Clinical Trial

Ultra Hypofractionnated Radiotherapy With HDR Brachytherapy Boost.

Study acronym: HYPO-5
Recruiting
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Record status
This record was last updated September 9, 2025 (before its estimated June 2026 completion). Its status may not reflect the trial's current state.
Summary
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.
Protocol Amendment History 2 amendments
This ClinicalTrials.gov record has been amended 2 times since 2023-03-14; most recent amendment 2025-09-07.
Trial Details
NCT Number NCT05786742
Lead Sponsor CHU de Quebec-Universite Laval
Conditions Prostate Cancer, Radiotherapy Side Effect, Hypofractionation, Brachytherapy, Radiotherapy, Localized Prostate Carcinoma
Enrollment 205 participants
Start Date 2014-04
Primary Completion 2026-06 (estimated)
Study Completion 2033-12 (estimated)
Updated on ClinicalTrials.gov 2025-09-09