<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/NCT03014973</url>
  </required_header>
  <id_info>
    <org_study_id>2016/03</org_study_id>
    <secondary_id>2016-A00020-51</secondary_id>
    <nct_id>NCT03014973</nct_id>
  </id_info>
  <brief_title>Castration-resistant Prostate Cancer and Intra-prostatic Hormonal Status</brief_title>
  <acronym>HORM</acronym>
  <official_title>Castration-resistant Prostate Cancer and Intra-prostatic Hormonal Status</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hopital Foch</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Hopital Foch</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The main objective of the study is to determine the intra-prostatic concentration of sexual&#xD;
      steroids when castration resistance appears in castration-resistant prostate cancer patients&#xD;
      compared to patients naif of hormonal treatment&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Withdrawn</overall_status>
  <start_date type="Anticipated">January 2017</start_date>
  <completion_date type="Anticipated">December 2018</completion_date>
  <primary_completion_date type="Anticipated">June 2018</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>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>intra-prostatic concentration of sexual steroids</measure>
    <time_frame>2 weeks</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Androgen receptor immuno-histochemical expression level</measure>
    <time_frame>2 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Androgen receptor RNA expression level</measure>
    <time_frame>2 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Steroid 5-alphareductase immuno-histochemical expression level</measure>
    <time_frame>2 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Steroid 5-alphareductase RNA expression level</measure>
    <time_frame>2 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Steroid aromatase immuno-histochemical expression level</measure>
    <time_frame>2 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Steroid aromatase RNA expression level</measure>
    <time_frame>2 weeks</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">0</enrollment>
  <condition>Prostate Cancer</condition>
  <arm_group>
    <arm_group_label>prostate cancer patients resistant to castration</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>patients naif of hormonal treatment</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>intra-prostatic concentration of sexual steroids</intervention_name>
    <arm_group_label>patients naif of hormonal treatment</arm_group_label>
    <arm_group_label>prostate cancer patients resistant to castration</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Trans-rectal biopsy</intervention_name>
    <arm_group_label>patients naif of hormonal treatment</arm_group_label>
    <arm_group_label>prostate cancer patients resistant to castration</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  group 1: patients with a locally advanced prostate cancer naif of any hormonal&#xD;
             treatment&#xD;
&#xD;
          -  group 2: Patients with a castration-resistant prostate cancer resisting defined by a&#xD;
             biological progression&#xD;
&#xD;
          -  group 2a: without radiotherapy&#xD;
&#xD;
          -  group 2b: with radiotherapy&#xD;
&#xD;
          -  Affiliated to a social security scheme&#xD;
&#xD;
          -  Having given a written consent.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patient unable to supply a written consent (patient not understanding French, under&#xD;
             guardianship patient).&#xD;
&#xD;
          -  neuro-endocrine form or sarcomatoid form prostate cancer&#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>Yann NEUZILLET, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Hopital Foch</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Henry Botto, MD</last_name>
    <role>Study Chair</role>
    <affiliation>Hopital Foch</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Hopital Foch</name>
      <address>
        <city>Suresnes</city>
        <zip>92150</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>January 2017</verification_date>
  <study_first_submitted>December 30, 2016</study_first_submitted>
  <study_first_submitted_qc>January 5, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 9, 2017</study_first_posted>
  <last_update_submitted>September 12, 2018</last_update_submitted>
  <last_update_submitted_qc>September 12, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">September 13, 2018</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/NCT03014973
org study id: 2016/03
secondary id: 2016-A00020-51
nct id: NCT03014973
lead sponsor: 
has dmc: No
The main objective of the study is to determine the intra-prostatic concentration of sexual
      steroids when castration resistance appears in castration-resistant prostate cancer patients
      compared to patients naif of hormonal treatment
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Other
masking: None (Open Label)
measure: intra-prostatic concentration of sexual steroids
time frame: 2 weeks
measure: Androgen receptor immuno-histochemical expression level
time frame: 2 weeks
measure: Androgen receptor RNA expression level
time frame: 2 weeks
measure: Steroid 5-alphareductase immuno-histochemical expression level
time frame: 2 weeks
measure: Steroid 5-alphareductase RNA expression level
time frame: 2 weeks
measure: Steroid aromatase immuno-histochemical expression level
time frame: 2 weeks
measure: Steroid aromatase RNA expression level
time frame: 2 weeks
arm group label: prostate cancer patients resistant to castration
arm group type: Experimental
arm group label: patients naif of hormonal treatment
arm group type: Experimental
intervention type: Biological
intervention name: intra-prostatic concentration of sexual steroids
arm group label: patients naif of hormonal treatment
arm group label: prostate cancer patients resistant to castration
intervention type: Procedure
intervention name: Trans-rectal biopsy
arm group label: patients naif of hormonal treatment
arm group label: prostate cancer patients resistant to castration
criteria: 
gender: Male
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Yann NEUZILLET, MD
role: Principal Investigator
affiliation: Hopital Foch
last name: Henry Botto, MD
role: Study Chair
affiliation: Hopital Foch
facility: 
country: France
responsible party type: Sponsor
mesh term: Prostatic Neoplasms
sharing ipd: No