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.
Conditions: Prostate Cancer
Eligibility Criteria
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
Eligibility criteria are kept as the original English records from ClinicalTrials.gov; actual eligibility is determined by the research team's formal assessment and the informed consent form. Source: ClinicalTrials.gov, updated automatically every two weeks. Last synced: 2026年10月8日.