NCT00326638

3D-Conformal Radiation vs Helical Tomotherapy in Prostate Cancer

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 72 (estimated)
• Sponsor: Ottawa Hospital Research Institute · Academic / Other
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

In this study we are comparing two forms of radiotherapy. This study is being done because it is not clear at present time whether intensity modulated radiotherapy (IMRT) can reduce side effects of radiotherapy compared to standard radiotherapy (called 3D-Conformal Radiotherapy).

Detailed description

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.

Conditions

• Prostate Cancer

Interventions

Type	Name	Description
RADIATION	Arm B: Helical Tomotherapy Intensity Modulated Radiotherapy	IMRT using Helical Tomotherapy\* 7800 cGY/39 Fractions once daily Monday to Friday for 8 weeks * Initial IMRT to Nodes/Prostate + Seminal Vesicles 4,600 cGy/23 * Boost IMRT to Prostate 3,200 cGy/16
OTHER	Arm A: 3D-Conformal Radiation	3DCRT 7800 cGY/39 Fractions/ STD Technique\* once daily Monday to Friday for 8 weeks * Initial 4F 3DCRT to Nodes/ Prostate + Seminal Vesicles 4,600 cGy/23 * Boost 6 F 3DCRT to Prostate 3,200 cGy/16

Timeline

• Start date: 2005-03-01
• Primary completion: 2015-01-01
• Completion: 2020-06-30
• First posted: 2006-05-17
• Last updated: 2020-04-17

Locations

1 site across 1 country: Canada