High Dose Rate Brachytherapy: 2 fractions of MRI-guided HDR Brachytherapy (13Gy each) delivered over 14 days (± 7 days).
Study summary
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.
Eligibility
Sex
MALE
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria:
1. Patients who received previous RT to the prostate bed +/- pelvic nodal regions
2. Prostate-bed recurrence identified by biopsy and/or MRI and/or PSMA-PET scan
3. At least two continuous PSA elevations post RT and PSA above 0.2 ng/dl
4. With or without ADT PSA doubling time from nadir greater than 6 months
5. ECOG 0-2
6. Age greater than 18 years
Exclusion Criteria:
1. Radiological (e.g. PSMA PET, CT, MRI or bone scan) evidence of or distant metastases
2. History of ≥G3 gastrointestinal (GI) and genitourinary (GU) toxicities following RT
3. Any contraindications to MR and/or brachytherapy
Primary outcome measure(s)
Dosimetry Parameters — 5 Years 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) — 5 Years 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
Trial sites (1)
Facility
City
Region
Status
Princess Margaret Cancer Centre
Toronto
Ontario
Recruiting
More University Health Network, Toronto trials in Canada
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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