (1986) used to assess whether the tumor volume estimated by the ultrasound imaging technique agrees with the tumor volume measured at pathology. An ultrasound based elasticity measurement technique will detect differences in prostate hardness by using sophisticated mathematical techniques to analyze ultrasound images obtained before and after small compressions of the prostate gland with the ultrasound probe, detecting differences in hardness by measuring relative displacements of portions of the gland. Elasticity images obtained during standard, medically-indicated prostate sonography.
2 Years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

M.D. Anderson Cancer Center

Investigators

  • Principal Investigator: John W. Davis, MD, UT MD Anderson Cancer Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2008

Primary Completion (ACTUAL)

November 1, 2013

Study Completion (ACTUAL)

November 1, 2013

Study Registration Dates

First Submitted

January 15, 2009

First Submitted That Met QC Criteria

January 15, 2009

First Posted (ESTIMATE)

January 19, 2009

Study Record Updates

Last Update Posted (ESTIMATE)

January 9, 2015

Last Update Submitted That Met QC Criteria

January 7, 2015

Last Verified

December 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2007-0949

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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