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/NCT06009549</url>
    </required_header>
    <id_info>
      <org_study_id>88079658</org_study_id>
      <nct_id>NCT06009549</nct_id>
    </id_info>
    <brief_title>A Journey Into Participation Patterns Among Metastatic Prostate Cancer Patients</brief_title>
    <official_title>Engagement Trends in Clinical Trials for Metastatic Prostate Cancer - A Journey Into Participation Patterns Among Individuals Affected by the Condition</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Power Life Sciences Inc.</agency>
        <agency_class>Industry</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Power Life Sciences Inc.</source>
    <oversight_info>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        Taking part in clinical trials usually favors a particular demographic group. But there is&#xD;
        limited research available to explain what trial attributes affect the completion of these&#xD;
        specific demographic groups.&#xD;
  &#xD;
        This research will admit a wide range of data on the clinical study experience of metastatic&#xD;
        prostate cancer patients to determine which factors prevail in limiting a patient's ability&#xD;
        to join or finish a trial.&#xD;
  &#xD;
        It will also try to analyze data from the perspective of different demographic groups to&#xD;
        check for recurring trends which might yield insights for the sake of future patients with&#xD;
        metastatic prostate cancer.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 2024</start_date>
    <completion_date type="Anticipated">September 2026</completion_date>
    <primary_completion_date type="Anticipated">September 2025</primary_completion_date>
    <study_type>Observational</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <observational_model>Case-Crossover</observational_model>
      <time_perspective>Prospective</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>Number of patients who decide to participate in a metastatic prostate cancer clinical research</measure>
      <time_frame>3 months</time_frame>
    </primary_outcome>
    <primary_outcome>
      <measure>Rate of patients who remain in metastatic prostate cancer clinical research to trial completion</measure>
      <time_frame>12 months</time_frame>
    </primary_outcome>
    <enrollment type="Anticipated">500</enrollment>
    <condition>Metastatic Prostate Cancer</condition>
    <eligibility>
      <study_pop>
        <textblock>
          Patients with metastatic prostate cancer who are actively considering enrolling in a&#xD;
          clinical study, but have not yet completed enrollment and randomization.&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Patient is at least 18 years of age&#xD;
  &#xD;
            -  Diagnosis of metastatic prostate cancer&#xD;
  &#xD;
            -  Ability to understand and the willingness to sign a written informed consent document&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Enrolled in another research study&#xD;
  &#xD;
            -  Patients with psychiatric illness/social situations that would limit compliance with&#xD;
               study requirements&#xD;
  &#xD;
            -  Inability to provide written informed consent&#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>Michael B Gill</last_name>
      <role>Study Director</role>
      <affiliation>Power Life Sciences Inc.</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Michael B Gill</last_name>
      <phone>4159004227</phone>
      <email>bask@withpower.com</email>
    </overall_contact>
    <location>
      <facility>
        <name>Power Life Sciences</name>
        <address>
          <city>San Francisco</city>
          <state>California</state>
          <zip>94107</zip>
          <country>United States</country>
        </address>
      </facility>
      <contact>
        <last_name>Michael B Gill</last_name>
        <phone>415-900-4227</phone>
        <email>https://www.withpower.com/contact-us@withpower.com</email>
      </contact>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <reference>
      <citation>Pouliot F, Beauregard JM, Saad F, Trudel D, Richard PO, Turcotte E, Rousseau E, Probst S, Kassouf W, Anidjar M, Camirand Lemyre F, Bouvet GF, Neveu B, Tetu A, Guerin B. The Triple-Tracer strategy against Metastatic PrOstate cancer (3TMPO) study protocol. BJU Int. 2022 Sep;130(3):314-322. doi: 10.1111/bju.15621. Epub 2021 Nov 11.</citation>
      <PMID>34674367</PMID>
    </reference>
    <reference>
      <citation>Vlaming M, Bleiker EMA, van Oort IM, Kiemeney LALM, Ausems MGEM. Mainstream germline genetic testing in men with metastatic prostate cancer: design and protocol for a multicenter observational study. BMC Cancer. 2022 Dec 30;22(1):1365. doi: 10.1186/s12885-022-10429-2.</citation>
      <PMID>36581909</PMID>
    </reference>
    <reference>
      <citation>Presti J Jr, Alexeeff S, Horton B, Prausnitz S, Avins AL. Changes in Prostate Cancer Presentation Following the 2012 USPSTF Screening Statement: Observational Study in a Multispecialty Group Practice. J Gen Intern Med. 2020 May;35(5):1368-1374. doi: 10.1007/s11606-019-05561-y. Epub 2019 Dec 9.</citation>
      <PMID>31820217</PMID>
    </reference>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 18, 2023</study_first_submitted>
    <study_first_submitted_qc>August 18, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 24, 2023</study_first_posted>
    <last_update_submitted>August 18, 2023</last_update_submitted>
    <last_update_submitted_qc>August 18, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 24, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>metastatic prostate cancer</keyword>
    <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>Undecided</sharing_ipd>
    </patient_data>
    <provided_document_section>
      <provided_document>
        <document_type>Informed Consent Form</document_type>
        <document_has_protocol>No</document_has_protocol>
        <document_has_icf>Yes</document_has_icf>
        <document_has_sap>No</document_has_sap>
        <document_date>August 18, 2023</document_date>
        <document_url>https://ClinicalTrials.gov/ProvidedDocs/49/NCT06009549/ICF_000.pdf</document_url>
      </provided_document>
    </provided_document_section>
    <!-- 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/NCT06009549
  org study id: 88079658
  nct id: NCT06009549
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  Taking part in clinical trials usually favors a particular demographic group. But there is
        limited research available to explain what trial attributes affect the completion of these
        specific demographic groups.
  
        This research will admit a wide range of data on the clinical study experience of metastatic
        prostate cancer patients to determine which factors prevail in limiting a patient's ability
        to join or finish a trial.
  
        It will also try to analyze data from the perspective of different demographic groups to
        check for recurring trends which might yield insights for the sake of future patients with
        metastatic prostate cancer.
  observational model: Case-Crossover
  time perspective: Prospective
  measure: Number of patients who decide to participate in a metastatic prostate cancer clinical research
  time frame: 3 months
  measure: Rate of patients who remain in metastatic prostate cancer clinical research to trial completion
  time frame: 12 months
  study pop: 
  sampling method: Probability Sample
  criteria: 
  gender: Male
  gender based: Yes
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Michael B Gill
  role: Study Director
  affiliation: Power Life Sciences Inc.
  last name: Michael B Gill
  phone: 4159004227
  email: bask@withpower.com
  facility: 
  contact: 
  country: United States
  citation: Pouliot F, Beauregard JM, Saad F, Trudel D, Richard PO, Turcotte E, Rousseau E, Probst S, Kassouf W, Anidjar M, Camirand Lemyre F, Bouvet GF, Neveu B, Tetu A, Guerin B. The Triple-Tracer strategy against Metastatic PrOstate cancer (3TMPO) study protocol. BJU Int. 2022 Sep;130(3):314-322. doi: 10.1111/bju.15621. Epub 2021 Nov 11.
  PMID: 34674367
  citation: Vlaming M, Bleiker EMA, van Oort IM, Kiemeney LALM, Ausems MGEM. Mainstream germline genetic testing in men with metastatic prostate cancer: design and protocol for a multicenter observational study. BMC Cancer. 2022 Dec 30;22(1):1365. doi: 10.1186/s12885-022-10429-2.
  PMID: 36581909
  citation: Presti J Jr, Alexeeff S, Horton B, Prausnitz S, Avins AL. Changes in Prostate Cancer Presentation Following the 2012 USPSTF Screening Statement: Observational Study in a Multispecialty Group Practice. J Gen Intern Med. 2020 May;35(5):1368-1374. doi: 10.1007/s11606-019-05561-y. Epub 2019 Dec 9.
  PMID: 31820217
  responsible party type: Sponsor
  mesh term: Prostatic Neoplasms
  sharing ipd: Undecided
  provided document: 