The purpose of this study is to compare the effects (good and bad) on patients with prostate cancer by comparing the standard dose of radiation therapy (44 treatments over 8½-9 weeks) with a higher daily dose of radiation (5 treatments over 1-2 weeks) to see if the effects of the treatments are similar or better.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
150
Dose: 38 Gy(RBE); 7.6 GY(RBE) five days a week in 5 treatments over 1-2 weeks
Dose: 79.2 GY(RBE); 1.8 GY(RBE) five days a week in 44 treatments over 8.5-9 weeks
Mayo Clinic Cancer Center
Phoenix, Arizona, United States
Northwestern Medicine Chicago Proton Center
Warrenville, Illinois, United States
Maryland Proton Treatment Center
Baltimore, Maryland, United States
Oklahoma Proton Center
Oklahoma City, Oklahoma, United States
To assess if hypo-fractionation will result in 2-year freedom from failure (FFF) that is non-inferior to 2-year FFF following standard fractionation. FFF will be measured by recurrence, metastasis, PSA or start of salvage therapy.
The events for FFF will be the first occurrence of clinical failure (local recurrence, regional recurrence, or distant metastasis), biochemical failure by the Phoenix definition (PSA ≥ 2 ng/ml over the current nadir PSA),or the start of salvage therapy including androgen deprivation.
Time frame: At 5 years post treatment completion +/- 90 days
To determine the incidence of grade 2 or greater GU and GI toxicity in each of the regimens.
Time frame: At 6 months and 2 years post randomization
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Hampton University Proton Therapy Institute
Hampton, Virginia, United States