Prostate Cancer IRE Study (PRIS)

Launched by KAROLINSKA INSTITUTET · Aug 23, 2022

Keywords

ClinConnect Summary

The Prostate Cancer IRE Study (PRIS) is investigating a new treatment approach for men with localized prostate cancer. This study aims to see if a method called Irreversible Electroporation (IRE) can effectively control the cancer while causing fewer side effects compared to traditional treatments like surgery or radiation. Researchers are specifically looking for men aged 40 and older who have a certain type of prostate cancer that can be seen on an MRI and meets other specific medical criteria.

To participate, men need to have a single, significant cancer lesion that isn’t too large, and their overall health must allow for a life expectancy of at least 10 years. Participants will receive detailed information about the study and its potential risks and benefits. This trial is currently recruiting eligible participants, and it's important to note that those with a history of certain health conditions or previous prostate cancer treatments may not be eligible. If you or a loved one are interested in learning more about this study, please reach out for more information.

Gender

MALE

Eligibility criteria

• 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