<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/NCT02235142</url>
  </required_header>
  <id_info>
    <org_study_id>2013/01</org_study_id>
    <secondary_id>2012-A01742-41</secondary_id>
    <nct_id>NCT02235142</nct_id>
  </id_info>
  <brief_title>Prostatic Cancer Versus Androgen Deficiency</brief_title>
  <acronym>AndroCan</acronym>
  <official_title>Localised Cancer of Prostate and Androgen Deficiency.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hopital Foch</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Hopital Foch</source>
  <brief_summary>
    <textblock>
      Open study to make a comparison between hypogonadism and euogonadism patients regarding the&#xD;
      severity of prostate cancer. The purpose of this study is to determine the importance of the&#xD;
      relationship between the hormonal status and the type of the tumor at the time of surgical&#xD;
      intervention as well as follow up of the patients.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 3, 2013</start_date>
  <completion_date type="Actual">December 22, 2021</completion_date>
  <primary_completion_date type="Actual">June 27, 2016</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>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Testosteron Serum level</measure>
    <time_frame>The day prior to surgery</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Gleason score</measure>
    <time_frame>5 years</time_frame>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">1614</enrollment>
  <condition>Cancer of Prostate</condition>
  <arm_group>
    <arm_group_label>Localised prostat cancer and androgen deficiency</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Blood sample</intervention_name>
    <arm_group_label>Localised prostat cancer and androgen deficiency</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Male patients over than 18 years of age, with localized, stage I or II prostate&#xD;
             cancer, not receiving local treatment (radiation, phototherapy, thermotherapy,…) or&#xD;
             hormonal therapy, showing indication of radical prostatectomy.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Absence of radical prostatectomy indication&#xD;
&#xD;
          -  Patient received local or hormonal therapy prior to surgery&#xD;
&#xD;
          -  Patients already enrolled in other clinical study incompatible with the study&#xD;
&#xD;
          -  Patients on a treatment which can affect hormonal level (Prednisone, Ketoconazole,&#xD;
             Abiraterone, Finasteride, Dutasteride)&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Hôpital Foch</name>
      <address>
        <city>Suresnes</city>
        <state>Ile De France</state>
        <zip>92150</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinique Saint Augustin</name>
      <address>
        <city>Bordeaux</city>
        <zip>33000</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hôpitaux Civils de Colmar</name>
      <address>
        <city>Colmar</city>
        <zip>68000</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hôpital Henri Mondor</name>
      <address>
        <city>Créteil</city>
        <zip>94000</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>La Pitié-Salpêtrière (AP-HP)</name>
      <address>
        <city>Paris</city>
        <zip>75013</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Institut Mutualiste Montsouris</name>
      <address>
        <city>Paris</city>
        <zip>75014</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHU Pointe à Pitre</name>
      <address>
        <city>Pointe-à-Pitre</city>
        <zip>97110</zip>
        <country>Guadeloupe</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHU Fort de France</name>
      <address>
        <city>Fort-de-France</city>
        <zip>97200</zip>
        <country>Martinique</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
    <country>Guadeloupe</country>
    <country>Martinique</country>
  </location_countries>
  <verification_date>January 2022</verification_date>
  <study_first_submitted>September 5, 2014</study_first_submitted>
  <study_first_submitted_qc>September 5, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 9, 2014</study_first_posted>
  <last_update_submitted>January 19, 2022</last_update_submitted>
  <last_update_submitted_qc>January 19, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">January 20, 2022</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>
  <!-- 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/NCT02235142
org study id: 2013/01
secondary id: 2012-A01742-41
nct id: NCT02235142
lead sponsor: 
Open study to make a comparison between hypogonadism and euogonadism patients regarding the
      severity of prostate cancer. The purpose of this study is to determine the importance of the
      relationship between the hormonal status and the type of the tumor at the time of surgical
      intervention as well as follow up of the patients.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Other
masking: None (Open Label)
measure: Testosteron Serum level
time frame: The day prior to surgery
measure: Gleason score
time frame: 5 years
arm group label: Localised prostat cancer and androgen deficiency
arm group type: Experimental
intervention type: Other
intervention name: Blood sample
arm group label: Localised prostat cancer and androgen deficiency
criteria: 
gender: Male
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: France
country: Guadeloupe
country: Martinique
responsible party type: Sponsor
mesh term: Prostatic Neoplasms