Focal Therapy for Localised Prostate Cancer Using Irreversible Electroporation (Nano)

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

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™).

Study Overview

• Status: Unknown
• Conditions: Prostate Cancer
• Intervention / Treatment: Device: Irreversible Electroporation

• Study Type: Interventional
• Enrollment (Anticipated): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • London, United Kingdom, NW1 2PG
    • University College London Hospitals

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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).

Study Plan

How is the study designed?

Design Details

• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Irreversible Electroporation	Device: Irreversible Electroporation

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Role of follow-up MRI	• Assessment of postoperative MRI value in predicting residual prostate cancer using biopsy as a reference test	Six months
Anxiety	• Change in anxiety levels as measured by significant change in the Memorial Anxiety Scale for Prostate Cancer	Up to 1 year

Collaborators and Investigators

• Sponsor: University College London Hospitals
• Investigators: Principal Investigator: Hashim U Ahmed, PhD, UCLH; Principal Investigator: Mark Emberton, Professor, UCLH

Study record dates

Study Major Dates

• Study Start: October 1, 2013
• Primary Completion (Anticipated): August 1, 2015

Study Registration Dates

• First Submitted: October 30, 2012
• First Submitted That Met QC Criteria: November 11, 2012
• First Posted (Estimate): November 15, 2012

Study Record Updates

• Last Update Posted (Estimate): June 18, 2014
• Last Update Submitted That Met QC Criteria: June 17, 2014
• Last Verified: June 1, 2014

More Information

Terms related to this study

• Keywords: Focal Therapy
• Additional Relevant MeSH Terms: Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Genital Neoplasms, Male; Prostatic Diseases; Prostatic Neoplasms
• Other Study ID Numbers: 12/0399