Comparing MRI-Ultrasound Fusion and Cognitive-guided Biopsy for the Detection of csPCa: the PROFUSION Trial

Recruiting now · Not applicable

Conditions studied: Prostate Cancer

In brief

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.

Key facts

Study ID

NCT06303622

Run by

Chinese University of Hong Kong

People needed

1250

Starts

2025-01-08

Expected to finish

2027-03-31

Last updated by the study team

2026-02-17

Who can join

Age: 18 and older. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• Men ≥18 years of age
• Clinical suspicion of prostate cancer and indicated for prostate biopsy
• Serum Prostate-specific antigen (PSA) < 20 ng/mL
• Digital rectal examination ≤ cT2 (organ-confined cancer)
• Able to provide written informed consent
• MRI prostate (contrast or plain) showing 1-3 suspicious lesion(s) with PI-RADS score 3-5

You may not qualify if…

• Prior prostate biopsy in the 2 years before screening visit
• Prior diagnosis of prostate cancer
• Contraindicated to prostate biopsy: active urinary tract infection, failed insertion of transrectal ultrasound probe into rectum (abdominal perineal resection, anal stenosis), uncorrectable coagulopathy, antiplatelet or anticoagulant which cannot be stopped (continue low-dose aspirin before and after biopsy is permitted)
• Patient refusal for biopsy

Where it is running

• Prince of Wales Hospital — Hong Kong, Hong Kong (enrolling)

Full record on ClinicalTrials.gov

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