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| ID | Type | Description | Link |
|---|---|---|---|
| OTT 05-02 |
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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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm A: 3D-Conformal Radiation | Other | Intervention: Standard radiation treatment for high risk prostate cancer. Once daily Monday to Friday for 8 weeks. 3DCRT 7800 cGY/39 Fractions/ STD Technique*
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| Arm B: Helical Tomotherapy Intensity Modulated Radiotherapy | Experimental | Intervention: Helical Tomotherapy Intensity Modulated Radiotherapy (IMRT) once daily Monday to Friday for 8 weeks. IMRT using Helical Tomotherapy* 7800 cGY/39 Fractions Boost IMRT to Prostate 3,200 cGy/16 |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Arm B: Helical Tomotherapy Intensity Modulated Radiotherapy | Radiation | IMRT using Helical Tomotherapy* 7800 cGY/39 Fractions once daily Monday to Friday for 8 weeks
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| Measure | Description | Time Frame |
|---|---|---|
| Late rectal toxicity from radiotherapy of the prostate | Outcome measurements will be determined by physical exam and bloodwork. | Month 1, 4, 8, every 4 months during year 1-2, then every 6 months during years 2-5, then every 12 months until disease progression |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Outcome measurements will be determined by physical exam and bloodwork. | Month 1, 4, 8, every 4 months during year 1-2, then every 6 months during years 2-5, then every 12 months until disease progression |
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Inclusion Criteria:
A pathologic diagnosis of adenocarcinoma of the prostate
Age greater than 18 years
ECOG performance status of 2 or less.
Presence of any of the following high risk features:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Shawn Malone, MD | Ottawa Hospital Research Institute | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Ottawa Hospital Regional Cancer Centre | Ottawa | Ontario | K1H 8L6 | Canada |
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| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| D009369 | Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D005832 | Genital Diseases, Male |
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| ID | Term |
|---|---|
| D011878 | Radiotherapy |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
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| Arm A: 3D-Conformal Radiation | Other | 3DCRT 7800 cGY/39 Fractions/ STD Technique* once daily Monday to Friday for 8 weeks
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| D000091662 |
| Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |