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

  • United States
    • Pennsylvania
      • 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)
Drug: Contrast Enhanced-Transrectal Ultrasound
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
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.

Sponsor

Sidney Kimmel Cancer Center at Thomas Jefferson University

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

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)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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