Irreversible electroporation, IRE: IRE involves the use of high voltage electrical pulses to treat solid tumors by increasing membrane permeability and inducing membrane disruption, leading to cell death. The technique is used in Sweden today in radical ablative therapies in the treatment of tumors in the liver, kidney and pancreas. Prior to treatment a Foley catheter is placed. During the treatment, which takes place under anesthesia, the patient is placed in gynecological position and the tumour lesion is located with BK transrectal fusion ultrasound. Thereafter the needles are placed transperineal around the tumor in the prostate using a brachytherapy grid (17Ga Civco brachytherapy grid), guided by the ultrasound/MRI fusion images. Through the needles electrical pulses are then sent to treat the tumor in the center using the Nanoknife technique. After treatment patients are treated with diuretics to flush the kidneys post treatment.
Radical prostatectomy: Radical prostatectomy
Radiation therapy: Radiation therapy for prostate cancer
Study summary
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.
Eligibility
Sex
MALE
Min age
40 Years
Max age
—
Healthy volunteers
No
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
Primary outcome measure(s)
Primary outcome in PRIS 1: Urinary continence — 12 months postoperatively Urinary incontinence defined by Q3 in EPIC-26, ≥1 pad/day ("Yes") versus none ("No")
Primary outcome in PRIS 2: Irritative urinary symptoms — 12 months postoperatively Irritative urinary symptoms defined by Q4e in EPIC-26, Moderate/big problem ("Yes") Versus no/small problem ("No")
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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