Focal Therapy for Localised Prostate Cancer Using Irreversible Electroporation

Prostate Cancer Clinical Trial

— Nano  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01726894
• Other study ID #: 12/0399
• Status: Active, not recruiting
• Phase: N/A
• First received: October 30, 2012
• Last updated: June 17, 2014
• Start date: October 2013

Study information

• Verified date: June 2014
• Source: University College London Hospitals
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: National Institute for Health Research
• Study type: Interventional

Clinical Trial 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™).

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 20
• Est. primary completion date: August 2015
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Device:
• Irreversible Electroporation

Locations

Country	Name	City	State
United Kingdom	University College London Hospitals	London

Sponsors (1)

Lead Sponsor	Collaborator
University College London Hospitals

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Role of follow-up MRI	• Assessment of postoperative MRI value in predicting residual prostate cancer using biopsy as a reference test	Six months	No
Other	Anxiety	• Change in anxiety levels as measured by significant change in the Memorial Anxiety Scale for Prostate Cancer	Up to 1 year	No
Primary	Safety Profile	Number of patients with adverse events using the National Cancer Institute Common Terminology Criteria (NCI CTC) classification system.	Up to 1 year	Yes
Secondary	Sexual Side Effects	• Change in erectile function measured by the IIEF-15 questionnaire	Up to 1 year	Yes
Secondary	Continence side effect	• Number of patients with urinary incontinence as determined by the UCLA-EPIC urinary continence questionnaire	Up to 1 year	Yes
Secondary	Rectal side effects	• Number of patients with grade I-II-III type rectal toxicity	Up to 1 year	Yes
Secondary	Cancer Control	Number of patients having residual prostate cancer at 6 months biopsy	Six months	No