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: * Acute gastrointestinal (GI) and genitourinary (GU) Common Terminology Criteria for Adverse Events (CTCAE) v3.0 toxicities Secondary Endpoints: * Late GI and GU Radiation Therapy Oncology Group (RTOG) toxicities * Biochemical disease-free survival * Biopsy positive rate at 3 years * Quality of life using the Expanded Prostate Cancer Index Composite (EPIC) questionnaire * Develop a biobank of DNA and serum extracted from blood and urine to analyze and develop new biomarkers for prostate cancer progression or susceptibility to severe toxicity
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
30
40 Gy in 5 fractions to prostate, 30 Gy in 5 fractions to seminal vesicles; total treatment duration 29 days
Odette Cancer Centre, Sunnybrook Health Sciences Centre
Toronto, Ontario, Canada
Incidence of grade 3+ rectal toxicity
Common Terminology Criteria for Adverse Events (CTCAE) v3.0
Time frame: Acute period (up to 3 months)
Incidence of grade 3+ urinary toxicity
Common Terminology Criteria for Adverse Events (CTCAE) v3.0
Time frame: Acute (up to 3 months) and Late (after 6 months of follow-up)
Quality of Life
Expanded Prostate Cancer Index Composite (EPIC)
Time frame: 5 years
Biochemical (ie.prostate specific antigen) disease free survival
Time frame: 5 years
Incidence of grade 3+ rectal toxicity
Common Terminology Criteria for Adverse Events (CTCAE) v3.0
Time frame: Late (after 6 months of follow-up)
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