<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/NCT03800784</url>
  </required_header>
  <id_info>
    <org_study_id>J1863</org_study_id>
    <secondary_id>IRB00150136</secondary_id>
    <nct_id>NCT03800784</nct_id>
  </id_info>
  <brief_title>Study of 18F-DCFPyL PET/CT Imaging in Patients With Prostate Cancer</brief_title>
  <official_title>Study of 18F-DCFPyL PET/CT, for Detection of Radiological Progression in Patients With Metastatic (M+) and Non-metastatic (M0) Castration Resistant Prostate Cancer Receiving Standard Androgen Receptor Targeted Treatment</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>
      This study evaluates the rate of radiological disease progression with the new 2nd generation&#xD;
      positron emission tomography (PET) radiopharmaceutical, 18F-DCFPyL, in patients with&#xD;
      metastatic castration (mCRPC) and non-metastatic (nmCRPC) castration resistant prostate&#xD;
      cancer who have evidence of biochemical (PSA) disease progression without evidence of&#xD;
      radiological disease progression on conventional standard radiologic testing (99mTc-methylene&#xD;
      diphosphonate bone scan and CT).&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Withdrawn</overall_status>
  <why_stopped>
    Lack of funding&#xD;
  </why_stopped>
  <start_date type="Actual">October 1, 2019</start_date>
  <completion_date type="Actual">October 21, 2021</completion_date>
  <primary_completion_date type="Actual">October 21, 2021</primary_completion_date>
  <phase>Phase 2/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>Sensitivity 18F-DCFPyL PET/CT imaging to detect metastatic prostate cancer</measure>
    <time_frame>3 years</time_frame>
    <description>Proportion of patients demonstrating disease progression by conventional criteria evaluated by CT scan and 99mTc-methylene diphosphonate bone scan and on 18F-DCFPyL PET/CT.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Correlation of findings on 18F-DCFPyL PET/CT with conventional imaging as determined by Number of Lesions detected on each imaging modality</measure>
    <time_frame>3 years</time_frame>
    <description>Number of lesions detected on 18F-DCFPyL PET/CT in comparison to number of lesions detected on conventional imaging (99mTc-methylene diphosphonate bone scan and CT)</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">0</enrollment>
  <condition>Prostate Cancer</condition>
  <arm_group>
    <arm_group_label>18F-DCFPyL Injection</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>A single dose of 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>
    <other_name>PyL</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Histological confirmation of prostate cancer&#xD;
&#xD;
          -  Patients receiving androgen deprivation treatment (ADT) with GnRH analogs, GnRH&#xD;
             antagonists or bilateral orchiectomy of any duration.&#xD;
&#xD;
          -  Cohort A: nmCRPC (status post- primary treatment with radical prostatectomy, radiation&#xD;
             of any type or both)&#xD;
&#xD;
               -  Negative 99mTc-methylene diphosphonate bone scan and CT of the chest abdomen and&#xD;
                  pelvis within 6 weeks of 18F-DCFPyL PET/CT&#xD;
&#xD;
               -  Treatment with ADT with or without a second line novel AR targeted treatment&#xD;
                  (abiraterone, enzalutamide, or both) or 4 weeks after discontinuation of first&#xD;
                  generation antiandrogen (bicalutamide , flutamide, nilutamide- one or more&#xD;
                  permitted) for ≥ 12 months.&#xD;
&#xD;
               -  Rising PSA ≥ 10 ng/ml (confirmed by 2 determinations one week apart)&#xD;
&#xD;
               -  PSADT ≤ 9 months&#xD;
&#xD;
          -  Cohort B: mCRPC&#xD;
&#xD;
               -  Treatment with ADT with or without abiraterone and or enzalutamide or both for ≥&#xD;
                  6 months and/or 4 weeks after discontinuation of first generation antiandrogen&#xD;
                  (bicalutamide , flutamide, nilutamide- one or more permitted).&#xD;
&#xD;
               -  PSA ≥ 2.0 ng/ml confirmed X 1 week apart, any PSADT&#xD;
&#xD;
          -  Patients enrolled in other clinical trials are eligible if they satisfy all other&#xD;
             criteria of eligibility.&#xD;
&#xD;
          -  No new therapeutic interventions planned or scheduled to be instituted prior to the&#xD;
             course of this study both on cohorts A and B before conventional radiologic&#xD;
             progression is evidenced.&#xD;
&#xD;
          -  Patients or their legal representatives must have the ability to read, understand and&#xD;
             provide written informed consent for the initiation of any study related procedures.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patient will be excluded from enrollment if he had a radioisotope within 5 physical&#xD;
             half-lives prior to PET imaging&#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>Mark Markowski</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>December 2021</verification_date>
  <study_first_submitted>January 9, 2019</study_first_submitted>
  <study_first_submitted_qc>January 9, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 11, 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>18F-DCFPyL PET/CT PyL</keyword>
  <keyword>PSMA</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/NCT03800784
org study id: J1863
secondary id: IRB00150136
nct id: NCT03800784
lead sponsor: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
This study evaluates the rate of radiological disease progression with the new 2nd generation
      positron emission tomography (PET) radiopharmaceutical, 18F-DCFPyL, in patients with
      metastatic castration (mCRPC) and non-metastatic (nmCRPC) castration resistant prostate
      cancer who have evidence of biochemical (PSA) disease progression without evidence of
      radiological disease progression on conventional standard radiologic testing (99mTc-methylene
      diphosphonate bone scan and CT).
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Diagnostic
masking: None (Open Label)
measure: Sensitivity 18F-DCFPyL PET/CT imaging to detect metastatic prostate cancer
time frame: 3 years
description: Proportion of patients demonstrating disease progression by conventional criteria evaluated by CT scan and 99mTc-methylene diphosphonate bone scan and on 18F-DCFPyL PET/CT.
measure: Correlation of findings on 18F-DCFPyL PET/CT with conventional imaging as determined by Number of Lesions detected on each imaging modality
time frame: 3 years
description: Number of lesions detected on 18F-DCFPyL PET/CT in comparison to number of lesions detected on conventional imaging (99mTc-methylene diphosphonate bone scan and CT)
arm group label: 18F-DCFPyL Injection
arm group type: Experimental
description: A single dose of 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
other name: PyL
criteria: 
gender: Male
gender based: Yes
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Mark Markowski
role: Principal Investigator
affiliation: Johns Hopkins University
facility: 
country: United States
responsible party type: Sponsor
mesh term: Prostatic Neoplasms
sharing ipd: No