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RecruitingNCT04100174fBTsRTUpdated Mar 13, 2025

Focal HDR Brachytherapy Boost to Stereotactic Radiotherapy

A Phase 2 interventional study of focal brachytherapy boost to SBRT in Prostate Cancer, sponsored by Centre hospitalier de l'Université de Montréal (CHUM). Recruiting at 2 sites in Canada. Open to male participants. Per ClinicalTrials.gov, last updated 2025-03-13.

Sponsored by Centre hospitalier de l'Université de Montréal (CHUM) · Phase 2, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by May 2025, 1 year 4 months ago, but the record still lists the study as recruiting.
  • Started Jul 2019; still recruiting 7 years 3 months later.
Phase
Phase 2
Study type
Interventional
Enrollment
150
Allocation
Randomized
Sex
Male
01

Study 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

Read the 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.

02

Conditions studied

  • Prostate Cancer

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03

In context

Prostatic Neoplasms

6,370 studies on the registry are indexed under Prostatic Neoplasms; 1,400 are open to participants now.

This study's planned enrollment of 150 is above the median of 58 across 4,822 interventional studies indexed under Prostatic Neoplasms.

Browse Prostatic Neoplasms studies →

Lead sponsor

Centre hospitalier de l'Université de Montréal (CHUM) is the lead sponsor of 370 studies on the registry; 110 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
Male
Accepts healthy volunteers
No

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 criteria

Exclusion - none

05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Sequential assignment
Masking
None (open label)
Enrollment
150 participants (estimated)

Interventions

  • Radiationfocal brachytherapy boost to SBRT

    As above

06

What researchers measure

Primary outcomes

  1. Urinary Quality of Life

    EPIC

    Time frame: 12-24 months

07

Study locations

2 of 2 sites recruiting
  • Centre Hospitalier de l'Université de Montréal
    Montréal, Quebec, Canada
    Recruiting
  • CHUQ
    Québec, Quebec, Canada
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 13, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04100174
Lead sponsor
Centre hospitalier de l'Université de Montréal (CHUM)
Responsible party
Sponsor
First posted
Sep 24, 2019
Start date
Jul 1, 2019
Primary completion
May 30, 2025 (estimated)
Completion
Jun 30, 2025 (estimated)
Last update
Mar 13, 2025

Study contacts

Mom Phat
Contact
mom.phat.chum@ssss.gouv.qc.ca
514-890-8254

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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