這是一項前瞻性臨床研究,招募510名有前列腺癌(PCa)風險的男性,接受尿液、血液、AI輔助超聲及AI輔助MRI檢查,以對臨床顯著前列腺癌(csPCa)的風險進行分層。(樣本量計算見第5節)
適應症:Prostate Cancer
收案條件
納入條件
- 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
排除條件
- 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
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。