Recruiting
Phase 2

HDR Brachytherapy & Stereotactic Radiotherapy

Sponsor:

Centre hospitalier de l'Université de Montréal (CHUM)

Code:

NCT04100174

Conditions

Prostate Cancer

Eligibility Criteria

Sex: Male

Age: 0+

Healthy Volunteers: Not accepted

Interventions

focal brachytherapy boost to SBRT

Study Details

Brief 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

Conditions

Prostate Cancer

Study ID

NCT04100174

Start date

Jul 1, 2019

Status verified date

Mar, 2025

Completion date

Jun 30, 2025

Anticipated

Primary completion date

May 30, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Male

Age: 0+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

150 participants

Anticipated

Allocation

Randomized

Intervention Model

Sequential

Primary purpose

Treatment

Interventions and Outcome Measures

Interventions

focal brachytherapy boost to SBRT

As above

Primary outcome measure

  • Urinary Quality of Life [ Time Frame: 12-24 months ]

Central Contacts and Locations

Central contacts

Mom Phat

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

Locations

Centre Hospitalier de l'Université de Montréal

Recruiting

Montréal, Quebec, Canada

Contacts

Mom Phat

514-890-8000mom.phat.chum@ssss.gouv.qc.ca

Principal Investigator:

Cynthia Menard, MD

CHUQ

Recruiting

Québec, Quebec, Canada

Contacts

Josee Allard

Josee.Allard@chudequebec.ca

Principal Investigator:

Eric Vigneault, MD

More Information

Sponsor

Centre hospitalier de l'Université de Montréal (CHUM)

Last update posted

Mar 13, 2025

Last verified

Mar, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Centre hospitalier de l'Université de Montréal (CHUM) on 2025-03-13.