Ultra Hypofractionnated Radiotherapy With HDR Brachytherapy Boost.
Recruiting · NCT05786742 · Interventional (participants receive a specific treatment) · Lead sponsor: CHU de Quebec-Universite Laval
View the official record on ClinicalTrials.gov →Interventions studied
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.
Who can take part
Inclusion criteria
- Biopsy proven Prostate adenocarcinoma
- Stage T1c, T2 (Annex 2)
- Stage Nx or N0
- Stage Mx or M0
- PSA \< 20ng/ml
- Gleason Score 6 or 7
- Having the ability to sing a written consent
Exclusion criteria
- Age \< 18ans
- Clinical Stage T3 or T4
- Stage N1
- Stage M1
- PSA \> 20
- Gleason Score 8 to 10
- IPSS Score \> 20 alpha-blocking medication.
- Prior pelvic radiotherapy.
- History of active collagenosis (Lupus, Sclerodermia, Dermatomyosis)
- Past history of Inflammatory Bowell Disease
- Bilateral hip prosthesis
Where it is running
1 location listed.
- CHUdeQuebec - Québec, Canada