The specific objective of this study is to compare the relative efficacy of the combination of a temporary iridium implant plus external beam irradiation versus standard external beam irradiation alone in patients with Stage B2 and C prostatic carcinoma. Benefit will be assessed in terms of local recurrence, survival, and toxicity.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
112
Temporary iridium implant of the prostate will be done and a dose of 3000 cGy will be delivered in the next 48-72 hours. Two weeks later 20 fractions of external beam radiation at a dose of 4000 cGy will be administered over a period of 4 weeks.
Standard external beam irradiation at a dose of 6400 cGy in 32 fractions over 6 and a half weeks will be administered.
Juravinski Cancer Centre
Hamilton, Ontario, Canada
Rate of local control as determined by biopsy at 18 months
Time frame: 18-months
Distant metastasis
Time frame: survival
Overall mortality
Time frame: survival
Mortality due to prostate cancer
Time frame: survival
Local complications of radiation
Time frame: 2-5 years
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