Clinical trial · Interventional
Efficacy and Safety Assessment of IRE of Localized Prostate Cancer
Efficacy and Safety Assessment of Nanoknife (AngyoDynamics, USA) for Irreversible Electroporation (IRE) of Localized Prostate Cancer
- 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 purpose of this study is to evaluate safety and short-term oncological efficacy of the NanoKnife Irreversible Electroporation System for localised prostate cancer. Irreversible electroporation (IRE) is the method of focal treatment for prostate cancer, which is already proven by FDA as method of the surgical ablation of soft tissue. It has not received clearance for the therapy or treatment of any specific disease or condition.
Conditions
Conditions (2)
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 Adenocarcinoma | Prostate Adenocarcinoma | ONTOLOGY_EXACT | 0.98 |
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Focal irreversible electroporation of the prostate cancer | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- IRE patients
- description
- patients who will underwent 'Focal irreversible electroporation of the prostate cancer'
- interventionNames
- Device: Focal irreversible electroporation of the prostate cancer
Primary outcomes (2)
- measure
- PSA level
- timeFrame
- 3 months, 6 months, 9 months, 12 months
- description
- Stable decrease of PSA level after surgery (\<1 ng/ml)
- measure
- Complications
- timeFrame
- 1 year
- description
- Short and long term surgical complications according to Clavien-Dindo
Secondary outcomes (4)
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 40 Years
- Maximum age
- 85 Years
Show eligibility criteria text
Inclusion Criteria: * Verified with MR-fusion biopsy localized Pca * PSA \< 20 ng/ml * Gleason score 3+3=6; 3+4=7 OR Grade Group 1 and 2 * Life expectancy \> 10 years * No post-void residual urine or infravesical obstruction Exclusion Criteria: * patients with artificial cardiac pacemaker * patients not eligible for general anesthesia * patients after primary Pca treatment * hormonal therapy six months before the study * radiotherapy of pelvic organs * urinary infection * extracapsular Pca * patients with metastatic lesions
References
Publications (0)
Data not yet available