Comparing Moderately Ultra Hypofractionated Radiation Treatments for Prostate Cancer
A Phase II Randomized Trial: ALTERNATE DAY ULTRAHYPOFRACTIONATED OR DAILY MODERATELY HYPOFRACTIONATED POST OPERATIVE RADIOTHERAPY
University Health Network, Toronto
204 participants
Nov 26, 2024
INTERVENTIONAL
Conditions
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
Inclusion Criteria6
- 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
Exclusion Criteria4
- 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.
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Interventions
Non-institutional-standard radiotherapy
Locations(2)
View Full Details on ClinicalTrials.gov
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NCT06409910