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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
75
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.
Sunnybrook Health Sciences Center
Toronto, Ontairo, Canada
Acute Toxicity
To document the acute urinary toxicity using the Common Terminology Criteria for Adverse Events (CTCAE v4.0) criteria
Time frame: 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
Time frame: Baseline to 3 months post completion of treatment
Quality of Life outcome
Measuring quality of life using Expanded Prostate Index Composite (EPIC)
Time frame: Baseline to end of 5 year follow up
Biochemical disease-free survival
Biochemical disease-free survival
Time frame: Baseline to end of 5 year follow up
Quality of life outcome
Health utilities using the EQ-5D Quality of Life Questionnaire tool
Time frame: Baseline to end of 5 year follow up
Quality of life outcome
Health utilities using PORPUS-U Quality of Life Questionnaire tool
Time frame: 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.
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Time frame: Baseline to end of 5 year follow up