<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/NCT02989623</url>
  </required_header>
  <id_info>
    <org_study_id>15F.264</org_study_id>
    <nct_id>NCT02989623</nct_id>
  </id_info>
  <brief_title>Copper Cu 64 TP3805 PET in Detecting Prostate Cancer in Patients With Persistently Elevated PSA</brief_title>
  <official_title>A Pilot Phase I Open Label Study of Cu-64-TP3805 PET Imaging for Detection of Prostate Cancer in Men With Persistently Elevated PSA</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Sidney Kimmel Cancer Center at Thomas Jefferson University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Institutes of Health (NIH)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>Thomas Jefferson University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This pilot phase I trial studies how well copper Cu 64 TP3805 positron emission tomography&#xD;
      (PET) works in detecting prostate cancer in patients with persistently elevated prostate&#xD;
      specific antigen (PSA). The copper Cu 64 TP3805 PET scan uses copper Cu 64 TP3805, a compound&#xD;
      made of a radioactive agent attached to a molecule that looks like a hormone that binds to&#xD;
      cancer cells to detect prostate cancer during PET scans. Copper Cu 64 TP3805 PET may be able&#xD;
      to see tumors at an earlier stage than the standard of care.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      PRIMARY OBJECTIVES:&#xD;
&#xD;
      I. To assess the ability of Cu-64-TP3805 (copper Cu 64 TP3805) to detect prostate cancer&#xD;
      (PC), or absence thereof, within the prostate gland.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 1, 2015</start_date>
  <completion_date type="Actual">April 25, 2019</completion_date>
  <primary_completion_date type="Actual">April 24, 2019</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>Prostate cancer detection within the prostate gland by copper Cu 64 TP3805 PET</measure>
    <time_frame>Up to 3 years</time_frame>
    <description>The proportion of lesions detected with copper Cu-64 PET will be determined with the lesion as the unit of analysis. 95% confidence intervals will be calculated.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Incidence of multiple lesions in an individual patient</measure>
    <time_frame>Up to 3 years</time_frame>
    <description>Generalized Estimating Equations will be utilized.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">20</enrollment>
  <condition>Prostate Cancer</condition>
  <arm_group>
    <arm_group_label>Diagnostic (copper Cu 64 TP3805, PET/CT, biopsy)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients receive copper Cu 64 TP3805 IV over 5 minutes and 30 minutes and 2 hours later, undergo whole body Positron Emission Tomography/Computed Tomography (PET/CT) imaging over 1 hour.</description>
  </arm_group>
  <intervention>
    <intervention_type>Radiation</intervention_type>
    <intervention_name>Copper Cu 64 TP3805</intervention_name>
    <description>Given Intravenously</description>
    <arm_group_label>Diagnostic (copper Cu 64 TP3805, PET/CT, biopsy)</arm_group_label>
    <other_name>Cu-64-TP3805</other_name>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Positron Emission Tomography and Computed Tomography Scan</intervention_name>
    <description>Undergo copper Cu 64 TP3805 PET/CT scan</description>
    <arm_group_label>Diagnostic (copper Cu 64 TP3805, PET/CT, biopsy)</arm_group_label>
    <other_name>PET/CT SCAN</other_name>
    <other_name>Positron Emission Tomography/Computed Tomography</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Ability to provide signed informed consent and willingness to comply with protocol&#xD;
             requirements&#xD;
&#xD;
          -  Persistently elevated PSA&#xD;
&#xD;
          -  Scheduled for magnetic resonance imaging (MRI) fusion/transrectal ultrasound (TRUS)&#xD;
             biopsy, followed by histology&#xD;
&#xD;
          -  Agree to use an acceptable form of birth control for a period of 7 days after the&#xD;
             Cu-64-TP3805 injection&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Participating would significantly delay the scheduled standard of care therapy&#xD;
&#xD;
          -  Administered a radioisotope within 10 physical half-lives prior to study drug&#xD;
             injection&#xD;
&#xD;
          -  Have any medical condition or other circumstances that, in the opinion of the&#xD;
             investigator, would significantly decrease obtaining reliable data, achieving study&#xD;
             objectives or completing the study&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>21 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Madhukar Thakur, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Thomas Jefferson University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Thomas Jefferson University</name>
      <address>
        <city>Philadelphia</city>
        <state>Pennsylvania</state>
        <zip>19107</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>http://hospitals.jefferson.edu/</url>
    <description>Thomas Jefferson University Hospital</description>
  </link>
  <verification_date>June 2019</verification_date>
  <study_first_submitted>December 8, 2016</study_first_submitted>
  <study_first_submitted_qc>December 8, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 12, 2016</study_first_posted>
  <last_update_submitted>June 25, 2019</last_update_submitted>
  <last_update_submitted_qc>June 25, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">June 28, 2019</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>Copper</mesh_term>
  </intervention_browse>
  <pending_results>
    <submitted>July 11, 2023</submitted>
    <returned>July 31, 2023</returned>
    <submitted>August 4, 2023</submitted>
    <returned>August 29, 2023</returned>
  </pending_results>
  <!-- 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/NCT02989623
org study id: 15F.264
nct id: NCT02989623
lead sponsor: 
collaborator: 
has dmc: Yes
This pilot phase I trial studies how well copper Cu 64 TP3805 positron emission tomography
      (PET) works in detecting prostate cancer in patients with persistently elevated prostate
      specific antigen (PSA). The copper Cu 64 TP3805 PET scan uses copper Cu 64 TP3805, a compound
      made of a radioactive agent attached to a molecule that looks like a hormone that binds to
      cancer cells to detect prostate cancer during PET scans. Copper Cu 64 TP3805 PET may be able
      to see tumors at an earlier stage than the standard of care.
PRIMARY OBJECTIVES:

      I. To assess the ability of Cu-64-TP3805 (copper Cu 64 TP3805) to detect prostate cancer
      (PC), or absence thereof, within the prostate gland.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Diagnostic
masking: None (Open Label)
measure: Prostate cancer detection within the prostate gland by copper Cu 64 TP3805 PET
time frame: Up to 3 years
description: The proportion of lesions detected with copper Cu-64 PET will be determined with the lesion as the unit of analysis. 95% confidence intervals will be calculated.
measure: Incidence of multiple lesions in an individual patient
time frame: Up to 3 years
description: Generalized Estimating Equations will be utilized.
arm group label: Diagnostic (copper Cu 64 TP3805, PET/CT, biopsy)
arm group type: Experimental
description: Patients receive copper Cu 64 TP3805 IV over 5 minutes and 30 minutes and 2 hours later, undergo whole body Positron Emission Tomography/Computed Tomography (PET/CT) imaging over 1 hour.
intervention type: Radiation
intervention name: Copper Cu 64 TP3805
description: Given Intravenously
arm group label: Diagnostic (copper Cu 64 TP3805, PET/CT, biopsy)
other name: Cu-64-TP3805
intervention type: Procedure
intervention name: Positron Emission Tomography and Computed Tomography Scan
description: Undergo copper Cu 64 TP3805 PET/CT scan
arm group label: Diagnostic (copper Cu 64 TP3805, PET/CT, biopsy)
other name: PET/CT SCAN
other name: Positron Emission Tomography/Computed Tomography
criteria: 
gender: Male
minimum age: 21 Years
maximum age: N/A
healthy volunteers: No
last name: Madhukar Thakur, PhD
role: Principal Investigator
affiliation: Thomas Jefferson University
facility: 
country: United States
url: http://hospitals.jefferson.edu/
description: Thomas Jefferson University Hospital
responsible party type: Sponsor
mesh term: Prostatic Neoplasms
mesh term: Copper
submitted: July 11, 2023
returned: July 31, 2023
submitted: August 4, 2023
returned: August 29, 2023