Comparing MRI-Ultrasound Fusion and Cognitive-guided Biopsy for the Detection of csPCa: the PROFUSION Trial
Recruiting · NCT06303622 · Interventional (participants receive a specific treatment) · Lead sponsor: Chinese University of Hong Kong
View the official record on ClinicalTrials.gov →Interventions studied
Cognitive-guided approachMRI-USG fusion approach
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.
Who can take part
Age range
18 Years and older
Sex
Male
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- 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 criteria
- 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
1 location listed.
- Prince of Wales Hospital - Hong Kong, Hong Kong