Comparing two prostate biopsy methods for finding cancer after suspicious MRI
Compares two prostate biopsy methods in men with a suspicious MRI lesion.
Plain-language title generated from the registry record
Registry title: Comparing MRI-Ultrasound Fusion and Cognitive-guided Biopsy for the Detection of csPCa: the PROFUSION Trial
Key facts
- Where
- Hong Kong, Hong KongSee the site
Where in Hong Kong
- Prince of Wales HospitalHong Kong, Hong KongTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Chinese University of Hong Kong
- Trial code
- NCT06303622
- Record updated
- 27 October 2026
- Original description
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.Read full original descriptionShow less
A Randomised Controlled Trial Comparing MRI-Ultrasound Fusion and Cognitive-guided Biopsy for the Detection of Clinically Significant Prostate Cancer: the PROFUSION Trial
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.
Inclusion: 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.
Exclusion: 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.