Ignite Creation Date:
2024-10-26 @ 3:35 PM
Last Modification Date:
2024-10-26 @ 3:35 PM
Study NCT ID:
NCT06508567
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-03-15
Brief Title:
Salvage MR-guided High-Dose-Rate Brachytherapy for Prostate Bed Recurrence After Radiotherapy in the PSMA PET Scan Era
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Salvage MR-guided High-Dose-Rate Brachytherapy for Prostate Bed Recurrence After Radiotherapy in the PSMA PET Scan Era
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SHAPE-PSMA
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 GTVHDR delineation based on MRI-guided and PSMA PET biopsy data as applicable
Follow-Up after treatment 60 months PSA CTCAE v50 MRI pelvis - PSMA-PET scan optional at 24 months
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 GTVHDR delineation based on MRI-guided and PSMA PET biopsy data as applicable
Follow-Up after treatment 60 months PSA CTCAE v50 MRI pelvis - PSMA-PET scan optional at 24 months
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None