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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01726894
Recruitment Status : Unknown
Verified June 2014 by Professor Mark Emberton, University College London Hospitals.
Recruitment status was:  Active, not recruiting
First Posted : November 15, 2012
Last Update Posted : June 18, 2014
Information provided by (Responsible Party):
Professor Mark Emberton, University College London Hospitals

Tracking Information
First Submitted Date  ICMJE October 30, 2012
First Posted Date  ICMJE November 15, 2012
Last Update Posted Date June 18, 2014
Study Start Date  ICMJE October 2013
Estimated Primary Completion Date August 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 11, 2012)
Safety Profile [ Time Frame: Up to 1 year ]
Number of patients with adverse events using the National Cancer Institute Common Terminology Criteria (NCI CTC) classification system.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 11, 2012)
  • Sexual Side Effects [ Time Frame: Up to 1 year ]
    • Change in erectile function measured by the IIEF-15 questionnaire
  • Continence side effect [ Time Frame: Up to 1 year ]
    • Number of patients with urinary incontinence as determined by the UCLA-EPIC urinary continence questionnaire
  • Rectal side effects [ Time Frame: Up to 1 year ]
    • Number of patients with grade I-II-III type rectal toxicity
  • Cancer Control [ Time Frame: Six months ]
    Number of patients having residual prostate cancer at 6 months biopsy
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: November 11, 2012)
  • Role of follow-up MRI [ Time Frame: Six months ]
    • Assessment of postoperative MRI value in predicting residual prostate cancer using biopsy as a reference test
  • Anxiety [ Time Frame: Up to 1 year ]
    • Change in anxiety levels as measured by significant change in the Memorial Anxiety Scale for Prostate Cancer
Original Other Pre-specified Outcome Measures Same as current
Descriptive Information
Brief Title  ICMJE Focal Therapy for Localised Prostate Cancer Using Irreversible Electroporation
Official Title  ICMJE A Prospective Development Study Evaluating Focal Therapy Using Irreversible Electroporation (Nanoknife®) in Men With Localised Prostate Cancer
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 Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Condition  ICMJE Prostate Cancer
Intervention  ICMJE Device: Irreversible Electroporation
Study Arms  ICMJE Experimental: Irreversible Electroporation
Intervention: Device: Irreversible Electroporation
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: November 11, 2012)
Original Estimated Enrollment  ICMJE Same as current
Study Completion Date  ICMJE Not Provided
Estimated Primary Completion Date August 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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).
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United Kingdom
Removed Location Countries  
Administrative Information
NCT Number  ICMJE NCT01726894
Other Study ID Numbers  ICMJE 12/0399
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Professor Mark Emberton, University College London Hospitals
Study Sponsor  ICMJE University College London Hospitals
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Hashim U Ahmed, PhD UCLH
Principal Investigator: Mark Emberton, Professor UCLH
PRS Account University College London Hospitals
Verification Date June 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP