<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/NCT01729676</url>
  </required_header>
  <id_info>
    <org_study_id>000059</org_study_id>
    <nct_id>NCT01729676</nct_id>
  </id_info>
  <brief_title>Impact of the Geographical FACTor on the Prostate Cancer Stage at Hormonal Therapy Initiation</brief_title>
  <acronym>FACT</acronym>
  <official_title>Impact of the Geographical FACTor on the Prostate Cancer Stage at Hormonal Therapy Initiation: FACT STUDY</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Ferring Pharmaceuticals</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Ferring Pharmaceuticals</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      French epidemiological data have shown a heterogeneous distribution of the risk of mortality&#xD;
      from prostate cancer according to region. The main objective is to describe the distribution&#xD;
      of prostate cancer stages when first line hormonal therapy is introduced (overall and by&#xD;
      region).&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>May 2013</start_date>
  <completion_date type="Actual">May 2014</completion_date>
  <primary_completion_date type="Actual">May 2014</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Estimated percentage of different prostate cancer stages (overall and by region)</measure>
    <time_frame>During a single consultation when first-line prostate cancer hormone therapy is started</time_frame>
    <description>The stages of prostate cancer are classified as locally advanced, metastatic and biological recurrence.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>The characteristics of the patients with prostate cancer by region</measure>
    <time_frame>During a single consultation when first-line prostate cancer hormone therapy is started</time_frame>
    <description>Characteristics are described by demography, tumour characteristics, Gleason score, D'Amico score, prostate specific antigen (PSA), Testosterone and treatment history</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The influence of regional factors on staging of prostate cancer</measure>
    <time_frame>During a single consultation when first-line prostate cancer hormone therapy is started</time_frame>
    <description>The regional influence will be demonstrated by modelling the probability of a patient being at one of the cancer stages (locally advanced cancer, metastatic cancer, biological recurrence).</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">315</enrollment>
  <condition>Prostate Cancer</condition>
  <arm_group>
    <arm_group_label>Group A</arm_group_label>
    <description>Degarelix or gonadotrophin releasing hormone (GnRH) agonist for treatment of prostate cancer according to physicians current practice</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Degarelix or GnRH agonist</intervention_name>
    <description>Degarelix or GnRH agonist for treatment of prostate cancer according to physicians current practice</description>
    <arm_group_label>Group A</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Men never previously treated with hormononal therapy for prostate cancer&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients with histologically demonstrated prostatic adenocarcinoma.&#xD;
&#xD;
          -  Patients never previously treated with hormonal therapy for prostate cancer.&#xD;
&#xD;
          -  Patients eligible for hormonal therapy after initial consultation (alone or in&#xD;
             combination with curative treatment).&#xD;
&#xD;
          -  Patients agreeing to the collection of personal health data for the purposes of the&#xD;
             study.&#xD;
&#xD;
          -  Patients with locally advanced or metastatic prostatic cancer tumours or a biological&#xD;
             recurrence after curative treatment.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients participating in a clinical study involving prostate cancer at the time of&#xD;
             inclusion in the investigation.&#xD;
&#xD;
          -  Patients having received or currently receiving hormonal treatment for prostate cancer&#xD;
             (surgical castration or other hormonal manipulation, including GnRH receptor&#xD;
             antagonists, antiandrogens, oestrogens, 5 alpha reductase inhibitors).&#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>Clinical Development Support</last_name>
    <role>Study Director</role>
    <affiliation>Ferring Pharmaceuticals</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Hôpital Robert Boulin</name>
      <address>
        <city>Libourne</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>July 2014</verification_date>
  <study_first_submitted>October 23, 2012</study_first_submitted>
  <study_first_submitted_qc>November 14, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 20, 2012</study_first_posted>
  <last_update_submitted>July 16, 2014</last_update_submitted>
  <last_update_submitted_qc>July 16, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">July 17, 2014</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/NCT01729676
org study id: 000059
nct id: NCT01729676
lead sponsor: 
has dmc: No
French epidemiological data have shown a heterogeneous distribution of the risk of mortality
      from prostate cancer according to region. The main objective is to describe the distribution
      of prostate cancer stages when first line hormonal therapy is introduced (overall and by
      region).
observational model: Cohort
time perspective: Prospective
measure: Estimated percentage of different prostate cancer stages (overall and by region)
time frame: During a single consultation when first-line prostate cancer hormone therapy is started
description: The stages of prostate cancer are classified as locally advanced, metastatic and biological recurrence.
measure: The characteristics of the patients with prostate cancer by region
time frame: During a single consultation when first-line prostate cancer hormone therapy is started
description: Characteristics are described by demography, tumour characteristics, Gleason score, D'Amico score, prostate specific antigen (PSA), Testosterone and treatment history
measure: The influence of regional factors on staging of prostate cancer
time frame: During a single consultation when first-line prostate cancer hormone therapy is started
description: The regional influence will be demonstrated by modelling the probability of a patient being at one of the cancer stages (locally advanced cancer, metastatic cancer, biological recurrence).
arm group label: Group A
description: Degarelix or gonadotrophin releasing hormone (GnRH) agonist for treatment of prostate cancer according to physicians current practice
intervention type: Drug
intervention name: Degarelix or GnRH agonist
description: Degarelix or GnRH agonist for treatment of prostate cancer according to physicians current practice
arm group label: Group A
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: Male
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Clinical Development Support
role: Study Director
affiliation: Ferring Pharmaceuticals
facility: 
country: France
responsible party type: Sponsor
mesh term: Prostatic Neoplasms