RecruitingNot ApplicableNCT06508567
Salvage MR-guided High-Dose-Rate Brachytherapy for Prostate Bed Recurrence After Radiotherapy in the PSMA PET Scan Era
Sponsor
University Health Network, Toronto
Enrollment
20 participants
Start Date
Aug 8, 2024
Study Type
INTERVENTIONAL
Conditions
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: MALEMin Age: 18 Years
Inclusion Criteria6
- 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
- ECOG 0-2
- Age greater than 18 years
Exclusion Criteria3
- 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
Interventions
RADIATIONHigh Dose Rate Brachytherapy
2 fractions of MRI-guided HDR Brachytherapy (13Gy each) delivered over 14 days (± 7 days).
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT06508567
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