ConditionsProstate CancerRadiotherapy Side EffectHypofractionationBrachytherapyRadiotherapyLocalized Prostate Carcinoma
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexMale
Age18-95
SponsorCHU de Quebec-Universite Laval
About this trial
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.
Eligibility criteria
Qualifiers
Biopsy proven Prostate adenocarcinoma
Stage T1c, T2 (Annex 2)
Stage Nx or N0
Stage Mx or M0
Disqualifiers
Age < 18ans
Clinical Stage T3 or T4
Stage N1
Stage M1
Trial design
Treatments tested in this trial
- grade and compare reported side effects between groups
Treatment groups
205 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov