search
Back to results

Focal HDR Brachytherapy Boost to Stereotactic Radiotherapy (fBTsRT)

Primary Purpose

Prostate Cancer

Status
Recruiting
Phase
Phase 2
Locations
Canada
Study Type
Interventional
Intervention
focal brachytherapy boost to SBRT
Sponsored by
Centre hospitalier de l'Université de Montréal (CHUM)
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Prostate Cancer

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

  • Centre Hospitalier de l'Université de MontréalRecruiting
  • CHUQRecruiting

Outcomes

Primary Outcome Measures

Urinary Quality of Life
EPIC

Secondary Outcome Measures

Full Information

First Posted
September 20, 2019
Last Updated
October 17, 2023
Sponsor
Centre hospitalier de l'Université de Montréal (CHUM)
search

1. Study Identification

Unique Protocol Identification Number
NCT04100174
Brief Title
Focal HDR Brachytherapy Boost to Stereotactic Radiotherapy
Acronym
fBTsRT
Official Title
Focal HDR Brachytherapy Boost to Stereotactic Radiotherapy
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 1, 2019 (Actual)
Primary Completion Date
October 30, 2024 (Anticipated)
Study Completion Date
June 30, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre hospitalier de l'Université de Montréal (CHUM)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Sequential Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
150 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Radiation
Intervention Name(s)
focal brachytherapy boost to SBRT
Intervention Description
As above
Primary Outcome Measure Information:
Title
Urinary Quality of Life
Description
EPIC
Time Frame
12-24 months

10. Eligibility

Sex
Male
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mom Phat
Phone
514-890-8254
Email
mom.phat.chum@ssss.gouv.qc.ca
Facility Information:
Facility Name
Centre Hospitalier de l'Université de Montréal
City
Montréal
State/Province
Quebec
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mom Phat
Phone
514-890-8000
Ext
26906
Email
mom.phat.chum@ssss.gouv.qc.ca
First Name & Middle Initial & Last Name & Degree
Cynthia Menard, MD
Facility Name
CHUQ
City
Québec
State/Province
Quebec
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Josee Allard
Email
Josee.Allard@chudequebec.ca
First Name & Middle Initial & Last Name & Degree
Eric Vigneault, MD

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Focal HDR Brachytherapy Boost to Stereotactic Radiotherapy

We'll reach out to this number within 24 hrs