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

October 30, 2012
November 19, 2013
October 2013
April 2015   (final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01726894 on ClinicalTrials.gov Archive Site
  • 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
Same as current
  • 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
Same as current
 
Focal Therapy for Localised Prostate Cancer Using Irreversible Electroporation
A Prospective Development Study Evaluating Focal Therapy Using Irreversible Electroporation (Nanoknife®) in Men With Localised Prostate Cancer

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™).

Not Provided
Interventional
Not Provided
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Prostate Cancer
Device: Irreversible Electroporation
Experimental: Irreversible Electroporation
Intervention: Device: Irreversible Electroporation
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
20
Not Provided
April 2015   (final data collection date for primary outcome measure)

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).
Male
18 Years and older
No
Contact: Massimo Valerio, MD 0044(0)7449854071 massimo.valerio@chuv.ch
United Kingdom
 
NCT01726894
12/0399
Yes
Professor Mark Emberton, University College London Hospitals
University College London Hospitals
Not Provided
Principal Investigator: Hashim U Ahmed, PhD UCLH
Principal Investigator: Mark Emberton, Professor UCLH
University College London Hospitals
November 2013

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