Focal Therapy for Localised Prostate Cancer Using Irreversible Electroporation

Study Overview
=================
Brief Summary
-----------------
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™).

Official Title
-----------------
A Prospective Development Study Evaluating Focal Therapy Using Irreversible Electroporation (Nanoknife®) in Men With Localised Prostate Cancer

Conditions
-----------------
Prostate Cancer

Intervention / Treatment
-----------------
* Device: Irreversible Electroporation


Participation Criteria
=================
Eligibility Criteria
-----------------
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).

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
Male

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Irreversible Electroporation<br> | Device: Irreversible Electroporation<br> <br> |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety Profile | Number of patients with adverse events using the National Cancer Institute Common Terminology Criteria (NCI CTC) classification system. | Up to 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sexual Side Effects | • Change in erectile function measured by the IIEF-15 questionnaire | Up to 1 year | 
| Continence side effect | • Number of patients with urinary incontinence as determined by the UCLA-EPIC urinary continence questionnaire | Up to 1 year | 
| Rectal side effects | • Number of patients with grade I-II-III type rectal toxicity | Up to 1 year | 
| Cancer Control | Number of patients having residual prostate cancer at 6 months biopsy | Six months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Focal Therapy