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

18 Years
Not Enrolling
Prostate Cancer

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Trial Information

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

Inclusion Criteria:

- Histologically proven prostate cancer, Gleason Score
- 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
- 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

- 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).

Type of Study:


Study Design:

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

Outcome Measure:

Safety Profile

Outcome Description:

Number of patients with adverse events using the National Cancer Institute Common Terminology Criteria (NCI CTC) classification system.

Outcome Time Frame:

Up to 1 year

Safety Issue:


Principal Investigator

Hashim U Ahmed, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:



United Kingdom: National Health Service

Study ID:




Start Date:

January 2013

Completion Date:

Related Keywords:

  • Prostate Cancer
  • Focal Therapy
  • Prostatic Neoplasms