Actively Recruiting
Comparing MRI-Ultrasound Fusion and Cognitive-guided Biopsy for the Detection of csPCa: the PROFUSION Trial
Led by Chinese University of Hong Kong · Updated on 2026-02-17
1250
Participants Needed
1
Research Sites
116 weeks
Total Duration
On this page
Sponsors
C
Chinese University of Hong Kong
Lead Sponsor
N
Nanjing Drum Tower Hospital, China
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Comparing MRI-Ultrasound Fusion and Cognitive-guided Biopsy for the Detection of csPCa: the PROFUSION Trial
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Men 18 years of age or older
- Clinical suspicion of prostate cancer and recommended for prostate biopsy
- Serum Prostate-specific antigen (PSA) less than 20 ng/mL
- Digital rectal examination showing organ-confined cancer (stage cT2 or less)
- Able to provide written informed consent
- MRI prostate (contrast or plain) showing 1 to 3 suspicious lesions with PI-RADS score 3 to 5
You will not qualify if you...
- Prior prostate biopsy within 2 years before screening visit
- Prior diagnosis of prostate cancer
- Contraindications to prostate biopsy including active urinary tract infection, failed insertion of transrectal ultrasound probe (due to abdominal perineal resection or anal stenosis), uncorrectable coagulopathy
- Use of antiplatelet or anticoagulant medications that cannot be stopped (low-dose aspirin allowed before and after biopsy)
- Patient refusal to undergo biopsy
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Prince of Wales Hospital
Hong Kong, Hong Kong
Actively Recruiting
Research Team
P
Peter Ka-Fungq CHIU, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
DIAGNOSTIC
Number of Arms
2
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