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.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
60
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.
Duke University Medical Center
Durham, North Carolina, United States
Number of Participants With Genitourinary Acute Toxicity
Genitourinary Acute Toxicity is defined as Grade 3 or higher occurring within 90 days from the end of radiation treatment
Time frame: </= 90 days post radiation treatment, a total of 90 days
Number of Participants With Genitourinary Late Toxicity
Genitourinary Late Toxicity is defined as Grade 3 or higher occurring \>90 days from the end of radiation treatment
Time frame: >90 days from the end of treatment, up to 3 years
Number of Participants With Gastrointestinal Acute Toxicity
Gastrointestinal Acute Toxicity is defined as Grade 3 or higher occurring within 90 days of the end of radiation treatment
Time frame: </= 90 days post radiation treatment, a total of 90 days
Number of Participants With Gastrointestinal Late Toxicity
Gastrointestinal Late Toxicity is defined as Grade 3 or higher occurring \> 90 days from the end of radiation treatment
Time frame: >90 days from the end of treatment, up to 3 years
Disease Free Survival
Time frame: 5 yrs
Quality of Life, as Measured by the Expanded Prostate Cancer Index Composite (EPIC-26) Short Form
The EPIC-26 Short Form is a 13-item questionnaire. Scores range from 0-100, with higher scores representing better quality of life.
Time frame: 3 years post-treatment
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