- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01748890
A Pilot Trial of Sonoelastography for Planning Tumor-targeted Prostate Biopsy
Study Overview
Detailed Description
Background and Significance Prostate cancer is the most common cancer and the second-leading cause of cancer death amongst men in the United States. Initially, tumors biopsy guided by detected by conventional B-mode transrectal ultrasound (TRUS). Unfortunately, prostate cancer had a highly variable ultrasound echo pattern and may be indistinguishable from normal prostate, and the sonographic appearance of BPH overlaps with that of prostatic carcinoma, which limited the accuracy of conventional ultrasound, producing sensitivity and specificity for prostate carcinoma of only 40-50%. There is therefore an urgent need for better localization and more accurate biopsy of prostate cancer.
Sonoelastography is an imaging technology predicated on reproducible differences in the backscattered ultrasound signal produced by compression of tissues of varying stiffness. It permits measurement of the elastic properties of tissue. These measurements can be transposed onto conventional anatomic ultrasound images, producing a colorized overlay that allows direct visualization of the anatomic distribution of tissue stiffness.
Previously, several studies have reported that the feasibility of sonoelastography to distinguish between benign and malignant nodules and thereby guide biopsy. These assessments were based on the change in anatomic appearance of nodules after compression with a transrectal ultrasound probe. However, these reports did not specify the criteria used to determine that lesions seen by elastography were the same lesions seen by histopathology, did not assess whether biopsies planned with the assistance of sonoelastography would have intersected with the foci of prostate cancer, and did not address the histopathologic characteristics of areas of the prostate that were falsely positive at sonoelastography.
If sonoelastography were to more accurately delineate foci of tumor in the prostate than B mode ultrasound, and it could be used to guide biopsy, then there would be fewer missed cancers at biopsy. In addition, sonoelastography-guided biopsies may be more representative of the ultimate Gleason Score of the tumor.
Specific Aims:
Aim 1: To determine whether prostate biopsies planned with sonoelastographic guidance would be more likely than random prostate biopsies to intersect with foci of carcinoma in the prostate gland.
Aim 2: To determine whether prostate biopsies planned with sonoelastographic guidance would be more likely than random prostate biopsies to yield histopathology representative of the final Gleason Score obtained at pathologic assessment of the resected prostate.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Massachusetts
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Boston, Massachusetts, United States, 02114
- Massachusetts General Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Age 18 years of age or older.
- Serum PSA between 4 and 10 ng/mL.
- A diagnosis of prostate cancer based on extended (twelve core) random prostate biopsy within three months prior to study entry.
- Clinically localized prostate carcinoma i.e. TNM stage T2c or less.
- The patient has elected to undergo radical prostatectomy to treat the prostate carcinoma.
- The patient consents to undergo a diagnostic transrectal ultrasound of the prostate with elastography.
Exclusion Criteria:
1. Any contraindication to transrectal ultrasonography, including prior anorectal surgery, inflammatory bowel disease, rectal fistula, or fissure-in-ano.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: Sonoelastography
Sonoelastography is an imaging technology predicated on reproducible differences in the backscattered ultrasound signal produced by compression of tissues of varying stiffness.
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Sonoelastography is an imaging technology predicated on reproducible differences in the backscattered ultrasound signal produced by compression of tissues of varying stiffness.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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The Number of Core Biopsies in These Targeted Regions
Time Frame: Participants will be followed until prostatectomy pathology is available (average 1 week)
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From elastography-prostatectomy pathology correlation, the following data will be obtained, 1) The number of planned core biopsies that would intersect foci of prostate carcinoma, 2) The Gleason Score that would be obtained, assuming that elastographically targeted biopsies sample the targeted region.
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Participants will be followed until prostatectomy pathology is available (average 1 week)
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Anthony E. Samir, MD, Massachusetts General Hospital
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 09-395
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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