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

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ClinicalTrials.gov Identifier: NCT00824902
Recruitment Status : Terminated (Technical Issues)
First Posted : January 19, 2009
Last Update Posted : January 9, 2015
Sponsor:
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Prostate Cancer Procedure: Tissue Elastography Imaging Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 13 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Pilot Trial Evaluation of Ultrasound Elasticity/Tissue Strain-Hardening Imaging for Prostate Cancer in Patients Undergoing Radical Prostatectomy
Study Start Date : December 2008
Actual Primary Completion Date : November 2013
Actual Study Completion Date : November 2013

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  1. 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00824902


Locations
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United States, Texas
UT MD Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
Investigators
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Principal Investigator: John W. Davis, MD UT MD Anderson Cancer Center

Additional Information:
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Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00824902     History of Changes
Other Study ID Numbers: 2007-0949
First Posted: January 19, 2009    Key Record Dates
Last Update Posted: January 9, 2015
Last Verified: December 2013
Keywords provided by M.D. Anderson Cancer Center:
Prostate Cancer
Prostate
Radical Prostatectomy
Tissue Elastography
Tissue Elastography Imaging
Software Program Measuring Prostate Elasticity
Elasticity/Tissue Strain-Hardening Imaging
Ultrasound
Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases