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/NCT06010914</url>
    </required_header>
    <id_info>
      <org_study_id>22523</org_study_id>
      <nct_id>NCT06010914</nct_id>
    </id_info>
    <brief_title>A Study to Learn More About How Safe Darolutamide is Under Real-world Conditions in Participants With Metastatic Hormone-Sensitive Prostate Cancer</brief_title>
    <acronym>DADOX</acronym>
    <official_title>Drug Use Investigation of Darolutamide in Addition to Standard Androgen Deprivation Therapy (ADT) and Docetaxel in Patients With Metastatic Hormone-sensitive Prostate Cancer (mHSPC)</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>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        This is an observational study in which only data are collected from participants receiving&#xD;
        their usual treatment.&#xD;
  &#xD;
        In this study, data will be collected and studied from men with metastatic hormone-sensitive&#xD;
        prostate cancer (mHSPC). Prostate cancer is a common cancer in men that starts in the&#xD;
        prostate gland, a male reproductive gland found below the bladder. Metastatic means that the&#xD;
        cancer has spread to other parts of the body. Hormone-sensitive means it can be treated with&#xD;
        hormone-therapy such as androgen deprivation therapy (ADT). ADT lowers the level of&#xD;
        testosterone, a male hormone, and slows down the growth of cancer cells.&#xD;
  &#xD;
        Men with mHSPC and who have been decided by their own doctors to be treated with darolutamide&#xD;
        in combination with ADT and docetaxel can join this study. Darolutamide works by blocking the&#xD;
        testosterone signals to slow the growth of the cancer cells. Docetaxel is a medicine used to&#xD;
        treat different types of cancer. It works by stopping the growth and spread of cancer cells.&#xD;
  &#xD;
        Darolutamide in combination with docetaxel and ADT is an approved treatment for men with&#xD;
        mHSPC. It was approved based on a study called ARASENS. More information is needed on how&#xD;
        safe darolutamide is when given with ADT and docetaxel in Japanese men with mHSPC.&#xD;
  &#xD;
        The main purpose of this study is to collect information about the safety of this combination&#xD;
        treatment in Japanese participants with mHSPC under real-world conditions.&#xD;
  &#xD;
        The main information that researchers will collect:&#xD;
  &#xD;
        Number and severity of heart-related medical problems participants have during the treatment&#xD;
  &#xD;
        Other information that researchers will collect:&#xD;
  &#xD;
        Number and severity of all medical problems participants have during the study&#xD;
  &#xD;
        Age and other information about the participants such as their illness, medical history, and&#xD;
        other medicines taken at the same time&#xD;
  &#xD;
        Treatment pattern of darolutamide such as the amount of medicine given, the duration for&#xD;
        which it is given, and any changes made to the treatment&#xD;
  &#xD;
        Data will be collected from August 2023 to July 2026. Researchers will observe participants&#xD;
        from the start of darolutamide treatment until 30 days after they receive their last dose of&#xD;
        docetaxel, which is expected to be approximately 6 months for each participant.&#xD;
  &#xD;
        In this study, data from regular health visits will be collected. No visits or tests are&#xD;
        required as part of this study.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">August 31, 2023</start_date>
    <completion_date type="Anticipated">January 31, 2027</completion_date>
    <primary_completion_date type="Anticipated">July 31, 2026</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>Number of participants with cardiac treatment-emergent adverse events (TEAEs)</measure>
      <time_frame>From the start of darolutamide treatment to 30 days after the last dose of docetaxel</time_frame>
      <description>Incidence of cardiac disorders (TEAEs based on MedDRA SOC), including severity, seriousness, onset date and outcome.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Outcomes of cardiac TEAEs</measure>
      <time_frame>From the start of darolutamide treatment to 30 days after the last dose of docetaxel</time_frame>
      <description>Causal relationship (i.e. if a specific AE is related to daroluatmide) between darolutamide and cardiac disorders.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Dose modifications due to cardiac TEAEs</measure>
      <time_frame>From the start of darolutamide treatment to 30 days after the last dose of docetaxel</time_frame>
      <description>Action taken related to darolutamide (dose modifications and time periods).</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Number of participants with adverse events (AEs)</measure>
      <time_frame>From the start of darolutamide treatment to 30 days after the last dose of docetaxel</time_frame>
      <description>Occurrence of AEs, including severity, seriousness, onset date and outcome. Adverse event (AE): Any untoward medical occurrence in a patient administered a pharmaceutical product and which does not necessarily have to have a causal relationship (association) with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the product, whether or not related to the product.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Patient demographics/characteristics</measure>
      <time_frame>From the start of darolutamide treatment to 30 days after the last dose of docetaxel</time_frame>
      <description>All background data such as patient demographics, diagnosis and prior treatment, past medical history, concomitant diseases, and concomitant medications.&#xD;
  Baseline characteristics (vital signs, Gleason Score, ECOG PS, PSA)&#xD;
  Prostate cancer history&#xD;
  Prior and ongoing Co-morbidities&#xD;
  Darolutamide, GnRH agonist/antagonist, docetaxel use:&#xD;
  Initiation and termination dates and reasons for ending treatment.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Descriptive summary of dosing patterns of darolutamide</measure>
      <time_frame>From the start of darolutamide treatment to 30 days after the last dose of docetaxel</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Outcomes of AEs</measure>
      <time_frame>From the start of darolutamide treatment to 30 days after the last dose of docetaxel</time_frame>
      <description>Causal relationship (i.e. if a specific AE is related to daroluatmide) between darolutamide and AE/ADR, and action taken related to darolutamide (dose modifications and time periods).</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Dose modifications due to AEs</measure>
      <time_frame>From the start of darolutamide treatment to 30 days after the last dose of docetaxel</time_frame>
      <description>Dosing patterns.</description>
    </secondary_outcome>
    <number_of_groups>1</number_of_groups>
    <enrollment type="Anticipated">100</enrollment>
    <condition>Metastatic Hormone-sensitive Prostate Cancer (mHSPC)</condition>
    <arm_group>
      <arm_group_label>mHSPC patients to treat with darolutamide in combination with docetaxel and ADT</arm_group_label>
      <description>Patients over the age of 18 years with a diagnosis of mHSPC and for whom a decision to treat with darolutamide in combination with docetaxel and ADT has been made by the treating physician before study enrollment.</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>No Intervention</intervention_name>
      <description>Following the manner of observational study, no intervention will be provided in the study.&#xD;
  The decision on the dose and duration of treatment is solely at the discretion of the treating physician, based on the recommendations written in the local product information.</description>
      <arm_group_label>mHSPC patients to treat with darolutamide in combination with docetaxel and ADT</arm_group_label>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          Male patients with a diagnosis of mHSPC will be enrolled after the decision for treatment&#xD;
          with darolutamide in combination with docetaxel and ADT has been made by the physician or a&#xD;
          delegate.&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Men over the age of 18 years&#xD;
  &#xD;
            -  Histologically or cytologically confirmed adenocarcinoma prostate cancer&#xD;
  &#xD;
            -  Metastatic disease confirmed either by a positive bone scan, or for soft tissue or&#xD;
               visceral metastases, either by contrast-enhanced abdominal/pelvic/chest computed&#xD;
               tomography (CT) or magnetic resonance imaging (MRI) scan&#xD;
  &#xD;
            -  Patients diagnosed with mHSPC by the investigator under routine clinical practice, and&#xD;
               must be judged appropriate for/decided to be treated with darolutamide plus ADT and&#xD;
               docetaxel therapy by the investigator under routine clinical practice&#xD;
  &#xD;
            -  ADT (GnRH agonist/antagonist or orchiectomy) before or simultaneous treatment with&#xD;
               darolutamide&#xD;
  &#xD;
            -  Signed informed consent&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Participation in an investigational program with interventions outside of routine&#xD;
               clinical practice&#xD;
  &#xD;
            -  Contraindications according to the local marketing authorization&#xD;
  &#xD;
            -  Previous treatment with darolutamide&#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>Many Locations</name>
        <address>
          <city>Multiple Locations</city>
          <country>Japan</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Japan</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 21, 2023</study_first_submitted>
    <study_first_submitted_qc>August 24, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 25, 2023</study_first_posted>
    <last_update_submitted>August 24, 2023</last_update_submitted>
    <last_update_submitted_qc>August 24, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 25, 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>
      <mesh_term>Hypersensitivity</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/NCT06010914
  org study id: 22523
  nct id: NCT06010914
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  This is an observational study in which only data are collected from participants receiving
        their usual treatment.
  
        In this study, data will be collected and studied from men with metastatic hormone-sensitive
        prostate cancer (mHSPC). Prostate cancer is a common cancer in men that starts in the
        prostate gland, a male reproductive gland found below the bladder. Metastatic means that the
        cancer has spread to other parts of the body. Hormone-sensitive means it can be treated with
        hormone-therapy such as androgen deprivation therapy (ADT). ADT lowers the level of
        testosterone, a male hormone, and slows down the growth of cancer cells.
  
        Men with mHSPC and who have been decided by their own doctors to be treated with darolutamide
        in combination with ADT and docetaxel can join this study. Darolutamide works by blocking the
        testosterone signals to slow the growth of the cancer cells. Docetaxel is a medicine used to
        treat different types of cancer. It works by stopping the growth and spread of cancer cells.
  
        Darolutamide in combination with docetaxel and ADT is an approved treatment for men with
        mHSPC. It was approved based on a study called ARASENS. More information is needed on how
        safe darolutamide is when given with ADT and docetaxel in Japanese men with mHSPC.
  
        The main purpose of this study is to collect information about the safety of this combination
        treatment in Japanese participants with mHSPC under real-world conditions.
  
        The main information that researchers will collect:
  
        Number and severity of heart-related medical problems participants have during the treatment
  
        Other information that researchers will collect:
  
        Number and severity of all medical problems participants have during the study
  
        Age and other information about the participants such as their illness, medical history, and
        other medicines taken at the same time
  
        Treatment pattern of darolutamide such as the amount of medicine given, the duration for
        which it is given, and any changes made to the treatment
  
        Data will be collected from August 2023 to July 2026. Researchers will observe participants
        from the start of darolutamide treatment until 30 days after they receive their last dose of
        docetaxel, which is expected to be approximately 6 months for each participant.
  
        In this study, data from regular health visits will be collected. No visits or tests are
        required as part of this study.
  observational model: Cohort
  time perspective: Prospective
  measure: Number of participants with cardiac treatment-emergent adverse events (TEAEs)
  time frame: From the start of darolutamide treatment to 30 days after the last dose of docetaxel
  description: Incidence of cardiac disorders (TEAEs based on MedDRA SOC), including severity, seriousness, onset date and outcome.
  measure: Outcomes of cardiac TEAEs
  time frame: From the start of darolutamide treatment to 30 days after the last dose of docetaxel
  description: Causal relationship (i.e. if a specific AE is related to daroluatmide) between darolutamide and cardiac disorders.
  measure: Dose modifications due to cardiac TEAEs
  time frame: From the start of darolutamide treatment to 30 days after the last dose of docetaxel
  description: Action taken related to darolutamide (dose modifications and time periods).
  measure: Number of participants with adverse events (AEs)
  time frame: From the start of darolutamide treatment to 30 days after the last dose of docetaxel
  description: Occurrence of AEs, including severity, seriousness, onset date and outcome. Adverse event (AE): Any untoward medical occurrence in a patient administered a pharmaceutical product and which does not necessarily have to have a causal relationship (association) with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the product, whether or not related to the product.
  measure: Patient demographics/characteristics
  time frame: From the start of darolutamide treatment to 30 days after the last dose of docetaxel
  description: All background data such as patient demographics, diagnosis and prior treatment, past medical history, concomitant diseases, and concomitant medications.
  Baseline characteristics (vital signs, Gleason Score, ECOG PS, PSA)
  Prostate cancer history
  Prior and ongoing Co-morbidities
  Darolutamide, GnRH agonist/antagonist, docetaxel use:
  Initiation and termination dates and reasons for ending treatment.
  measure: Descriptive summary of dosing patterns of darolutamide
  time frame: From the start of darolutamide treatment to 30 days after the last dose of docetaxel
  measure: Outcomes of AEs
  time frame: From the start of darolutamide treatment to 30 days after the last dose of docetaxel
  description: Causal relationship (i.e. if a specific AE is related to daroluatmide) between darolutamide and AE/ADR, and action taken related to darolutamide (dose modifications and time periods).
  measure: Dose modifications due to AEs
  time frame: From the start of darolutamide treatment to 30 days after the last dose of docetaxel
  description: Dosing patterns.
  arm group label: mHSPC patients to treat with darolutamide in combination with docetaxel and ADT
  description: Patients over the age of 18 years with a diagnosis of mHSPC and for whom a decision to treat with darolutamide in combination with docetaxel and ADT has been made by the treating physician before study enrollment.
  intervention type: Other
  intervention name: No Intervention
  description: Following the manner of observational study, no intervention will be provided in the study.
  The decision on the dose and duration of treatment is solely at the discretion of the treating physician, based on the recommendations written in the local product information.
  arm group label: mHSPC patients to treat with darolutamide in combination with docetaxel and ADT
  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: Japan
  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
  mesh term: Hypersensitivity
  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.