ALTERNATE DAY ULTRAHYPOFRACTIONATED OR DAILY MODERATELY HYPOFRACTIONATED POST OPERATIVE RADIOTHERAPY (AMPORA)
NCT ID: NCT06409910
Last Updated: 2024-12-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
204 participants
INTERVENTIONAL
2024-11-25
2030-11-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
Arm 2: External beam radiotherapy 30 Gy in 5 fractions to prostate bed +/- 25 Gy in 5 fractions to pelvic lymph nodes delivered on alternate days.
TREATMENT
NONE
Study Groups
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Arm 1: Moderately Hypofractionated Radiotherapy
External beam radiotherapy 54 Gy in 20 fractions to prostate bed +/- 44 Gy in 20 fractions to pelvic lymph nodes delivered daily.
Radiotherapy
Non-institutional-standard radiotherapy
Arm 2: Ultrahypofractionated Radiotherapy
External beam radiotherapy 30 Gy in 5 fractions to prostate bed +/- 25 Gy in 5 fractions to pelvic lymph nodes delivered on alternate days.
Radiotherapy
Non-institutional-standard radiotherapy
Interventions
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Radiotherapy
Non-institutional-standard radiotherapy
Eligibility Criteria
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Inclusion Criteria
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
2. Contraindications to radiotherapy
3. Mets confirmed as per (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.
18 Years
MALE
No
Sponsors
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University Health Network, Toronto
OTHER
Responsible Party
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Locations
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University Health Network - Princess Margaret Cancer Centre
Toronto, Ontario, Canada
Countries
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Central Contacts
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Facility Contacts
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Andrew McPartlin
Role: primary
Other Identifiers
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23-5813
Identifier Type: -
Identifier Source: org_study_id