Clinical trial NCT00635167: Contrast Enhanced Transrectal Ultrasonography (TRUS) to Assess Prostatic Vascularity After Radiotherapy (XRT)
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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Prostate Cancer
Keywords: Prostate cancer
prostatic vascularity
External Beam Radiation treatment
Contrast Enhanced transrectal Ultrasound
Lead sponsor: Thomas Jefferson University
Sponsor class: OTHER
First posted: 2008-03-13
Enrollment: 1
Sex: MALE
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.


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.

Primary outcomes:
measure: Measurable Decrease in Prostate Vascularity During and/or After Radiation Treatment
timeFrame: 1 year
Secondary outcomes:
measure: Sonographic Appearance of Prostate and Prostate Vascularity Before, During and After External Beam Radiotherapy (Standard of Care) for Prostate Cancer
timeFrame: 1 year
measure: Patient Tolerance of TRUS Evaluation During/After Radiation Treatment
timeFrame: 1 year
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Thomas Jefferson University
state: Pennsylvania
Study officials:
affiliation: Thomas Jefferson University
name: Edouard J Trabulsi, MD
role: PRINCIPAL_INVESTIGATOR
References:
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. doi: 10.1148/radiol.2251011938.
citation: 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.
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. doi: 10.1016/j.urology.2007.07.067.
citation: 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.