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

18 Years
Open (Enrolling)
Prostate Cancer

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Trial Information

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

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.

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

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.

Type of Study:


Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Investigator, Outcomes Assessor), Primary Purpose: Diagnostic

Outcome Measure:

The number of core biopsies in these targeted regions

Outcome Description:

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.

Outcome Time Frame:

Participants will be followed until prostatectomy pathology is available (average 1 week)

Safety Issue:


Principal Investigator

Anthony E. Samir, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Massachusetts General Hospital


United States: Institutional Review Board

Study ID:




Start Date:

December 2009

Completion Date:

September 2013

Related Keywords:

  • Prostate Cancer
  • Prostatic Neoplasms



Massachusetts General Hospital Boston, Massachusetts  02114-2617