Contrast Enhanced Transrectal Ultrasonography (TRUS) to Assess Prostatic Vascularity After Radiotherapy (XRT)

NCT00635167 | Terminated Results DMC

• 2 other identifiers: 07D.218JT 1259
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Prostate Cancer

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Measurable Decrease in Prostate Vascularity During and/or After Radiation Treatment

  1 year

Secondary Outcomes (2)

• Sonographic Appearance of Prostate and Prostate Vascularity Before, During and After External Beam Radiotherapy (Standard of Care) for Prostate Cancer

  1 year

• Patient Tolerance of TRUS Evaluation During/After Radiation Treatment

  1 year

Study Arms (1)

Contrast Enhanced Transrectal Ultrasound (TRUS)

EXPERIMENTAL

Drug: Contrast Enhanced-Transrectal Ultrasound

Interventions

Contrast Enhanced-Transrectal Ultrasound DRUG

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 \[Visit 7\]).

Contrast Enhanced Transrectal Ultrasound (TRUS)

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sidney Kimmel Cancer Center at Thomas Jefferson University: lead

Study Sites (1)

Thomas Jefferson University

Philadelphia, Pennsylvania, 19107, United States

Location

Related Publications (4)

• 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.

  PMID: 12354987 BACKGROUND

• 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.

  PMID: 11906872 BACKGROUND

• 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.

  PMID: 18158034 BACKGROUND

• 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.

  PMID: 17874649 BACKGROUND

Related Links

• Thomas Jefferson University Hospital

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Dr. Edouard Trabulsi
• Organization: Sidney Kimmel Cancer Center at Thomas Jefferson University

edouard.trabulsi@jefferson.edu

215-955-1000

Study Officials

• Edouard J Trabulsi, MD

  Thomas Jefferson University

  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: SPONSOR

Study Record Dates

• First Submitted: March 5, 2008
• First Posted: March 13, 2008
• Study Start: June 1, 2007
• Primary Completion: May 12, 2011
• Study Completion: May 12, 2011
• Last Updated: May 16, 2025
• Results First Posted: August 10, 2018

Record last verified: 2025-05

Locations

US (1)