Prostate Cancer, Prostate Cancer Recurrent
Conditions
Brief 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)
Interventions
RADIATIONHigh Dose Rate Brachytherapy
2 fractions of MRI-guided HDR Brachytherapy (13Gy each) delivered over 14 days (± 7 days).
Sponsors
University Health Network, Toronto
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Biochemical Control assessed by PSA | 5 Years | Determine the number of patients demonstrating biochemical control of PSA following salvage HDR Brachytherapy treatment. |
| Local Disease Control | 2 Years | Assessed by MRI/PSMA-PET imaging at 2 years |
| Changes in Quality of Life | 5 years | Assessed with EPIC Quality of Life scores yearly for 5 years. |
Countries
Canada
Contacts
CONTACTPeter Chung, MD
Outcome results
None listed