In Vivo Dosimetry During Prostate Cancer Radiotherapy
Primary Purpose
Prostate Disease
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Plastic Scintillation Detectors
Sponsored by
About this trial
This is an interventional treatment trial for Prostate Disease focused on measuring Fiber optic radiation detectors, Enhanced endorectal balloon, Radiation treatment, Radiotherapy, External beam radiation, Dosimetry
Eligibility Criteria
Inclusion Criteria:
- Any patients with prostate cancer who are undergoing routine radiation therapy for their prostate cancer, including post-prostatectomy patients.
- The selection criteria will be limited to the patient's ability to withstand insertion of a rectal balloon and his willingness to participate in the study.
- We will choose patients undergoing photon and proton treatments.
Exclusion Criteria:
N/A
Sites / Locations
- University of Texas MD Anderson Cancer Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
In Vivo Dosimetry
Arm Description
Modified endorectal device capable of real-time dose measurement during prostate radiation therapy
Outcomes
Primary Outcome Measures
Measurement of True In Vivo Radiation to Rectal Wall During Prostate Radiotherapy
Twice a week in vivo measurements of radiation dose absorbed by the rectal wall during intensity-modulated radiotherapy (IMRT) of prostate.
Secondary Outcome Measures
Full Information
NCT ID
NCT01307852
First Posted
March 1, 2011
Last Updated
April 4, 2016
Sponsor
M.D. Anderson Cancer Center
Collaborators
National Cancer Institute (NCI)
1. Study Identification
Unique Protocol Identification Number
NCT01307852
Brief Title
In Vivo Dosimetry During Prostate Cancer Radiotherapy
Official Title
Pilot Study to Evaluate In Vivo Plastic Scintillation Detectors for Real-Time Radiation Dosimetry During Prostate Cancer Radiotherapy
Study Type
Interventional
2. Study Status
Record Verification Date
April 2016
Overall Recruitment Status
Completed
Study Start Date
November 2011 (undefined)
Primary Completion Date
September 2015 (Actual)
Study Completion Date
September 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
M.D. Anderson Cancer Center
Collaborators
National Cancer Institute (NCI)
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The goal of this clinical research study is to learn if a rectal balloon with attached radiation detectors can be used to help researchers monitor the dose of external beam radiation that is delivered to the prostate during treatment. This may help researchers better understand the side effects of radiation therapy, such as rectal bleeding, and may lead to changes in treatment planning or treatment delivery.
Detailed Description
As a part of your standard of care, you will have external beam radiation therapy. You will have a computerized tomography (CT) scan of the pelvis before the external beam radiation therapy.
For the CT scan, you will be given an enema to empty your bowel, and you will drink about 16 to 24 ounces of water to fill your bladder
A rectal balloon will then be inserted into your rectum and filled with either air or water. You will then have the CT scan. The CT scan should take about 45 minutes.
If you agree to take part in this study, very thin (millimeter-sized) radiation detectors will be attached to the rectal balloon during each of two CT scans per week you will have while you are receiving radiation. You may have additional CT scans (without the detector) each week if your doctor thinks it is needed.
The doses read by the radiation detectors will be compared to the doses that you were originally scheduled to receive after each radiation treatment and at the end of the study.
You will be off study after your final radiation treatment using the rectal balloon.
This is an investigational study. Up to 15 patients will take part in this study. All will be enrolled at MD Anderson.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Disease
Keywords
Fiber optic radiation detectors, Enhanced endorectal balloon, Radiation treatment, Radiotherapy, External beam radiation, Dosimetry
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
7 (Actual)
8. Arms, Groups, and Interventions
Arm Title
In Vivo Dosimetry
Arm Type
Experimental
Arm Description
Modified endorectal device capable of real-time dose measurement during prostate radiation therapy
Intervention Type
Device
Intervention Name(s)
Plastic Scintillation Detectors
Intervention Description
Radiation detectors attached to rectal balloon for each CT scan done during each radiation treatment. Treatment delivery Monday through Friday for 7 weeks.
Primary Outcome Measure Information:
Title
Measurement of True In Vivo Radiation to Rectal Wall During Prostate Radiotherapy
Description
Twice a week in vivo measurements of radiation dose absorbed by the rectal wall during intensity-modulated radiotherapy (IMRT) of prostate.
Time Frame
Twice a week for 7 week treatment.
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Any patients with prostate cancer who are undergoing routine radiation therapy for their prostate cancer, including post-prostatectomy patients.
The selection criteria will be limited to the patient's ability to withstand insertion of a rectal balloon and his willingness to participate in the study.
We will choose patients undergoing photon and proton treatments.
Exclusion Criteria:
N/A
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sam Beddar, PHD
Organizational Affiliation
M.D. Anderson Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Texas MD Anderson Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
12. IPD Sharing Statement
Links:
URL
http://www.mdanderson.org
Description
University of Texas MD Anderson Cancer Center Website
Learn more about this trial
In Vivo Dosimetry During Prostate Cancer Radiotherapy
We'll reach out to this number within 24 hrs