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。