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Focal HDR Brachytherapy Boost to Stereotactic Radiotherapy

Study acronym: fBTsRT
StatusRecruiting
PhasePhase 2
Started2019-07-01
View on ClinicalTrials.gov ↗
Record status
This record was last updated March 13, 2025 (before its estimated May 30, 2025 completion). Its status may not reflect the trial's current state.

Amendment history

2025-03-12
minor
Study Status v5
Primary completion date2024-10-30→2025-05-30
2023-10-17
minor
Study Status v4
Primary completion date2023-06-30→2024-10-30
2022-11-09
minor
Study Status, Study Description, Contacts/Locations v3
Primary completion date2022-06-30→2023-06-30
Completion date2022-06-30→2025-06-30
Study sites1→2
Study descriptionrevised
[...] rinary irritation/obstructive QoL as measured by ePRO (EPIC-CP26) at 12 and 24 months post completion of therapy.
2021-01-25
minor
Study Status v2
Re-verified, no change to tracked fields
2019-09-24
minor
Study Status, Study Description, Eligibility, Contacts/Locations, IPDSharing v1
Eligibility criteria+17 characters
[...] % of the prostate gland and consistent with biopsy findings. Exclusion - none
Study description+11 characters
In this Phase IIR trial weinvestigators primarily seek to determine if fBT boost (15Gy) to SBRT (35 [...]
2019-09-20
minor
Original filing
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
Trial Details
NCT Number NCT04100174
Lead Sponsor Centre hospitalier de l'Université de Montréal (CHUM)
Conditions Prostate Cancer
Enrollment 150 participants
Start Date 2019-07-01
Primary Completion 2025-05-30 (estimated)
Study Completion 2025-06-30 (estimated)
Updated on ClinicalTrials.gov 2025-03-13