<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/NCT02998242</url>
  </required_header>
  <id_info>
    <org_study_id>ARCAP</org_study_id>
    <nct_id>NCT02998242</nct_id>
  </id_info>
  <brief_title>Apatinib in Combination With Stereotactic Body Radiation Therapy (SBRT) Treatment for Symptomatic Metastatic Prostate Cancer</brief_title>
  <acronym>ARCAP</acronym>
  <official_title>Apatinib in Combination With SBRT Treatment for Symptomatic Metastatic</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Sichuan Provincial People's Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Chang'An Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Hainan Medical College</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Sichuan Provincial People's Hospital</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      To study safety and efficacy of apatinib in combination of radiotherapy in patients with&#xD;
      symptomatic bony disease prostate cancer (SBPC), based on the potential synergistic antitumor&#xD;
      activity between Apatinib and Stereotactic Body Radiation Therapy (SBRT).&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">May 10, 2016</start_date>
  <completion_date type="Actual">December 10, 2017</completion_date>
  <primary_completion_date type="Actual">January 5, 2017</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>biochemical disease free survival</measure>
    <time_frame>2 years</time_frame>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">40</enrollment>
  <condition>Quality of Life</condition>
  <arm_group>
    <arm_group_label>RT alone</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>symptomatic bony metastatic site(s) receive SBRT less than 5 fractions</description>
  </arm_group>
  <arm_group>
    <arm_group_label>RT with apatinib</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>selected dose administered PO during and after SBRT</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Apatinib</intervention_name>
    <arm_group_label>RT with apatinib</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Radiation</intervention_type>
    <intervention_name>SBRT to symptomatic bony metastatic bony site(s)</intervention_name>
    <arm_group_label>RT alone</arm_group_label>
    <arm_group_label>RT with apatinib</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Histologic diagnosis of adenocarcinoma of the prostate&#xD;
&#xD;
          -  Metastatic and symptomatic prostate cancer (positive bone scan or measurable disease)&#xD;
&#xD;
          -  Patients must stop using any herbal product known to decrease PSA levels (eg., saw&#xD;
             palmetto and PC-SPES) or any systemic or topical corticosteroid at least 4 weeks prior&#xD;
             to screening. Progressive disease must be documented after discontinuation of these&#xD;
             products.&#xD;
&#xD;
          -  Progressive disease after androgen deprivation (or hormone therapy). For patients with&#xD;
             measurable disease, progression will be defined by Response Evaluation Criteria in&#xD;
             Solid Tumors (RECIST) criteria. For patients with progression in, or without any&#xD;
             measurable disease, a positive bone scan and elevated PSA will be required.&#xD;
&#xD;
          -  Patients receiving bisphosphate therapy must have been on stable doses for at least 4&#xD;
             weeks with stable symptoms prior to enrollment.&#xD;
&#xD;
          -  No prior chemotherapy or immunotherapy (tumor vaccine, cytokine, or growth factor&#xD;
             given to control prostate cancer).&#xD;
&#xD;
          -  Prior radiation therapy completed at least 4 weeks prior to enrollment. No prior&#xD;
             radiopharmaceuticals (strontium, samarium) within 8 weeks prior to enrollment.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  History of severe hypersensitivity reactions to drugs formulated with polysorbate 80.&#xD;
&#xD;
          -  Patients with active autoimmune disease or a history of autoimmune disease that&#xD;
             required systemic steroids or immunosuppressive medications, except for patients with&#xD;
             vitiligo.&#xD;
&#xD;
          -  Prior therapy with any anti-cytotoxic T-lymphocyte antigen 4 (anti-CTLA-4) antibody.&#xD;
&#xD;
          -  Active infection requiring therapy.&#xD;
&#xD;
          -  Concurrent medical condition requiring the use of systemic or topical corticosteroids;&#xD;
             systemic or topical corticosteroids must be discontinued at least 4 weeks prior to&#xD;
             enrollment. The use of inhaled corticosteroids is acceptable.&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>90 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <verification_date>May 2019</verification_date>
  <study_first_submitted>December 12, 2016</study_first_submitted>
  <study_first_submitted_qc>December 15, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 20, 2016</study_first_posted>
  <last_update_submitted>May 20, 2019</last_update_submitted>
  <last_update_submitted_qc>May 20, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">May 21, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Sichuan Provincial People's Hospital</investigator_affiliation>
    <investigator_full_name>ming zeng, MD</investigator_full_name>
    <investigator_title>Director of Cancer Center</investigator_title>
  </responsible_party>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Apatinib</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Yes</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/NCT02998242
org study id: ARCAP
nct id: NCT02998242
lead sponsor: 
collaborator: 
collaborator: 
has dmc: Yes
To study safety and efficacy of apatinib in combination of radiotherapy in patients with
      symptomatic bony disease prostate cancer (SBPC), based on the potential synergistic antitumor
      activity between Apatinib and Stereotactic Body Radiation Therapy (SBRT).
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Investigator)
measure: biochemical disease free survival
time frame: 2 years
arm group label: RT alone
arm group type: Active Comparator
description: symptomatic bony metastatic site(s) receive SBRT less than 5 fractions
arm group label: RT with apatinib
arm group type: Experimental
description: selected dose administered PO during and after SBRT
intervention type: Drug
intervention name: Apatinib
arm group label: RT with apatinib
intervention type: Radiation
intervention name: SBRT to symptomatic bony metastatic bony site(s)
arm group label: RT alone
arm group label: RT with apatinib
criteria: 
gender: Male
minimum age: 18 Years
maximum age: 90 Years
healthy volunteers: No
responsible party type: Principal Investigator
investigator affiliation: Sichuan Provincial People's Hospital
investigator full name: ming zeng, MD
investigator title: Director of Cancer Center
mesh term: Apatinib
sharing ipd: Yes