This is an interventional, single-centre, single-arm, non-randomized, prospective, feasibility trial investigating salvage MR-guided High-Dose-Rate brachytherapy for prostate bed recurrence after postoperative radiotherapy.
Patients who received previous adjuvant or salvage radiotherapy to the prostate bed \> Isolated prostate bed recurrence based on PSMA PET, biopsy-proven, and MR visible \> Baseline: QoLs questionnaires, PSA, pelvic magnetic resonance imaging (MRI) scan for RT planning \> Two fractions of 13 Gy each delivered over 7-21 days. GTV(HDR) delineation (based on MRI-guided and PSMA PET, biopsy data as applicable) \> Follow-Up after treatment 60 months: PSA, CTCAE v5.0, MRI pelvis +/- PSMA-PET scan (optional at 24 months)
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
20
2 fractions of MRI-guided HDR Brachytherapy (13Gy each) delivered over 14 days (± 7 days).
Princess Margaret Cancer Centre
Toronto, Ontario, Canada
RECRUITINGDosimetry Parameters
As this is a safety and feasibility study, the PTV coverage could be compromised to meet the OAR constraints
Time frame: 5 Years
Acute toxicity assessed by CTCAE V5.0 (Grade ≥3)
Determine the number of patients with late genitourinary, gastrointestinal and/or sexual toxicities as a result of salvage HDR Brachytherapy treatment at a grade ≥3
Time frame: 5 Years
Biochemical Control assessed by PSA
Determine the number of patients demonstrating biochemical control of PSA following salvage HDR Brachytherapy treatment.
Time frame: 5 Years
Local Disease Control
Assessed by MRI/PSMA-PET imaging at 2 years
Time frame: 2 Years
Changes in Quality of Life
Assessed with EPIC Quality of Life scores yearly for 5 years.
Time frame: 5 years
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.