A Randomised Controlled Trial Comparing MRI-Ultrasound Fusion and Cognitive-guided Biopsy for the Detection of csPCa: 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.
- EligibilityCriteria: 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 - HealthyVolunteers: No - Gender: Male - GenderBased: Yes - GenderDescription: Male - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult