RAD 1203: Pilot Trial Evaluating Stereotactic Body Radiotherapy With Integrated Boost for Clinically Localized Prostate Cancer
-Clinically assess the early toxicity of SBRT with integrated boost for clinically localized
- Determine the technical feasibility of stereotactic body radiotherapy (SBRT) with
integrated boost for clinically localized prostate cancer
- Determine the treatment planning and dosimetric feasibility
- Evaluate the treatment delivery quality assurance
- Clinically assess early efficacy, late toxicity, and quality of life for patients
receiving SBRT with integrated boost for clinically localized prostate cancer
Patients will undergo 5 total radiation treatments over 7-17 day period.
Patients will be asked to complete American Urological Association Symptom Index (AUA SI),
Sexual Health Inventory of Men (SHIM), and the Expanded Prostate Index Composite
(EPIC)questionnaires. The EPIC assesses bowel, urinary, and sexual function. These
questionnaires will be completed at the following time points: Baseline, AUA SI will be
collected on the last day of treatment, and every 3 months for the first year following the
start of radiation, then every 6 months for year 2.
After completion of study therapy, patients are followed-up every 3 months for the first
year, then every 6 months for year 2.
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Early toxicity of SBRT with Integrated Boost for localized prostate cancer
Early toxicity (defined as events occurring within 90 days of therapy) will be assessed by physician history and physical exams and patient toxicity/quality-of-life questionnaires to be administered at regular intervals.
Within 3 months of the completion of radiation therapy
John B Fiveash, MD
University of Alabama at Birmingham Radiation Oncology
United States: Institutional Review Board
|Hazelrig-Salter Radiation Oncology Center||Birmingham, Alabama 35249|