Post-Operative Prostate Cancer
Conditions
Brief summary
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.
Interventions
RADIATIONRadiotherapy
Non-institutional-standard radiotherapy
Sponsors
University Health Network, Toronto
TOLMAR PHARMACEUTIQUES CANADA, INC.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Arm 1: External beam radiotherapy 54 Gy in 20 fractions to prostate bed +/- 44 Gy in 20 fractions to pelvic lymph nodes delivered daily. Arm 2: External beam radiotherapy 30 Gy in 5 fractions to prostate bed +/- 25 Gy in 5 fractions to pelvic lymph nodes delivered on alternate days.
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Age \>/= 18 years 2. Able to provide informed consent 3. Histologic diagnosis of prostate adenocarcinoma 4. ECOG performance status 0-1 5. Previous radical prostatectomy \> 6 months prior to radiotherapy start date 6. Planned to receive post-operative radiation
Exclusion criteria
1. Prior pelvic radiotherapy 2. Contraindications to radiotherapy 3. Confirmed metastases (if scan has been done for clinical care) 4. Participants with visible disease in the prostate bed or pelvic lymph nodes on imaging are not eligible for treatment on study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rates of Acute Toxicity | 2 years | Acute grade ≥2 gastrointestinal toxicity (CTCAE v5.0) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Rates of Acute and Late Toxicity | 2 years | Acute grade ≥2 genitourinary toxicity (CTCAE v5.0) |
| Quality of Life Outcomes | 2 years | EPIC-26 Questionnaire |
| Biochemical disease-free survival | 2 years | 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 |
| Disease Control Rate | 2 years | Radiographic and/or histopathological disease control rate |
Countries
Canada
Contacts
CONTACTAndrew McPartlin, MBChB
Outcome results
None listed