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

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 40

Inclusion Criteria

In order to be eligible to participate in this study, a subject must meet all of the following
criteria:
- 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.

Exclusion Criteria

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.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>- Assessment of urinary incontinence in patients with localized PCa, 24 months<br /><br>after focal IRE therapy, measured by EPIC-26 questionnaire. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>- Assessment of genito-urinary and rectal side effects in patients with<br /><br>localized PCa after focal IRE therapy, measured by IPSS-QoL, EPIC-26, IIEF-15,<br /><br>EQ-5D, EORTC-QLQ-C30&PR25, SHIM, HADS, ICIQ and WAI.<br /><br>- Assessment of disease control in patients with localized PCa after focal IRE<br /><br>therapy, measured by mp-MRI 12 months after IRE therapy, by re-biopsy after 12<br /><br>months, and by periodic PSA testing.<br /><br>- Assessment of the utilization of mp-MRI in patients with localized PCa after<br /><br>focal IRE therapy, to evaluate ablation zone periodically, by mpMRI after 12<br /><br>months.<br /><br>- Assessment of complications in patients with localized PCa after focal IRE<br /><br>therapy, measured by the Clavien-Dindo classification of surgical<br /><br>complications.</p><br>