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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)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 2xHDR Brachytherapy | Experimental | Salvage MR-guided High-Dose-Rate Brachytherapy for Prostate Bed recurrence after Postoperative Radiotherapy. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| High Dose Rate Brachytherapy | Radiation | 2 fractions of MRI-guided HDR Brachytherapy (13Gy each) delivered over 14 days (± 7 days). |
|
| Measure | Description | Time Frame |
|---|---|---|
| Dosimetry Parameters | As this is a safety and feasibility study, the PTV coverage could be compromised to meet the OAR constraints | 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 | 5 Years |
| Measure | Description | Time Frame |
|---|---|---|
| Biochemical Control assessed by PSA | Determine the number of patients demonstrating biochemical control of PSA following salvage HDR Brachytherapy treatment. | 5 Years |
| Local Disease Control | Assessed by MRI/PSMA-PET imaging at 2 years |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Peter Chung, MD | Contact | 416-946-4501 | 3374 | peter.chung@uhn.ca |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Princess Margaret Cancer Centre | Recruiting | Toronto | Ontario | M5G1Z5 | Canada |
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| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| 2 Years |
| Changes in Quality of Life | Assessed with EPIC Quality of Life scores yearly for 5 years. | 5 years |
| D005832 |
| Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |