Comparing two types of post-operative radiotherapy for prostate cancer
Official title: A Phase II Randomized Trial: ALTERNATE DAY ULTRAHYPOFRACTIONATED OR DAILY MODERATELY HYPOFRACTIONATED POST OPERATIVE RADIOTHERAPY
Run by University Health Network, Toronto · NCT06409910 · Data updated 2026-11-12
This study is testing two different schedules of radiotherapy for men with prostate cancer after surgery to see which one works better for their recovery.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years and up |
| Sex | Men only |
| Enrollment | 204 (estimated) |
| Sponsor | University Health Network, Toronto Academic / other |
| Drugs / interventions | radiation |
| Locations | 3 sites (London, Ontario and 2 other locations) |
| Status | Recruiting |
| Started | November 26, 2024 |
| Main results expected | November 2030 |
| Study ends | November 2030 |
| Registry record updated | October 8, 2026 |
| Trial ID | NCT06409910 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates include men over 18 years old who have undergone radical prostatectomy more than 6 months prior and are planning to receive post-operative radiation.
✕Probably not a fit
Patients with prior pelvic radiotherapy, visible disease in the prostate bed or pelvic lymph nodes, or contraindications to radiotherapy may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This Phase II trial evaluates the effectiveness of two different radiotherapy regimens for patients with post-operative prostate cancer. It compares a daily treatment approach delivering 54 Gy in 20 fractions to the prostate bed and potentially 44 Gy to pelvic lymph nodes, against an alternate day regimen providing 30 Gy in 5 fractions to the prostate bed and possibly 25 Gy to pelvic lymph nodes. The study aims to determine if the alternate day regimen is non-inferior in terms of patient outcomes. Participants will be randomly assigned to one of the two treatment groups.
Why it matters
Potential benefit: If successful, this study could provide a more effective and potentially less burdensome radiotherapy schedule for patients recovering from prostate cancer surgery.
How similar studies have gone: Other studies have explored various radiotherapy regimens, but this specific comparison of alternate day versus daily treatment is relatively novel.
Who can join: the full rules
Show full inclusion / exclusion criteria
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.
Where it's running
-
London Health Sciences Centre
London, Ontario, Canada Recruiting -
Sunnybrook Health Sciences Centre - Sunnybrook Research Institute
Toronto, Ontario, Canada Recruiting -
University Health Network - Princess Margaret Cancer Centre
Toronto, Ontario, Canada Recruiting
Study contacts
- Study coordinator: Andrew McPartlin, MBChB
- Email: andrew.mcpartlin@uhn.ca
- Phone: 416-946-4501
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.