Prostate CancerPhase 2fBTsRTNCT04100174
Focal HDR Brachytherapy Boost to Stereotactic Radiotherapy
A Phase 2 study testing focal brachytherapy boost to SBRT in people with Prostate Cancer, run by Centre hospitalier de l'Université de Montréal (CHUM) at 2 sites in Canada.
Trial 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 more about this study
- Who is it for?
- Any age, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- focal brachytherapy boost to SBRT
- Type of treatment
- Surgery or procedure
- How many people
- 150 participants
- Where
- 2 sitesCanada
- Study dates
- 1 Jul 2019to 30 Jun 2025
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Men only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
None listed.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Canada2 sites, 2 recruiting
- Recruiting
Centre Hospitalier de l'Université de Montréal
Montreal, Quebec
Mom Phat, 514-890-8000 ext. 26906, mom.phat.chum@ssss.gouv.qc.ca
Cynthia Menard, MD
- Recruiting
CHUQ
Québec, Quebec
Josee Allard, Josee.Allard@chudequebec.ca
Eric Vigneault, MD
About this study
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.
- Conditions
- Prostate Cancer
- Being tested
- focal brachytherapy boost to SBRT
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
focal brachytherapy boost to SBRTRadiation
As above
What is being measured
The primary outcome is the main question the study is designed to answer.
Urinary Quality of Life
EPIC
Measured: 12-24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2019
- Study start1 Jul 2019
- Primary completion30 May 2025 (estimated)
- Study completion30 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- More trials run by Centre hospitalier de l'Université de Montréal (CHUM)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04100174
- Sponsor's protocol ID
- 18.295
- Acronym
- fBTsRT
- Status last verified
- Mar 2025
- First submitted
- 20 Sep 2019
- Last updated
- 13 Mar 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 42032732Belliveau 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.
PubMed 36494834
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Focal HDR Brachytherapy Boost to Stereotactic Radiotherapy
- ClinicalTrials.gov ID
- NCT04100174
- Acronym / sponsor ID
- fBTsRT / 18.295
- Conditions
- Prostate Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Centre hospitalier de l'Université de Montréal (CHUM)University, hospital or other
- Study start
- 1 Jul 2019 (actual)
- Primary completion
- 30 May 2025 (estimated)
- Study completion
- 30 Jun 2025 (estimated)
- First posted
- 24 Sep 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
Who may qualify
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| focal brachytherapy boost to SBRTAs above | Radiation | – |
Primary outcome
Urinary Quality of Life
Time frame: 12-24 months
EPIC
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2025.
- Derived from this study: PubMed 42032732Giguere 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.
- Derived from this study: PubMed 36494834Belliveau 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing focal brachytherapy boost to SBRT in people with Prostate Cancer, run by Centre hospitalier de l'Université de Montréal (CHUM) at 2 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 13 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mom Phat (514-890-8254, mom.phat.chum@ssss.gouv.qc.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Urinary Quality of Life (time frame: 12-24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04100174, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Mar 2025.