Prostate Cancer
Conditions
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.
Interventions
RADIATIONfocal brachytherapy boost to SBRT
As above
Sponsors
Centre hospitalier de l'Université de Montréal (CHUM)
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Urinary Quality of Life | 12-24 months | EPIC |
Countries
Canada
Contacts
Primary ContactMom Phat
Outcome results
None listed