这是一项前瞻性临床研究，招募510名有前列腺癌（PCa）风险的男性，接受尿液、血液、AI辅助超声及AI辅助MRI检查，以对临床显著前列腺癌（csPCa）的风险进行分层。（样本量计算见第5节）
适应症：Prostate Cancer
入组条件
纳入标准
- Men ≥18 years of age
- Clinical suspicion of prostate cancer
- Serum Prostate-specific antigen (PSA) 4-20 ng/mL
- Digital rectal examination ≤ cT2 (organ confined cancer)
- Able to provide written informed consent
排除标准
- Prior prostate biopsy
- Past or current history of prostate cancer
- Contraindicated to undergo plain MRI scan (e.g. pacemaker in-situ, claustrophobia)
- Contraindicated to transperineal prostate biopsy: active urinary tract infection, fail TRUS probe insertion or lithotomy position, uncorrectable coagulopathy, antiplatelet or anticoagulant which cannot be stopped
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。