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Clinical Trial Summary

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.


Clinical Trial Description

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 Design


Related Conditions & MeSH terms


NCT number NCT02446366
Study type Interventional
Source University of Southern California
Contact
Status Active, not recruiting
Phase N/A
Start date May 12, 2015
Completion date February 12, 2023

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