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Focal HDR Brachytherapy Boost to Stereotactic Radiotherapy

Focal HDR Brachytherapy Boost to Stereotactic Radiotherapy

Recruiting
Male
Phase 2
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Overview

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

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.

Eligibility

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 details
    Prostate Cancer

NCT04100174

Centre hospitalier de l'Université de Montréal (CHUM)

27 January 2024

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