Ignite Creation Date:
2024-05-06 @ 8:08 PM
Last Modification Date:
2024-10-26 @ 3:21 PM
Study NCT ID:
NCT06262633
Status:
RECRUITING
Last Update Posted:
2024-03-19
First Post:
2024-01-21
Brief Title:
A Multi-centre Trial on Targeted Microwave Ablation TMA for Localized Prostate Cancer
Sponsor:
Chinese University of Hong Kong
Organization:
Chinese University of Hong Kong
Study Overview
Official Title:
A Multi-centre Trial on Targeted Microwave Ablation TMA for Localized Prostate Cancer Using Organ Based Tracking OBT Navigation
Status:
RECRUITING
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study is to investigate the efficacy of Targeted Microwave Ablation TMA under MRI-Ultrasound fusion and organ-based tracking OBT navigation in localized prostate cancer PCa in a multi-centre trial
Detailed Description:
This is a prospective multi-centre trial in 5 hospitals in 3 countries to investigate the efficacy and complications of targeted Microwave Ablation as a minimally invasive focal therapy for prostate cancer Men aged 50-75 with PSA 20ngmL and clinically significant prostate cancer with 1-2 MRI lesions 15mm and ISUP grade group 3 will be recruited Transperineal targeted Microwave Ablation of the prostate tumors will be done with repeated ablations by a single microwave needle guided by MRI-Ultrasound fusion and organ-based tracking navigation The primary outcome is any clinically significant prostate cancer detected on biopsy of treated areas per patient at 6 months
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None