xml: <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/NCT06013475</url>
    </required_header>
    <id_info>
      <org_study_id>22625</org_study_id>
      <nct_id>NCT06013475</nct_id>
    </id_info>
    <brief_title>An Observational Cohort Study to Describe and Compare the Use of Darolutamide, Enzalutamide and Apalutamide and How Well These Work in Men With Non-metastatic Castration-resistant Prostate Cancer (nmCRPC) in Real World Settings</brief_title>
    <acronym>DEAR-EXT</acronym>
    <official_title>Use of Darolutamide, Enzalutamide and Apalutamide for Non-metastatic Castration-Resistant Prostate Cancer (nmCRPC) - EXTension of the DEAR Real-world Study (NCT05362149)</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Bayer</agency>
        <agency_class>Industry</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Bayer</source>
    <oversight_info>
      <has_dmc>No</has_dmc>
    </oversight_info>
    <brief_summary>
      <textblock>
        This is an observational cohort study in men with non-metastatic castration-resistant&#xD;
        prostate cancer who received their usual treatment, which is 'Androgen receptor inhibitors'&#xD;
        (ARIs) including darolutamide, enzalutamide, and apalutamide.&#xD;
  &#xD;
        The main purpose of this study is to collect data on the length of time men with nmCRPC&#xD;
        continued treatment with darolutamide, enzalutamide, or apalutamide as prescribed by their&#xD;
        doctors. Researchers will only include men who had not been treated with any new type of&#xD;
        medication that blocks the action of hormones.&#xD;
  &#xD;
        The data will come from an electronic health record database called Precision Point Specialty&#xD;
        (PPS) Prostate Cancer Electronic Medical Record (EMR) for men in the United States of&#xD;
        America. EMR data will be verified and supplemented via patient chart review. Data collected&#xD;
        will be from January 2019 to September 2023. .&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">August 31, 2023</start_date>
    <completion_date type="Anticipated">August 31, 2024</completion_date>
    <primary_completion_date type="Anticipated">May 31, 2024</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>Retrospective</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>Time to ARI treatment discontinuation</measure>
      <time_frame>Retrospective analysis from 01-Aug-2019 to 30 Sep 2023</time_frame>
    </primary_outcome>
    <secondary_outcome>
      <measure>Reasons for ARI treatment discontinuation</measure>
      <time_frame>Retrospective analysis from 01-Aug-2019 to 30 Sep 2023</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Proportion of patients, who switched to another ARI therapy</measure>
      <time_frame>Retrospective analysis from 01-Aug-2019 to 30 Sep 2023</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Frequency of adverse events</measure>
      <time_frame>Retrospective analysis from 01-Aug-2019 to 30 Sep 2023</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Time to progression to mCRPC</measure>
      <time_frame>Retrospective analysis from 01-Aug-2019 to 30 Sep 2023</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Dose modification of initial ARI</measure>
      <time_frame>Retrospective analysis from 01-Aug-2019 to 30 Sep 2023</time_frame>
    </secondary_outcome>
    <number_of_groups>3</number_of_groups>
    <enrollment type="Anticipated">1170</enrollment>
    <condition>Non-metastatic Castration-resistant Prostate Cancer</condition>
    <arm_group>
      <arm_group_label>Apalutamide</arm_group_label>
    </arm_group>
    <arm_group>
      <arm_group_label>Darolutamide</arm_group_label>
    </arm_group>
    <arm_group>
      <arm_group_label>Enzalutamide</arm_group_label>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Apalutamide</intervention_name>
      <description>Decision by the treating physician</description>
      <arm_group_label>Apalutamide</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Darolutamide (BAY 1841788)</intervention_name>
      <description>Decision by the treating physician</description>
      <arm_group_label>Darolutamide</arm_group_label>
      <other_name>Nubeqa</other_name>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Enzalutamide</intervention_name>
      <description>Decision by treating physician</description>
      <arm_group_label>Enzalutamide</arm_group_label>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          Adult men previously not treated with a novel antihormonal agent and starting the initial&#xD;
          ARI treatment for nmCRPC during the study period, in US community urology practices&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. Men diagnosed with prostate cancer.&#xD;
  &#xD;
            2. Diagnosis of nmCRPC prior to or within 90 days after the first ARI treatment&#xD;
               initiation&#xD;
  &#xD;
            3. Treatment with Darolutamide, Enzalutamide, or Apalutamide initiated for the first time&#xD;
  &#xD;
            4. Age ≥ 18 years at treatment start&#xD;
  &#xD;
            5. At least 6 months of Electro-Medical-Record activity after the treatment start unless&#xD;
               the patient died earlier than 6 months.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. Evidence of metastatic disease before or 30 days after treatment start&#xD;
  &#xD;
            2. Prior history of other primary cancers&#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_contact>
      <last_name>Bayer Clinical Trials Contact</last_name>
      <phone>(+)1-888-84 22937</phone>
      <email>clinical-trials-contact@bayer.com</email>
    </overall_contact>
    <location>
      <facility>
        <name>Bayer</name>
        <address>
          <city>Whippany</city>
          <state>New Jersey</state>
          <zip>07981</zip>
          <country>United States</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <link>
      <url>https://clinicaltrials.bayer.com/</url>
      <description>Click here to find information for studies related to Bayer products. To find this study enter the ClinicalTrials.gov identifier (NCT) number or Bayer Study Identifier (ID) in the search field.</description>
    </link>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 18, 2023</study_first_submitted>
    <study_first_submitted_qc>August 25, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 28, 2023</study_first_posted>
    <last_update_submitted>August 25, 2023</last_update_submitted>
    <last_update_submitted_qc>August 25, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 28, 2023</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>
      <ipd_description>Availability of this study's data will later be determined according to Bayer's commitment to the EFPIA/PhRMA &quot;Principles for responsible clinical trial data sharing&quot;. This pertains to scope, timepoint and process of data access. As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014. Interested researchers can use www.vivli.org to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the member section of the portal.</ipd_description>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06013475
  org study id: 22625
  nct id: NCT06013475
  lead sponsor: 
  has dmc: No
  This is an observational cohort study in men with non-metastatic castration-resistant
        prostate cancer who received their usual treatment, which is 'Androgen receptor inhibitors'
        (ARIs) including darolutamide, enzalutamide, and apalutamide.
  
        The main purpose of this study is to collect data on the length of time men with nmCRPC
        continued treatment with darolutamide, enzalutamide, or apalutamide as prescribed by their
        doctors. Researchers will only include men who had not been treated with any new type of
        medication that blocks the action of hormones.
  
        The data will come from an electronic health record database called Precision Point Specialty
        (PPS) Prostate Cancer Electronic Medical Record (EMR) for men in the United States of
        America. EMR data will be verified and supplemented via patient chart review. Data collected
        will be from January 2019 to September 2023. .
  observational model: Cohort
  time perspective: Retrospective
  measure: Time to ARI treatment discontinuation
  time frame: Retrospective analysis from 01-Aug-2019 to 30 Sep 2023
  measure: Reasons for ARI treatment discontinuation
  time frame: Retrospective analysis from 01-Aug-2019 to 30 Sep 2023
  measure: Proportion of patients, who switched to another ARI therapy
  time frame: Retrospective analysis from 01-Aug-2019 to 30 Sep 2023
  measure: Frequency of adverse events
  time frame: Retrospective analysis from 01-Aug-2019 to 30 Sep 2023
  measure: Time to progression to mCRPC
  time frame: Retrospective analysis from 01-Aug-2019 to 30 Sep 2023
  measure: Dose modification of initial ARI
  time frame: Retrospective analysis from 01-Aug-2019 to 30 Sep 2023
  arm group label: Apalutamide
  arm group label: Darolutamide
  arm group label: Enzalutamide
  intervention type: Drug
  intervention name: Apalutamide
  description: Decision by the treating physician
  arm group label: Apalutamide
  intervention type: Drug
  intervention name: Darolutamide (BAY 1841788)
  description: Decision by the treating physician
  arm group label: Darolutamide
  other name: Nubeqa
  intervention type: Drug
  intervention name: Enzalutamide
  description: Decision by treating physician
  arm group label: Enzalutamide
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: Male
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Bayer Clinical Trials Contact
  phone: (+)1-888-84 22937
  email: clinical-trials-contact@bayer.com
  facility: 
  country: United States
  url: https://clinicaltrials.bayer.com/
  description: Click here to find information for studies related to Bayer products. To find this study enter the ClinicalTrials.gov identifier (NCT) number or Bayer Study Identifier (ID) in the search field.
  responsible party type: Sponsor
  mesh term: Prostatic Neoplasms
  sharing ipd: No
  ipd description: Availability of this study's data will later be determined according to Bayer's commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing". This pertains to scope, timepoint and process of data access. As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014. Interested researchers can use www.vivli.org to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the member section of the portal.