NCT05513443Active, not recruiting
Prostate Cancer IRE Study (PRIS)
Prostate Cancer IRE Study (PRIS) - A Randomized Controlled Trial Comparing Focal to Radical Treatment in Localized Prostate Cancer
Source: ClinicalTrials.gov · Last updated 7 Aug 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Study type
- Interventional
- Enrollment
- 184 (estimated)
- First submitted
- 17 Aug 2022
- Start date
- 1 Sept 2022
- Primary completion date
- 1 Jun 2027
- Lead sponsor
- Karolinska Institutet
- Diseases
- Prostate cancer
- NCT number
- NCT05513443
What you commit to
- Study type: Interventional
- Planned participants: 184
- From 1 Sept 2022 to the primary completion date, 1 Jun 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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 previous pelvic radiotherapy
Other illness
- History of treatment for prostate cancer; surgery, radiation, chemotherapy or hormonal treatment
- History of cardiac arrythmias
- History of bladder cancer
Lab values
- Renal insufficiency; GFR\<30
Other
- Intraductal tumour
- Pacemaker
Who the study is looking for
- 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=
Age in the registry: 40 years to - · Sex: Male · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Karolinska Institutet Coordinator of this site? Confirm its status | Stockholm | Sweden | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.