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

Who May Qualify: - 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 willing to sign a consent form - MRI prostate (contrast or plain) showing 1-3 suspicious lesion(s) with PI-RADS score 3-5 Who Should NOT Join This Trial: - 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 Always talk to your doctor about whether this trial is right for you.