Comparing Moderately Ultra Hypofractionated Radiation Treatments for Prostate Cancer
Recruiting · NCT06409910 · Interventional (participants receive a specific treatment) · Lead sponsor: University Health Network, Toronto
View the official record on ClinicalTrials.gov →Interventions studied
Radiotherapy
What this trial is about
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.
Who can take part
Age range
18 Years and older
Sex
Male
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 2
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- 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 criteria
- 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.
Where it is running
2 locations listed.
- London Health Sciences Centre - London, Ontario, Canada
- University Health Network - Princess Margaret Cancer Centre - Toronto, Ontario, Canada