Prostate Cancer IRE Study (PRIS) - A Randomized Controlled Trial Comparing Focal to Radical Treatment in Localized Prostate Cancer
The aim of this study is to evaluate the feasibility to treat localized prostate cancer diagnosed with MRI and targeted/systematic biopsies, with IRE in comparison with conventional radical treatments with the primary objective to locally control the tumour with a minimum of side effects.
• Age at inclusion ≥ 40 years
• MRI-visible lesion
⁃ EPE 3\* \<1.5 cubic cm3 lesion volume
• Gleason score 3 + 4 or 4 + 3 from a single MRI-visible lesion without any Gleason grade 4 in systematic biopsies outside of the target
• PSA level ≤ 20 ng/ml
• Clinical stage ≤ T2c disease
• Unifocal significant disease
• Life expectancy of ≥ 10 years
• Sufficient proficiency in the Swedish language to understand written and verbal information about the trial, its consent process and the study questionnaires
⁃ Extraprostatic extension; 5-grade Likert scale 1=