NL-OMON46509
Recruiting
Not Applicable
Efficacy of MRI-guided Prostate Irreversible Electroporation (IRE) therapy; the EMPIRE-trial. - EMPIRE-trial
Overview
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Sint Antonius Ziekenhuis
- Enrollment
- 40
Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
Eligibility Criteria
- Ages
- 18 to 99 (—)
Inclusion Criteria
- •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.
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.
Investigators
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