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Prostate Cancer IRE Study (PRIS)

RECRUITINGN/ASponsored by Karolinska Institutet
Actively Recruiting
PhaseN/A
SponsorKarolinska Institutet
Started2022-09-01
Est. completion2026-02-01
Eligibility
Age40 Years+
SexMALE
Healthy vol.Accepted

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

Age: 40 Years+Sex: MALEHealthy volunteers accepted
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

Conditions2

CancerProstate Cancer

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