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.
Additional locations may be listed on ClinicalTrials.gov for NCT01923506.
See trial information on ClinicalTrials.gov for a list of participating sites.
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.
Lead OrganizationCity of Hope Comprehensive Cancer Center
Principal InvestigatorSagus Sampath