Daily Target Guided Radiation Therapy Using the Calypso 4D Localization System in Patients Who Have Had a Prostatectomy for Prostate Cancer
|ClinicalTrials.gov Identifier: NCT01624623|
Recruitment Status : Unknown
Verified September 2015 by Dusten Macdonald, MD, Madigan Army Medical Center.
Recruitment status was: Active, not recruiting
First Posted : June 20, 2012
Last Update Posted : September 11, 2015
This study will evaluate the daily use of a unique daily organ tracking system on target localization in patients treated with radiation therapy after radical prostatectomy for prostate cancer.
Improved coverage of the target volume with radiotherapy could result in improved cancer control rates and decreased coverage of surrounding structures potentially decreasing treatment toxicity.
|Condition or disease|
This prospective study evaluates the clinical utility of a novel real-time localization system of the prostate bed during adjuvant or salvage radiotherapy after radical prostatectomy. This study will also determine positioning errors using daily cone-beam computed tomography in patients set up with the Calypso 4D Localization System. Subjects will have Beacon® Transponders implanted into the prostate bed. The Calypso 4D Localization System will localize the position of the prostate bed. Cone beam CT will be used daily to measure inter-transponder distance. The Calypso system will also track the prostate bed position in real time during the entire radiation treatment. The treatments will be adjusted as required to ensure accurate treatment of the clinical target volume. The time of, the number, and extent of adjustments will be recorded for analysis.
Daily cone-beam computed tomography images will also be retrospectively analyzed to assess for adequate target coverage. The analysis will be performed retrospectively through manual 3-D registration of the cone-beam CT dataset with the treatment planning CT scan. This information will determine the margins necessary for the PTV using the Calypso 4D Localization System and potentially may allow a reduction in the PTV volumes on future studies.
|Study Type :||Observational|
|Estimated Enrollment :||20 participants|
|Official Title:||Post-prostatectomy Daily Target Guided Radiotherapy Using Real-Time, State-of-the-Art Motion Tracking With the Calypso 4D Localization System: A Feasibility Study|
|Study Start Date :||March 2010|
|Estimated Primary Completion Date :||May 2016|
|Estimated Study Completion Date :||August 2016|
- Interfraction prostate bed motion [ Time Frame: Approximately 7.5 weeks (36-39 fractions per pt.) ]
For each fraction, measurements from the registered CTV (clinical target volume) at the midline will be obtained to structures at 3 points to assess for the degree of motion.
- Inferior (defined as 8 mm below VUA)
- Superior (top of seminal vesicle remnant or superior most CTV slice)
- Middle (defined as the slice equally distant from the inferior and superior slices above)
- Intrafraction prostate bed motion [ Time Frame: Approximately 7.5 weeks (36-39 fractions per pt.) ]Calypso session reports measuring intrafraction motion in x,y,z axis will be recorded and analyzed.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01624623
|United States, Washington|
|Madigan Healthcare System|
|Tacoma, Washington, United States, 98431|
|Principal Investigator:||Dusten Macdonald, MD||Department of the Army|