A Phase II Randomized Trial: ALTERNATE DAY ULTRAHYPOFRACTIONATED OR DAILY MODERATELY HYPOFRACTIONATED POST OPERATIVE RADIOTHERAPY
Status: Recruiting
Location: See location...
Intervention Type: Radiation
Study Type: Interventional
Study Phase: Phase 2
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.
Eligibility
Participation Requirements
Sex: Male
Minimum Age: 18
Healthy Volunteers: f
View:
• Age \> 18 years
• Able to provide informed consent
• Histologic diagnosis of prostate adenocarcinoma
• ECOG performance status 0-1
• Previous radical prostatectomy \> 6 months prior to radiotherapy start date
• Planned to receive post-operative radiation
Locations
Other Locations
Canada
University Health Network - Princess Margaret Cancer Centre
RECRUITING
Toronto
Contact Information
Primary
Andrew McPartlin, MBChB
andrew.mcpartlin@uhn.ca
416-946-4501
Time Frame
Start Date: 2024-11-25
Estimated Completion Date: 2030-11
Participants
Target number of participants: 204
Treatments
Experimental: Arm 1: Moderately Hypofractionated Radiotherapy
External beam radiotherapy 54 Gy in 20 fractions to prostate bed +/- 44 Gy in 20 fractions to pelvic lymph nodes delivered daily.
Experimental: Arm 2: Ultrahypofractionated Radiotherapy
External beam radiotherapy 30 Gy in 5 fractions to prostate bed +/- 25 Gy in 5 fractions to pelvic lymph nodes delivered on alternate days.
Related Therapeutic Areas
Sponsors
Leads: University Health Network, Toronto