本研究是一項國際多中心隨機對照試驗，旨在比較認知引導與 MRI-USG 引導活檢在 MRI 有可疑病灶的男性中偵測具臨床意義前列腺癌（csPCa）的能力。
適應症：Prostate Cancer
收案條件
納入條件
- 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
排除條件
- 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
收案條件維持 ClinicalTrials.gov 原始英文登錄資料，實際收案資格以研究團隊的正式評估與受試者同意書為準。資料來源：ClinicalTrials.gov，每兩週自動更新，最後同步：2026年10月8日。