NCT04100174

Focal HDR Brachytherapy Boost to Stereotactic Radiotherapy

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 150 (estimated)
• Sponsor: Centre hospitalier de l'Université de Montréal (CHUM) · Academic / Other
• Sex: Male
• Age: —
• Healthy volunteers: Not accepted

Summary

To determine if fBT+sRT is superior to standard care in terms of urinary toxicity by having fewer patients experience a minimal important decline (MID) in urinary irritation/obstructive QoL

Detailed description

In this Phase IIR trial investigators primarily seek to determine if fBT boost (15Gy) to SBRT (35Gy/5) can be shown to be superior to standard care (whole-gland BT boost 15Gy to RT 37.5Gy/15) in terms of urinary toxicity by having fewer patients experience a minimal important decline (MID) in urinary irritation/obstructive QoL as measured by ePRO (EPIC-26) at 12 and 24 months post completion of therapy.

Conditions

• Prostate Cancer

Interventions

Type	Name	Description
RADIATION	focal brachytherapy boost to SBRT	As above

Timeline

• Start date: 2019-07-01
• Primary completion: 2025-05-30
• Completion: 2025-06-30
• First posted: 2019-09-24
• Last updated: 2025-03-13

Locations

2 sites across 1 country: Canada