Focal HDR Brachytherapy Boost to Stereotactic Radiotherapy (fBTsRT)

Centre hospitalier de l'Université de Montréal (CHUM)

Status and phase

Enrolling

Phase 2

Conditions

Prostate Cancer

Treatments

Radiation: focal brachytherapy boost to SBRT

Study type

Interventional

Funder types

Other

Identifiers

NCT04100174

18.295

Details and patient eligibility

About

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

Full 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.

Enrollment

150 estimated patients

Sex

Male

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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