招募中 NCT07788625

F-PSMA-1007 PET-CT導向的MRI隱形前列腺癌局竈治療

前列腺癌膀胱癌/泌尿道上皮癌不適用PSMA

多參數磁共振成像( mpMRI )是前列腺癌診斷和局竈性治療規劃的標準成像方式。然而, 10-20%的臨床顯著前列腺癌( csPCa )在mpMRI上不可見( PI-RADS 1-2 )。

適應症:Prostate Cancer

收案條件

納入條件

  • Men aged ≥50 years
  • Life expectancy \>10 years
  • Histologically confirmed localized prostate cancer, ISUP Grade Group 2 or 3
  • At least one clinically significant cancer focus (≥1 systematic biopsy core with Grade Group 2-3) that is MRI-invisible, defined as:
  • \- The corresponding sextant/region on mpMRI (performed within 6 months) shows PI-RADS v2.1 score 1 or 2, or no identifiable lesion that could account for the positive biopsy
  • Total of 1-2 discrete cancer foci (MRI-visible + PET-detected MRI-invisible) on study entry, with each MRI-visible focus having maximum diameter ≤15 mm on mpMRI
  • Organ-confined disease on mpMRI and no evidence of seminal vesicle invasion or lymph node/distant metastasis
  • Serum PSA \<20 ng/mL
  • Able to provide informed consent

排除條件

  • Previous treatment for prostate cancer (radiotherapy, surgery, focal therapy, androgen deprivation)
  • Prior pelvic radiotherapy for any cause
  • Contraindication to MRI or gadolinium contrast
  • Contraindication to PSMA PET-CT (e.g. severe claustrophobia, inability to lie flat)
  • Contraindication to general or spinal anaesthesia
  • Uncorrectable coagulopathy (INR \>1.5, platelet \<50×10⁹/L) or anticoagulant/antiplatelet therapy that cannot be stopped (low-dose aspirin 80-100 mg is permitted)
  • Active urinary tract infection or acute prostatitis
  • MRI-invisible focus located in a region where focal therapy would likely cause sphincter or rectal injury, as determined by biopsy mapping and anatomical constraints
  • Bladder pathology (bladder stone, bladder cancer) or known urethral stricture

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。