Prostate Cancer IRE Study (PRIS) (NCT05513443) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Prostate Cancer IRE Study (PRIS)
Sweden184 participantsStarted 2022-09-01
Plain-language 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.
Who can participate
Age range
40 Years
Sex
MALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Primary outcome in PRIS 1: Urinary continence
Timeframe: 12 months postoperatively
2
Primary outcome in PRIS 2: Irritative urinary symptoms