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

Open (Enrolling)
Prostate Cancer

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Trial Information

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

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.


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.

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)

Type of Study:


Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

To learn if tissue elastography can accurately show cancerous areas of the prostate.

Outcome Time Frame:

2 Years

Safety Issue:


Principal Investigator

John W. Davis, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

UT MD Anderson Cancer Center


United States: Institutional Review Board

Study ID:




Start Date:

December 2008

Completion Date:

Related Keywords:

  • Prostate Cancer
  • Prostate Cancer
  • Prostate
  • Radical Prostatectomy
  • Tissue Elastography
  • Tissue Elastography Imaging
  • Software Program Measuring Prostate Elasticity
  • Elasticity/Tissue Strain-Hardening Imaging
  • Ultrasound
  • Prostatic Neoplasms



UT MD Anderson Cancer Center Houston, Texas  77030