<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/NCT02200809</url>
  </required_header>
  <id_info>
    <org_study_id>2010/185</org_study_id>
    <nct_id>NCT02200809</nct_id>
  </id_info>
  <brief_title>MR-guided Focal Laser Ablation of the Prostate</brief_title>
  <official_title>MR-guided Focal Laser Ablation of the Prostate</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Radboud University Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Canisius-Wilhelmina Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Ziekenhuisgroep Twente</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Radboud University Medical Center</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Purpose of the investigators study is to determine the short and medium term histological&#xD;
      cancer control of focal therapy using MR-guided focal laser ablation therapy in the treatment&#xD;
      of localised prostate cancer.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 2014</start_date>
  <completion_date type="Actual">December 2019</completion_date>
  <primary_completion_date type="Actual">December 2019</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>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Disease free survival</measure>
    <time_frame>36 months.</time_frame>
    <description>The short and medium term histological cancer control defined as the percentage of patients with disease free survival according to the pathological MR-guided biopsy results after 36 months.</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">20</enrollment>
  <condition>Prostate Cancer</condition>
  <condition>MRI</condition>
  <condition>Focal Laser Ablation</condition>
  <arm_group>
    <arm_group_label>MR-guided focal laser ablation</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>MR-guided focal laser ablation</intervention_name>
    <arm_group_label>MR-guided focal laser ablation</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Newly diagnosed and biopsy proven prostate cancer&#xD;
&#xD;
          -  Intermediate risk patients (PSA &lt;= 20 ng/mL, Gleason ≤ 7, T2b)&#xD;
&#xD;
          -  No previous treatment for prostate cancer&#xD;
&#xD;
          -  Cancer lesion located at least 1 cm away from the neurovascular bundle according to&#xD;
             Multimodality MR images&#xD;
&#xD;
          -  Signed informed consent by patient&#xD;
&#xD;
          -  Age 18 years or older&#xD;
&#xD;
          -  Signed screening form (to determine exclusion for metal device/foreign&#xD;
             bodies/claustrophobia)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Impossibility to obtain a valid informed consent&#xD;
&#xD;
          -  Patients unable to undergo MR imaging, including those with contra-indications&#xD;
&#xD;
          -  Contra-indications to MR guided focal laser therapy (colitis ulcerosa, rectal&#xD;
             pathology or abdomino perineal resection)&#xD;
&#xD;
          -  Metallic hip implant or any other metallic implant or device that distorts local&#xD;
             magnetic field and compromises the quality of MR imaging&#xD;
&#xD;
          -  Patients with evidence for nodal or metastatic disease&#xD;
&#xD;
          -  Patients with an estimated Glomerular Filtration Ratio (eGFR) &lt; 40 mL/min/1.73 m2&#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>Jurgen Futterer, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Radboud University Nijmegen Medical Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Radboud University Medical Center</name>
      <address>
        <city>Nijmegen</city>
        <state>Gelderland</state>
        <zip>6500 HB</zip>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Canisius Wilhelmina Hospital</name>
      <address>
        <city>Nijmegen</city>
        <state>Gelderland</state>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ziekenhuisgroep Twente</name>
      <address>
        <city>Hengelo</city>
        <state>Overijssel</state>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Netherlands</country>
  </location_countries>
  <verification_date>April 2018</verification_date>
  <study_first_submitted>July 21, 2014</study_first_submitted>
  <study_first_submitted_qc>July 24, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 25, 2014</study_first_posted>
  <last_update_submitted>April 23, 2020</last_update_submitted>
  <last_update_submitted_qc>April 23, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">April 24, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>MR-guided therapy</keyword>
  <keyword>Focal laser ablation</keyword>
  <keyword>Prostate cancer</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/NCT02200809
org study id: 2010/185
nct id: NCT02200809
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
Purpose of the investigators study is to determine the short and medium term histological
      cancer control of focal therapy using MR-guided focal laser ablation therapy in the treatment
      of localised prostate cancer.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Disease free survival
time frame: 36 months.
description: The short and medium term histological cancer control defined as the percentage of patients with disease free survival according to the pathological MR-guided biopsy results after 36 months.
arm group label: MR-guided focal laser ablation
arm group type: Experimental
intervention type: Device
intervention name: MR-guided focal laser ablation
arm group label: MR-guided focal laser ablation
criteria: 
gender: Male
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Jurgen Futterer, MD, PhD
role: Principal Investigator
affiliation: Radboud University Nijmegen Medical Center
facility: 
facility: 
facility: 
country: Netherlands
responsible party type: Sponsor
mesh term: Prostatic Neoplasms