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Trial Title:
Salvage MR-guided High-Dose-Rate Brachytherapy for Prostate Bed Recurrence After Radiotherapy in the PSMA PET Scan Era
NCT ID:
NCT06508567
Condition:
Prostate Cancer Recurrent
Prostate Cancer
Conditions: Official terms:
Prostatic Neoplasms
Recurrence
Study type:
Interventional
Study phase:
N/A
Overall status:
Not yet recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Radiation
Intervention name:
High Dose Rate Brachytherapy
Description:
2 fractions of MRI-guided HDR Brachytherapy (13Gy each) delivered over 14 days (± 7
days).
Arm group label:
2xHDR Brachytherapy
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)
Criteria for eligibility:
Criteria:
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 < 6 months
5. ECOG 0-2
6. Age > 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
Gender:
Male
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Start date:
August 2024
Completion date:
March 1, 2031
Lead sponsor:
Agency:
University Health Network, Toronto
Agency class:
Other
Source:
University Health Network, Toronto
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06508567
