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| Name | Class |
|---|---|
| Prostate Cure Foundation | UNKNOWN |
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Stereotactic Ablative Body Radiotherapy (SABR) given in 5 weekly fractions. Simultaneously treating the pelvic lymph nodes, prostate and MRI-nodule to a total dose of 25 Gy, 35 Gy and up to 50 Gy, respectively. The radiation will be given with 6-18 months of ADT.
5-fraction SABR is a feasible, well-tolerated, effective and cost effective treatment for high-intermediate and high risk prostate cancer with/without an image-guided intraprostatic boost.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Stereotactic Ablative Body Radiotherapy (SABR) 35-50 Gy/5 | Experimental | Stereotactic Ablative Body Radiotherapy (SABR) given in 5 weekly fractions. Simultaneously treating the pelvic lymph nodes, prostate and MRI-nodule to a total dose of 25 Gy, 35 Gy and up to 50 Gy, respectively. The radiation will be given with 6-18 months of ADT. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Stereotactic Ablative Body Radiotherapy (SABR) 35-50 Gy/5 | Radiation | Stereotactic Ablative Body Radiotherapy (SABR) given in 5 weekly fractions. Simultaneously treating the pelvic lymph nodes, prostate and MRI-nodule to a total dose of 25 Gy, 35 Gy and up to 50 Gy, respectively. The radiation will be given with 6-18 months of ADT. |
| Measure | Description | Time Frame |
|---|---|---|
| Acute Toxicity | To document the acute urinary toxicity using the Common Terminology Criteria for Adverse Events (CTCAE v4.0) criteria | Baseline to 3 months post completion of treatment |
| Acute Toxicity | To document the acute bowel toxicity using the Common Terminology Criteria for Adverse Events (CTCAE v4.0) criteria | Baseline to 3 months post completion of treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Quality of Life outcome | Measuring quality of life using Expanded Prostate Index Composite (EPIC) | Baseline to end of 5 year follow up |
| Biochemical disease-free survival | Biochemical disease-free survival |
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Inclusion Criteria
Exclusion Criteria
Male patients with Prostate cancer
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| Name | Affiliation | Role |
|---|---|---|
| Andrew Loblaw, MD | Sunnybrook Health Sciences Centre | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sunnybrook Health Sciences Center | Toronto | Ontairo | M4N 3M5 | Canada |
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Analysis of acute toxicity will be performed approximately 6 months after the last patient has been accrued, in August 2020. The final analysis will be performed when all patients have completed 5 years of follow-up, in early 2025.
The primary endpoint analysis will be shared thru publications
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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 |
|---|---|
| D016634 | Radiosurgery |
| ID | Term |
|---|---|
| D011878 | Radiotherapy |
| D013812 | Therapeutics |
| D013238 | Stereotaxic Techniques |
| D019635 | Neurosurgical Procedures |
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|
| Baseline to end of 5 year follow up |
| Quality of life outcome | Health utilities using the EQ-5D Quality of Life Questionnaire tool | Baseline to end of 5 year follow up |
| Quality of life outcome | Health utilities using PORPUS-U Quality of Life Questionnaire tool | Baseline to end of 5 year follow up |
| Economic analysis | Cost effectiveness of treatment.Quality of life and cost estimates will be captured for each patient from time of the initiation of treatment until death. The effectiveness endpoints will be biochemical disease free survival and quality-adjusted life years (QALYs). QALY will be calculated by survival (in years) multiplied by a utility weight associated with a certain condition. | Baseline to end of 5 year follow up |
| D005832 |
| Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
| D013514 |
| Surgical Procedures, Operative |
| D008919 | Investigative Techniques |