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

NCT01748890 | Terminated Results DMC

• 1 other identifier: 09-395
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Prostate Cancer

Outcome Measures

Primary Outcomes (1)

• The Number of Core Biopsies in These Targeted Regions

  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.

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

Study Arms (1)

Sonoelastography

EXPERIMENTAL

Sonoelastography is an imaging technology predicated on reproducible differences in the backscattered ultrasound signal produced by compression of tissues of varying stiffness.

Device: Sonoelastography

Interventions

Sonoelastography DEVICE

Sonoelastography is an imaging technology predicated on reproducible differences in the backscattered ultrasound signal produced by compression of tissues of varying stiffness.

Also known as: Hitachi, HI VISION Preirus

Sonoelastography

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• \. Any contraindication to transrectal ultrasonography, including prior anorectal surgery, inflammatory bowel disease, rectal fistula, or fissure-in-ano.

Sponsors & Collaborators

• Massachusetts General Hospital: lead

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Elasticity Imaging Techniques

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Ultrasonography; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis

Results Point of Contact

• Title: Anthony E. Samir
• Organization: Massachusetts General Hospital

asamir@partners.org

6178523241

Study Officials

• Anthony E. Samir, MD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Radiologist, Ultrasound Imaging Services Assistant Radiologist, Abdominal Imaging & Intervention

Study Record Dates

• First Submitted: October 31, 2012
• First Posted: December 13, 2012
• Study Start: December 1, 2009
• Primary Completion: December 1, 2012
• Study Completion: December 1, 2012
• Last Updated: October 20, 2017
• Results First Posted: May 20, 2014

Record last verified: 2017-10

Locations

US (1)