Clinical trial · Interventional
Focal Therapy for Localised Prostate Cancer Using Irreversible Electroporation
A Prospective Development Study Evaluating Focal Therapy Using Irreversible Electroporation (Nanoknife®) in Men With Localised Prostate Cancer
NCT01726894CI-TRIAL-00014863NanounknownN/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)
To determine the adverse events and genito-urinary side-effect profile of focal therapy to treat localised low to intermediate risk prostate cancer using irreversible electroporation (Nanoknife™).
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 (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Irreversible Electroporation | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Irreversible Electroporation
- interventionNames
- Device: Irreversible Electroporation
Primary outcomes (1)
- measure
- Safety Profile
- timeFrame
- Up to 1 year
- description
- Number of patients with adverse events using the National Cancer Institute Common Terminology Criteria (NCI CTC) classification system.
Secondary outcomes (4)
- measure
- Sexual Side Effects
- timeFrame
- Up to 1 year
- description
- • Change in erectile function measured by the IIEF-15 questionnaire
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically proven prostate cancer, Gleason Score \</=7 * An anterior visible lesion on mpMRI, that is accessible to IRE treatment * Transperineal prostate biopsies (template mapping and/or limited targeted) correlating with clinically significant lesion in the area of the MR-visible lesion (within 2 Barzell zones) * Absence of clinically significant disease outside of the planned treatment zone, from histopathology and/or mpMRI findings * Stage radiologicalT1-T2cN0M0 disease, as determined by local guidelines * Serum PSA \</=15 ng/ml * Life expectancy of \>/= 10 years * Signed informed consent by patient * An understanding of the English language sufficient to understand written and verbal information about the trial and consent process Exclusion Criteria: * Men who have had previous radiation therapy * Men who have had androgen suppression/hormone treatment within the previous 12 months for their prostate cancer * Men with evidence of metastatic disease or nodal disease outside the prostate on bone scan or cross-sectional imaging * Men with a non-visible tumour on mpMRI * Men with an inability to tolerate a transrectal ultrasound * Men with latex allergies * Men who have undergone prior significant rectal surgery preventing insertion of the TRUS probe (decided on the type of surgery in individual cases) * Men who have had previous IRE, HIFU, cryosurgery, thermal or microwave therapy to the prostate. * Men who have undergone a Transurethral Resection of the Prostate (TURP) for symptomatic lower urinary tract symptoms within 6 months. These patients may be included within the trial if deferred from consenting and screening until at least 6 months following the TURP. * Men not fit for major surgery as assessed by a Consultant Anaesthetist * Men unable to have pelvic MRI scanning (severe claustrophobia, permanent cardiac pacemaker, metallic implant etc likely to contribute significant artefact to images) * Presence of metal implants/stents in the urethra * Men with renal impairment with a GFR of \<35ml/min (unable to tolerate Gadolinium dynamic contrast enhanced MRI).
References
Publications (0)
Data not yet available
No reference posted for this study.