Daily Target Guided Radiation Therapy Using the Calypso 4D Localization System in Patients Who Have Had a Prostatectomy for Prostate Cancer
Recruitment status was Recruiting
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.
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|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|
- Interfraction prostate bed motion [ Time Frame: Approximately 7.5 weeks (36-39 fractions per pt.) ] [ Designated as safety issue: No ]
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.) ] [ Designated as safety issue: No ]Calypso session reports measuring intrafraction motion in x,y,z axis will be recorded and analyzed.
|Study Start Date:||March 2010|
|Estimated Study Completion Date:||September 2014|
|Estimated Primary Completion Date:||August 2013 (Final data collection date for primary outcome measure)|
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01624623
|Contact: Stephanie Ninneman, RNfirstname.lastname@example.org|
|United States, Washington|
|Madigan Healthcare System||Recruiting|
|Tacoma, Washington, United States, 98431|
|Principal Investigator:||Dusten Macdonald, MD||Department of the Army|