Comparing two types of post-operative radiotherapy for prostate cancer
A Phase II Randomized Trial: ALTERNATE DAY ULTRAHYPOFRACTIONATED OR DAILY MODERATELY HYPOFRACTIONATED POST OPERATIVE RADIOTHERAPY
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 |
| Enrollment | 204 (estimated) |
| Ages | 18 Years and up |
| Sex | Male |
| Sponsor | University Health Network, Toronto Academic / other |
| Drugs / interventions | radiation |
| Locations | 2 sites (London, Ontario and 1 other locations) |
| Trial ID | NCT06409910 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: Other studies have explored various radiotherapy regimens, but this specific comparison of alternate day versus daily treatment is relatively novel.
Eligibility criteria
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 this trial is running
London, Ontario and 1 other locations
- London Health Sciences Centre — London, 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.