招募中 NCT06262633

针对局部前列腺癌的靶向微波消融(TMA)多中心试验

前列腺癌膀胱癌/尿路上皮癌不适用EGFR

本研究为多中心试验,旨在探讨在MRI-超声融合及器官追踪(OBT)导航下,以靶向微波消融(TMA)治疗局部前列腺癌(PCa)的疗效。

适应症:Prostate Cancer

入组条件

纳入标准

  • 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

排除标准

  • 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.

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。