Contrast Enhanced Transrectal Ultrasonography (TRUS) to Assess Prostatic Vascularity After Radiotherapy (XRT)
May 14, 2025 updated by: Sidney Kimmel Cancer Center at Thomas Jefferson University
Contrast Enhanced Transrectal Ultrasound (TRUS) to Assess Prostatic Vascularity as a Measure of Treatment Response and Early Prediction of Treatment Failure After XRT
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.
Study Overview
Status
Terminated
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
1
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Pennsylvania
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Philadelphia, Pennsylvania, United States, 19107
- Thomas Jefferson University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
40 years to 80 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
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 |
|---|---|
|
Experimental: Contrast Enhanced Transrectal Ultrasound (TRUS)
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Drug 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]).
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Measurable Decrease in Prostate Vascularity During and/or After Radiation Treatment
Time Frame: 1 year
|
1 year
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Sonographic Appearance of Prostate and Prostate Vascularity Before, During and After External Beam Radiotherapy (Standard of Care) for Prostate Cancer
Time Frame: 1 year
|
1 year
|
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Patient Tolerance of TRUS Evaluation During/After Radiation Treatment
Time Frame: 1 year
|
1 year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Edouard J Trabulsi, MD, Thomas Jefferson University
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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. doi: 10.1016/j.urology.2007.07.067.
- 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. doi: 10.1148/radiol.2251011938.
- 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. doi: 10.2214/ajr.178.4.1780915.
- Linden RA, Halpern EJ. Advances in transrectal ultrasound imaging of the prostate. Semin Ultrasound CT MR. 2007 Aug;28(4):249-57. doi: 10.1053/j.sult.2007.05.002.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
June 1, 2007
Primary Completion (Actual)
May 12, 2011
Study Completion (Actual)
May 12, 2011
Study Registration Dates
First Submitted
March 5, 2008
First Submitted That Met QC Criteria
March 12, 2008
First Posted (Estimated)
March 13, 2008
Study Record Updates
Last Update Posted (Actual)
May 16, 2025
Last Update Submitted That Met QC Criteria
May 14, 2025
Last Verified
May 1, 2025
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 07D.218
- JT 1259 (Other Identifier: JeffTrial Number)
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