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.
Age >/= 18 years
Able to provide informed consent
Histologic diagnosis of prostate adenocarcinoma
ECOG performance status 0-1
Prior pelvic radiotherapy
Contraindications to radiotherapy
Confirmed metastases (if scan has been done for clinical care)
Participants with visible disease in the prostate bed or pelvic lymph nodes on imaging are not eligible for treatment on study.
Parallel
Radiotherapy
RadiationNon-institutional-standard radiotherapy
Rates of Acute Toxicity
Acute grade ≥2 gastrointestinal toxicity (CTCAE v5.0)
Rates of Acute and Late Toxicity
Acute grade ≥2 genitourinary toxicity (CTCAE v5.0)
Quality of Life Outcomes
EPIC-26 Questionnaire
Quality of Life Outcomes
IPSS Questionnaire
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
Click on the lead sponsor to view all of their trials.
University Health Network, Toronto
Lead sponsor
TOLMAR PHARMACEUTIQUES CANADA, INC.
Collaborator
