Focal HDR Brachytherapy Boost to Stereotactic Radiotherapy
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: focal brachytherapy boost to SBRT.
- Who it may be relevant to
- Registry conditions: Prostate Cancer. Basic parameters: No limits · Male.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Canada
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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.
Interventions
- Radiation focal brachytherapy boost to SBRT
As above
Primary outcome measures
- Urinary Quality of Life [Time frame: 12-24 months]
Eligibility criteria
Inclusion criteria
- Histological diagnosis of prostate cancer planned for curative-intent HDR brachytherapy boost to external beam radiotherapy to the prostate gland.
- ECOG 0-1
- Charlson Comorbidity Index ≤ 4
- Imaging visible disease encompassing < 50% of the prostate gland and consistent with biopsy findings.
Exclusion - none
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Sequential
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Canada · 2 centers
- Centre Hospitalier de l'Université de Montréal — Montreal
- CHUQ — Québec
Publications
- Giguere P, Bahig H, Westra S, Roberge D, Bourque JM, Masucci GL, Nkurunziza ES, Freire V, Belliveau C, Duplan D, Vigneault E, Wong P, Lang P, Menard C. Platform for the Evaluation of innovations in Radiation oncology through registry-based conduct of multi-centric pragmatic randomized trials: PERa implementation. Trials. 2026 Apr 24;27(1):437. doi: 10.1186/s13063-026-09709-0. PMID 42032732
- Belliveau C, Barkati M, Delouya G, Taussky D, Beauchemin MC, Lambert C, Beaulieu L, Beliveau-Nadeau D, Nicolas B, Carrier JF, Vigneault E, Menard C. Focal HDR brachytherapy boost to stereotactic radiotherapy (fBTsRT) for prostate cancer: a phase II randomized controlled trial. Radiat Oncol. 2022 Dec 9;17(1):203. doi: 10.1186/s13014-022-02173-5. PMID 36494834
Identifiers
NCT: NCT04100174 · 18.295