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 decrese of PSA level after surgery (\<1 ng/ml)
- measure
- Complications
- timeFrame
- 1 year
- description
- Short and long term surgical complications
Secondary outcomes (4)
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Verified with MR-fusion biopsy localized Pca * PSA \< 15 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 without rectum * patients not eligible for general anesthesia * PIRADS\<3 * 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 (2)
- BACKGROUNDRubinsky B. Irreversible electroporation in medicine. Technol Cancer Res Treat. 2007 Aug;6(4):255-60. doi: 10.1177/153303460700600401. PMID 17668932
- BACKGROUNDScheltema MJ, Chang JI, Bohm M, van den Bos W, Blazevski A, Gielchinsky I, Kalsbeek AMF, van Leeuwen PJ, Nguyen TV, de Reijke TM, Siriwardana AR, Thompson JE, de la Rosette JJ, Stricker PD. Pair-matched patient-reported quality of life and early oncological control following focal irreversible electroporation versus robot-assisted radical prostatectomy. World J Urol. 2018 Sep;36(9):1383-1389. doi: 10.1007/s00345-018-2281-z. Epub 2018 Mar 28. PMID 29594551