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A Pilot Trial of Sonoelastography for Planning Tumor-targeted Prostate Biopsy

This study has been terminated.
(Insufficient recruitment)
Sponsor:
Information provided by (Responsible Party):
Anthony Samir, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT01748890
First received: October 31, 2012
Last updated: April 17, 2014
Last verified: April 2014
  Purpose

Prostate cancer is the most common cancer and the second-leading cause of cancer death amongst men in the United States. 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. In this study, we aim 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, and 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.


Condition Intervention
Prostate Cancer
Device: Sonoelastography

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Investigator, Outcomes Assessor)
Primary Purpose: Diagnostic
Official Title: A Pilot Trial of Sonoelastography for Planning Tumor-targeted Prostate Biopsy

Resource links provided by NLM:


Further study details as provided by Massachusetts General Hospital:

Primary Outcome Measures:
  • The Number of Core Biopsies in These Targeted Regions [ Time Frame: Participants will be followed until prostatectomy pathology is available (average 1 week) ] [ Designated as safety issue: No ]
    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.


Enrollment: 4
Study Start Date: December 2009
Study Completion Date: December 2012
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Sonoelastography
Sonoelastography is an imaging technology predicated on reproducible differences in the backscattered ultrasound signal produced by compression of tissues of varying stiffness.
Device: Sonoelastography
Sonoelastography is an imaging technology predicated on reproducible differences in the backscattered ultrasound signal produced by compression of tissues of varying stiffness.
Other Names:
  • Hitachi
  • HI VISION Preirus

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Age 18 years of age or older.
  2. Serum PSA between 4 and 10 ng/mL.
  3. A diagnosis of prostate cancer based on extended (twelve core) random prostate biopsy within three months prior to study entry.
  4. Clinically localized prostate carcinoma i.e. TNM stage T2c or less.
  5. The patient has elected to undergo radical prostatectomy to treat the prostate carcinoma.
  6. 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.

  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01748890

Locations
United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Sponsors and Collaborators
Massachusetts General Hospital
Investigators
Principal Investigator: Anthony E. Samir, MD Massachusetts General Hospital
  More Information

No publications provided

Responsible Party: Anthony Samir, Assistant Radiologist, Ultrasound Imaging Services Assistant Radiologist, Abdominal Imaging & Intervention, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT01748890     History of Changes
Other Study ID Numbers: 09-395
Study First Received: October 31, 2012
Results First Received: April 17, 2014
Last Updated: April 17, 2014
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Diseases, Male
Genital Neoplasms, Male
Neoplasms
Neoplasms by Site
Prostatic Diseases
Urogenital Neoplasms

ClinicalTrials.gov processed this record on November 20, 2014