<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/NCT03824275</url>
  </required_header>
  <id_info>
    <org_study_id>AAAS1862</org_study_id>
    <nct_id>NCT03824275</nct_id>
  </id_info>
  <brief_title>18F-DCFPyL Positron Emission Tomography (PET)/Computed Tomography (CT) in Men With Prostate Cancer</brief_title>
  <official_title>18F-DCFPyL Positron Emission Tomography (PET)/Computed Tomography (CT) in Men With Prostate Cancer</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Columbia University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Columbia University</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>
      PyL, also known as [18F]DCFPyL, is a second-generation fluorinated prostate-specific membrane&#xD;
      antigen (PSMA) targeted PET imaging agent. In preliminary studies it demonstrates a higher&#xD;
      detection of metastatic prostate lesions compared to standard imaging. Its ability to image&#xD;
      metastatic prostate cancer sites was comparable to 68Ga-PSMA with high tumor-to-background&#xD;
      ratios.Additionally, [18F] PyL demonstrated higher mean tumor-to-background ratios when using&#xD;
      kidney, spleen, or parotid as reference organs. However, the role of [18F] PyL in tumor&#xD;
      response to therapy has not been evaluated, specifically the potential to serve as a&#xD;
      predictive biomarker of response. Given the high cost of current therapeutic agents in mCRPC,&#xD;
      there is a need for an early response biomarker to stratify which patients will benefit from&#xD;
      therapy and which will not. This will also allow for earlier change in management of patients&#xD;
      who will not response to these therapies, potentially improving patient outcomes.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The investigators will conduct a prospective phase II/III study of 300 men diagnosed with&#xD;
      prostate cancer with a rising prostate-specific antigen (PSA). Upon enrollment, subjects will&#xD;
      undergo standard of care imaging (defined as a CT or MRI of the chest, abdomen, and pelvis,&#xD;
      and 99mTc bone scans) if not obtained within 45 days of enrollment. Subjects will have&#xD;
      standard of care laboratory evaluations and undergo 18F- DCFPyL PET/CT.&#xD;
&#xD;
      [18F]DCFPyL will be used for study imaging.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">February 12, 2019</start_date>
  <completion_date type="Anticipated">December 2023</completion_date>
  <primary_completion_date type="Anticipated">December 2022</primary_completion_date>
  <phase>Phase 2/Phase 3</phase>
  <study_type>Interventional</study_type>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <intervention_model_description>Prospective, non-randomized</intervention_model_description>
    <primary_purpose>Diagnostic</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>To determine the positive predictive value of 18F-DCFPyL PET/CT on a per-patient basis</measure>
    <time_frame>3.5 years</time_frame>
    <description>To determine the positive predictive value of 18F-DCFPyL PET/CT on a per-patient basis</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>To determine the positive predictive value of 18F-DCFPyL PET/CT on a per-region basis, with regions being the prostate or prostate bed, pelvis, extra pelvis, and bones</measure>
    <time_frame>3.5 years</time_frame>
    <description>To determine the positive predictive value of 18F-DCFPyL PET/CT on a per-region basis</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>To determine the sensitivity and specificity of 18F-DCFPyL PET/CT on a per patient and region basis</measure>
    <time_frame>3.5 years</time_frame>
    <description>To determine the sensitivity and specificity of 18F-DCFPyL PET/CT on a per patient and region basis</description>
  </secondary_outcome>
  <other_outcome>
    <measure>To characterize ctDNA and exosomes in patients with prostate cancer</measure>
    <time_frame>3.5 years</time_frame>
    <description>To characterize ctDNA and exosomes in patients with prostate cancer</description>
  </other_outcome>
  <other_outcome>
    <measure>To determine correlation with ctDNA and/or exosome levels with disease burden</measure>
    <time_frame>3.5 years</time_frame>
    <description>To determine correlation with ctDNA and/or exosome levels with disease burden</description>
  </other_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">129</enrollment>
  <condition>Prostatic Neoplasms</condition>
  <arm_group>
    <arm_group_label>18F- DCFPyL PET/CT</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Upon enrollment, subjects will undergo standard of care imaging (defined as a CT or MRI of the chest, abdomen, and pelvis, and 99mTc bone scans) if not obtained within 45 days of enrollment. Subjects will have standard of care laboratory evaluations including complete blood count (CBC), serum chemistries, hepatic panel, lactate dehydrogenase (LDH), and PSA. Liquid biopsies for circulating tumor DNA (ctDNA) and exosome analysis will occur at the same time. Subjects will then undergo 18F- DCFPyL PET/CT.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>18F- DCFPyL PET/CT</intervention_name>
    <description>A CT scan using a radioactive marker to better image tumors</description>
    <arm_group_label>18F- DCFPyL PET/CT</arm_group_label>
    <other_name>CT scan</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Histologically confirmed diagnosis of prostate cancer&#xD;
&#xD;
          2. PSA ≥ 0.2ng/ml&#xD;
&#xD;
          3. Age ≥ 18 years of age&#xD;
&#xD;
          4. Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2 (karnofsky ≥ 60%)&#xD;
&#xD;
          5. Ability to understand and willingness to sign a written informed consent document&#xD;
&#xD;
          6. Wiling to comply with clinical trial instructions and requirements&#xD;
&#xD;
          7. Willing to cover the cost of PyL PET/CT imaging if funds are not available&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. History of another active malignancy within 3 years, other than basal cell and&#xD;
             squamous cell carcinoma of the skin&#xD;
&#xD;
          2. Presence of prostate brachytherapy implants unless approved by the PI&#xD;
&#xD;
          3. Administration of another radioisotope within five physical half-lives of trial&#xD;
             enrollment&#xD;
&#xD;
          4. Radiation or chemotherapy within 2 weeks prior to trial enrollment&#xD;
&#xD;
          5. Serum creatinine &gt; 3 times the upper limit of normal&#xD;
&#xD;
          6. Serum total bilirubin &gt; 3 times the upper limit of normal&#xD;
&#xD;
          7. Aspartate transaminase (AST) or alanine aminotransferase (ALT) &gt;5 times the upper&#xD;
             limit of normal&#xD;
&#xD;
          8. Inadequate venous access&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Matthew C. Dallos, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Assistant Professor of Medicine</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Columbia University Irving Medical Center</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10032</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>May 2022</verification_date>
  <study_first_submitted>January 29, 2019</study_first_submitted>
  <study_first_submitted_qc>January 30, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 31, 2019</study_first_posted>
  <last_update_submitted>May 6, 2022</last_update_submitted>
  <last_update_submitted_qc>May 6, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">May 11, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Columbia University</investigator_affiliation>
    <investigator_full_name>Matthew Dallos</investigator_full_name>
    <investigator_title>Associate Clinical Professor of 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/NCT03824275
org study id: AAAS1862
nct id: NCT03824275
lead sponsor: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
PyL, also known as [18F]DCFPyL, is a second-generation fluorinated prostate-specific membrane
      antigen (PSMA) targeted PET imaging agent. In preliminary studies it demonstrates a higher
      detection of metastatic prostate lesions compared to standard imaging. Its ability to image
      metastatic prostate cancer sites was comparable to 68Ga-PSMA with high tumor-to-background
      ratios.Additionally, [18F] PyL demonstrated higher mean tumor-to-background ratios when using
      kidney, spleen, or parotid as reference organs. However, the role of [18F] PyL in tumor
      response to therapy has not been evaluated, specifically the potential to serve as a
      predictive biomarker of response. Given the high cost of current therapeutic agents in mCRPC,
      there is a need for an early response biomarker to stratify which patients will benefit from
      therapy and which will not. This will also allow for earlier change in management of patients
      who will not response to these therapies, potentially improving patient outcomes.
The investigators will conduct a prospective phase II/III study of 300 men diagnosed with
      prostate cancer with a rising prostate-specific antigen (PSA). Upon enrollment, subjects will
      undergo standard of care imaging (defined as a CT or MRI of the chest, abdomen, and pelvis,
      and 99mTc bone scans) if not obtained within 45 days of enrollment. Subjects will have
      standard of care laboratory evaluations and undergo 18F- DCFPyL PET/CT.

      [18F]DCFPyL will be used for study imaging.
allocation: N/A
intervention model: Single Group Assignment
intervention model description: Prospective, non-randomized
primary purpose: Diagnostic
masking: None (Open Label)
measure: To determine the positive predictive value of 18F-DCFPyL PET/CT on a per-patient basis
time frame: 3.5 years
description: To determine the positive predictive value of 18F-DCFPyL PET/CT on a per-patient basis
measure: To determine the positive predictive value of 18F-DCFPyL PET/CT on a per-region basis, with regions being the prostate or prostate bed, pelvis, extra pelvis, and bones
time frame: 3.5 years
description: To determine the positive predictive value of 18F-DCFPyL PET/CT on a per-region basis
measure: To determine the sensitivity and specificity of 18F-DCFPyL PET/CT on a per patient and region basis
time frame: 3.5 years
description: To determine the sensitivity and specificity of 18F-DCFPyL PET/CT on a per patient and region basis
measure: To characterize ctDNA and exosomes in patients with prostate cancer
time frame: 3.5 years
description: To characterize ctDNA and exosomes in patients with prostate cancer
measure: To determine correlation with ctDNA and/or exosome levels with disease burden
time frame: 3.5 years
description: To determine correlation with ctDNA and/or exosome levels with disease burden
arm group label: 18F- DCFPyL PET/CT
arm group type: Experimental
description: Upon enrollment, subjects will undergo standard of care imaging (defined as a CT or MRI of the chest, abdomen, and pelvis, and 99mTc bone scans) if not obtained within 45 days of enrollment. Subjects will have standard of care laboratory evaluations including complete blood count (CBC), serum chemistries, hepatic panel, lactate dehydrogenase (LDH), and PSA. Liquid biopsies for circulating tumor DNA (ctDNA) and exosome analysis will occur at the same time. Subjects will then undergo 18F- DCFPyL PET/CT.
intervention type: Drug
intervention name: 18F- DCFPyL PET/CT
description: A CT scan using a radioactive marker to better image tumors
arm group label: 18F- DCFPyL PET/CT
other name: CT scan
criteria: 
gender: Male
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Matthew C. Dallos, MD
role: Principal Investigator
affiliation: Assistant Professor of Medicine
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Columbia University
investigator full name: Matthew Dallos
investigator title: Associate Clinical Professor of Medicine
mesh term: Prostatic Neoplasms
sharing ipd: No