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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
204
Non-institutional-standard radiotherapy
London Health Sciences Centre
London, Ontario, Canada
RECRUITINGUniversity Health Network - Princess Margaret Cancer Centre
Toronto, Ontario, Canada
RECRUITINGRates of Acute Toxicity
Acute grade ≥2 gastrointestinal toxicity (CTCAE v5.0)
Time frame: 2 years
Rates of Acute and Late Toxicity
Acute grade ≥2 genitourinary toxicity (CTCAE v5.0)
Time frame: 2 years
Quality of Life Outcomes
EPIC-26 Questionnaire
Time frame: 2 years
Quality of Life Outcomes
IPSS Questionnaire
Time frame: 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
Time frame: 2 years
Disease Control Rate
Radiographic and/or histopathological disease control rate
Time frame: 2 years
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