<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/NCT03001895</url>
  </required_header>
  <id_info>
    <org_study_id>16-291</org_study_id>
    <nct_id>NCT03001895</nct_id>
  </id_info>
  <brief_title>Correlation Between SUV on 18F-DCFPyL PET/CT and Gleason Score in Prostate Cancer</brief_title>
  <official_title>Correlation Between SUV on 18F-DCFPyL PET/CT and Gleason Score 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>
  </oversight_info>
  <brief_summary>
    <textblock>
      Prostate specific membrane antigen (PSMA) is a unique membrane bound glycoprotein, which is&#xD;
      overexpressed manifold on prostate cancer cells and is well-characterized as an imaging&#xD;
      biomarker of prostate cancer. Positron emission tomography / computer tomography (PET/CT) is&#xD;
      a nuclear medicine procedure based on the measurement of positron emission from radiolabeled&#xD;
      tracer molecules. 18F-DCFPyL is a tracer for prostate cancer PET imaging which binds to PSMA.&#xD;
      The strength of functional imaging methods is in distinguishing tissues according to&#xD;
      metabolism rather than structure. Studies have shown that PET/CT imaging with 18F-DCFPyL can&#xD;
      detect prostate cancer lesions with excellent contrast and a high detection rate even when&#xD;
      the level of prostate specific antigen is low.&#xD;
&#xD;
      The objective of this study is to evaluate if the patient-wide SUVmax on 18F-DCFPyL PET/CT in&#xD;
      locoregional and metastatic prostate cancer correlates with histopathologic Gleason score at&#xD;
      initial biopsy. It is hypothesized that SUVmax will correlate positively with Gleason score.&#xD;
      This is of interest because non-invasive risk stratification may be possible in the future.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 1, 2017</start_date>
  <completion_date type="Actual">October 5, 2018</completion_date>
  <primary_completion_date type="Actual">October 5, 2018</primary_completion_date>
  <phase>Phase 2</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>SUVmax on 18F-DCFPyL PET/CT</measure>
    <time_frame>24 hours</time_frame>
    <description>Maximum standard uptake value (SUVmax) on 18F-DCFPyL PET/CT in locoregional and metastatic prostate cancer</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">120</enrollment>
  <condition>Prostate Cancer</condition>
  <arm_group>
    <arm_group_label>18F-DCFPyL PET/CT</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>18F-DCFPyL PET/CT Scan</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>18F-DCFPyL PET/CT</intervention_name>
    <description>18F-DCFPyL PET/CT</description>
    <arm_group_label>18F-DCFPyL PET/CT</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Resident of Canada&#xD;
&#xD;
          -  Male sex&#xD;
&#xD;
          -  Age 18 years or older&#xD;
&#xD;
          -  Previous diagnosis of prostate cancer with Gleason Score available&#xD;
&#xD;
          -  ECOG performance status 0 - 3, inclusive&#xD;
&#xD;
          -  Able to understand and provide written informed consent&#xD;
&#xD;
          -  Under referring physician's care&#xD;
&#xD;
          -  Able to tolerate the physical/logistical requirements of a PET/CT scan including lying&#xD;
             supine for up to 40 minutes with the arms above the head and tolerating intravenous&#xD;
             cannulation&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Medically unstable patients (e.g. acute cardiac or respiratory distress or&#xD;
             hypotensive, etc.)&#xD;
&#xD;
          -  Patients who exceed the safe weight limit of the PET/CT bed (200 kg) or who cannot fit&#xD;
             through the PET/CT bore (70 cm diameter)&#xD;
&#xD;
          -  Patients with unmanageable claustrophobia&#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>February 2019</verification_date>
  <study_first_submitted>December 21, 2016</study_first_submitted>
  <study_first_submitted_qc>December 22, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 23, 2016</study_first_posted>
  <last_update_submitted>February 12, 2019</last_update_submitted>
  <last_update_submitted_qc>February 12, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">February 15, 2019</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</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>
  <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/NCT03001895
org study id: 16-291
nct id: NCT03001895
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Prostate specific membrane antigen (PSMA) is a unique membrane bound glycoprotein, which is
      overexpressed manifold on prostate cancer cells and is well-characterized as an imaging
      biomarker of prostate cancer. Positron emission tomography / computer tomography (PET/CT) is
      a nuclear medicine procedure based on the measurement of positron emission from radiolabeled
      tracer molecules. 18F-DCFPyL is a tracer for prostate cancer PET imaging which binds to PSMA.
      The strength of functional imaging methods is in distinguishing tissues according to
      metabolism rather than structure. Studies have shown that PET/CT imaging with 18F-DCFPyL can
      detect prostate cancer lesions with excellent contrast and a high detection rate even when
      the level of prostate specific antigen is low.

      The objective of this study is to evaluate if the patient-wide SUVmax on 18F-DCFPyL PET/CT in
      locoregional and metastatic prostate cancer correlates with histopathologic Gleason score at
      initial biopsy. It is hypothesized that SUVmax will correlate positively with Gleason score.
      This is of interest because non-invasive risk stratification may be possible in the future.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Diagnostic
masking: None (Open Label)
measure: SUVmax on 18F-DCFPyL PET/CT
time frame: 24 hours
description: Maximum standard uptake value (SUVmax) on 18F-DCFPyL PET/CT in locoregional and metastatic prostate cancer
arm group label: 18F-DCFPyL PET/CT
arm group type: Experimental
description: 18F-DCFPyL PET/CT Scan
intervention type: Drug
intervention name: 18F-DCFPyL PET/CT
description: 18F-DCFPyL PET/CT
arm group label: 18F-DCFPyL PET/CT
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
investigator title: Chief of Nuclear Medicine
mesh term: Prostatic Neoplasms
sharing ipd: No