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/NCT05968599</url>
    </required_header>
    <id_info>
      <org_study_id>C3431047</org_study_id>
      <nct_id>NCT05968599</nct_id>
    </id_info>
    <brief_title>A Study to Learn About the Study Medicines Called Enzalutamide and Abiraterone in People With Metastatic Castration-resistant Prostate Cancer</brief_title>
    <official_title>A Real-World Comparison of Clinical Outcomes in Chemotherapy-naive Metastatic Castration-resistant Prostate Cancer(mCRPC) Patients Who Initiated Enzalutamide vs. Abiraterone Acetate (Abiraterone) in Flatiron Electronic Health Record (EHR) Database</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Pfizer</agency>
        <agency_class>Industry</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>Astellas Pharma Inc</agency>
        <agency_class>Industry</agency_class>
      </collaborator>
    </sponsors>
    <source>Pfizer</source>
    <brief_summary>
      <textblock>
        The purpose of this real-world study is to learn about the effects of 2 study medicines&#xD;
        called enzalutamide and abiraterone used to treat metastatic castration-resistant prostate&#xD;
        cancer (mCRPC).&#xD;
  &#xD;
        Prostate cancer is one of the most common cancers in men. The prostate is a gland in the male&#xD;
        body that helps make semen. Most prostate cancers need male sex hormones, such as&#xD;
        testosterone, to grow. Prostate cancer that keeps growing even when the amount of&#xD;
        testosterone in the body is reduced to very low levels is known as &quot;castration-resistant&quot;.&#xD;
        Metastatic cancer is a cancer that has spread to other parts of the body.&#xD;
  &#xD;
        This is a real-world study, not a clinical trial. This means that researchers will look at&#xD;
        what happens when men receive the treatments prescribed by their own doctor as part of their&#xD;
        usual healthcare treatment. In this study, researchers will use information from the Flatiron&#xD;
        Electronic Health Record (EHR) database.&#xD;
  &#xD;
        The study will include patients' information from the database for men who:&#xD;
  &#xD;
          -  Were confirmed by medical tests to have mCRPC&#xD;
  &#xD;
          -  Started first-line treatment with enzalutamide or abiraterone (index date) for mCRPC&#xD;
  &#xD;
          -  Had not received chemotherapy treatment before index date&#xD;
  &#xD;
          -  Were 18 years of age or older on index date&#xD;
  &#xD;
        Men who are part of this study will receive enzalutamide or abiraterone as part of their&#xD;
        usual treatment for mCRPC.&#xD;
  &#xD;
        We will compare the following between men receiving enzalutamide and men receiving&#xD;
        abiraterone:&#xD;
  &#xD;
          -  time from treatment start until death,&#xD;
  &#xD;
          -  treatment duration, and&#xD;
  &#xD;
          -  time to next treatment. This study will use patient information from the database until&#xD;
             the end of information that is available.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">August 1, 2023</start_date>
    <completion_date type="Anticipated">December 31, 2023</completion_date>
    <primary_completion_date type="Anticipated">December 31, 2023</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>Overall Survival</measure>
      <time_frame>Up to approximately 8 years</time_frame>
      <description>Overall survival (OS) will be defined as the time from the initiation of enzalutamide or abiraterone to the date of death.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Overall survival among patients without subsequent therapy</measure>
      <time_frame>Up to approximately 8 years</time_frame>
      <description>Overall survival (OS) among the subgroup of patients who received only enzalutamide without any subsequent therapy or received only abiraterone without any subsequent therapy.&#xD;
  OS will be defined as the time from the initiation of enzalutamide or abiraterone (i.e., index date) to the date of death.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Treatment duration</measure>
      <time_frame>Up to approximately 8 years</time_frame>
      <description>Treatment duration will be defined as the time from the initiation of enzalutamide or abiraterone to the discontinuation date. Discontinuation will be defined as the earliest of 1) death, 2) last abstracted end date for enzalutamide or abiraterone, or 3) day before the start of next line of therapy.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Time to subsequent therapy</measure>
      <time_frame>Up to approximately 8 years</time_frame>
      <description>Time to subsequent therapy will be defined as the time from the initiation of enzalutamide or abiraterone to the start of next line of therapy.</description>
    </secondary_outcome>
    <number_of_groups>2</number_of_groups>
    <enrollment type="Anticipated">2800</enrollment>
    <condition>Prostatic Neoplasms, Castration-Resistant</condition>
    <arm_group>
      <arm_group_label>Enzalutamide cohort</arm_group_label>
      <description>Patients with mCRPC initiating enzalutamide</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Abiraterone cohort</arm_group_label>
      <description>Patients with mCRPC initiating abiraterone acetate</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Enzalutamide</intervention_name>
      <description>As provided in real-world setting</description>
      <arm_group_label>Enzalutamide cohort</arm_group_label>
      <other_name>Xtandi</other_name>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Abiraterone acetate</intervention_name>
      <description>As provided in real-world setting</description>
      <arm_group_label>Abiraterone cohort</arm_group_label>
      <other_name>Yonsa, Zytiga</other_name>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          Men with chemotherapy-naïve mCRPC (aged ≥18 years) who initiated enzalutamide or&#xD;
          abiraterone and met eligibility criteria will be included in the study. Patients will be&#xD;
          identified from the Flatiron EHR database.&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Male with metastatic prostate cancer diagnosis and abstracted castration-resistant&#xD;
               prostate cancer diagnosis&#xD;
  &#xD;
            -  Initiated enzalutamide or abiraterone within 14 days prior to or after the metastatic&#xD;
               castration-resistant prostate cancer diagnosis. The initiation date of enzalutamide or&#xD;
               abiraterone will be defined as the index date.&#xD;
  &#xD;
            -  At least 18 years old at the index date&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Received chemotherapy, novel hormonal therapy, radium-223, olaparib/rucaparib, or&#xD;
               immunotherapy prior to the index date&#xD;
  &#xD;
            -  Had a prior history of other cancers&#xD;
        </textblock>
      </criteria>
      <gender>Male</gender>
      <gender_based>Yes</gender_based>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Pfizer CT.gov Call Center</last_name>
      <role>Study Director</role>
      <affiliation>Pfizer</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Pfizer CT.gov Call Center</last_name>
      <phone>1-800-718-1021</phone>
      <email>ClinicalTrials.gov_Inquiries@pfizer.com</email>
    </overall_contact>
    <location>
      <facility>
        <name>Pfizer Inc</name>
        <address>
          <city>New York</city>
          <state>New York</state>
          <zip>10001</zip>
          <country>United States</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>July 21, 2023</study_first_submitted>
    <study_first_submitted_qc>July 21, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 1, 2023</study_first_posted>
    <last_update_submitted>July 21, 2023</last_update_submitted>
    <last_update_submitted_qc>July 21, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 1, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>metastatic castration-resistant prostate cancer</keyword>
    <keyword>mCRPC</keyword>
    <keyword>enzalutamide</keyword>
    <keyword>abiraterone</keyword>
    <keyword>overall survival</keyword>
    <keyword>OS</keyword>
    <keyword>treatment duration</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Prostatic Neoplasms</mesh_term>
      <mesh_term>Prostatic Neoplasms, Castration-Resistant</mesh_term>
    </condition_browse>
    <intervention_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Abiraterone Acetate</mesh_term>
    </intervention_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
      <ipd_description>Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.</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/NCT05968599
  org study id: C3431047
  nct id: NCT05968599
  lead sponsor: 
  collaborator: 
  The purpose of this real-world study is to learn about the effects of 2 study medicines
        called enzalutamide and abiraterone used to treat metastatic castration-resistant prostate
        cancer (mCRPC).
  
        Prostate cancer is one of the most common cancers in men. The prostate is a gland in the male
        body that helps make semen. Most prostate cancers need male sex hormones, such as
        testosterone, to grow. Prostate cancer that keeps growing even when the amount of
        testosterone in the body is reduced to very low levels is known as "castration-resistant".
        Metastatic cancer is a cancer that has spread to other parts of the body.
  
        This is a real-world study, not a clinical trial. This means that researchers will look at
        what happens when men receive the treatments prescribed by their own doctor as part of their
        usual healthcare treatment. In this study, researchers will use information from the Flatiron
        Electronic Health Record (EHR) database.
  
        The study will include patients' information from the database for men who:
  
          -  Were confirmed by medical tests to have mCRPC
  
          -  Started first-line treatment with enzalutamide or abiraterone (index date) for mCRPC
  
          -  Had not received chemotherapy treatment before index date
  
          -  Were 18 years of age or older on index date
  
        Men who are part of this study will receive enzalutamide or abiraterone as part of their
        usual treatment for mCRPC.
  
        We will compare the following between men receiving enzalutamide and men receiving
        abiraterone:
  
          -  time from treatment start until death,
  
          -  treatment duration, and
  
          -  time to next treatment. This study will use patient information from the database until
             the end of information that is available.
  observational model: Cohort
  time perspective: Retrospective
  measure: Overall Survival
  time frame: Up to approximately 8 years
  description: Overall survival (OS) will be defined as the time from the initiation of enzalutamide or abiraterone to the date of death.
  measure: Overall survival among patients without subsequent therapy
  time frame: Up to approximately 8 years
  description: Overall survival (OS) among the subgroup of patients who received only enzalutamide without any subsequent therapy or received only abiraterone without any subsequent therapy.
  OS will be defined as the time from the initiation of enzalutamide or abiraterone (i.e., index date) to the date of death.
  measure: Treatment duration
  time frame: Up to approximately 8 years
  description: Treatment duration will be defined as the time from the initiation of enzalutamide or abiraterone to the discontinuation date. Discontinuation will be defined as the earliest of 1) death, 2) last abstracted end date for enzalutamide or abiraterone, or 3) day before the start of next line of therapy.
  measure: Time to subsequent therapy
  time frame: Up to approximately 8 years
  description: Time to subsequent therapy will be defined as the time from the initiation of enzalutamide or abiraterone to the start of next line of therapy.
  arm group label: Enzalutamide cohort
  description: Patients with mCRPC initiating enzalutamide
  arm group label: Abiraterone cohort
  description: Patients with mCRPC initiating abiraterone acetate
  intervention type: Drug
  intervention name: Enzalutamide
  description: As provided in real-world setting
  arm group label: Enzalutamide cohort
  other name: Xtandi
  intervention type: Drug
  intervention name: Abiraterone acetate
  description: As provided in real-world setting
  arm group label: Abiraterone cohort
  other name: Yonsa, Zytiga
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: Male
  gender based: Yes
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Pfizer CT.gov Call Center
  role: Study Director
  affiliation: Pfizer
  last name: Pfizer CT.gov Call Center
  phone: 1-800-718-1021
  email: ClinicalTrials.gov_Inquiries@pfizer.com
  facility: 
  country: United States
  responsible party type: Sponsor
  mesh term: Prostatic Neoplasms
  mesh term: Prostatic Neoplasms, Castration-Resistant
  mesh term: Abiraterone Acetate
  sharing ipd: No
  ipd description: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.