RecruitingPhase 2NCT06409910

Comparing Moderately Ultra Hypofractionated Radiation Treatments for Prostate Cancer

A Phase II Randomized Trial: ALTERNATE DAY ULTRAHYPOFRACTIONATED OR DAILY MODERATELY HYPOFRACTIONATED POST OPERATIVE RADIOTHERAPY


Sponsor

University Health Network, Toronto

Enrollment

204 participants

Start Date

Nov 26, 2024

Study Type

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

Sex: MALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This trial compares two radiation therapy schedules for men who had their prostate removed and now need post-surgery radiation. One schedule delivers radiation every other day at a higher dose (ultrahypofractionated); the other delivers radiation daily at a moderate dose. Both aim to kill remaining cancer cells, but in fewer total visits. **You may be eligible if...** - You are over 18 years old with a biopsy-confirmed prostate cancer diagnosis - You had your prostate removed (radical prostatectomy) more than 6 months ago - You are in good health (ECOG 0–1) - You are scheduled to receive post-operative radiation therapy **You may NOT be eligible if...** - You have had prior pelvic radiation therapy - There is visible cancer remaining in the prostate bed or pelvic lymph nodes on imaging - Your cancer has spread to other parts of the body Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

RADIATIONRadiotherapy

Non-institutional-standard radiotherapy


Locations(2)

London Health Sciences Centre

London, Ontario, Canada

University Health Network - Princess Margaret Cancer Centre

Toronto, Ontario, Canada

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NCT06409910