<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/NCT03001869</url>
  </required_header>
  <id_info>
    <org_study_id>16-293</org_study_id>
    <nct_id>NCT03001869</nct_id>
  </id_info>
  <brief_title>68Ga-PSMA PET/CT in Prostate Cancer</brief_title>
  <official_title>The Safety and Efficacy of 68Ga-HBED-CC-PSMA PET/CT in Prostate Cancer</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Sir Mortimer B. Davis - Jewish General Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Sir Mortimer B. Davis - Jewish General Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      The objectives of this study are to replicate the safety and efficacy of 68Ga-PSMA PET/CT and&#xD;
      as a diagnostic and decision making tool in the management prostate cancer patients.The&#xD;
      primary endpoints of the study are the incidence of adverse events (AE) in the study&#xD;
      population up to 7 days following the scan, and the sensitivity and specificity of 68Ga-PSMA&#xD;
      PET/CT vs CT on a per-patient and per-lesion basis.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Positron emission tomography / computer tomography (PET/CT) is a nuclear medicine diagnostic&#xD;
      imaging procedure based on the measurement of positron emission from radiolabeled tracer&#xD;
      molecules in vivo. A radiotracer in use today is 68Ga-HBED-CC-PSMA (DKFZ-11) - hereinafter&#xD;
      abbreviated 68Ga-PSMA - which is a radiolabeled urea-based ligand for prostate specific&#xD;
      membrane antigen (PSMA) PET/CT. Imaging with 68Ga-PSMA PET is used to characterize and&#xD;
      localize prostate cancer in humans in vivo. There is extensive data in the literature showing&#xD;
      the value of 68Ga-PSMA PET/CT imaging in accurately staging and restaging prostate cancer.&#xD;
      The objectives of this study are to replicate the safety and efficacy of 68Ga-PSMA PET/CT and&#xD;
      to establish our ability to reproduce results from the literature using 68Ga-PSMA PET/CT as a&#xD;
      diagnostic and decision making tool in the management prostate cancer patients. During the&#xD;
      study eligible prostate cancer patients will undergo one 68Ga-PSMA PET/CT. The primary&#xD;
      endpoints of the study are the incidence of adverse events (AE) in the study population up to&#xD;
      7 days following the scan, and the sensitivity and specificity of 68Ga-PSMA PET/CT vs CT on a&#xD;
      per-patient and per-lesion basis.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Enrolling by invitation</overall_status>
  <start_date type="Actual">July 1, 2017</start_date>
  <completion_date type="Anticipated">July 2026</completion_date>
  <primary_completion_date type="Anticipated">July 2025</primary_completion_date>
  <phase>Phase 3</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>Safety of Ga68-PSMA PET/CT imaging as measured by the incidence of adverse events (AE)</measure>
    <time_frame>7 days</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Efficacy of Ga68-PSMA PET/CT imaging as measured by sensitivity and specificity vs CT on a per patient basis as compared to standard of truth</measure>
    <time_frame>12 months</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Efficacy of Ga68-PSMA PET/CT imaging as measured by sensitivity and specificity vs CT on a per lesion basis as compared to standard of truth</measure>
    <time_frame>12 months</time_frame>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">1500</enrollment>
  <condition>Prostate Cancer</condition>
  <arm_group>
    <arm_group_label>68Ga-PSMA PET/CT</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>68Ga-HBED-CC-PSMA PET/CT</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>68Ga-HBED-CC-PSMA PET/CT</intervention_name>
    <description>68Ga-HBED-CC-PSMA PET/CT Scan</description>
    <arm_group_label>68Ga-PSMA PET/CT</arm_group_label>
    <other_name>68Ga-PSMA-11</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Global Inclusion Criteria:&#xD;
&#xD;
          -  Resident of Canada&#xD;
&#xD;
          -  Male sex&#xD;
&#xD;
          -  Age 18 years or older&#xD;
&#xD;
          -  Previously diagnosed with prostate cancer, under referring physician's care&#xD;
&#xD;
          -  ECOG performance status 0 - 3, inclusive&#xD;
&#xD;
          -  Able to understand and provide written informed consent&#xD;
&#xD;
          -  Able to tolerate the physical/logistical requirements of a PET/CT scan including lying&#xD;
             supine (or prone) for up to 40 minutes and tolerating intravenous cannulation&#xD;
&#xD;
        Global Exclusion Criteria:&#xD;
&#xD;
          -  Patients who are medically unstable (e.g. acute cardiac or respiratory distress or&#xD;
             hypotensive)&#xD;
&#xD;
          -  Patients who exceed the safe weight limit of the PET/CT bed (usually approximately 400&#xD;
             lbs.) or who cannot fit through the PET/CT bore (usually approximately 70 cm diameter)&#xD;
&#xD;
          -  Patients with unmanageable claustrophobia&#xD;
&#xD;
        Clinical Indication Criteria Subgroups:&#xD;
&#xD;
          -  BCR: Biochemical recurrence as defined by serum PSA &gt; 0.1 ng/ml following either&#xD;
             radical prostatectomy or curative-intent radiotherapy or other prostate-ablative&#xD;
             definitive management&#xD;
&#xD;
          -  HRS: Staging of high risk patients as defined by any one of the following:&#xD;
&#xD;
               -  Gleason score &gt; 7&#xD;
&#xD;
               -  Serum PSA &gt; 10 ng/ml&#xD;
&#xD;
               -  T stage of T3 or greater on TNM staging&#xD;
&#xD;
               -  Equivocal conventional staging such as CT, MRI or bone scan&#xD;
&#xD;
               -  Clinical suspicion of advance stage disease (e.g. bone pain)&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>120 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Jewish General Hospital</name>
      <address>
        <city>Montreal</city>
        <state>Quebec</state>
        <zip>H3T1E2</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <verification_date>October 2022</verification_date>
  <study_first_submitted>December 21, 2016</study_first_submitted>
  <study_first_submitted_qc>December 21, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 23, 2016</study_first_posted>
  <last_update_submitted>October 24, 2022</last_update_submitted>
  <last_update_submitted_qc>October 24, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">October 25, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Sir Mortimer B. Davis - Jewish General Hospital</investigator_affiliation>
    <investigator_full_name>Stephan Probst, MD</investigator_full_name>
    <investigator_title>Chief of Nuclear Medicine</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>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Gallium 68 PSMA-11</mesh_term>
  </intervention_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/NCT03001869
org study id: 16-293
nct id: NCT03001869
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
is us export: No
The objectives of this study are to replicate the safety and efficacy of 68Ga-PSMA PET/CT and
      as a diagnostic and decision making tool in the management prostate cancer patients.The
      primary endpoints of the study are the incidence of adverse events (AE) in the study
      population up to 7 days following the scan, and the sensitivity and specificity of 68Ga-PSMA
      PET/CT vs CT on a per-patient and per-lesion basis.
Positron emission tomography / computer tomography (PET/CT) is a nuclear medicine diagnostic
      imaging procedure based on the measurement of positron emission from radiolabeled tracer
      molecules in vivo. A radiotracer in use today is 68Ga-HBED-CC-PSMA (DKFZ-11) - hereinafter
      abbreviated 68Ga-PSMA - which is a radiolabeled urea-based ligand for prostate specific
      membrane antigen (PSMA) PET/CT. Imaging with 68Ga-PSMA PET is used to characterize and
      localize prostate cancer in humans in vivo. There is extensive data in the literature showing
      the value of 68Ga-PSMA PET/CT imaging in accurately staging and restaging prostate cancer.
      The objectives of this study are to replicate the safety and efficacy of 68Ga-PSMA PET/CT and
      to establish our ability to reproduce results from the literature using 68Ga-PSMA PET/CT as a
      diagnostic and decision making tool in the management prostate cancer patients. During the
      study eligible prostate cancer patients will undergo one 68Ga-PSMA PET/CT. The primary
      endpoints of the study are the incidence of adverse events (AE) in the study population up to
      7 days following the scan, and the sensitivity and specificity of 68Ga-PSMA PET/CT vs CT on a
      per-patient and per-lesion basis.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Diagnostic
masking: None (Open Label)
measure: Safety of Ga68-PSMA PET/CT imaging as measured by the incidence of adverse events (AE)
time frame: 7 days
measure: Efficacy of Ga68-PSMA PET/CT imaging as measured by sensitivity and specificity vs CT on a per patient basis as compared to standard of truth
time frame: 12 months
measure: Efficacy of Ga68-PSMA PET/CT imaging as measured by sensitivity and specificity vs CT on a per lesion basis as compared to standard of truth
time frame: 12 months
arm group label: 68Ga-PSMA PET/CT
arm group type: Experimental
description: 68Ga-HBED-CC-PSMA PET/CT
intervention type: Drug
intervention name: 68Ga-HBED-CC-PSMA PET/CT
description: 68Ga-HBED-CC-PSMA PET/CT Scan
arm group label: 68Ga-PSMA PET/CT
other name: 68Ga-PSMA-11
criteria: 
gender: Male
minimum age: 18 Years
maximum age: 120 Years
healthy volunteers: No
facility: 
country: Canada
responsible party type: Principal Investigator
investigator affiliation: Sir Mortimer B. Davis - Jewish General Hospital
investigator full name: Stephan Probst, MD
investigator title: Chief of Nuclear Medicine
mesh term: Prostatic Neoplasms
mesh term: Gallium 68 PSMA-11
sharing ipd: Undecided