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 RT to the prostate bed +/- pelvic nodal regions
Prostate-bed recurrence identified by biopsy and/or MRI and/or PSMA-PET scan
At least two continuous PSA elevations post RT and PSA above 0.2 ng/dl
With or without ADT PSA doubling time from nadir greater than 6 months
Radiological (e.g. PSMA PET, CT, MRI or bone scan) evidence of or distant metastases
History of ≥G3 gastrointestinal (GI) and genitourinary (GU) toxicities following RT
Any contraindications to MR and/or brachytherapy
Single group
High Dose Rate Brachytherapy
Radiation2 fractions of MRI-guided HDR Brachytherapy (13Gy each) delivered over 14 days (± 7 days).
Dosimetry Parameters
As this is a safety and feasibility study, the PTV coverage could be compromised to meet the OAR constraints
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
Biochemical Control assessed by PSA
Determine the number of patients demonstrating biochemical control of PSA following salvage HDR Brachytherapy treatment.
Local Disease Control
Assessed by MRI/PSMA-PET imaging at 2 years
Changes in Quality of Life
Assessed with EPIC Quality of Life scores yearly for 5 years.
Click on the lead sponsor to view all of their trials.
