本研究是一项多中心随机对照试验，旨在比较MRI引导（MRI组）活检与MRI+18F-PSMA引导（联合组）活检在MRI前列腺扫描结果不明确的男性中，对临床显著前列腺癌（csPCa）的检测及／或临床管理改变的情况。若在结果不明确的MRI中加入18F-PSMA PET能显示额外临床价值，则此应成为新的标准治疗。
适应症：Prostate Cancer
入组条件
纳入标准
- Men ≥18 years of age
- Serum Prostate-specific antigen (PSA) 4-15 ng/mL, repeated at least once
- Prostate mpMRI done within 6 months
- MRI prostate with PI-RADS (11) scores of:
- PI-RADS score 2 with red flag (PSA density \>0.2 OR Prostate health index, PHI\>35),
- PI-RADS 3, OR
- PI-RADS 4 with lower csPCa risks (PSAd \<0.1 OR PHI\<35)
- Normal Digital rectal examination
- Patient agrees for targeted and systematic prostate biopsy
排除标准
- Prostate biopsy within past 5 years
- Past or current history of prostate cancer
- Contraindicated to undergo PSMA PET-CT scan
- Contraindicated to prostate biopsy: active urinary tract infection, fail insertion of transrectal ultrasound probe into rectum (abdominal perineal resection, anal stenosis), fail to be placed in lithotomy position, uncorrectable coagulopathy, antiplatelet or anticoagulant which cannot be stopped (keep aspirin before and after biopsy is permitted)
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。