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Trial Title:
Adaptive Moderately Hypofractionated Post Operative Radiotherapy
NCT ID:
NCT06409910
Condition:
Post-Operative Prostate Cancer
Conditions: Official terms:
Prostatic Neoplasms
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Not yet recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Intervention model description:
Arm 1: External beam radiotherapy 54 Gy in 20 fractions to prostate bed +/- 44 Gy in 20
fractions to pelvic lymph nodes delivered daily.
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.
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Radiation
Intervention name:
Radiotherapy
Description:
Non-institutional-standard radiotherapy
Arm group label:
Arm 1: Moderately Hypofractionated Radiotherapy
Arm group label:
Arm 2: Ultrahypofractionated Radiotherapy
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.
Criteria for 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 Criteria:
1. Prior pelvic radiotherapy
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.
Gender:
Male
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Start date:
September 2024
Completion date:
September 2030
Lead sponsor:
Agency:
University Health Network, Toronto
Agency class:
Other
Source:
University Health Network, Toronto
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06409910
