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/NCT05995236</url>
    </required_header>
    <id_info>
      <org_study_id>019.NMD.2022.D</org_study_id>
      <nct_id>NCT05995236</nct_id>
    </id_info>
    <brief_title>Prostate-Specific Membrane Antigen (PSMA) Radionuclide Therapy</brief_title>
    <official_title>Prostate-Specific Membrane Antigen (PSMA) Radionuclide Therapy for the Treatment of Metastatic Castration-Resistant Prostate Cancer</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Methodist Health System</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Methodist Health System</source>
    <oversight_info>
      <has_dmc>Yes</has_dmc>
      <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>
        This study is a single-center registry study collecting clinical data regarding the treatment&#xD;
        of PSMA-positive metastatic castration-resistant prostate cancer treated with PSMA&#xD;
        radionuclide therapy per the treating physician's discretion. Clinical data from candidates&#xD;
        for or who undergo the PSMA procedure at Methodist Dallas Medical Center from August 2022 to&#xD;
        August 2027 will be collected after discharge and patients will undergo clinical follow-up&#xD;
        per the treating physician's discretion.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        This study is a single-center registry study collecting clinical data regarding the treatment&#xD;
        of PSMA-positive metastatic castration-resistant prostate cancer treated with PSMA&#xD;
        radionuclide therapy per the treating physician's discretion. Clinical data from candidates&#xD;
        for or who undergo the PSMA procedure at Methodist Dallas Medical Center from August 2022 to&#xD;
        August 2027 will be collected after discharge and patients will undergo clinical follow-up&#xD;
        per the treating physician's discretion.&#xD;
  &#xD;
        Participants will be followed for two years following the first PSMA procedure. During these&#xD;
        visits, participants will also be asked to report any change in their medications.&#xD;
        Participants will not need to visit the study doctor more often than their usual treatment&#xD;
        unless they have other medical needs. However, if participants experience any significant&#xD;
        change in their medical condition they may be asked to have additional tests such as computed&#xD;
        tomography (CT) scans, blood tests, etc.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">August 2, 2023</start_date>
    <completion_date type="Anticipated">August 2, 2024</completion_date>
    <primary_completion_date type="Anticipated">August 2, 2024</primary_completion_date>
    <study_type>Observational</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <observational_model>Other</observational_model>
      <time_perspective>Other</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>collect clinical data related to treatment of PSMA-positive metastatic castration-resistant prostate cancer</measure>
      <time_frame>Clinical data from candidates for or who undergo the PSMA procedure at Methodist Dallas Medical Center from August 2022 to August 2027 will be collected after discharge and patients will undergo clinical follow-up per the treating physician's discretion</time_frame>
      <description>To collect clinical data related to patient characteristics, treatment responses and survival outcomes related to the treatment of PSMA-positive metastatic castration-resistant prostate cancer treated with PSMA radionuclide therapy</description>
    </primary_outcome>
    <enrollment type="Anticipated">400</enrollment>
    <condition>PSMA-positive Metastatic Castration-resistant Prostate Cancer Treated With PSMA Radionuclide Therapy</condition>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>PSMA radionuclide therapy</intervention_name>
      <description>Collect clinical data related to treatment of PSMA-positive metastatic castration-resistant prostate cancer treated with PSMA radionuclide therapy</description>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          The plan for Methodist Dallas Medical Center will be to collect data from 10-20 patients&#xD;
          with PSMA-positive metastatic castration-resistant prostate cancer per year for anticipated&#xD;
          50-100 total patients over the next five years. We estimated this number based on the&#xD;
          number of patient with prostate cancer treated within Methodist Heath System.&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  1. &gt;18 years of age&#xD;
  &#xD;
            -  2. Diagnosed with PSMA-positive metastatic castration-resistant prostate cancer and -&#xD;
               has consented to undergo PSMA nuclear therapy per the treating physician.&#xD;
               Specifically:&#xD;
  &#xD;
                 -  Metastatic or Locally Advanced AND Inoperable&#xD;
  &#xD;
                 -  Clear disease progression on PSMA-PET/CT&#xD;
  &#xD;
                 -  PSMA-PET/CT scan positive disease within 6 weeks&#xD;
  &#xD;
                 -  Labs:&#xD;
  &#xD;
                      -  Hemoglobin: &gt;8 g/dL&#xD;
  &#xD;
                      -  White blood cell count: &gt;2K cells/µL&#xD;
  &#xD;
                      -  Platelet (Thrombocyte) count: &gt;75 x 109/L&#xD;
  &#xD;
                 -  No prior therapy with Radium-223 Dichloride&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Patients who do not meet the Inclusion Criteria laid out in section 4.2 will be&#xD;
               excluded from the study.&#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>Alexandru Bageac, MD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Methodist Health System</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Kavya Vinod Mankulangara, PharmD</last_name>
      <phone>(214) 947-74604</phone>
      <email>clinicalresearch@mhd.com</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Bethany Brauer, MPH</last_name>
      <phone>(214) 947-4459</phone>
      <email>clinicalresearch@mhd.com</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Methodist Dallas Medical Center</name>
        <address>
          <city>Dallas</city>
          <state>Texas</state>
          <zip>75203</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Colette N Ngo Ndjom, MS</last_name>
        <phone>214-947-1289</phone>
        <phone_ext>71289</phone_ext>
        <email>mhsirb@mhd.com</email>
      </contact>
      <contact_backup>
        <last_name>Loretta W Bedell, MPH</last_name>
        <phone>217-947-4680</phone>
        <phone_ext>74680</phone_ext>
        <email>mhsirb@mhd.com</email>
      </contact_backup>
      <investigator>
        <last_name>Alejandro Bageac, MD</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 9, 2023</study_first_submitted>
    <study_first_submitted_qc>August 9, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 16, 2023</study_first_posted>
    <last_update_submitted>August 9, 2023</last_update_submitted>
    <last_update_submitted_qc>August 9, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 16, 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>
    <patient_data>
      <sharing_ipd>Undecided</sharing_ipd>
    </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/NCT05995236
  org study id: 019.NMD.2022.D
  nct id: NCT05995236
  lead sponsor: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  is us export: No
  This study is a single-center registry study collecting clinical data regarding the treatment
        of PSMA-positive metastatic castration-resistant prostate cancer treated with PSMA
        radionuclide therapy per the treating physician's discretion. Clinical data from candidates
        for or who undergo the PSMA procedure at Methodist Dallas Medical Center from August 2022 to
        August 2027 will be collected after discharge and patients will undergo clinical follow-up
        per the treating physician's discretion.
  This study is a single-center registry study collecting clinical data regarding the treatment
        of PSMA-positive metastatic castration-resistant prostate cancer treated with PSMA
        radionuclide therapy per the treating physician's discretion. Clinical data from candidates
        for or who undergo the PSMA procedure at Methodist Dallas Medical Center from August 2022 to
        August 2027 will be collected after discharge and patients will undergo clinical follow-up
        per the treating physician's discretion.
  
        Participants will be followed for two years following the first PSMA procedure. During these
        visits, participants will also be asked to report any change in their medications.
        Participants will not need to visit the study doctor more often than their usual treatment
        unless they have other medical needs. However, if participants experience any significant
        change in their medical condition they may be asked to have additional tests such as computed
        tomography (CT) scans, blood tests, etc.
  observational model: Other
  time perspective: Other
  measure: collect clinical data related to treatment of PSMA-positive metastatic castration-resistant prostate cancer
  time frame: Clinical data from candidates for or who undergo the PSMA procedure at Methodist Dallas Medical Center from August 2022 to August 2027 will be collected after discharge and patients will undergo clinical follow-up per the treating physician's discretion
  description: To collect clinical data related to patient characteristics, treatment responses and survival outcomes related to the treatment of PSMA-positive metastatic castration-resistant prostate cancer treated with PSMA radionuclide therapy
  intervention type: Drug
  intervention name: PSMA radionuclide therapy
  description: Collect clinical data related to treatment of PSMA-positive metastatic castration-resistant prostate cancer treated with PSMA radionuclide therapy
  study pop: 
  sampling method: Probability Sample
  criteria: 
  gender: Male
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Alexandru Bageac, MD
  role: Principal Investigator
  affiliation: Methodist Health System
  last name: Kavya Vinod Mankulangara, PharmD
  phone: (214) 947-74604
  email: clinicalresearch@mhd.com
  last name: Bethany Brauer, MPH
  phone: (214) 947-4459
  email: clinicalresearch@mhd.com
  facility: 
  status: Recruiting
  contact: 
  contact backup: 
  investigator: 
  country: United States
  responsible party type: Sponsor
  mesh term: Prostatic Neoplasms
  sharing ipd: Undecided