Status:
COMPLETED
Extended Systematic Versus Mri-Assisted pRostate Transperineal Biopsy
Lead Sponsor:
Chinese University of Hong Kong
Conditions:
Prostate Cancer
Eligibility:
MALE
18+ years
Phase:
NA
Brief Summary
This is a randomized controlled trial to evaluate the detection of clinically significant prostate cancer (csPCa) by MRI-targeted approach (MRI-arm) versus 24-core transperineal (TP) systematic biopsy...
Detailed Description
The current study is a randomized controlled trial using a superiority design with the subjects randomized in 1:1 manner to either MRI-arm or TP-arm. In the MRI-arm, multiparametric MRI is performed f...
Eligibility Criteria
Inclusion
- Men ≥18 years of age
- Clinical suspicion of prostate cancer and indicated for prostate biopsy
- Serum Prostate-specific antigen (PSA) 4-20 ng/mL
- Digital rectal examination ≤ cT2 (organ confined cancer)
- Able to provide written informed consent
Exclusion
- Prior prostate biopsy
- Past or current history of prostate cancer
- MRI prostate performed within past 5 years
- Contraindicated to undergo MRI scan (e.g. pacemaker in-situ, claustrophobia, estimated glomerular filtration rate \< 50ml/min in serum renal function test within 3 months)
- Contraindicated to transperineal prostate biopsy: active urinary tract infection, fail insertion of transrectal ultrasound probe into rectum (abdominal perineal resection, anal stenosis), fail to be placed in lithotomy position, uncorrectable coagulopathy, antiplatelet or anticoagulant which cannot be stopped (keep aspirin before and after biopsy is permitted)
Key Trial Info
Start Date :
May 27 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 24 2024
Estimated Enrollment :
403 Patients enrolled
Trial Details
Trial ID
NCT04685928
Start Date
May 27 2021
End Date
September 24 2024
Last Update
May 6 2025
Active Locations (8)
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1
Kwong Wah Hospital
Hong Kong, Hong Kong
2
North District Hospital
Hong Kong, Hong Kong
3
Pamela Youde Nethersole Eastern Hospital
Hong Kong, Hong Kong
4
Prince of Wales Hospital
Hong Kong, Hong Kong