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/NCT06031805</url>
    </required_header>
    <id_info>
      <org_study_id>D0817R00049</org_study_id>
      <nct_id>NCT06031805</nct_id>
    </id_info>
    <brief_title>PRostate Olaparib Real World Evidence Study</brief_title>
    <acronym>PROWESs</acronym>
    <official_title>a French Observational Prospective Multicenter Study of Adult Patients Treated in the Real-life Setting With Olaparib for the Treatment of Metastatic Castration-resistant Prostate Cancer</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>AstraZeneca</agency>
        <agency_class>Industry</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>AstraZeneca</source>
    <brief_summary>
      <textblock>
        This French non-interventional prospective multicenter cohort study is conducted to study the&#xD;
        added value of olaparib in the treatment of patients with mCRPC in the real world setting in&#xD;
        terms of treatment sequencing, effectiveness, safety and BRCA testing patterns and thus&#xD;
        inform future clinical practice.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">October 13, 2023</start_date>
    <completion_date type="Anticipated">October 13, 2028</completion_date>
    <primary_completion_date type="Anticipated">October 13, 2028</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>Time to treatment discontinuation (TTD)</measure>
      <time_frame>Up to 36 months from olaparib initiation</time_frame>
      <description>TTD is defined as the time from the first day of olaparib treatment to the day that olaparib stopped for whatever reason or the date of death due to any cause, whichever comes first</description>
    </primary_outcome>
    <enrollment type="Anticipated">300</enrollment>
    <condition>Metastatic Castration-resistant Prostate Cancer</condition>
    <eligibility>
      <study_pop>
        <textblock>
          Adult male patients with metastatic castration-resistant prostate cancer who have initiated&#xD;
          olaparib or for whom the decision to be treated with olaparib has been made by their&#xD;
          physician.&#xD;
  &#xD;
          A sample of approximately 300 patients is expected to be enrolled from around 60 french&#xD;
          sites.&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Adult male patients (≥ 18 years old)&#xD;
  &#xD;
            -  With metastatic castration-resistant prostate cancer - Who have initiated olaparib&#xD;
               within the last two months of study entry, or for whom the decision to be treated with&#xD;
               olaparib has been made by their physician&#xD;
  &#xD;
            -  Who have been informed and are not opposed to this data collection&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Patients opposed to the collection of their data&#xD;
  &#xD;
            -  Patients participating in a clinical trial with an investigational prostate cancer&#xD;
               targeted drug within 30 days prior to Olaparib initiation&#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>AstraZeneca Clinical Study Information Center</last_name>
      <phone>1-877-240-9479</phone>
      <email>information.center@astrazeneca.com</email>
    </overall_contact>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>September 4, 2023</study_first_submitted>
    <study_first_submitted_qc>September 4, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 11, 2023</study_first_posted>
    <last_update_submitted>September 4, 2023</last_update_submitted>
    <last_update_submitted_qc>September 4, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 11, 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>
    <!-- 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/NCT06031805
  org study id: D0817R00049
  nct id: NCT06031805
  lead sponsor: 
  This French non-interventional prospective multicenter cohort study is conducted to study the
        added value of olaparib in the treatment of patients with mCRPC in the real world setting in
        terms of treatment sequencing, effectiveness, safety and BRCA testing patterns and thus
        inform future clinical practice.
  observational model: Cohort
  time perspective: Prospective
  measure: Time to treatment discontinuation (TTD)
  time frame: Up to 36 months from olaparib initiation
  description: TTD is defined as the time from the first day of olaparib treatment to the day that olaparib stopped for whatever reason or the date of death due to any cause, whichever comes first
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: Male
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: AstraZeneca Clinical Study Information Center
  phone: 1-877-240-9479
  email: information.center@astrazeneca.com
  responsible party type: Sponsor
  mesh term: Prostatic Neoplasms