This phase I trial studies the side effects and best dose of stereotactic body radiation therapy in treating patients with prostate cancer after undergoing surgery. Stereotactic body radiation therapy may be able to send x-rays directly to the tumor and cause less damage to normal tissue.
PRIMARY OBJECTIVES: I. To determine the maximum tolerated dose (MTD) with an upper limit of 45 Gray (Gy) in 5 fractions, in the delivery of stereotactic body radiation therapy (SBRT) to the prostate fossa. SECONDARY OBJECTIVES: I. To assess acute and late toxicities from treatment. II. To assess biochemical progression-free survival. III. To collect prospective quality-of-life data related to bowel, urinary, and sexual health. OUTLINE: This is a dose-escalation study. Patients receive 5 fractions of SBRT over 1.5 weeks. After completion of study treatment, patients are followed up at 90 days and then periodically for 3 years.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
26
Undergo SBRT
Ancillary studies
Correlative studies
City of Hope Medical Center
Duarte, California, United States
MTD, defined as the highest dose tested in which fewer than 33% of patients experienced dose limiting toxicity, graded according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
Tables will be created to summarize these toxicities and side effects by dose level.
Time frame: 90 days
Incidence of acute toxicities observed at each dose level graded according to the NCI CTCAE version 4.0
Tables will be created to summarize these toxicities and side effects by dose level.
Time frame: Up to 90 days
Incidence of late toxicities observed at each dose level graded according to the NCI CTCAE version 4.0
Tables will be created to summarize these toxicities and side effects by dose level.
Time frame: Up to 3 years
Biochemical progression-free survival
Estimated using Kaplan-Meier. 95% confidence intervals should be provided.
Time frame: Up to 3 years
Prospective quality-of-life data related to bowel, urinary, and sexual health using the numerical scores generated from the patient questionnaires
Quality of life questionnaires include the International Prostate Symptom Scale (IPSS), sexual health inventory for men (SHIM), and Merrick rectal function scale.
Time frame: Up to 3 years
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