Contrast Enhanced Transrectal Ultrasonography (TRUS) to Assess Prostatic Vascularity After Radiotherapy (XRT) - Full Text View

Sponsored by:	Thomas Jefferson University
Information provided by:	Thomas Jefferson University
ClinicalTrials.gov Identifier:	NCT00635167

Purpose

Solid tumors, including prostate cancer, commonly exhibit tumor-associated neovascularity (growth of new blood vessels to feed the tumor) with increased microvessel density. Systemic, hormonal, and radiotherapy treatments typically decrease or suppress tumor - associated vascularity through several mechanisms, including apoptosis (process of cell death) and anti-angiogenic pathways (ways to destroy new blood vessel growth). Previously at the investigators' center, they have demonstrated that increased prostatic vascularity (blood vessels defined to prostate) detected ultrasonographically correlated with disease free survival after radical prostatectomy (surgical removal of entire prostate), and may be indicative of higher grade, higher stage disease. The significance of prostate neovascularity in response to treatment with external beam radiotherapy (EBRT) (standard of care) has not been well studied. The investigators hypothesize that prostate cancer that recurs after radiotherapy may exhibit measurable patterns of tumor-associated vascularity, which may represent a minimally invasive marker of cancer stage, grade and response to treatment. The investigators propose a pilot study to assess the feasibility of serial enhanced transrectal ultrasonography (TRUS) examinations during and after radiotherapy for prostate cancer.

Condition	Intervention
Prostate Cancer	Procedure: Contrast Enhanced-Transrectal Ultrasound

Study Type:	Interventional
Study Design:	Diagnostic, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title:	Contrast Enhanced Transrectal Ultrasound (TRUS) to Assess Prostatic Vascularity as a Measure of Treatment Response and Early Prediction of Treatment Failure After XRT

Resource links provided by NLM:

MedlinePlus related topics: Cancer Prostate Cancer Radiation Therapy Ultrasound

U.S. FDA Resources

Further study details as provided by Thomas Jefferson University:

Primary Outcome Measures:

To demonstrate measurable decrease in prostate vascularity during and/or after radiation treatment [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

To assess the sonographic appearance of prostate and prostate vascularity before, during and after external beam radiotherapy (standard of care) for prostate cancer [ Time Frame: 1 year ] [ Designated as safety issue: No ]
To assess patient tolerance of TRUS evaluation during/after radiation treatment [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	14
Study Start Date:	January 2008
Estimated Study Completion Date:	June 2009
Estimated Primary Completion Date:	January 2009 (Final data collection date for primary outcome measure)

Intervention Details:

Once a subject is identified TRUS schedule will be set up revolving around the EBRT treatment schedule. A schedule of 6 contrast enhanced TRUS examinations per subject is planned as follows: week 0 (prior to EBRT, baseline [Visit 2]); week 5 (middle of treatment [Visit 3]); week 10 (end of treatment [Visit 4]); week 18 (2 months after end of EBRT [Visit 5]); week 26 (4 months after end of EBRT [Visit 6]); and week 36 (6 months after end of EBRT [Visit 7]).

Eligibility

Ages Eligible for Study:	40 Years to 80 Years
Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Men aged 40 - 80 years old
Biopsy proven intermediate/high risk clinically localized prostate cancer, as determined by a Gleason score of 7 or higher, clinical stage T2b or higher, or PSA > 10. Pathology will be confirmed by at least two reviews
Patients opting for EBRT (external beam radiation therapy, standard of care) without hormonal ablation
Ability to undergo serial TRUS procedures
Ability to give informed consent

Exclusion Criteria:

Subject has known hypersensitivity to octafluoropropane.
Evidence of distant metastatic disease on staging evaluation
Previous treatment for prostate cancer, including any form of androgen ablation
Previous procedures involving the anus or rectum, making serial TRUS difficult or dangerous
Expected life expectancy less than 10 years
Baseline testosterone < 200 ng/dL
Subject with cardiac shunts and elevated pulmonary hypertension
Subject has worsening or clinically unstable congestive heart failure.
Subject has acute myocardial infarction or acute coronary syndrome.
Subject has ventricular arrhythmias or is high risk for arrhythmias.
Subject has respiratory failure, severe emphysema or pulmonary emboli.
Subject has a history of cardiac shunt or pulmonary hypertension.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00635167

Contacts

Contact: Darlene Bewick, CRNP

215-503-2078

darlene.bewick@jefferson.edu

Locations

United States, Pennsylvania
Thomas Jefferson University	Recruiting
Philadelphia, Pennsylvania, United States, 19107
Contact: Darlene Bewick, CRNP 215-503-2078
Sub-Investigator: Ethan J Halpern, MD

Sponsors and Collaborators

Thomas Jefferson University

Investigators

Principal Investigator:

Edouard J Trabulsi, MD

Thomas Jefferson University

More Information

Publications:

Halpern EJ, Frauscher F, Strup SE, Nazarian LN, O'Kane P, Gomella LG. Prostate: high-frequency Doppler US imaging for cancer detection. Radiology. 2002 Oct;225(1):71-7.

Halpern EJ, Frauscher F, Rosenberg M, Gomella LG. Directed biopsy during contrast-enhanced sonography of the prostate. AJR Am J Roentgenol. 2002 Apr;178(4):915-9.

Nelson ED, Slotoroff CB, Gomella LG, Halpern EJ. Targeted biopsy of the prostate: the impact of color Doppler imaging and elastography on prostate cancer detection and Gleason score. Urology. 2007 Dec;70(6):1136-40.

Linden RA, Halpern EJ. Advances in transrectal ultrasound imaging of the prostate. Semin Ultrasound CT MR. 2007 Aug;28(4):249-57. Review.

Responsible Party:	Thomas Jefferson University ( Edouard J. Trabulsi, MD, Assistant Professor )
Study ID Numbers:	27012
Study First Received:	March 5, 2008
Last Updated:	April 9, 2008
ClinicalTrials.gov Identifier:	NCT00635167 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Thomas Jefferson University:

Prostate cancer
prostatic vascularity
External Beam Radiation treatment
Contrast Enhanced transrectal Ultrasound

Study placed in the following topic categories:

Prostatic Diseases
Genital Neoplasms, Male
Urogenital Neoplasms
Genital Diseases, Male
Prostatic Neoplasms

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Site
Prostatic Diseases
Genital Neoplasms, Male

Urogenital Neoplasms
Genital Diseases, Male
Prostatic Neoplasms

ClinicalTrials.gov processed this record on September 10, 2009