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Considering the promising results with hypofractionated in low and intermediate risk prostate cancer, our proposal is to translate this experience to patients with high risk prostate cancer. Patients with high risk disease would receive hypofractionated RT to the prostate and to the external and internal iliac lymph nodes using IMRT plus long-term hormonal therapy. The objective of the study is to show that long term grade>2 late toxicity is acceptable and similar to published data using hypofractionated technique in the prostate only.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| IMRT Hypofractionated | Experimental | Neo-adjuvant hormone therapy for three months followed by IMRT combined with a 24-month hormonal therapy. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| IMRT Technique | Radiation |
|
| Measure | Description | Time Frame |
|---|---|---|
| Toxicity | Acute and late toxicity following treatment with IMRT to the prostate and pelvic lymphatic chains will be assessed using the Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 (http://ctep.cancer.gov) for grading of all adverse events will be used in this study. | First 3 months (acute toxicity) |
| Measure | Description | Time Frame |
|---|---|---|
| Freedom from biochemical failure, patterns of failure. | To measure freedom from biochemical failure (PSA measurement) at 5 years. | At 5 years |
| Measure | Description | Time Frame |
|---|---|---|
| Toxicity | Late effects will be also scored prospectively using the RTOG/EORTC late scoring system. Erectile dysfunction will be assessed by the SHIM questionnaire | 3 years |
| Toxicity | Dose-volume histogram of the rectum and bladder will be correlated to the whole organ volumes doses and the development of GI and GU toxicity. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sergio Faria, M.D. | McGill University Health Centre/Research Institute of the McGill University Health Centre | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| McGill University Health Center | Montreal | Quebec | H3G 1A4 | Canada |
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| 3 years |
| Rate of failure | To determine the rate of local, regional and distant failures. | 5 years |
| Quality Assurance | To develop a quality assurance process for IMRT in prostate cancer at McGill University Health Center | 5 years |