Efficacy of MRI-guided Prostate Irreversible Electroporation (IRE) therapy; the EMPIRE-trial. - EMPIRE-trial

Sint Antonius Ziekenhuis0 个研究点目标入组 40 人开始时间: 待定最近更新: 2024年4月15日

适应症

试验速览

暂无简介。

•In order to be eligible to participate in this study, a subject must meet all of the following
•- Signed written informed consent
•- Age >40 years, and life expectancy of *10 years.
•- Serum PSA <15ng/mL.
•- Histologically proven low- to intermediate-risk PCa (i.e. Gleason *7 with max 3+4<=7).
•- Localized disease (i.e. no extracapsular extension, vesiculae seminalis invasion or suspected metastasis).
•- Stage radiological *T2cN0M0 on mp-MRI, with *1 visible and histology proven lesion(s) in the prostate (PI-RADS 3-5). Co-existing MRI-unvisible Gleason 6 disease is no exclusion
•- Prostatic lesion visible on mp-MRI, accessible for IRE with a maximum diameter of 20mm in the transversal plane.

•A potential subject who meets any of the following criteria will be excluded from participation
•in this study:
•- Patients who are unwilling to sign written informed consent
•- Patients with ASA *4
•- Patients with evidence of lesions in contact with the prostatic capsule on mpMRI.
•- Patients with evidence of metastatic or nodal disease outside the prostate on mpMRI.
•- Patients with GS >7.
•- Patient with capsular contact of tumour *6mm in the prostate.
•- Patients with previous treatment for PCa.
•- Patients with a history of radiotherapy to the pelvis.
•- Patients with a history of androgen suppression/hormonal therapy.
•- Patients unable to undergo a TRUS.
•- Patients who meet exclusion criteria for MRI following the protocol of the radiology department of the St. Antonius Hospital.
•- Patients fulfilling the exclusion criteria for the Gadovist gadolinium (Glomerular Filtration Rate (GFR) of < 30 mL/min/1.73m2.
•- Patients who underwent a transurethral resection of the prostate (TURP) or stenting of the prostate.
•- Patients with bleeding disorders or the inability to stop anticoagulant or antiplatelet therapy.
•- Patients with heart arrhythmia or an ICD or Pacemaker.

发起方