<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT01726894</url>
  </required_header>
  <id_info>
    <org_study_id>12/0399</org_study_id>
    <nct_id>NCT01726894</nct_id>
  </id_info>
  <brief_title>Focal Therapy for Localised Prostate Cancer Using Irreversible Electroporation</brief_title>
  <acronym>Nano</acronym>
  <official_title>A Prospective Development Study Evaluating Focal Therapy Using Irreversible Electroporation (Nanoknife®) in Men With Localised Prostate Cancer</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University College London Hospitals</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University College London Hospitals</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      To determine the adverse events and genito-urinary side-effect profile of focal therapy to&#xD;
      treat localised low to intermediate risk prostate cancer using irreversible electroporation&#xD;
      (Nanoknife™).&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Active, not recruiting</last_known_status>
  <start_date>October 2013</start_date>
  <primary_completion_date type="Anticipated">August 2015</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Safety Profile</measure>
    <time_frame>Up to 1 year</time_frame>
    <description>Number of patients with adverse events using the National Cancer Institute Common Terminology Criteria (NCI CTC) classification system.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Sexual Side Effects</measure>
    <time_frame>Up to 1 year</time_frame>
    <description>• Change in erectile function measured by the IIEF-15 questionnaire</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Continence side effect</measure>
    <time_frame>Up to 1 year</time_frame>
    <description>• Number of patients with urinary incontinence as determined by the UCLA-EPIC urinary continence questionnaire</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Rectal side effects</measure>
    <time_frame>Up to 1 year</time_frame>
    <description>• Number of patients with grade I-II-III type rectal toxicity</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cancer Control</measure>
    <time_frame>Six months</time_frame>
    <description>Number of patients having residual prostate cancer at 6 months biopsy</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Role of follow-up MRI</measure>
    <time_frame>Six months</time_frame>
    <description>• Assessment of postoperative MRI value in predicting residual prostate cancer using biopsy as a reference test</description>
  </other_outcome>
  <other_outcome>
    <measure>Anxiety</measure>
    <time_frame>Up to 1 year</time_frame>
    <description>• Change in anxiety levels as measured by significant change in the Memorial Anxiety Scale for Prostate Cancer</description>
  </other_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">20</enrollment>
  <condition>Prostate Cancer</condition>
  <arm_group>
    <arm_group_label>Irreversible Electroporation</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Irreversible Electroporation</intervention_name>
    <arm_group_label>Irreversible Electroporation</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Histologically proven prostate cancer, Gleason Score &lt;/=7&#xD;
&#xD;
          -  An anterior visible lesion on mpMRI, that is accessible to IRE treatment&#xD;
&#xD;
          -  Transperineal prostate biopsies (template mapping and/or limited targeted) correlating&#xD;
             with clinically significant lesion in the area of the MR-visible lesion (within 2&#xD;
             Barzell zones)&#xD;
&#xD;
          -  Absence of clinically significant disease outside of the planned treatment zone, from&#xD;
             histopathology and/or mpMRI findings&#xD;
&#xD;
          -  Stage radiologicalT1-T2cN0M0 disease, as determined by local guidelines&#xD;
&#xD;
          -  Serum PSA &lt;/=15 ng/ml&#xD;
&#xD;
          -  Life expectancy of &gt;/= 10 years&#xD;
&#xD;
          -  Signed informed consent by patient&#xD;
&#xD;
          -  An understanding of the English language sufficient to understand written and verbal&#xD;
             information about the trial and consent process&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Men who have had previous radiation therapy&#xD;
&#xD;
          -  Men who have had androgen suppression/hormone treatment within the previous 12 months&#xD;
             for their prostate cancer&#xD;
&#xD;
          -  Men with evidence of metastatic disease or nodal disease outside the prostate on bone&#xD;
             scan or cross-sectional imaging&#xD;
&#xD;
          -  Men with a non-visible tumour on mpMRI&#xD;
&#xD;
          -  Men with an inability to tolerate a transrectal ultrasound&#xD;
&#xD;
          -  Men with latex allergies&#xD;
&#xD;
          -  Men who have undergone prior significant rectal surgery preventing insertion of the&#xD;
             TRUS probe (decided on the type of surgery in individual cases)&#xD;
&#xD;
          -  Men who have had previous IRE, HIFU, cryosurgery, thermal or microwave therapy to the&#xD;
             prostate.&#xD;
&#xD;
          -  Men who have undergone a Transurethral Resection of the Prostate (TURP) for&#xD;
             symptomatic lower urinary tract symptoms within 6 months. These patients may be&#xD;
             included within the trial if deferred from consenting and screening until at least 6&#xD;
             months following the TURP.&#xD;
&#xD;
          -  Men not fit for major surgery as assessed by a Consultant Anaesthetist&#xD;
&#xD;
          -  Men unable to have pelvic MRI scanning (severe claustrophobia, permanent cardiac&#xD;
             pacemaker, metallic implant etc likely to contribute significant artefact to images)&#xD;
&#xD;
          -  Presence of metal implants/stents in the urethra&#xD;
&#xD;
          -  Men with renal impairment with a GFR of &lt;35ml/min (unable to tolerate Gadolinium&#xD;
             dynamic contrast enhanced MRI).&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Hashim U Ahmed, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>UCLH</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Mark Emberton, Professor</last_name>
    <role>Principal Investigator</role>
    <affiliation>UCLH</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University College London Hospitals</name>
      <address>
        <city>London</city>
        <zip>NW1 2PG</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <verification_date>June 2014</verification_date>
  <study_first_submitted>October 30, 2012</study_first_submitted>
  <study_first_submitted_qc>November 11, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 15, 2012</study_first_posted>
  <last_update_submitted>June 17, 2014</last_update_submitted>
  <last_update_submitted_qc>June 17, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">June 18, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University College London Hospitals</investigator_affiliation>
    <investigator_full_name>Professor Mark Emberton</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <keyword>Focal Therapy</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Prostatic Neoplasms</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT01726894
org study id: 12/0399
nct id: NCT01726894
lead sponsor: 
has dmc: Yes
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™).
allocation: N/A
intervention model: Single Group Assignment
masking: None (Open Label)
measure: Safety Profile
time frame: Up to 1 year
description: Number of patients with adverse events using the National Cancer Institute Common Terminology Criteria (NCI CTC) classification system.
measure: Sexual Side Effects
time frame: Up to 1 year
description: • Change in erectile function measured by the IIEF-15 questionnaire
measure: Continence side effect
time frame: Up to 1 year
description: • Number of patients with urinary incontinence as determined by the UCLA-EPIC urinary continence questionnaire
measure: Rectal side effects
time frame: Up to 1 year
description: • Number of patients with grade I-II-III type rectal toxicity
measure: Cancer Control
time frame: Six months
description: Number of patients having residual prostate cancer at 6 months biopsy
measure: Role of follow-up MRI
time frame: Six months
description: • Assessment of postoperative MRI value in predicting residual prostate cancer using biopsy as a reference test
measure: Anxiety
time frame: Up to 1 year
description: • Change in anxiety levels as measured by significant change in the Memorial Anxiety Scale for Prostate Cancer
arm group label: Irreversible Electroporation
arm group type: Experimental
intervention type: Device
intervention name: Irreversible Electroporation
arm group label: Irreversible Electroporation
criteria: 
gender: Male
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Hashim U Ahmed, PhD
role: Principal Investigator
affiliation: UCLH
last name: Mark Emberton, Professor
role: Principal Investigator
affiliation: UCLH
facility: 
country: United Kingdom
responsible party type: Principal Investigator
investigator affiliation: University College London Hospitals
investigator full name: Professor Mark Emberton
investigator title: Professor
mesh term: Prostatic Neoplasms