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

Study Overview
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Brief Summary
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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.

Official Title
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Contrast Enhanced Transrectal Ultrasound (TRUS) to Assess Prostatic Vascularity as a Measure of Treatment Response and Early Prediction of Treatment Failure After XRT

Conditions
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Prostate Cancer

Intervention / Treatment
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* Drug: Contrast Enhanced-Transrectal Ultrasound


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Contrast Enhanced Transrectal Ultrasound (TRUS)<br> | Drug: Contrast Enhanced-Transrectal Ultrasound<br>* 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]).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Measurable Decrease in Prostate Vascularity During and/or After Radiation Treatment |  | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Prostate cancer, prostatic vascularity, External Beam Radiation treatment, Contrast Enhanced transrectal Ultrasound