Comparing Moderately Ultra Hypofractionated Radiation Treatments for Prostate Cancer
Recruiting
Phase 2Interventional Study
Post-Operative Prostate Cancer
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
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At a Glance
Age
18 and older
Sex
Male
Trial phase
Phase 2
Study type
Interventional
Purpose
Treatment
Participants needed
204 (estimated)
Sponsor
University Health Network, Toronto · Other
Who this trial is looking for
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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.
Trial Locations
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Status
Eligibility 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 Cri…
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.
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