<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/NCT03011749</url>
  </required_header>
  <id_info>
    <org_study_id>H1603551</org_study_id>
    <nct_id>NCT03011749</nct_id>
  </id_info>
  <brief_title>Value of FLT PET/CT in Radium-223 Therapy of mCRPC Patients</brief_title>
  <official_title>Value of FLT PET/CT in Radium-223 Therapy of Patients With Metastatic Castration-resistant Prostate Cancer</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Rigshospitalet, Denmark</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Rigshospitalet, Denmark</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The aim of the study is to investigate whether positron emission tomography (PET) using the&#xD;
      tracer 18F-Fluorothymidine (FLT) can provide information on proliferative activity in bone&#xD;
      marrow of patients receiving Radium 223 therapy and potentially be a predictive marker of&#xD;
      hematological toxicity&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Terminated</overall_status>
  <start_date>January 2017</start_date>
  <completion_date type="Actual">February 2018</completion_date>
  <primary_completion_date type="Actual">February 2018</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Diagnostic</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Uptake of FLT in hematological bone marrow</measure>
    <time_frame>3 months</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Occurrence of hematological toxicity</measure>
    <time_frame>12 months</time_frame>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">6</enrollment>
  <condition>Metastatic Prostate Carcinoma</condition>
  <arm_group>
    <arm_group_label>FLT PET/CT</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>FLT PET/CT</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>FLT PET/CT</intervention_name>
    <description>FLT PET/CT before first series of Radium-223 and after 2 series</description>
    <arm_group_label>FLT PET/CT</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Metastatic castration resistant prostate cancer&#xD;
&#xD;
          -  Eligible for Radium-223 therapy&#xD;
&#xD;
          -  Informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Inability to understand study protocol&#xD;
&#xD;
          -  Extensive metastatic involvement of the axial skeleton (&quot;superscan&quot; on bone&#xD;
             scintigraphy)&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Rigshospitalet</name>
      <address>
        <city>Copenhagen</city>
        <zip>2100</zip>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Denmark</country>
  </location_countries>
  <verification_date>September 2019</verification_date>
  <study_first_submitted>January 4, 2017</study_first_submitted>
  <study_first_submitted_qc>January 4, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 5, 2017</study_first_posted>
  <last_update_submitted>September 10, 2019</last_update_submitted>
  <last_update_submitted_qc>September 10, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">September 12, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Rigshospitalet, Denmark</investigator_affiliation>
    <investigator_full_name>Marie Øbro Fosbøl</investigator_full_name>
    <investigator_title>MD</investigator_title>
  </responsible_party>
  <keyword>Radium-223 therapy</keyword>
  <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>


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/NCT03011749
org study id: H1603551
nct id: NCT03011749
lead sponsor: 
has dmc: No
The aim of the study is to investigate whether positron emission tomography (PET) using the
      tracer 18F-Fluorothymidine (FLT) can provide information on proliferative activity in bone
      marrow of patients receiving Radium 223 therapy and potentially be a predictive marker of
      hematological toxicity
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Diagnostic
masking: None (Open Label)
measure: Uptake of FLT in hematological bone marrow
time frame: 3 months
measure: Occurrence of hematological toxicity
time frame: 12 months
arm group label: FLT PET/CT
arm group type: Experimental
description: FLT PET/CT
intervention type: Other
intervention name: FLT PET/CT
description: FLT PET/CT before first series of Radium-223 and after 2 series
arm group label: FLT PET/CT
criteria: 
gender: Male
minimum age: N/A
maximum age: N/A
healthy volunteers: No
facility: 
country: Denmark
responsible party type: Principal Investigator
investigator affiliation: Rigshospitalet, Denmark
investigator full name: Marie Øbro Fosbøl
investigator title: MD
mesh term: Prostatic Neoplasms