Salvage MR-guided High-Dose-Rate Brachytherapy for Prostate Bed Recurrence After Radiotherapy in the PSMA PET Scan Era
NCT06508567 · NA · Toronto, Ontario, Canada
- Condition
- Prostate Cancer
- Disease stage
- Stage I-IV
- Phase
- NA
- Study type
- RADIATION
- Intervention
- High Dose Rate Brachytherapy
- Age
- 18 Years to
- Gender
- Male
- Sponsor
- University Health Network, Toronto
- Research institution
- University Health Network, Toronto
- Facility
- Princess Margaret Cancer Centre
- Research center
- Princess Margaret Cancer Centre
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.
Detailed description
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)
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 outcomes
Dosimetry Parameters; Acute toxicity assessed by CTCAE V5.0 (Grade ≥3)
Secondary outcomes
Biochemical Control assessed by PSA; Local Disease Control; Changes in Quality of Life