A Randomized Trial of a Shorter Radiation Fractionation Schedule for the Treatment of Localized Prostate Cancer
In this trial, men with intermediate risk prostate cancer will be randomized to a shorter
course of radiotherapy (6000cGy in 20 fractions over 4 weeks-hypofractionated) or treatment
with a conventional fractionation course (7800cGy in 39 fractions over 8 weeks-standard).
Three-dimensional conformal radiation treatment techniques, including intensity modulated
radiotherapy will be used for both hypofractionated and standard treatments to avoid normal
tissue exposure to radiation and minimize the risk of acute and late treatment related
toxicity. The primary outcome measure is biochemical (PSA) failure defined by the ASTRO
consensus criteria. Secondary outcomes include biochemical-clinical failure (BCF), mortality
from cancer, toxicity and health-related quality of life. It is planned to recruit 1204
patients to the study. If the safety and efficacy of the shorter course are demonstrated,
then its adoption would reduce the social, emotional and economic burden of treatment for
patients and their families.
Interventional
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Biochemical (PSA) Failure
five years
No
Charles Catton, MD
Principal Investigator
Princess Margaret Hospital, Canada
Canada: Health Canada
OCOG-2005-PROFIT
NCT00304759
May 2006
June 2020
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