Contrast Enhanced Transrectal Ultrasonography (TRUS) to Assess Prostatic Vascularity After Radiotherapy (XRT)
Primary Purpose
Prostate Cancer
Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Contrast Enhanced-Transrectal Ultrasound
Sponsored by
About this trial
This is an interventional diagnostic trial for Prostate Cancer focused on measuring Prostate cancer, prostatic vascularity, External Beam Radiation treatment, Contrast Enhanced transrectal Ultrasound
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.
Sites / Locations
- Thomas Jefferson University
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Contrast Enhanced Transrectal Ultrasound (TRUS)
Arm Description
Outcomes
Primary Outcome Measures
Measurable Decrease in Prostate Vascularity During and/or After Radiation Treatment
Secondary Outcome Measures
Sonographic Appearance of Prostate and Prostate Vascularity Before, During and After External Beam Radiotherapy (Standard of Care) for Prostate Cancer
Patient Tolerance of TRUS Evaluation During/After Radiation Treatment
Full Information
NCT ID
NCT00635167
First Posted
March 5, 2008
Last Updated
August 20, 2018
Sponsor
Sidney Kimmel Cancer Center at Thomas Jefferson University
1. Study Identification
Unique Protocol Identification Number
NCT00635167
Brief Title
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
2. Study Status
Record Verification Date
August 2018
Overall Recruitment Status
Terminated
Why Stopped
Closed by PI final report submitted
Study Start Date
June 2007 (Actual)
Primary Completion Date
May 12, 2011 (Actual)
Study Completion Date
May 12, 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sidney Kimmel Cancer Center at Thomas Jefferson University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer
Keywords
Prostate cancer, prostatic vascularity, External Beam Radiation treatment, Contrast Enhanced transrectal Ultrasound
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
1 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Contrast Enhanced Transrectal Ultrasound (TRUS)
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Contrast Enhanced-Transrectal Ultrasound
Intervention Description
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]).
Primary Outcome Measure Information:
Title
Measurable Decrease in Prostate Vascularity During and/or After Radiation Treatment
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Sonographic Appearance of Prostate and Prostate Vascularity Before, During and After External Beam Radiotherapy (Standard of Care) for Prostate Cancer
Time Frame
1 year
Title
Patient Tolerance of TRUS Evaluation During/After Radiation Treatment
Time Frame
1 year
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Edouard J Trabulsi, MD
Organizational Affiliation
Thomas Jefferson University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Thomas Jefferson University
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
12354987
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.
Results Reference
background
PubMed Identifier
11906872
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.
Results Reference
background
PubMed Identifier
18158034
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.
Results Reference
background
PubMed Identifier
17874649
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.
Results Reference
background
Links:
URL
http://hospitals.jefferson.edu/
Description
Thomas Jefferson University Hospital
Learn more about this trial
Contrast Enhanced Transrectal Ultrasonography (TRUS) to Assess Prostatic Vascularity After Radiotherapy (XRT)
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