This phase I trial studies the side effects and the best dose of hypofractionated stereotactic body radiation therapy (SBRT) in treating patients with prostate cancer that was removed by surgery. Hypofractionated SBRT delivers higher doses of radiation therapy over a shorter period of time and may kill more tumor cells and may have fewer side effects than standard radiation therapy.
PRIMARY OBJECTIVES: I. To determine maximum tolerated dose-per-fraction for SBRT to the prostate fossa following prostatectomy based on acute toxicity (\< 90 days). SECONDARY OBJECTIVES: I. To describe the acute (\< 90 days) toxicities and adverse events associated with hypofractionated SBRT when administered to the prostate bed in the post-prostatectomy setting. II. To describe the late (\> 90 days from treatment) toxicities and adverse events associated with hypofractionated SBRT when administered to the prostate bed in the post-prostatectomy setting. TERTIARY OBJECTIVES: I. To describe the patient-reported toxicity/quality of life (QOL) following hypofractionated SBRT treatment. OUTLINE: This is a dose-escalation study. Patients undergo 5, 10, or 15 fractions of hypofractionated SBRT daily over 1-3 weeks. After completion of study treatment, patients are followed up at 2, 6, and 13 weeks and then at 6, 9, 12, 18, 24, 30 and 36 months.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
24
Correlative studies
Ancillary studies
Undergo hypofractionated SBRT
USC Norris Comprehensive Cancer Center
Los Angeles, California, United States
Maximum tolerated dose-per-fraction based on acute toxicity assessed according to the Common Terminology Criteria for Adverse Events (CTCAE) version (v.) 4.03
Maximum tolerated dose (MTD) is defined as the highest dose tested in which none or only one patient experienced dose limiting toxicity (DLT) attributable to the radiation therapy when 12 patients were treated at that dose and are evaluable for toxicity and is one dose level below the lowest dose level tested where two or more patients experienced radiation associated DLT. All toxicities and side effects of all patients who start SBRT will be recorded and summarized.
Time frame: < 90 days
Incidence of adverse events assessed according to CTCAE v. 4.03
All toxicities and side effects of all patients who start SBRT will be recorded and summarized.
Time frame: Up to 36 months after completion of SBRT
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