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ClinicalTrials.gov ID

NCT04100174

Lead Sponsor

Centre hospitalier de l'Université de Montréal (CHUM)OTHER

Overall Status

Recruiting

Study Type

Interventional

Phase

Phase 2

Enrollment

150Estimated

Last Update Posted

Mar 13, 2025Actual

Start Date

Jul 1, 2019Actual

Primary Completion Date

May 30, 2025Estimated

Completion Date

Jun 30, 2025Estimated

Official Title

Focal HDR Brachytherapy Boost to Stereotactic Radiotherapy

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.

• Prostate Cancer

• focal brachytherapy boost to SBRT

Ages Eligible for Study

Child (0-17)Adult (18-64)Older Adult (65+)

Sexes Eligible for Study

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

Primary Purpose

Treatment

Allocation

Randomized

Interventional Model

Sequential Assignment

Masking

None (Open Label)

Lead Sponsor

Centre hospitalier de l'Université de Montréal (CHUM)OTHER

Josee.Allard@chudequebec.ca