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/NCT06019676</url>
    </required_header>
    <id_info>
      <org_study_id>CCR5793</org_study_id>
      <nct_id>NCT06019676</nct_id>
    </id_info>
    <brief_title>Impact of Apalutamide in Metastatic Hormone Sensitive Prostate Cancer Patients</brief_title>
    <acronym>ADAPT-P</acronym>
    <official_title>Impact of Apalutamide in Metastatic Hormone Sensitive Prostate Cancer Patients, a Multicentre Prospective Observational Study</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Royal Marsden NHS Foundation Trust</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>Janssen, LP</agency>
        <agency_class>Industry</agency_class>
      </collaborator>
    </sponsors>
    <source>Royal Marsden NHS Foundation Trust</source>
    <oversight_info>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
      <is_us_export>No</is_us_export>
    </oversight_info>
    <brief_summary>
      <textblock>
        The ADAPT study is an observational study of apalutamide, which can be given to patients with&#xD;
        hormone sensitive metastatic prostate cancer as standard of care. The clinical decision for&#xD;
        patients to have apalutamide as part of their management plan will be decided by the&#xD;
        clinician. The patient will only be approached about the ADAPT study if they decide they want&#xD;
        to have apalutamide as part of their management.&#xD;
  &#xD;
        The aims of the ADAPT study include documenting the biochemical effectiveness, as determined&#xD;
        by the Prostate-Specific Antigen (PSA) and impact of apaluatmide on health related quality of&#xD;
        life. The blood test for PSA is regularly monitored as standard of care.&#xD;
  &#xD;
        Additionally, the impact of apalutamide on fatigue, cognitive function, patients reported&#xD;
        outcomes, health related quality of life will be evaluated using patient questionnaires&#xD;
        answered at defined timepoints. The questionnaires will be sent either electronically or via&#xD;
        post at week 12, 24, 36, 48, 72 and 104 weeks after commencement of apalutamide.&#xD;
  &#xD;
        Currently, the majority of data regarding tolerability and biochemical response to&#xD;
        apalutamide has been from large phase III trials, where there are strict eligibility&#xD;
        criteria. Real-world data as from the ADAPT study can provide valuable complementary data to&#xD;
        randomised controlled trials, which can be used to address the 'generalizability' limitations&#xD;
        of randomised control trials and can provide evidence on the external validity of their&#xD;
        findings. This information can advance knowledge of patterns of care, treatment effectiveness&#xD;
        and side-effects and inform clinical practice to improve outcomes.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 26, 2023</start_date>
    <completion_date type="Anticipated">April 1, 2027</completion_date>
    <primary_completion_date type="Anticipated">April 1, 2027</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>Undetectable PSA rate (defined as PSA &lt;0.2ng/ml by end of year 1 and year 2) in mHSPC patients receiving apalutamide</measure>
      <time_frame>August 2023 - April 2027</time_frame>
    </primary_outcome>
    <secondary_outcome>
      <measure>The impact of apalutamide on fatigue, assessed using patient-reported Brief Fatigue Inventory questionnaire</measure>
      <time_frame>August 2023 - April 2027</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>The impact of apalutamide on cognitive function, using patient-reported FACT-Cog questionnaire</measure>
      <time_frame>August 2023 - April 2027</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>The impact of apalutamide on health-related quality of life, using patient-reported EQ-5D-5L questionnaire</measure>
      <time_frame>August 2023 - April 2027</time_frame>
    </secondary_outcome>
    <other_outcome>
      <measure>Health care professional experience on the use of apalutamide, assessed using Health Care Professional Questionnaire</measure>
      <time_frame>August 2023 - April 2027</time_frame>
    </other_outcome>
    <number_of_groups>1</number_of_groups>
    <enrollment type="Anticipated">170</enrollment>
    <condition>Metastatic Hormone-Sensitive Prostate Cancer (mHSPC)</condition>
    <arm_group>
      <arm_group_label>Patients with mHSPC and treatment decision for apalutamide by clinician</arm_group_label>
    </arm_group>
    <eligibility>
      <study_pop>
        <textblock>
          Males 18 years of age or older, with metastatic hormone sensitive prostate cancer&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Male 18 years of age or older&#xD;
  &#xD;
            -  Histologically confirmed diagnosis of adenocarcinoma of the prostate with both:&#xD;
  &#xD;
            -  Metastatic hormone sensitive prostate cancer&#xD;
  &#xD;
            -  Treatment decision for apalutamide by clinician&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Non-metastatic prostate cancer&#xD;
  &#xD;
            -  Prior chemotherapy / abiraterone / apalutamide / darolutamide / enzalutamide for&#xD;
               prostate cancer&#xD;
  &#xD;
            -  Unable to complete patient reported outcome questionnaires&#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_official>
      <last_name>Julia Murray, Dr.</last_name>
      <role>Principal Investigator</role>
      <affiliation>The Royal Marsden Hospital, NHS Foundation Trust</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Greta Bucinskaite</last_name>
      <phone>+442031865157</phone>
      <email>greta.bucinskaite@rmh.nsh.uk</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Kelly Jones</last_name>
      <phone>+442031865157</phone>
      <email>kelly.jones@rmh.nhs.uk</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Northern Ireland Cancer Centre, Belfast Health &amp; Social Care Trust</name>
        <address>
          <city>Belfast</city>
          <zip>BT9 7AB</zip>
          <country>United Kingdom</country>
        </address>
      </facility>
      <contact>
        <last_name>Kathy Byrne</last_name>
        <email>kathy.byrne@belfasttrust.hscni.net</email>
      </contact>
      <investigator>
        <last_name>Laura Feeney, Dr.</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>Addenbrooke's Hospital, Cambridge University Hospitals NHS Foundation Trust</name>
        <address>
          <city>Cambridge</city>
          <zip>CB2 0QQ</zip>
          <country>United Kingdom</country>
        </address>
      </facility>
      <contact>
        <last_name>Amy Strong</last_name>
        <phone>+441223216083</phone>
        <email>amy.strong2@nhs.net</email>
      </contact>
      <investigator>
        <last_name>Danish Mazhar, Dr.</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>Velindre Cancer Centre, Velindre University NHS Trust</name>
        <address>
          <city>Cardiff</city>
          <zip>CF14 2TL</zip>
          <country>United Kingdom</country>
        </address>
      </facility>
      <contact>
        <last_name>Amanda Jackson</last_name>
        <email>amanda.jackson2@wales.nhs.uk</email>
      </contact>
      <investigator>
        <last_name>Elin S Evans, Dr.</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>Clatterbrdige Cancer Centre, NHS Foundation Trust</name>
        <address>
          <city>Liverpool</city>
          <zip>CH63 4JY</zip>
          <country>United Kingdom</country>
        </address>
      </facility>
      <contact>
        <last_name>Kathryn Hughes</last_name>
        <phone>+447955689143</phone>
        <email>ccf-tr.researchteam@nhs.net</email>
      </contact>
      <investigator>
        <last_name>Isabel Syndikus, Prof.</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>University College London Hospital, NHS Foundation Trust</name>
        <address>
          <city>London</city>
          <zip>NW1 2PG</zip>
          <country>United Kingdom</country>
        </address>
      </facility>
      <contact>
        <last_name>Sophie Short</last_name>
        <phone>+447852905911</phone>
        <email>sophie.short6@nhs.net</email>
      </contact>
      <investigator>
        <last_name>Reena Davda, Dr.</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>The James Cook University Hospital, South Tees Hospitals NHS Foundation Trust</name>
        <address>
          <city>Middlesbrough</city>
          <zip>TS4 3BW</zip>
          <country>United Kingdom</country>
        </address>
      </facility>
      <contact>
        <last_name>Claire Elliott</last_name>
        <phone>+4401642835568</phone>
        <email>claire.elliott4@nhs.net</email>
      </contact>
      <investigator>
        <last_name>Darren Leaning, Dr.</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>The Rosemere Cancer Centre, Lancashire Teaching Hospitals NHS Foundation Trust</name>
        <address>
          <city>Middlesbrough</city>
          <country>United Kingdom</country>
        </address>
      </facility>
      <contact>
        <last_name>Nina Vekaria</last_name>
        <phone>+441772528263</phone>
        <email>nina.vekaria@lthtr.nhs.uk</email>
      </contact>
      <investigator>
        <last_name>Omi Parikh, Dr.</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>Freeman Hospital, The Newcastle upon Tyne Hospitals NHS Foundation Trust</name>
        <address>
          <city>Newcastle</city>
          <zip>NE7 7DN</zip>
          <country>United Kingdom</country>
        </address>
      </facility>
      <contact>
        <last_name>Stuart Robertson</last_name>
        <email>stuart.robertson@nhs.net</email>
      </contact>
      <investigator>
        <last_name>Rachel Pearson, Dr.</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location_countries>
      <country>United Kingdom</country>
    </location_countries>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>August 17, 2023</study_first_submitted>
    <study_first_submitted_qc>August 25, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 31, 2023</study_first_posted>
    <last_update_submitted>September 14, 2023</last_update_submitted>
    <last_update_submitted_qc>September 14, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 15, 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>
    <!-- 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/NCT06019676
  org study id: CCR5793
  nct id: NCT06019676
  lead sponsor: 
  collaborator: 
  is fda regulated drug: No
  is fda regulated device: No
  is us export: No
  The ADAPT study is an observational study of apalutamide, which can be given to patients with
        hormone sensitive metastatic prostate cancer as standard of care. The clinical decision for
        patients to have apalutamide as part of their management plan will be decided by the
        clinician. The patient will only be approached about the ADAPT study if they decide they want
        to have apalutamide as part of their management.
  
        The aims of the ADAPT study include documenting the biochemical effectiveness, as determined
        by the Prostate-Specific Antigen (PSA) and impact of apaluatmide on health related quality of
        life. The blood test for PSA is regularly monitored as standard of care.
  
        Additionally, the impact of apalutamide on fatigue, cognitive function, patients reported
        outcomes, health related quality of life will be evaluated using patient questionnaires
        answered at defined timepoints. The questionnaires will be sent either electronically or via
        post at week 12, 24, 36, 48, 72 and 104 weeks after commencement of apalutamide.
  
        Currently, the majority of data regarding tolerability and biochemical response to
        apalutamide has been from large phase III trials, where there are strict eligibility
        criteria. Real-world data as from the ADAPT study can provide valuable complementary data to
        randomised controlled trials, which can be used to address the 'generalizability' limitations
        of randomised control trials and can provide evidence on the external validity of their
        findings. This information can advance knowledge of patterns of care, treatment effectiveness
        and side-effects and inform clinical practice to improve outcomes.
  observational model: Cohort
  time perspective: Prospective
  measure: Undetectable PSA rate (defined as PSA <0.2ng/ml by end of year 1 and year 2) in mHSPC patients receiving apalutamide
  time frame: August 2023 - April 2027
  measure: The impact of apalutamide on fatigue, assessed using patient-reported Brief Fatigue Inventory questionnaire
  time frame: August 2023 - April 2027
  measure: The impact of apalutamide on cognitive function, using patient-reported FACT-Cog questionnaire
  time frame: August 2023 - April 2027
  measure: The impact of apalutamide on health-related quality of life, using patient-reported EQ-5D-5L questionnaire
  time frame: August 2023 - April 2027
  measure: Health care professional experience on the use of apalutamide, assessed using Health Care Professional Questionnaire
  time frame: August 2023 - April 2027
  arm group label: Patients with mHSPC and treatment decision for apalutamide by clinician
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: Male
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Julia Murray, Dr.
  role: Principal Investigator
  affiliation: The Royal Marsden Hospital, NHS Foundation Trust
  last name: Greta Bucinskaite
  phone: +442031865157
  email: greta.bucinskaite@rmh.nsh.uk
  last name: Kelly Jones
  phone: +442031865157
  email: kelly.jones@rmh.nhs.uk
  facility: 
  contact: 
  investigator: 
  facility: 
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  country: United Kingdom
  responsible party type: Sponsor
  mesh term: Prostatic Neoplasms
  mesh term: Hypersensitivity