Stereotactic Body Radiotherapy (SBRT) for Prostate Cancer (SMART)
The purpose of this study is to evaluate the incidence of urinary and gastrointestinal acute and late side effects in patients treated with stereotactic body radiotherapy (SBRT) to the prostate. Stereotactic radiation therapy is given as five treatments over a 2-3 week period. The prostate is localized and the plan is reoptimized as needed prior to each treatment.
|Study Design:||Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase II Study of Stereotactic Body Radiotherapy (SBRT) for Prostate Cancer Using Continuous Real-time Evaluation of Prostate Motion and IMRT Plan Reoptimization Based on the Anatomy of the Day|
- Toxicity [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
- Disease free survival [ Time Frame: 5 yrs ] [ Designated as safety issue: No ]
- Quality of Life [ Time Frame: 3 years ] [ Designated as safety issue: No ]
|Study Start Date:||November 2009|
|Estimated Study Completion Date:||December 2015|
|Estimated Primary Completion Date:||December 2014 (Final data collection date for primary outcome measure)|
Experimental: Stereotactic Radiotherapy
Five fractions of 7.4 Gy each
Radiation: SBRT Prostate
Five fractions of 7.4 Gy. The total dose will be 37 Gy. A minimum of 36 hours and a maximum of 96 hours should separate each treatment. No more than 3 fractions will be delivered per week. The total duration of treatment will be no shorter than 10 days and no longer than 18 days.
This protocol requires radiation treatments to be performed with a stereotactic technique with the use of a 3-D coordinate system defined by implanted transponders (i.e. Calypso) or use of the ExacTrac system and/or use cone-beam CT (CBCT) with fiducial markers.
|United States, North Carolina|
|Duke University Medical Center|
|Durham, North Carolina, United States, 27710|
|Principal Investigator:||William R Lee, MD||Duke University|