EICHORCondition: Prostate Cancer · Sponsor: Karolinska Institutet
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.
This description comes directly from the study's public registry record.
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Inclusion Criteria: * 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= Exclusion Criteria: * Intraductal tumour * History of treatment for prostate cancer; surgery, radiation, chemotherapy or hormonal treatment * History of cardiac arrythmias * Pacemaker * Renal insufficiency; GFR\<30 * Severe illnesses such as concomitant cancers, severe cardio-vascular disease or dementia * Contraindications for magnetic resonance imaging (MRI) e.g. magnetic cerebral clips, cochlear implants or severe claustrophobia * History of bladder cancer * History of previous pelvic radiotherapy
Reproduced word-for-word from the public registry record — the study team can answer questions about it.
| Karolinska Institutet | Stockholm, Solna, Sweden | — |
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Source record: clinicaltrials.gov/study/NCT05513443