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

NCT ID: NCT00635167

Last Updated: 2025-05-16

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 1 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-06-30
• Study Completion Date: 2011-05-12

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Contrast Enhanced Transrectal Ultrasound (TRUS)

Group Type: EXPERIMENTAL

Contrast Enhanced-Transrectal Ultrasound

Intervention Type: 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 \[Visit 7\]).

Interventions

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 \[Visit 7\]).

Intervention Type: DRUG

Eligibility 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.

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Sidney Kimmel Cancer Center at Thomas Jefferson University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Edouard J Trabulsi, MD

Role: PRINCIPAL_INVESTIGATOR

Thomas Jefferson University

Locations

Thomas Jefferson University

Philadelphia, Pennsylvania, United States

Countries

United States

References

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.

Reference Type: BACKGROUND

PMID: 12354987 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 11906872 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 18158034 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 17874649 (View on PubMed)

Related Links

http://hospitals.jefferson.edu/

Thomas Jefferson University Hospital

Other Identifiers

JT 1259

Identifier Type: OTHER

Identifier Source: secondary_id

07D.218

Identifier Type: -

Identifier Source: org_study_id