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

Prostate Cancer Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00635167
• Other study ID #: 07D.218
• Status: Terminated
• Phase: N/A
• Start date: June 2007
• Est. completion date: May 12, 2011

Study information

• Verified date: August 2018
• Source: Thomas Jefferson University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 1
• Est. completion date: May 12, 2011
• Est. primary completion date: May 12, 2011
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 40 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

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]).

Locations

Country	Name	City	State
United States	Thomas Jefferson University	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Sidney Kimmel Cancer Center at Thomas Jefferson University

Country where clinical trial is conducted

United States, 

References & Publications (4)

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. — View Citation

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. — View Citation

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

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Measurable Decrease in Prostate Vascularity During and/or After Radiation Treatment		1 year
Secondary	Sonographic Appearance of Prostate and Prostate Vascularity Before, During and After External Beam Radiotherapy (Standard of Care) for Prostate Cancer		1 year
Secondary	Patient Tolerance of TRUS Evaluation During/After Radiation Treatment		1 year

External Links

•   Sidney Kimmel Cancer Center at Thomas Jefferson University
•   Thomas Jefferson University Hospital