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Ultra Hypofractionnated Radiotherapy With HDR Brachytherapy Boost.

Study acronym: HYPO-5
StatusRecruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗
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.

Record History

  1. Primary completion date: Jun 2025 to Jun 2026
    • Site contact updated
    v3
  2. Primary completion date: Jun 2023 to Jun 2025v2
  3. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT05786742
Lead Sponsor CHU de Quebec-Universite Laval
Conditions
(from sponsor)		 Prostate Cancer, Radiotherapy Side Effect, Hypofractionation, Brachytherapy, Radiotherapy, Localized Prostate Carcinoma
Related terms Prostatic Neoplasms, Radiation Injuries
Enrollment 205 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov