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

This study is currently recruiting participants.
Verified November 2013 by University College London Hospitals
Sponsor:
Information provided by (Responsible Party):
Professor Mark Emberton, University College London Hospitals
ClinicalTrials.gov Identifier:
NCT01726894
First received: October 30, 2012
Last updated: November 19, 2013
Last verified: November 2013
  Purpose

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™).


Condition Intervention
Prostate Cancer
Device: Irreversible Electroporation

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Official Title: A Prospective Development Study Evaluating Focal Therapy Using Irreversible Electroporation (Nanoknife®) in Men With Localised Prostate Cancer

Resource links provided by NLM:


Further study details as provided by University College London Hospitals:

Primary Outcome Measures:
  • Safety Profile [ Time Frame: Up to 1 year ] [ Designated as safety issue: Yes ]
    Number of patients with adverse events using the National Cancer Institute Common Terminology Criteria (NCI CTC) classification system.


Secondary Outcome Measures:
  • Sexual Side Effects [ Time Frame: Up to 1 year ] [ Designated as safety issue: Yes ]
    • Change in erectile function measured by the IIEF-15 questionnaire

  • Continence side effect [ Time Frame: Up to 1 year ] [ Designated as safety issue: Yes ]
    • Number of patients with urinary incontinence as determined by the UCLA-EPIC urinary continence questionnaire

  • Rectal side effects [ Time Frame: Up to 1 year ] [ Designated as safety issue: Yes ]
    • Number of patients with grade I-II-III type rectal toxicity

  • Cancer Control [ Time Frame: Six months ] [ Designated as safety issue: No ]
    Number of patients having residual prostate cancer at 6 months biopsy


Other Outcome Measures:
  • Role of follow-up MRI [ Time Frame: Six months ] [ Designated as safety issue: No ]
    • Assessment of postoperative MRI value in predicting residual prostate cancer using biopsy as a reference test

  • Anxiety [ Time Frame: Up to 1 year ] [ Designated as safety issue: No ]
    • Change in anxiety levels as measured by significant change in the Memorial Anxiety Scale for Prostate Cancer


Estimated Enrollment: 20
Study Start Date: October 2013
Estimated Primary Completion Date: April 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Irreversible Electroporation Device: Irreversible Electroporation

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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).
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01726894

Contacts
Contact: Massimo Valerio, MD 0044(0)7449854071 massimo.valerio@chuv.ch

Locations
United Kingdom
University College London Hospitals Recruiting
London, United Kingdom, NW1 2PG
Contact: Massimo Valerio, MD       massimo.valerio@uclh.nhs.uk   
Contact: Caroline Morrice       caroline.morrice@uclh.nhs.uk   
Sponsors and Collaborators
University College London Hospitals
Investigators
Principal Investigator: Hashim U Ahmed, PhD UCLH
Principal Investigator: Mark Emberton, Professor UCLH
  More Information

No publications provided

Responsible Party: Professor Mark Emberton, Professor, University College London Hospitals
ClinicalTrials.gov Identifier: NCT01726894     History of Changes
Other Study ID Numbers: 12/0399
Study First Received: October 30, 2012
Last Updated: November 19, 2013
Health Authority: United Kingdom: National Institute for Health Research

Keywords provided by University College London Hospitals:
Focal Therapy

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases

ClinicalTrials.gov processed this record on April 16, 2014