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 groups

Locations

1
CHUdeQuebecG1R 2J6, Québec Canada

Sponsors and collaborators

CHU de Quebec-Universite Laval

Lead sponsor