Positioning and Tracking the Prostate During External Beam Radiation
The purpose of this study is to evaluate a non-ionizing electromagnetic method to align the prostate treatment site for radiation therapy and to monitor its position throughout radiation therapy delivery. The clinical study involves using an investigational device, the Calypso® 4D Localization System, and requires permanent implantation of three small sensors called Beacon® transponders in the prostate.
|Study Design:||Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Beacon® Transponder Implantation and Localization in the Prostate|
- Radiographic verification of at least five of approximately 40 radiation treatment days [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
- Adverse events check and International Prostate Symptom Score (IPSS) at baseline, at 7 times during treatment, and 6 and 12 months post treatment [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
- Patient Preference Questionnaire and SF 36 Health Survey at five radiation treatment days [ Time Frame: 8 week ] [ Designated as safety issue: Yes ]
|Study Start Date:||July 2005|
|Study Completion Date:||September 2008|
|Primary Completion Date:||September 2008 (Final data collection date for primary outcome measure)|
Device: Calypso® 4D Localization System
The goal for prostate radiation therapy is to give a high dose of radiation to the prostate and a minimal dose to the healthy tissue around the prostate. It is well known that the prostate moves slightly within the pelvis and that its position varies a few millimeters from day to day. There are several methods used to position the body and the prostate accurately at the beginning of each radiation therapy session.
One of the standard methods is to permanently implant small markers (gold spheres or cylinders) in the prostate and use x-rays in the radiation therapy treatment room to determine whether the markers are in the correct position. If the markers are in the correct position, then the assumption is that the prostate also is in the correct position. If the markers are not in the correct position on the x-ray, then the table that the patient lies on can be shifted so that the markers are in the right place.
In this study the Beacon® transponder will be used in place of the standard gold marker. During the radiation therapy visits, the patient position in the treatment room will be corrected using the Beacon transponder with an investigational system, called the Calypso® 4D Localization System. The Calypso system consists of a flat panel, placed over the pelvis and connected to a computer, which monitors the position of the Beacon transponders within the prostate. During five radiation therapy appointments and one extra visit, the position of the markers in the prostate will be confirmed with x-rays.
The Beacon transponder is a small glass cylinder that contains a tiny electrical circuit. The glass vial is completely sealed and separates the internal components (i.e., the electrical circuit) from the rest of the body. The glass vial is approximately one-third of one inch long and one-tenth of one inch in diameter. Three Beacon transponders will be implanted in the prostate. They will be permanently implanted.
|United States, Arizona|
|Scottsdale Healthcare - Osborn|
|Scottsdale, Arizona, United States, 85260|
|United States, California|
|Sharp Memorial Hospital|
|San Diego, California, United States, 92123|
|United States, Florida|
|M.D. Anderson Cancer Center Orlando|
|Orlando, Florida, United States, 32806|
|United States, Nebraska|
|The Nebraska Medical Center|
|Omaha, Nebraska, United States, 68105|
|United States, Ohio|
|The Cleveland Clinic|
|Cleveland, Ohio, United States, 44192|
|Study Director:||Lisa Levine, Ph.D.||Varian Medical|