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| Name | Class |
|---|---|
| TerSera Therapeutics LLC | INDUSTRY |
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This is a prospective, randomized phase II trial investigating if radiation treatment delivered every other day for 2 weeks has the same side effects as radiation treatment delivered once weekly for 6 weeks.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1 - Investigational | Experimental | Radiation treatment (36 Gy in 6 fractions) to be delivered every other day over 2 weeks (excluding weekends). |
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| Arm 2 - Standard | Other | Radiation treatment (36 Gy in 6 fractions) to be delivered once a week over 6 weeks. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Radiotherapy | Radiation | Standard of care radiotherapy administered as per institutional guidelines. |
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| Measure | Description | Time Frame |
|---|---|---|
| Rates of acute toxicity | Compare rates of acute toxicity between participants in Arm 1 and Arm 2. Acute toxicity will be measured using CTCAE V5.0 | 5 years |
| Measure | Description | Time Frame |
|---|---|---|
| Rates of late toxicity. | Compare rates of late toxicity between participants in Arm 1 and Arm 2. Late toxicity will be measured using CTCAE V5.0 | 5 years |
| Measure failure-free survival | Compare failure-free survival, collected through medical records, for participants in Arm 1 and Arm 2 |
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Inclusion Criteria:
Exclusion Criteria:
Prostate cancer excludes women
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Peter Chung, MD | Contact | 416-946-4501 | 2126 | peter.chung@rmp.uhn.ca |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Health Network, Princess Margaret Hospital | Recruiting | Toronto | Ontario | M5G 2M9 | Canada |
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| ID | Term |
|---|---|
| D011878 | Radiotherapy |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
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| 5 years |
| Quality of Life Outcomes | EPIC-26 Questionnaire | 5 years |