Ignite Creation Date:
2024-05-06 @ 8:15 PM
Last Modification Date:
2024-10-26 @ 3:23 PM
Study NCT ID:
NCT06303622
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-04-10
First Post:
2024-03-05
Brief Title:
Comparing MRI-Ultrasound Fusion and Cognitive-guided Biopsy for the Detection of csPCa the PROFUSION Trial
Sponsor:
Chinese University of Hong Kong
Organization:
Chinese University of Hong Kong
Study Overview
Official Title:
A Randomised Controlled Trial Comparing MRI-Ultrasound Fusion and Cognitive-guided Biopsy for the Detection of Clinically Significant Prostate Cancer the PROFUSION Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-04
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 an international multicentre RCT to compare the linically significant prostate cancer csPCa detection of cognitive-guided and MRI-USG guided biopsies in men with suspicious MRI lesion
Detailed Description:
This study is an international multicentre RCT to compare the csPCa detection of cognitive-guided and MRI-USG guided biopsies in men with suspicious MRI lesion This is a phase III randomised controlled trial to evaluate the detection of clinically significant prostate cancer csPCa by MRI-USG fusion approach MRUS arm versus Cognitive-guided approach COG arm The study hypothesis is that MRUS arm is superior to COG arm in detecting csPCa The result of this RCT would impact how MRI-guided prostate biopsies should be done in the future If the MRI-USG fusion approach is superior to cognitive-guidance in csPCa detection it should be the standard of practice in the future and dedicated MRI-USG fusion equipment should be available in centres performing prostate biopsies
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