Actively Recruiting
Ultra Hypofractionnated Radiotherapy With HDR Brachytherapy Boost.
Led by CHU de Quebec-Universite Laval · Updated on 2025-09-09
205
Participants Needed
1
Research Sites
1026 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Phase 1-2 study, comparing ultra-hypofractionnated (UH) to a moderately hypofractionnated (MH) radiation therapy, with image guided HDR prostate brachytherapy. Using iso-equivalent doses, a non-inferiority analysis will be done in order to prove UH non-inferior to MH, toxicity wise. Acceptability, tolerability, acute and late toxicity will be reported. MRI visible dominant intra-prostatic lesion will be outlines and variability between radiation oncologists and radiologists will be reported. As secondary objective, biochemical and clinical failure free survival will be reported at 5 \& 10 years.
CONDITIONS
Official Title
Ultra Hypofractionnated Radiotherapy With HDR Brachytherapy Boost.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Biopsy proven Prostate adenocarcinoma
- Clinical stage T1c or T2
- Lymph node stage Nx or N0
- Metastasis stage Mx or M0
- PSA less than 20 ng/ml
- Gleason Score 6 or 7
- Ability to sign written consent
You will not qualify if you...
- Age less than 18 years
- Clinical stage T3 or T4
- Lymph node stage N1
- Metastasis stage M1
- PSA greater than 20 ng/ml
- Gleason Score 8 to 10
- IPSS Score greater than 20 despite alpha-blocking medication
- Prior pelvic radiotherapy
- History of active collagenosis (Lupus, Sclerodermia, Dermatomyosis)
- Past history of Inflammatory Bowel Disease
- Presence of bilateral hip prosthesis
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
CHUdeQuebec
Québec, Canada, G1R 2J6
Actively Recruiting
Research Team
A
Andre-Guy Martin
CONTACT
J
Josee Allard
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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