<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/NCT02250014</url>
  </required_header>
  <id_info>
    <org_study_id>14-0071.cc</org_study_id>
    <secondary_id>14-0071</secondary_id>
    <nct_id>NCT02250014</nct_id>
  </id_info>
  <brief_title>The Immuno-Response to Primary Cryotherapy for the Treatment of Prostate Cancer</brief_title>
  <official_title>The Immuno-Response to Primary Cryotherapy for the Treatment of Prostate Cancer</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Colorado, Denver</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>EDAP TMS S.A.</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Colorado, Denver</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This randomized pilot phase I trial studies how well sargramostim after cryotherapy works in&#xD;
      treating patients with prostate cancer. Biological therapies, such as sargramostim, use&#xD;
      substances made from living organisms that may stimulate the immune system in different ways&#xD;
      and stop tumor cells from growing. Cryosurgery, also known as cryotherapy, kills tumor cells&#xD;
      by freezing them. Giving sargramostim after cryotherapy may work better in treating prostate&#xD;
      cancer.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      PRIMARY OBJECTIVES:&#xD;
&#xD;
      I. Determine an unknown normal immune response (T cell and B cell) to post-cryotherapy&#xD;
      treatment for prostate cancer.&#xD;
&#xD;
      II. Detect the altered immune response (T cell and B cell) post-GM-CSF (sargramostim)&#xD;
      response and post-cryotherapy for the prostate cancer.&#xD;
&#xD;
      Patients are randomized to 1 of 2 treatment arms.&#xD;
&#xD;
      ARM I (TREATMENT): Patients undergo cryotherapy on day 0 and receive sargramostim&#xD;
      subcutaneously (SC) on days 1, 3, 5, 8, 10, and 12.&#xD;
&#xD;
      ARM II (CONTROL): Patients undergo cryotherapy on day 0.&#xD;
&#xD;
      After completion of study treatment, patients are followed up for 6 months.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 5, 2015</start_date>
  <completion_date type="Actual">December 21, 2020</completion_date>
  <primary_completion_date type="Actual">December 1, 2017</primary_completion_date>
  <phase>Phase 1</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in B cell response identified by Serametrix assay</measure>
    <time_frame>Baseline to up to 3 months after cryotherapy</time_frame>
    <description>A scatter plot of each cytokine and antigen level will be created for each patient by marker to observe the behavior of the markers (rising, falling, flat, or combination over time). Patient specific pre-operative levels will be used to obtain individual baseline measures from which the difference in follow-up cytokine and antigen levels will be calculated, then a simple descriptive comparison of the mean elevation in the markers' levels across cohorts will be graphed.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in T cell responses identified by Intracellular cytokine assay and enzyme-linked immunospot</measure>
    <time_frame>Baseline to up to 3 months after cryotherapy</time_frame>
    <description>A scatter plot of each cytokine and antigen level will be created for each patient by marker to observe the behavior of the markers (rising, falling, flat, or combination over time). Patient specific pre-operative levels will be used to obtain individual baseline measures from which the difference in follow-up cytokine and antigen levels will be calculated, then a simple descriptive comparison of the mean elevation in the markers' levels across cohorts will be graphed.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in PSA levels in serum samples</measure>
    <time_frame>Up to 6 months after cryotherapy</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">19</enrollment>
  <condition>Recurrent Prostate Cancer</condition>
  <condition>Stage I Prostate Cancer</condition>
  <condition>Stage IIA Prostate Cancer</condition>
  <condition>Stage IIB Prostate Cancer</condition>
  <arm_group>
    <arm_group_label>Arm I (cryotherapy, sargramostim)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients undergo cryotherapy on day 0 and receive sargramostim subcutaneously on days 1, 3, 5, 8, 10, and 12.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Arm II (cryotherapy, standard of care)</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Patients undergo cryotherapy on day 0.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>cryotherapy</intervention_name>
    <description>Undergo cryotherapy</description>
    <arm_group_label>Arm I (cryotherapy, sargramostim)</arm_group_label>
    <arm_group_label>Arm II (cryotherapy, standard of care)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>sargramostim</intervention_name>
    <description>Given subcutaneously</description>
    <arm_group_label>Arm I (cryotherapy, sargramostim)</arm_group_label>
    <other_name>GM-CSF</other_name>
    <other_name>Leukine</other_name>
    <other_name>Prokine</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients diagnosed with prostate cancer that elect to undergo primary cryotherapy of&#xD;
             the prostate&#xD;
&#xD;
          -  Patients who are diagnosed with clinical stage T1a -T2c prostate cancer&#xD;
&#xD;
          -  Gleason score sum of less than or equal to 7&#xD;
&#xD;
          -  Prostate-specific antigen (PSA) &lt; 20 ng/dl&#xD;
&#xD;
          -  Patient will read, understand and sign the informed consent and Health Insurance&#xD;
             Portability and Accountability Act (HIPAA) agreement&#xD;
&#xD;
          -  Patients must have a life expectancy of at least one year&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Known hypersensitivity to granulocyte macrophage colony stimulating factor (GM-CSF) or&#xD;
             yeast&#xD;
&#xD;
          -  Anticipated blood donation within the next 90 days&#xD;
&#xD;
          -  Magnetic resonance imaging (MRI), computed tomography (CT) and bone scan evidence of&#xD;
             metastatic prostate cancer regardless the PSA level; (the indication for which is&#xD;
             clinically driven and at the discretion of the treating physician)&#xD;
&#xD;
          -  Any history of current or within the past 48 hours of acute or chronic bacterial,&#xD;
             fungal or viral infectious disease&#xD;
&#xD;
          -  Documented excessive leukemic myeloid blasts in the bone marrow or peripheral blood&#xD;
             (&gt;= 10%) in the past 6 months&#xD;
&#xD;
          -  Previous organ transplant&#xD;
&#xD;
          -  Immunosuppression including primary, secondary, iatrogenic and idiopathic&#xD;
&#xD;
          -  Other serious diseases (hematological, hepatic, renal, respiratory, central nervous&#xD;
             system, autoimmune or psychiatric)&#xD;
&#xD;
          -  Enrollment in other studies for any disease in the past 30 days&#xD;
&#xD;
          -  Diagnosis of cancer that in not considered cured, except basal cell carcinoma (BCC) of&#xD;
             skin&#xD;
&#xD;
          -  Prior transurethral resection of the prostate with a large tissue defect (at the&#xD;
             discretion of the investigator)&#xD;
&#xD;
          -  History of abdominoperineal resection for rectal cancer, rectal stenosis, or other&#xD;
             major rectal pathology&#xD;
&#xD;
          -  Patient currently receiving lithium, steroid, chemotherapy or radiotherapy treatment&#xD;
&#xD;
          -  Patients with a Hemoglobin of less than 12%&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>85 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Al Barqawi</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Colorado, Denver</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Colorado Cancer Center</name>
      <address>
        <city>Aurora</city>
        <state>Colorado</state>
        <zip>80045</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>February 2022</verification_date>
  <study_first_submitted>September 23, 2014</study_first_submitted>
  <study_first_submitted_qc>September 23, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 26, 2014</study_first_posted>
  <last_update_submitted>February 8, 2022</last_update_submitted>
  <last_update_submitted_qc>February 8, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">February 9, 2022</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>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Sargramostim</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</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/NCT02250014
org study id: 14-0071.cc
secondary id: 14-0071
nct id: NCT02250014
lead sponsor: 
collaborator: 
has dmc: Yes
This randomized pilot phase I trial studies how well sargramostim after cryotherapy works in
      treating patients with prostate cancer. Biological therapies, such as sargramostim, use
      substances made from living organisms that may stimulate the immune system in different ways
      and stop tumor cells from growing. Cryosurgery, also known as cryotherapy, kills tumor cells
      by freezing them. Giving sargramostim after cryotherapy may work better in treating prostate
      cancer.
PRIMARY OBJECTIVES:

      I. Determine an unknown normal immune response (T cell and B cell) to post-cryotherapy
      treatment for prostate cancer.

      II. Detect the altered immune response (T cell and B cell) post-GM-CSF (sargramostim)
      response and post-cryotherapy for the prostate cancer.

      Patients are randomized to 1 of 2 treatment arms.

      ARM I (TREATMENT): Patients undergo cryotherapy on day 0 and receive sargramostim
      subcutaneously (SC) on days 1, 3, 5, 8, 10, and 12.

      ARM II (CONTROL): Patients undergo cryotherapy on day 0.

      After completion of study treatment, patients are followed up for 6 months.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Change in B cell response identified by Serametrix assay
time frame: Baseline to up to 3 months after cryotherapy
description: A scatter plot of each cytokine and antigen level will be created for each patient by marker to observe the behavior of the markers (rising, falling, flat, or combination over time). Patient specific pre-operative levels will be used to obtain individual baseline measures from which the difference in follow-up cytokine and antigen levels will be calculated, then a simple descriptive comparison of the mean elevation in the markers' levels across cohorts will be graphed.
measure: Change in T cell responses identified by Intracellular cytokine assay and enzyme-linked immunospot
time frame: Baseline to up to 3 months after cryotherapy
description: A scatter plot of each cytokine and antigen level will be created for each patient by marker to observe the behavior of the markers (rising, falling, flat, or combination over time). Patient specific pre-operative levels will be used to obtain individual baseline measures from which the difference in follow-up cytokine and antigen levels will be calculated, then a simple descriptive comparison of the mean elevation in the markers' levels across cohorts will be graphed.
measure: Change in PSA levels in serum samples
time frame: Up to 6 months after cryotherapy
arm group label: Arm I (cryotherapy, sargramostim)
arm group type: Experimental
description: Patients undergo cryotherapy on day 0 and receive sargramostim subcutaneously on days 1, 3, 5, 8, 10, and 12.
arm group label: Arm II (cryotherapy, standard of care)
arm group type: Active Comparator
description: Patients undergo cryotherapy on day 0.
intervention type: Procedure
intervention name: cryotherapy
description: Undergo cryotherapy
arm group label: Arm I (cryotherapy, sargramostim)
arm group label: Arm II (cryotherapy, standard of care)
intervention type: Biological
intervention name: sargramostim
description: Given subcutaneously
arm group label: Arm I (cryotherapy, sargramostim)
other name: GM-CSF
other name: Leukine
other name: Prokine
criteria: 
gender: Male
minimum age: 18 Years
maximum age: 85 Years
healthy volunteers: No
last name: Al Barqawi
role: Principal Investigator
affiliation: University of Colorado, Denver
facility: 
country: United States
responsible party type: Sponsor
mesh term: Prostatic Neoplasms
mesh term: Sargramostim
sharing ipd: No