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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
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.
Age
All ages
Sex
MALE
Healthy Volunteers
No
Centre Hospitalier de l'Université de Montréal
Montreal, Quebec, Canada
CHUQ
Québec, Quebec, Canada
Start Date
July 1, 2019
Primary Completion Date
May 30, 2025
Completion Date
June 30, 2025
Last Updated
March 13, 2025
150
ESTIMATED participants
focal brachytherapy boost to SBRT
RADIATION
Lead Sponsor
Centre hospitalier de l'Université de Montréal (CHUM)
NCT04550494
NCT05691465
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
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