<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/NCT03793543</url>
  </required_header>
  <id_info>
    <org_study_id>J18127</org_study_id>
    <secondary_id>IRB00174393</secondary_id>
    <nct_id>NCT03793543</nct_id>
  </id_info>
  <brief_title>Test-Retest Reproducibility of 18F-DCFPyL PET/CT in the Evaluation of Patients With Metastatic Prostate Cancer</brief_title>
  <official_title>Test-Retest Reproducibility of 18F-DCFPyL PET/CT in the Evaluation of Patients With Metastatic Prostate Cancer - an Interscan Variability and Intraobserver Agreement Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      In this study, the investigators intend to validate 18F-DCFPyL test-retest reproducibility in&#xD;
      metastatic lesions, in order to investigate whether it serves as a reliable response&#xD;
      assessment tool, both to interpret existing studies and to design future longitudinal trials.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The investigators will image patients with widely metastatic castration-sensitive (CSPC) or&#xD;
      castration-resistant prostate cancer (CRPC) using 18F-DCFPyL-PET/CT for detection of tumor&#xD;
      burden and perform a lesion-based head-to-head comparison with a subsequent near-term (one to&#xD;
      seven days) 18F-DCFPyL-PET/CT follow-up scan, to assess test-retest reproducibility of this&#xD;
      second-generation PSMA-targeted compound. Second, as it has not been specifically&#xD;
      investigated with this compound before, intra-observer agreement as well as inter-scan&#xD;
      variability will be assessed.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 27, 2019</start_date>
  <completion_date type="Actual">October 15, 2021</completion_date>
  <primary_completion_date type="Actual">March 6, 2020</primary_completion_date>
  <phase>Phase 1</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>Change in number of metastatic lesions detected on on 18F-DCFPyL PET/CT from baseline</measure>
    <time_frame>Change from baseline to up to 4 weeks</time_frame>
    <description>Change in number of metastatic lesions detected on 18F-DCFPyL PET/CT at baseline with a subsequent near-term 18F-DCFPyL PET/CT scan.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Test the intraobserver agreement as assessed by percentage of scans that are read the same on second read</measure>
    <time_frame>3 years</time_frame>
    <description>The scans of every patient completing the 2 imaging time points will be reread by the same reader about 4 weeks after the first reading.</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">23</enrollment>
  <condition>Prostate Cancer</condition>
  <arm_group>
    <arm_group_label>18F-DCFPyL Injection</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>9±1 mCi (333±37 MBq) IV injection of 18F-DCFPyL</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>18F-DCFPyL Injection</intervention_name>
    <description>A single dose of 9±1 mCi (333±37 MBq) IV injection of 18F-DCFPyL</description>
    <arm_group_label>18F-DCFPyL Injection</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Willing and able to provide written informed consent&#xD;
&#xD;
          -  History of histologically or cytologically confirmed adenocarcinoma of the prostate&#xD;
             without neuroendocrine differentiation or small cell histology&#xD;
&#xD;
          -  Patients with metastatic castration-sensitive (CSPC) or castration-resistant prostate&#xD;
             cancer (CRPC) with evidence of metastatic disease on conventional imaging with CT or&#xD;
             bone scan.&#xD;
&#xD;
          -  Prior docetaxel-based chemotherapy is permitted&#xD;
&#xD;
          -  Documented metastatic prostate cancer progression as assessed by the treating&#xD;
             oncologist with either one or both of the following and has not initiated a new&#xD;
             therapy after determination of progression: Rising PSA over a minimum 1-week interval&#xD;
             and/or radiographic progression in soft tissue and bone metastases (combination of&#xD;
             bony and soft tissue metastases)&#xD;
&#xD;
          -  Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 2&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Serious or uncontrolled co-existent non-malignant disease, including active and&#xD;
             uncontrolled infection&#xD;
&#xD;
          -  Administered a radioisotope ≤5 physical half-lives prior to the date of study PET/CT&#xD;
&#xD;
          -  Administered IV X-ray contrast medium ≤24 hours prior to the date of study PET/CT&#xD;
&#xD;
          -  Administered oral contrast medium ≤120 hours prior to the date of study PET/CT&#xD;
&#xD;
          -  Condition or situation which, in the investigator's opinion, may put the patient at&#xD;
             significant risk, may confound the study results, or may interfere significantly with&#xD;
             patient's participation in the study&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <gender_based>Yes</gender_based>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Steven Rowe, M.D., Ph.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Johns Hopkins University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Johns Hopkins University</name>
      <address>
        <city>Baltimore</city>
        <state>Maryland</state>
        <zip>21287</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>March 2021</verification_date>
  <study_first_submitted>January 2, 2019</study_first_submitted>
  <study_first_submitted_qc>January 2, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 4, 2019</study_first_posted>
  <last_update_submitted>December 14, 2021</last_update_submitted>
  <last_update_submitted_qc>December 14, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">December 15, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>J18127 PSMA PyL 18F-DCFPyL PET/CT</keyword>
  <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/NCT03793543
org study id: J18127
secondary id: IRB00174393
nct id: NCT03793543
lead sponsor: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
In this study, the investigators intend to validate 18F-DCFPyL test-retest reproducibility in
      metastatic lesions, in order to investigate whether it serves as a reliable response
      assessment tool, both to interpret existing studies and to design future longitudinal trials.
The investigators will image patients with widely metastatic castration-sensitive (CSPC) or
      castration-resistant prostate cancer (CRPC) using 18F-DCFPyL-PET/CT for detection of tumor
      burden and perform a lesion-based head-to-head comparison with a subsequent near-term (one to
      seven days) 18F-DCFPyL-PET/CT follow-up scan, to assess test-retest reproducibility of this
      second-generation PSMA-targeted compound. Second, as it has not been specifically
      investigated with this compound before, intra-observer agreement as well as inter-scan
      variability will be assessed.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Diagnostic
masking: None (Open Label)
measure: Change in number of metastatic lesions detected on on 18F-DCFPyL PET/CT from baseline
time frame: Change from baseline to up to 4 weeks
description: Change in number of metastatic lesions detected on 18F-DCFPyL PET/CT at baseline with a subsequent near-term 18F-DCFPyL PET/CT scan.
measure: Test the intraobserver agreement as assessed by percentage of scans that are read the same on second read
time frame: 3 years
description: The scans of every patient completing the 2 imaging time points will be reread by the same reader about 4 weeks after the first reading.
arm group label: 18F-DCFPyL Injection
arm group type: Experimental
description: 9±1 mCi (333±37 MBq) IV injection of 18F-DCFPyL
intervention type: Drug
intervention name: 18F-DCFPyL Injection
description: A single dose of 9±1 mCi (333±37 MBq) IV injection of 18F-DCFPyL
arm group label: 18F-DCFPyL Injection
criteria: 
gender: Male
gender based: Yes
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Steven Rowe, M.D., Ph.D.
role: Principal Investigator
affiliation: Johns Hopkins University
facility: 
country: United States
responsible party type: Sponsor
mesh term: Prostatic Neoplasms
sharing ipd: No