<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/NCT03023345</url>
  </required_header>
  <id_info>
    <org_study_id>P160301</org_study_id>
    <nct_id>NCT03023345</nct_id>
  </id_info>
  <brief_title>Trans-rectal Focal Microwave Ablation of the Index Tumor in Patients With Low-risk Prostate Cancer</brief_title>
  <acronym>FOSTINE</acronym>
  <official_title>Evaluation of the Feasibility and Tolerance of Trans-rectal Focal Microwave Ablation of the Index Tumor in Patients With Low-risk Prostate Cancer</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Assistance Publique - Hôpitaux de Paris</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Assistance Publique - Hôpitaux de Paris</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to determine if trans-rectal microwave ablation of the index&#xD;
      tumor of patients with low-risk prostate cancer is sufficiently precise and safe, using&#xD;
      MRI-transrectal ultrasound image registration.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      In men with low-risk prostate cancer, European and American guidelines recommend either&#xD;
      active surveillance or whole-gland treatments, with significant induced morbidity and burden&#xD;
      on quality of life. Focal treatments of the index tumor are currently under investigation to&#xD;
      decrease morbidity while proposing active treatment.&#xD;
&#xD;
      The purpose of this study is to determine the feasibility, precision and safety of a novel&#xD;
      ablation treatment using microwaves, delivered transrectally under real-time guidance with&#xD;
      MRI-transrectal ultrasound image registration. The index tumor will be detected with prostate&#xD;
      MRI and characterized with targeted biopsies using MRI-transrectal ultrasound image&#xD;
      registration. It will then be ablated with microwaves using the same transrectal approach and&#xD;
      guidance system (KOELIS).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 12, 2017</start_date>
  <completion_date type="Actual">April 23, 2019</completion_date>
  <primary_completion_date type="Actual">November 5, 2018</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>Complete necrosis of the index tumor on prostate MRI</measure>
    <time_frame>7 days</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Margins of necrosis around the index tumor on prostate MRI</measure>
    <time_frame>7 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Erectile and Ejaculatory function using the International Index Erectile Function (IIEF) self questionnaire</measure>
    <time_frame>7 days</time_frame>
    <description>to assess sexual tolerance</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Erectile and Ejaculatory function using the International Index Erectile Function (IIEF) self questionnaire</measure>
    <time_frame>1 month</time_frame>
    <description>to assess sexual tolerance</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Erectile and Ejaculatory function using the International Index Erectile Function (IIEF) self questionnaire</measure>
    <time_frame>3 months</time_frame>
    <description>to assess sexual tolerance</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Erectile and Ejaculatory function using the International Index Erectile Function (IIEF) self questionnaire</measure>
    <time_frame>6 months</time_frame>
    <description>to assess sexual tolerance</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Urinary symptoms using IPSS</measure>
    <time_frame>7 days</time_frame>
    <description>to assess urinary tolerance</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Urinary symptoms using IPSS</measure>
    <time_frame>1 month</time_frame>
    <description>to assess urinary tolerance</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Urinary symptoms using IPSS</measure>
    <time_frame>3 months</time_frame>
    <description>to assess urinary tolerance</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Urinary symptoms using IPSS</measure>
    <time_frame>6 months</time_frame>
    <description>to assess urinary tolerance</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of cancer on targeted biopsies within the treated volume</measure>
    <time_frame>6 months</time_frame>
    <description>to assess oncological efficacy</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">11</enrollment>
  <condition>Low-Risk Prostate Cancer</condition>
  <arm_group>
    <arm_group_label>Microwave</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Microwave trans rectal focal treatment</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Microwave trans rectal focal treatment</intervention_name>
    <description>Microwave trans-rectal ablation of the prostatic index tumor using MRI-transrectal ultrasound image registration</description>
    <arm_group_label>Microwave</arm_group_label>
    <other_name>Microwave thermal ablation system called TATO (Biomedical)</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients aged from 45 to 76 years old ;&#xD;
&#xD;
          -  Life expectancy above 10 years ;&#xD;
&#xD;
          -  Diagnosis of prostate cancer confirmed on prostate biopsies ;&#xD;
&#xD;
          -  Low risk of progression, defined with D'Amico criteria :&#xD;
&#xD;
               -  T1c or T2a stage&#xD;
&#xD;
               -  Maximum Gleason score of 3+4, including targeted biopsies corresponding to less&#xD;
                  than 50% grade 4 for the tumor&#xD;
&#xD;
               -  Prostate Specific Antigen &lt;15 ng/mL&#xD;
&#xD;
          -  Detection of the index tumor with prostate MRI, characterized with targeted biopsies&#xD;
             using MRI-transrectal ultrasound image registration ;&#xD;
&#xD;
          -  Patient accepting to be followed after the procedure using active surveillance&#xD;
             protocol standards ;&#xD;
&#xD;
          -  Patient affiliated to national health care insurance ;&#xD;
&#xD;
          -  Free consent, informed and written, dated and signed by the patient and the&#xD;
             investigator before enrollment.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Medical past history of prostatic surgery ;&#xD;
&#xD;
          -  Medical past history of radiotherapy or pelvic trauma ;&#xD;
&#xD;
          -  Medical past history of acute or chronic prostatitis&#xD;
&#xD;
          -  severe BPH-related urinary tract symptoms defined as an IPSS &gt;18 ;&#xD;
&#xD;
          -  Extra-capsular extension or seminal vesicle invasion on prostate MRI.&#xD;
&#xD;
          -  Tumor involvement &gt; 3 mm on systematic biopsies outside the tumor volume detected on&#xD;
             MRI.&#xD;
&#xD;
          -  Tumor largest axis &gt; 20 mm on prostate MRI ;&#xD;
&#xD;
          -  Distance of less than 5 mm between the tumor and the rectum&#xD;
&#xD;
          -  Patient unable to understand the course of the study&#xD;
&#xD;
          -  History of allergy or non-tolerance to gadolinium salts used in MRI&#xD;
&#xD;
          -  Patient with a contraindication to performing an MRI&#xD;
&#xD;
          -  Person placed under safeguard of justice&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>45 Years</minimum_age>
    <maximum_age>76 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Nicolas BARRY DELONGCHAMPS, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Assistance Publique - Hôpitaux de Paris</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Assistance Publique - Hôpitaux de Paris</name>
      <address>
        <city>Paris</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>July 2021</verification_date>
  <study_first_submitted>January 13, 2017</study_first_submitted>
  <study_first_submitted_qc>January 13, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 18, 2017</study_first_posted>
  <last_update_submitted>July 31, 2021</last_update_submitted>
  <last_update_submitted_qc>July 31, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">August 3, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>cancer</keyword>
  <keyword>prostate</keyword>
  <keyword>PSA</keyword>
  <keyword>biopsies</keyword>
  <keyword>microwave trans rectal focal treatment</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Prostatic Neoplasms</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT03023345
org study id: P160301
nct id: NCT03023345
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
The purpose of this study is to determine if trans-rectal microwave ablation of the index
      tumor of patients with low-risk prostate cancer is sufficiently precise and safe, using
      MRI-transrectal ultrasound image registration.
In men with low-risk prostate cancer, European and American guidelines recommend either
      active surveillance or whole-gland treatments, with significant induced morbidity and burden
      on quality of life. Focal treatments of the index tumor are currently under investigation to
      decrease morbidity while proposing active treatment.

      The purpose of this study is to determine the feasibility, precision and safety of a novel
      ablation treatment using microwaves, delivered transrectally under real-time guidance with
      MRI-transrectal ultrasound image registration. The index tumor will be detected with prostate
      MRI and characterized with targeted biopsies using MRI-transrectal ultrasound image
      registration. It will then be ablated with microwaves using the same transrectal approach and
      guidance system (KOELIS).
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Complete necrosis of the index tumor on prostate MRI
time frame: 7 days
measure: Margins of necrosis around the index tumor on prostate MRI
time frame: 7 days
measure: Erectile and Ejaculatory function using the International Index Erectile Function (IIEF) self questionnaire
time frame: 7 days
description: to assess sexual tolerance
measure: Erectile and Ejaculatory function using the International Index Erectile Function (IIEF) self questionnaire
time frame: 1 month
description: to assess sexual tolerance
measure: Erectile and Ejaculatory function using the International Index Erectile Function (IIEF) self questionnaire
time frame: 3 months
description: to assess sexual tolerance
measure: Erectile and Ejaculatory function using the International Index Erectile Function (IIEF) self questionnaire
time frame: 6 months
description: to assess sexual tolerance
measure: Urinary symptoms using IPSS
time frame: 7 days
description: to assess urinary tolerance
measure: Urinary symptoms using IPSS
time frame: 1 month
description: to assess urinary tolerance
measure: Urinary symptoms using IPSS
time frame: 3 months
description: to assess urinary tolerance
measure: Urinary symptoms using IPSS
time frame: 6 months
description: to assess urinary tolerance
measure: Number of cancer on targeted biopsies within the treated volume
time frame: 6 months
description: to assess oncological efficacy
arm group label: Microwave
arm group type: Experimental
description: Microwave trans rectal focal treatment
intervention type: Device
intervention name: Microwave trans rectal focal treatment
description: Microwave trans-rectal ablation of the prostatic index tumor using MRI-transrectal ultrasound image registration
arm group label: Microwave
other name: Microwave thermal ablation system called TATO (Biomedical)
criteria: 
gender: Male
minimum age: 45 Years
maximum age: 76 Years
healthy volunteers: No
last name: Nicolas BARRY DELONGCHAMPS, MD, PhD
role: Principal Investigator
affiliation: Assistance Publique - Hôpitaux de Paris
facility: 
country: France
responsible party type: Sponsor
mesh term: Prostatic Neoplasms
sharing ipd: No