<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/NCT02971995</url>
  </required_header>
  <id_info>
    <org_study_id>OBS025</org_study_id>
    <nct_id>NCT02971995</nct_id>
  </id_info>
  <brief_title>Trimodal (18)F-choline-PET/mpMRI/TRUS Targeted Prostate Biopsies</brief_title>
  <acronym>PROSTEPIRM</acronym>
  <official_title>Trimodal (18)F-choline-PET/mpMRI/TRUS Targeted Prostate Biopsies in Prostate Cancer Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Lille Catholic University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Lille Catholic University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Prostate cancer is the first cancer in humans (25%). The most widely used tracer in oncology,&#xD;
      the 18-Fluoro DeoxyGlucose does not allow the study of prostatic neoplasia. On the other&#xD;
      hand, Choline, which is an amino alcohol, is involved in the synthesis of cell membranes and&#xD;
      has an affinity for prostate cells. Its concentration is directly proportional to cell&#xD;
      proliferation. The analogue of choline has the advantage of having a rapid and stable&#xD;
      accumulation over time in cancer cells, with a rapid urinary excretion (4 minutes after&#xD;
      injection).&#xD;
&#xD;
      The goal of this study is to assess the feasibility and the accuracy for targeting image&#xD;
      guided prostate biopsy to detect prostate cancer after Imaging fusion of choline-PET/CT&#xD;
      compared to 1.5T multiparametric magnetic resonance imaging (mpMRI) with 3D-transrectal&#xD;
      ultrasound (TRUS) .&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>December 2014</start_date>
  <completion_date type="Actual">October 2016</completion_date>
  <primary_completion_date type="Actual">March 2016</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Diagnostic</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number of image guided prostate biopsy in the zones detected by the TEP scan</measure>
    <time_frame>at inclusion</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of image guided prostate biopsy in the zones detected by the mpMRI</measure>
    <time_frame>at inclusion</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">31</enrollment>
  <condition>Prostatic Neoplasm</condition>
  <condition>Positron-Emission Tomography</condition>
  <condition>Fluorocholine</condition>
  <arm_group>
    <arm_group_label>Prostate cancer/TEP scan</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Prostate cancer/mpMRI</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>PET Scan ou TEP-TDM</intervention_name>
    <description>Performance of the PET/CT using Flurocholine in order to detect the localization of the pathological fixation of the tracer and to determine the place where to take the biopsy</description>
    <arm_group_label>Prostate cancer/TEP scan</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>mpMRI</intervention_name>
    <description>Performance of the mpMRI in order to determine the place where to take the biopsy</description>
    <arm_group_label>Prostate cancer/mpMRI</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients with suspicion of prostate cancer&#xD;
&#xD;
          -  Patients who performed prostate mpMRI and F-Choline 18 PET scan&#xD;
&#xD;
          -  Patient capable of receiving clear informations&#xD;
&#xD;
          -  Patient giving a written consent for their participation via a consent signed by both&#xD;
             parents of the patient (or legal tutor)&#xD;
&#xD;
          -  Patient covered by a healthcare insurance&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients without suspect image of neoplasia after mpMRI and F-Choline 18 PET scan&#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>Jean Louis Bonnal, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>GHICL</affiliation>
  </overall_official>
  <verification_date>June 2015</verification_date>
  <study_first_submitted>November 16, 2016</study_first_submitted>
  <study_first_submitted_qc>November 21, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 23, 2016</study_first_posted>
  <last_update_submitted>November 21, 2016</last_update_submitted>
  <last_update_submitted_qc>November 21, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">November 23, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <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/NCT02971995
org study id: OBS025
nct id: NCT02971995
lead sponsor: 
has dmc: No
Prostate cancer is the first cancer in humans (25%). The most widely used tracer in oncology,
      the 18-Fluoro DeoxyGlucose does not allow the study of prostatic neoplasia. On the other
      hand, Choline, which is an amino alcohol, is involved in the synthesis of cell membranes and
      has an affinity for prostate cells. Its concentration is directly proportional to cell
      proliferation. The analogue of choline has the advantage of having a rapid and stable
      accumulation over time in cancer cells, with a rapid urinary excretion (4 minutes after
      injection).

      The goal of this study is to assess the feasibility and the accuracy for targeting image
      guided prostate biopsy to detect prostate cancer after Imaging fusion of choline-PET/CT
      compared to 1.5T multiparametric magnetic resonance imaging (mpMRI) with 3D-transrectal
      ultrasound (TRUS) .
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Diagnostic
masking: None (Open Label)
measure: Number of image guided prostate biopsy in the zones detected by the TEP scan
time frame: at inclusion
measure: Number of image guided prostate biopsy in the zones detected by the mpMRI
time frame: at inclusion
arm group label: Prostate cancer/TEP scan
arm group type: Experimental
arm group label: Prostate cancer/mpMRI
arm group type: Active Comparator
intervention type: Device
intervention name: PET Scan ou TEP-TDM
description: Performance of the PET/CT using Flurocholine in order to detect the localization of the pathological fixation of the tracer and to determine the place where to take the biopsy
arm group label: Prostate cancer/TEP scan
intervention type: Device
intervention name: mpMRI
description: Performance of the mpMRI in order to determine the place where to take the biopsy
arm group label: Prostate cancer/mpMRI
criteria: 
gender: Male
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Jean Louis Bonnal, MD
role: Principal Investigator
affiliation: GHICL
responsible party type: Sponsor
mesh term: Prostatic Neoplasms
sharing ipd: No