Focal Therapy for Localised Prostate Cancer Using Irreversible Electroporation

Not Applicable

• Conditions: Prostate Cancer

• Registration Number: NCT01726894
• Lead Sponsor: University College London Hospitals

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™).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-10-30
• Study First Submitted QC: 2012-11-11
• Study First Posted: 2012-11-15
• Study Start: 2013-10
• Status Verified: 2014-06
• Last Update Submitted: 2014-06-17
• Last Update Posted: 2014-06-18
• Primary Completion: 2015-08

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Male
• Target Recruitment: 20

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Safety Profile	Up to 1 year	Number of patients with adverse events using the National Cancer Institute Common Terminology Criteria (NCI CTC) classification system.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

University College London Hospitals; 🇬🇧 London, United Kingdom