<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/NCT03247010</url>
  </required_header>
  <id_info>
    <org_study_id>Radium-Trombocyt</org_study_id>
    <nct_id>NCT03247010</nct_id>
  </id_info>
  <brief_title>Bone Marrow Suppression and Recovery During Radionuclide Treatment</brief_title>
  <official_title>Characterization of Bone Marrow Suppression and Recovery During Radionuclide Treatment Using Functional Tests of Thrombocytes and Hemostasis</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>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Radium-223-dichloride is approved therapy for patients with metastatic castration-resistant&#xD;
      prostate cancer and bone metastases. More than 20 % of patients treated at Rigshospitalet&#xD;
      develop bone marrow suppression as a side effect to Radium therapy The aim of the study is to&#xD;
      examine biomarkers of bone marrow suppression and recovery during Radium therapy as well as&#xD;
      markers of bone remodeling.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Radium-223-dichloride is approved therapy for patients with metastatic castration-resistant&#xD;
      prostate cancer and bone metastases. Therapy is administered intravenously every 4 weeks for&#xD;
      up to 6 cycles. More than 20 % of patients treated at Rigshospitalet develop bone marrow&#xD;
      suppression as a side effect to Radium therapy, which delays or excludes the patient from&#xD;
      further oncological therapy. Especially thrombocytopenia is a frequent side-effect and can be&#xD;
      long lasting.&#xD;
&#xD;
      The aim of the study is to examine whether biomarkers of bone marrow recovery (immature&#xD;
      platelets, platelet volume, reticulocytes, red cell distribution width) can predict&#xD;
      development of hematological toxicity during Radium therapy. Furthermore, to investigate&#xD;
      whether these biomarkers can predict recovery from toxicity in patients who develop bone&#xD;
      marrow suppression during therapy.&#xD;
&#xD;
      A secondary aim of the study is to evaluate whether dynamics in biomarkers of bone remodeling&#xD;
      during Radium therapy is correlated to overall survival and time to symptomatic skeletal&#xD;
      event. Optimally these biomarkers can aid in monitoring therapy.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 20, 2017</start_date>
  <completion_date type="Actual">October 1, 2020</completion_date>
  <primary_completion_date type="Actual">October 1, 2019</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>Thrombocytopenia</measure>
    <time_frame>Within 1 year from inclusion</time_frame>
    <description>CTCAE grade 1-5</description>
  </primary_outcome>
  <primary_outcome>
    <measure>OS</measure>
    <time_frame>within 1 year from inclusion</time_frame>
    <description>Survival from first Radium-223</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Bone markers</measure>
    <time_frame>Within 12 months from inclusion</time_frame>
    <description>Changes in bone metabolic markers during Radium-223</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Leucopenia</measure>
    <time_frame>Within 1 year from inclusion</time_frame>
    <description>CTCAE grade 1-5</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Anemia</measure>
    <time_frame>Within 1 year from inclusion</time_frame>
    <description>CTCAE grade 3-5</description>
  </secondary_outcome>
  <enrollment type="Actual">68</enrollment>
  <condition>Castration-resistant Prostate Cancer</condition>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Blood sampling</intervention_name>
    <description>Blood samples are taken before each cycle of Radium 223</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients with metastatic castration-resistant prostate cancer, who initiate therapy with&#xD;
        Radium-223 at Rigshospitalet, Copenhagen, Denmark&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Metastatic castration resistant prostate cancer&#xD;
&#xD;
          -  Planned to initiate Radium therapy&#xD;
&#xD;
          -  Age &gt; 18 years&#xD;
&#xD;
          -  Able to understand study protocol and give informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  None&#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>Jann Ø Mortensen, DMSc</last_name>
    <role>Study Director</role>
    <affiliation>Rigshospitalet, Department of Clinical Physiology, Nuclear Medicine &amp; PET</affiliation>
  </overall_official>
  <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>November 2022</verification_date>
  <study_first_submitted>August 7, 2017</study_first_submitted>
  <study_first_submitted_qc>August 10, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 11, 2017</study_first_posted>
  <last_update_submitted>November 4, 2022</last_update_submitted>
  <last_update_submitted_qc>November 4, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">November 9, 2022</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, PhD student</investigator_title>
  </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>


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/NCT03247010
org study id: Radium-Trombocyt
nct id: NCT03247010
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Radium-223-dichloride is approved therapy for patients with metastatic castration-resistant
      prostate cancer and bone metastases. More than 20 % of patients treated at Rigshospitalet
      develop bone marrow suppression as a side effect to Radium therapy The aim of the study is to
      examine biomarkers of bone marrow suppression and recovery during Radium therapy as well as
      markers of bone remodeling.
Radium-223-dichloride is approved therapy for patients with metastatic castration-resistant
      prostate cancer and bone metastases. Therapy is administered intravenously every 4 weeks for
      up to 6 cycles. More than 20 % of patients treated at Rigshospitalet develop bone marrow
      suppression as a side effect to Radium therapy, which delays or excludes the patient from
      further oncological therapy. Especially thrombocytopenia is a frequent side-effect and can be
      long lasting.

      The aim of the study is to examine whether biomarkers of bone marrow recovery (immature
      platelets, platelet volume, reticulocytes, red cell distribution width) can predict
      development of hematological toxicity during Radium therapy. Furthermore, to investigate
      whether these biomarkers can predict recovery from toxicity in patients who develop bone
      marrow suppression during therapy.

      A secondary aim of the study is to evaluate whether dynamics in biomarkers of bone remodeling
      during Radium therapy is correlated to overall survival and time to symptomatic skeletal
      event. Optimally these biomarkers can aid in monitoring therapy.
observational model: Cohort
time perspective: Prospective
measure: Thrombocytopenia
time frame: Within 1 year from inclusion
description: CTCAE grade 1-5
measure: OS
time frame: within 1 year from inclusion
description: Survival from first Radium-223
measure: Bone markers
time frame: Within 12 months from inclusion
description: Changes in bone metabolic markers during Radium-223
measure: Leucopenia
time frame: Within 1 year from inclusion
description: CTCAE grade 1-5
measure: Anemia
time frame: Within 1 year from inclusion
description: CTCAE grade 3-5
intervention type: Other
intervention name: Blood sampling
description: Blood samples are taken before each cycle of Radium 223
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: Male
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Jann Ø Mortensen, DMSc
role: Study Director
affiliation: Rigshospitalet, Department of Clinical Physiology, Nuclear Medicine & PET
facility: 
country: Denmark
responsible party type: Principal Investigator
investigator affiliation: Rigshospitalet, Denmark
investigator full name: Marie Øbro Fosbøl
investigator title: MD, PhD student
mesh term: Prostatic Neoplasms
sharing ipd: Undecided