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The purpose of this study is to determine the safety and efficacy of a short course of radiotherapy (40Gy/5 fractions/29 days) for the treatment of high risk prostate cancer currently being managed with primary androgen deprivation therapy (PADT).
Primary Endpoints:
Secondary Endpoints:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Hypofractionated radiation | Experimental | 40 Gy in 5 fractions over 29 to prostate; 30 Gy in 5 fractions over 29 days to seminal vesicles |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hypofractionated radiation | Radiation | 40 Gy in 5 fractions to prostate, 30 Gy in 5 fractions to seminal vesicles; total treatment duration 29 days |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of grade 3+ rectal toxicity | Common Terminology Criteria for Adverse Events (CTCAE) v3.0 | Acute period (up to 3 months) |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of grade 3+ urinary toxicity | Common Terminology Criteria for Adverse Events (CTCAE) v3.0 | Acute (up to 3 months) and Late (after 6 months of follow-up) |
| Quality of Life | Expanded Prostate Cancer Index Composite (EPIC) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Andrew Loblaw, MD, FRCPC | Sunnybrook Health Sciences Centre | Principal Investigator |
| Suneil Jain, MD | suneil.jain@sunnybrook.ca | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Odette Cancer Centre, Sunnybrook Health Sciences 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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| ID | Term |
|---|---|
| D000069473 | Radiation Dose Hypofractionation |
| ID | Term |
|---|---|
| D019583 | Dose Fractionation, Radiation |
| D011879 | Radiotherapy Dosage |
| D011878 | Radiotherapy |
| D013812 | Therapeutics |
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|
| 5 years |
| Biochemical (ie.prostate specific antigen) disease free survival | 5 years |
| Incidence of grade 3+ rectal toxicity | Common Terminology Criteria for Adverse Events (CTCAE) v3.0 | Late (after 6 months of follow-up) |
| D005832 |
| Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |