招募中 NCT06262633

針對局部前列腺癌的標靶微波消融(TMA)多中心試驗

前列腺癌膀胱癌/泌尿道上皮癌不適用EGFR

本研究為多中心試驗,旨在探討在MRI-超聲融合及器官追蹤(OBT)導航下,以標靶微波消融(TMA)治療局部前列腺癌(PCa)的療效。

適應症:Prostate Cancer

收案條件

納入條件

  • Men aged between 45 - 75 years
  • Life expectancy \> 10 years upon recruitment
  • Able to understand the trial and can provide informed and written consent, dated and signed before the enrollment and before any exam required by the trial
  • Localized low or intermediate risk prostate cancer diagnosed on MRI-Ultrasound fusion targeted biopsy
  • Organ-confined prostate cancer on MRI
  • PSA \< 20 ng/mL
  • MRI visible lesion present and size ≤15mm, with targeted biopsy showing:
  • ISUP grade group 2 or 3, or
  • ISUP grade group 1 with tumor size ≥10mm

排除條件

  • Patients not fit for general or spinal anaesthesia
  • Patients unfit for MRI exam or MR gadolinium contrast (e.g. estimated glomerular filtration rate (eGFR) of \<50 ml/min)
  • Patients with coagulopathy that cannot be corrected
  • Patients on anticoagulants or antiplatelets that cannot be stopped (Low dose Aspirin, e.g. 80-100mg, is acceptable and no need to stop before or during TMA treatment)
  • Patients with previous treatment of prostate cancer
  • Patients with prior pelvic radiotherapy for prostate cancer or other cancer
  • Patients with maximal length of target lesion \>15mm
  • Patients with MRI-visible or invisible lesion within 10mm from rectum or 10mm from sphincter on MRI
  • Patients with \>2 areas (MRI-visible or invisible) of prostate cancer
  • Patients with Gleason score 4+4 or any Gleason pattern 5 cancer
  • Patients with systematic cores showing any Gleason 4 pattern PCa which are not adjacent to the target lesions (1 core of pure Gleason 3 pattern PCa on systematic cores in contralateral lobe is acceptable)
  • Patients with definite cT3 or above disease on imaging (prostate capsular contact without definite extra-capsular extension is acceptable)
  • Patients with bladder pathology including bladder stone and bladder cancer
  • Patients with known urethral stricture
  • Patient with a suspected COVID-19 disease or an active SARS-CoV-2 infection.

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。