- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04100174
Focal HDR Brachytherapy Boost to Stereotactic Radiotherapy (fBTsRT)
October 17, 2023 updated by: Centre hospitalier de l'Université de Montréal (CHUM)
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
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Estimated)
150
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Mom Phat
- Phone Number: 514-890-8254
- Email: mom.phat.chum@ssss.gouv.qc.ca
Study Locations
-
-
Quebec
-
Montréal, Quebec, Canada
- Recruiting
- Centre Hospitalier de l'Université de Montréal
-
Principal Investigator:
- Cynthia Menard, MD
-
Contact:
- Mom Phat
- Phone Number: 26906 514-890-8000
- Email: mom.phat.chum@ssss.gouv.qc.ca
-
Québec, Quebec, Canada
- Recruiting
- CHUQ
-
Contact:
- Josee Allard
- Email: Josee.Allard@chudequebec.ca
-
Principal Investigator:
- Eric Vigneault, MD
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Sequential Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Urinary Quality of Life
Time Frame: 12-24 months
|
EPIC
|
12-24 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
July 1, 2019
Primary Completion (Estimated)
October 30, 2024
Study Completion (Estimated)
June 30, 2025
Study Registration Dates
First Submitted
September 20, 2019
First Submitted That Met QC Criteria
September 20, 2019
First Posted (Actual)
September 24, 2019
Study Record Updates
Last Update Posted (Actual)
October 18, 2023
Last Update Submitted That Met QC Criteria
October 17, 2023
Last Verified
October 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 18.295
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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