<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/NCT02229253</url>
  </required_header>
  <id_info>
    <org_study_id>000171</org_study_id>
    <nct_id>NCT02229253</nct_id>
  </id_info>
  <brief_title>Real-life Data of Cardiovascular Events Occuring During Degarelix Therapy for Prostate Cancer</brief_title>
  <sponsors>
    <lead_sponsor>
      <agency>Ferring Pharmaceuticals</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Ferring Pharmaceuticals</source>
  <brief_summary>
    <textblock>
      Patients with prostate cancer and a history of cardiovascular disease treated with degarelix&#xD;
      for their prostate cancer, will be followed for a period of one year. In this real-life,&#xD;
      non-interventional trial, any cardiovascular events occurring during degarelix therapy will&#xD;
      be documented.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 2014</start_date>
  <completion_date type="Actual">October 4, 2017</completion_date>
  <primary_completion_date type="Actual">October 4, 2017</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>Cardiovascular event rate in hormone naïve prostate cancer patients with cardiovascular comorbidity at baseline, treated with degarelix in daily practice</measure>
    <time_frame>Up to 1 year</time_frame>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">112</enrollment>
  <condition>Advanced Hormone Sensitive Prostate Cancer</condition>
  <arm_group>
    <arm_group_label>Degarelix</arm_group_label>
    <description>Treatment according to standard clinical practice.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>degarelix</intervention_name>
    <arm_group_label>Degarelix</arm_group_label>
    <other_name>Firmagon®</other_name>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients will be selected from prostate cancer patients in a hospital setting, meeting the&#xD;
        inclusion criteria.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients with prostate cancer and a history of cardiovascular disease, prescribed&#xD;
             degarelix for the treatment of their prostate cancer&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients who have received a form of androgen deprivation therapy for their prostate&#xD;
             cancer, during the 12 months preceding this study are excluded&#xD;
&#xD;
          -  Planned intermittent or short-term (&lt; 12 months) degarelix treatment&#xD;
&#xD;
          -  Planned addition of, or switch to another form of androgen deprivation therapy during&#xD;
             the study&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>N/A</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>Groene Hart Ziekenhuis (there may be other sites in this country)</name>
      <address>
        <city>Gouda</city>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Netherlands</country>
  </location_countries>
  <verification_date>November 2017</verification_date>
  <study_first_submitted>August 28, 2014</study_first_submitted>
  <study_first_submitted_qc>August 28, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 1, 2014</study_first_posted>
  <last_update_submitted>November 23, 2017</last_update_submitted>
  <last_update_submitted_qc>November 23, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">November 27, 2017</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/NCT02229253
org study id: 000171
nct id: NCT02229253
lead sponsor: 
Patients with prostate cancer and a history of cardiovascular disease treated with degarelix
      for their prostate cancer, will be followed for a period of one year. In this real-life,
      non-interventional trial, any cardiovascular events occurring during degarelix therapy will
      be documented.
observational model: Cohort
time perspective: Prospective
measure: Cardiovascular event rate in hormone naïve prostate cancer patients with cardiovascular comorbidity at baseline, treated with degarelix in daily practice
time frame: Up to 1 year
arm group label: Degarelix
description: Treatment according to standard clinical practice.
intervention type: Drug
intervention name: degarelix
arm group label: Degarelix
other name: Firmagon®
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: Male
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: Clinical Development Support
role: Study Director
affiliation: Ferring Pharmaceuticals
facility: 
country: Netherlands
responsible party type: Sponsor
mesh term: Prostatic Neoplasms