Clinical trial · Interventional
Prostate Cancer IRE Study (PRIS)
Prostate Cancer IRE Study (PRIS) - A Randomized Controlled Trial Comparing Focal to Radical Treatment in Localized Prostate Cancer
NCT05513443CI-TRIAL-00121072PRISactive not recruitingN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Irreversible electroporation, IRE | Procedure | — | UNRESOLVED |
| Radiation therapy | Radiation | — | UNRESOLVED |
| Radical prostatectomy | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (4)
- type
- EXPERIMENTAL
- label
- PRIS 1, arm 1
- description
- Men randomized to the experimental arms will be offered focal treatment of prostate cancer with IRE technology. IRE stands for "irreversible electroporation" and involves the use of high voltage electrical pulses to treat solid tumors by increasing membrane permeability and inducing membrane disruption, leading to cell death.
- interventionNames
- Procedure: Irreversible electroporation, IRE
- type
- ACTIVE_COMPARATOR
- label
- PRIS 1, arm 2
- description
- Men eligible for radical prostatectomy and randomized to the control arm will undergo radical prostatectomy in line with national guidelines.
- interventionNames
- Procedure: Radical prostatectomy
- type
- EXPERIMENTAL
- label
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 40 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.