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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Professor Mark Emberton, University College London Hospitals
ClinicalTrials.gov Identifier:
NCT01726894
First received: October 30, 2012
Last updated: June 17, 2014
Last verified: June 2014
  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: August 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01726894

Locations
United Kingdom
University College London Hospitals
London, United Kingdom, NW1 2PG
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: June 17, 2014
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 July 24, 2014