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| Name | Class |
|---|---|
| TOLMAR PHARMACEUTIQUES CANADA, INC. | UNKNOWN |
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This is a multi-institution, randomized, non-inferiority Phase II trial comparing external beam radiotherapy delivered as 54 Gy in 20 fractions to prostate bed +/- 44 Gy in 20 fractions to pelvic lymph nodes delivered daily with external beam radiotherapy delivered as 30 Gy in 5 fractions to prostate bed +/- 25 Gy in 5 fractions to pelvic lymph nodes delivered on alternate days.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1: Moderately Hypofractionated Radiotherapy | Experimental | External beam radiotherapy 54 Gy in 20 fractions to prostate bed +/- 44 Gy in 20 fractions to pelvic lymph nodes delivered daily. |
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| Arm 2: Ultrahypofractionated Radiotherapy | Experimental | External beam radiotherapy 30 Gy in 5 fractions to prostate bed +/- 25 Gy in 5 fractions to pelvic lymph nodes delivered on alternate days. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Radiotherapy | Radiation | Non-institutional-standard radiotherapy |
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| Measure | Description | Time Frame |
|---|---|---|
| Rates of Acute Toxicity | Acute grade ≥2 gastrointestinal toxicity (CTCAE v5.0) | 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Rates of Acute and Late Toxicity | Acute grade ≥2 genitourinary toxicity (CTCAE v5.0) | 2 years |
| Quality of Life Outcomes | EPIC-26 Questionnaire |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Andrew McPartlin, MBChB | Contact | 416-946-4501 | 4855 | andrew.mcpartlin@uhn.ca |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| London Health Sciences Centre | Recruiting | London | Ontario | N6A 5W9 | Canada |
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| ID | Term |
|---|---|
| D011878 | Radiotherapy |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
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Arm 1: External beam radiotherapy 54 Gy in 20 fractions to prostate bed +/- 44 Gy in 20 fractions to pelvic lymph nodes delivered daily.
Arm 2: External beam radiotherapy 30 Gy in 5 fractions to prostate bed +/- 25 Gy in 5 fractions to pelvic lymph nodes delivered on alternate days.
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| 2 years |
| Quality of Life Outcomes | IPSS Questionnaire | 2 years |
| Biochemical disease-free survival | Defined as survival until evidence of either biochemical progression (defined as a rise in prostate-specific antigen (PSA) ≥0.2ng/ml above the PSA nadir followed by a sequentially equal or higher value) following postoperative radiotherapy, clinical or radiological progression, initiation of non-protocol systemic therapy, or death from prostate cancer | 2 years |
| Disease Control Rate | Radiographic and/or histopathological disease control rate | 2 years |
| University Health Network - Princess Margaret Cancer Centre | Recruiting | Toronto | Ontario | M5G 2C1 | Canada |
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