3D-Conformal Radiation vs Helical Tomotherapy in Prostate Cancer

Titre officiel

Randomized Phase III Trial of 3D Conformal Radiation Therapy Versus Helical Tomotherapy IMRT in High-Risk Prostate Cancer

Sommaire:

Durant cette étude, nous comparerons deux types de radiothérapie. Cette étude est réalisée parce que nous ignorons toujours si la radiothérapie par modulation d’intensité peut réduire les effets secondaires de la radiothérapie comparativement à la radiothérapie standard (radiothérapie conformationnelle tridimensionnelle).

Description de l'essai

Primary Outcome:

• Late rectal toxicity from radiation therapy of the prostate

Secondary Outcome:

• Acute rectal toxicity, Acute and late bladder toxicity, Disease specific survival at 5 years, Biochemical relapse free survival at 5 years, Local control rates at 5 years, Quality of Life

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 radiation therapy 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 radiation therapy as compared to three-dimensional conformal radiation (3DCRT) in high-risk prostate cancer patients.

Voir cet essai sur ClinicalTrials.gov