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Randomized trial comparing 2 external beam radiotherapy fractionation schemes in patients with localized high risk prostate cancer. Primary endpoint is acute toxicity.
Patients enrolled onto this study will be randomized to one of the following treatment arms:
In addition, all patients receive 1.5- 3 years of androgen deprivation therapy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard Fractionation | Active Comparator | Using 2 sequential IMRT plans, the pelvic lymph nodes and prostate will initially be treated to 46 Gy in 23 fractions, followed by a subsequent boost to the prostate to a total dose of 78 Gy. |
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| Hypofractionation | Experimental | Using a one phase IMRT plan, the pelvic lymph nodes will be treated to a dose of 48 Gy in 25 fractions, while the prostate will be treated to a dose of 68 Gy in 25 fractions concomitantly (simulataneous integrated boost). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Conventionally Fractionated versus Hypofractionated Boost | Radiation |
|
| Measure | Description | Time Frame |
|---|---|---|
| Acute Toxicity | Proportion of patients experiencing grade >=2 acute toxicity | within 3 months after starting radiotherapy |
| Measure | Description | Time Frame |
|---|---|---|
| Late Toxicity | Proportion of patients experiencing grade >= 2 late toxicity | beyond 3 months of starting radiotherapy |
| Biochemical Control (Phoenix Definition) | Actuarial measure of patients failing biochemically (defined as PSA nadir + 2 ng/mL) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Patrick Cheung, MD | Toronto Sunnybrook Regional Cancer Centre | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sunnybrook Odette Cancer Centre | Toronto | Ontario | M4N 3M5 | Canada |
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| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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Randomized Trial
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| at 5 years |
| Overall Survival | Actuarial measure of patients being alive | at 5 years |
| D005832 |
| Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |