本研究是一項多中心隨機對照試驗，旨在比較MRI引導（MRI組）活檢與MRI+18F-PSMA引導（聯合組）活檢在MRI前列腺掃描結果不明確的男性中，對臨床顯著前列腺癌（csPCa）的檢測及／或臨床管理改變的情況。若在結果不明確的MRI中加入18F-PSMA PET能顯示額外臨床價值，則此應成為新的標準治療。
適應症：Prostate Cancer
收案條件
納入條件
- 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
排除條件
- 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)
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。