Randomized trial comparing 2 external beam radiotherapy fractionation schemes in patients with localized high risk prostate cancer. Primary endpoint is acute toxicity.
Patients enrolled onto this study will be randomized to one of the following treatment arms: * Standard fractionation: Using 2 sequential IMRT plans, the pelvic lymph nodes and prostate will initially be treated to 46 Gy in 23 fractions, followed by a subsequent boost to the prostate to a total dose of 78 Gy. * Hypofractionation: Using a one phase IMRT plan, the pelvic lymph nodes will be treated to a dose of 48 Gy in 25 fractions, while the prostate will be treated to a dose of 68 Gy in 25 fractions concomitantly (simulataneous integrated boost). In addition, all patients receive 1.5- 3 years of androgen deprivation therapy.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
178
Sunnybrook Odette Cancer Centre
Toronto, Ontario, Canada
Acute Toxicity
Proportion of patients experiencing grade \>=2 acute toxicity
Time frame: within 3 months after starting radiotherapy
Late Toxicity
Proportion of patients experiencing grade \>= 2 late toxicity
Time frame: beyond 3 months of starting radiotherapy
Biochemical Control (Phoenix Definition)
Actuarial measure of patients failing biochemically (defined as PSA nadir + 2 ng/mL)
Time frame: at 5 years
Overall Survival
Actuarial measure of patients being alive
Time frame: at 5 years
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