<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/NCT02234089</url>
  </required_header>
  <id_info>
    <org_study_id>000156</org_study_id>
    <nct_id>NCT02234089</nct_id>
  </id_info>
  <brief_title>Therapy Pathways in the Treatment of Hormone Naïve Prostate Cancer Patients With and Without Comorbidities Treated With Degarelix or Luteinizing-Hormone-Releasing-Hormone (LHRH) Agonists.</brief_title>
  <acronym>ProComD</acronym>
  <sponsors>
    <lead_sponsor>
      <agency>Ferring Pharmaceuticals</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Ferring Pharmaceuticals</source>
  <brief_summary>
    <textblock>
      The purpose of this study is to detect factors influencing decision making for treatment&#xD;
      pathways of hormone-naïve prostate cancer patients with and without comorbidities receiving&#xD;
      medicinal androgen deprivation therapy (Degarelix or LHRH agonists).&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 2014</start_date>
  <completion_date type="Actual">June 30, 2019</completion_date>
  <primary_completion_date type="Actual">June 30, 2019</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>Level of urologist's knowledge of patients' medical history at the point of decision making and during Androgen Deprivation Therapy (ADT)</measure>
    <time_frame>Up to 4 years</time_frame>
    <description>Measured by questionnaires by quantifying the frequency of urologists' entries</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Level of urologist's knowledge of patients' comorbidities at the point of decision making and during ADT</measure>
    <time_frame>Up to 4 years</time_frame>
    <description>Measured by questionnaires by quantifying the frequency of urologists' entries</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Level of urologist's knowledge of patients' concomitant medications at the point of decision making and during ADT</measure>
    <time_frame>Up to 4 years</time_frame>
    <description>Measured by questionnaires by quantifying the frequency of urologists' entries</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Level of urologist's knowledge of patients' risk factors at the point of decision making and during ADT</measure>
    <time_frame>Up to 4 years</time_frame>
    <description>Measured by questionnaires by quantifying the frequency of urologists' entries</description>
  </primary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">461</enrollment>
  <condition>Advanced Prostate Cancer</condition>
  <arm_group>
    <arm_group_label>Degarelix</arm_group_label>
  </arm_group>
  <arm_group>
    <arm_group_label>LHRH agonist</arm_group_label>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Degarelix</intervention_name>
    <description>According to medical practice</description>
    <arm_group_label>Degarelix</arm_group_label>
    <other_name>Firmagon®</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>LHRH agonist (Leuprorelinacetat, Goserelinacetat, Buserelinacetat, Triptorelinacetat)</intervention_name>
    <description>According to medical practice</description>
    <arm_group_label>LHRH agonist</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients with advanced prostate cancer where a treatment decision on therapy has already&#xD;
        been made according to medical practice.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Diagnosed with Prostate Cancer and indicated for ADT according to Summary of Product&#xD;
             Characteristics (SmPC)&#xD;
&#xD;
          -  Decision made to prescribe ADT (Degarelix or LHRH agonist) prior to enrolment&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patient had previous or is currently under hormonal management of Prostate Cancer,&#xD;
             except for a curative intention, where the duration of the neoadjuvant/adjuvant&#xD;
             therapy did not exceed 6 months and treatment should have been terminated at least 6&#xD;
             months prior to baseline.&#xD;
&#xD;
          -  Participation in a clinical trial at baseline and during the follow-up period&#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>Global Clinical Compliance</last_name>
    <role>Study Director</role>
    <affiliation>Ferring Pharmaceuticals</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Investigational site (there may be other sites in this country)</name>
      <address>
        <city>Rottweil</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Germany</country>
  </location_countries>
  <verification_date>July 2019</verification_date>
  <study_first_submitted>August 20, 2014</study_first_submitted>
  <study_first_submitted_qc>September 4, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 9, 2014</study_first_posted>
  <last_update_submitted>July 1, 2019</last_update_submitted>
  <last_update_submitted_qc>July 1, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">July 5, 2019</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/NCT02234089
org study id: 000156
nct id: NCT02234089
lead sponsor: 
The purpose of this study is to detect factors influencing decision making for treatment
      pathways of hormone-naïve prostate cancer patients with and without comorbidities receiving
      medicinal androgen deprivation therapy (Degarelix or LHRH agonists).
observational model: Cohort
time perspective: Prospective
measure: Level of urologist's knowledge of patients' medical history at the point of decision making and during Androgen Deprivation Therapy (ADT)
time frame: Up to 4 years
description: Measured by questionnaires by quantifying the frequency of urologists' entries
measure: Level of urologist's knowledge of patients' comorbidities at the point of decision making and during ADT
time frame: Up to 4 years
description: Measured by questionnaires by quantifying the frequency of urologists' entries
measure: Level of urologist's knowledge of patients' concomitant medications at the point of decision making and during ADT
time frame: Up to 4 years
description: Measured by questionnaires by quantifying the frequency of urologists' entries
measure: Level of urologist's knowledge of patients' risk factors at the point of decision making and during ADT
time frame: Up to 4 years
description: Measured by questionnaires by quantifying the frequency of urologists' entries
arm group label: Degarelix
arm group label: LHRH agonist
intervention type: Drug
intervention name: Degarelix
description: According to medical practice
arm group label: Degarelix
other name: Firmagon®
intervention type: Drug
intervention name: LHRH agonist (Leuprorelinacetat, Goserelinacetat, Buserelinacetat, Triptorelinacetat)
description: According to medical practice
arm group label: LHRH agonist
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: Male
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: Global Clinical Compliance
role: Study Director
affiliation: Ferring Pharmaceuticals
facility: 
country: Germany
responsible party type: Sponsor
mesh term: Prostatic Neoplasms