Randomized Phase III Trial of 3D Conformal Radiotherapy Versus Helical Tomotherapy IMRT in High-Risk Prostate Cancer
Radical radiation therapy plays an important role in the management of prostate cancer,
yielding comparable long-term outcomes to surgery. Unfortunately, long term disease free
survival data using PSA criteria have shown that less than 50% of high-risk patients are
free of disease at 10 years. To improve on the results of conventional dose radiotherapy
dose escalation with three-dimensional conformal radiation has been employed. Due to the
irregular shape of the prostate and the variable motion of this organ there is substantial
radiation of adjacent normal surrounding tissue during treatment which results in
radiation-induced toxicity. Intensity-modulated radiation therapy (IMRT) is a new form of
radiation therapy. Preliminary evidence suggests that IMRT improves the dose distribution
during radiation therapy of the prostate. The hypothesis of this study is that IMRT
delivered using Helical Tomotherapy can reduce late toxicity of radical radiotherapy as
compared to three-dimensional conformal radiation (3DCRT) in high-risk prostate cancer
patients.
Interventional
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Late rectal toxicity from radiotherapy of the prostate
Shawn Malone, MD
Study Director
Ottawa Hospital Research Institute
Canada: Health Canada
2005242-01H
NCT00326638
November 2005
May 2014
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