Status:
RECRUITING
Focal HDR Brachytherapy Boost to Stereotactic Radiotherapy
Lead Sponsor:
Centre hospitalier de l'Université de Montréal (CHUM)
Conditions:
Prostate Cancer
Eligibility:
MALE
Phase:
PHASE2
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...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
July 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 30 2025
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT04100174
Start Date
July 1 2019
End Date
June 30 2025
Last Update
March 13 2025
Active Locations (2)
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1
Centre Hospitalier de l'Université de Montréal
Montreal, Quebec, Canada
2
CHUQ
Québec, Quebec, Canada