本研究是一项国际多中心随机对照试验，旨在比较认知引导与 MRI-USG 引导活检在 MRI 有可疑病灶的男性中侦测具临床意义前列腺癌（csPCa）的能力。
适应症：Prostate Cancer
入组条件
纳入标准
- 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
排除标准
- 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
入组条件维持 ClinicalTrials.gov 原始英文登记资料，实际入组资格以研究团队的正式评估与受试者知情同意书为准。资料来源：ClinicalTrials.gov，每两周自动更新，最后同步：2026年10月8日。