<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/NCT04457232</url>
  </required_header>
  <id_info>
    <org_study_id>20-000177</org_study_id>
    <secondary_id>NCI-2020-02712</secondary_id>
    <secondary_id>20-000177</secondary_id>
    <nct_id>NCT04457232</nct_id>
  </id_info>
  <brief_title>Prospective Exploratory Study of FAPi PET/CT in Prostate Cancer With Histopathology Validation</brief_title>
  <acronym>FAPI PET Prost</acronym>
  <official_title>PET Biodistribution Study of 68Ga-FAPI-46 in Patients With Prostate Cancer: A Prospective Exploratory Biodistribution Study With Histopathology Validation</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Jonsson Comprehensive Cancer Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Prostate Cancer Foundation</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Jonsson Comprehensive Cancer Center</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>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      This exploratory study investigates how a new imaging technique called FAPI PET/CT can&#xD;
      determine where and to which degree the FAPI tracer (68Ga-FAPi-46) accumulates in normal and&#xD;
      cancer tissues in patients with prostate cancer. Because some cancers take up 68Ga-FAPi-46 it&#xD;
      can be seen with PET. FAP stands for Fibroblast Activation Protein. FAP is produced by cells&#xD;
      that surround tumors. The function of FAP is not well understood but imaging studies have&#xD;
      shown that FAP can be detected with FAPI PET/CT. Imaging FAP with FAPI PET/CT may in the&#xD;
      future provide additional information about various cancers including prostate cancer.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      PRIMARY OBJECTIVE:&#xD;
&#xD;
      I. To define the biodistribution of gallium 68Ga-FAPi-46 in normal and cancer tissues of&#xD;
      patients with prostate cancer.&#xD;
&#xD;
      SECONDARY OBJECTIVES:&#xD;
&#xD;
      I. To evaluate whether 68Ga-FAPi-46 and gallium Ga 68-labeled PSMA-11 (68Ga-PSMA-11)&#xD;
      accumulation observed by positron emission tomography (PET) correlates with the amount of&#xD;
      fibroblast activation protein (FAP) and prostate specific membrane antigen (PSMA) in excised&#xD;
      cancer tissue, respectively.&#xD;
&#xD;
      II. To assess the 68Ga-FAPI-46 biodistribution correlation with 68Ga-PSMA-11.&#xD;
&#xD;
      OUTLINE:&#xD;
&#xD;
      Patients receive 68Ga-FAPi-46 intravenously (IV) and undergo PET/computed tomography (CT)&#xD;
      imaging over 20-50 minutes.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">September 9, 2020</start_date>
  <completion_date type="Anticipated">September 9, 2024</completion_date>
  <primary_completion_date type="Anticipated">September 9, 2023</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>Basic Science</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>To define and document the biodistribution of gallium 68Ga-FAPi-46 in normal and cancer tissues of patients with prostate cancer</measure>
    <time_frame>60 minutes after tracer injection</time_frame>
    <description>To quantify tumor tissue and normal background organs positron emission tomography (PET) tracer uptake by semi-quantitative analysis (unit/metrics = standardized uptake values [SUV], SUVmean and SUVmax.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>To evaluate whether 68Ga-FAPi-46 accumulation observed by PET correlates with the amount of fibroblast activation protein (FAP) assessed by immunohistochemistry (IHC) in excised cancer tissue</measure>
    <time_frame>Up to date of surgery (range 1-60 days)</time_frame>
    <description>68Ga-FAPi-46 tumor SUVs will be correlated with FAP expression from surgically resected tumors. IHC will be scored with a semi-quantitative scoring system that accounts for staining intensity (0-2, where 0 is negative, 1 is weak, 2 is strong and eq. stands for equivocal). Correlations will be sought using least square regression analysis.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>To assess the 68Ga-FAPI-46 biodistribution correlation with 68Ga-PSMA-11 PET imaging</measure>
    <time_frame>60 minutes after tracer injection</time_frame>
    <description>The 68Ga-PSMA-11 and 68Ga-FAPI-46 tracer biodistribution will be described by mean and maximum standardized uptake values (SUVmean and SUVmax) and tested for correlation.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">30</enrollment>
  <condition>Metastatic Malignant Neoplasm in the Prostate Gland</condition>
  <condition>Prostate Carcinoma</condition>
  <condition>Recurrent Prostate Carcinoma</condition>
  <arm_group>
    <arm_group_label>Basic Science (68Ga-FAPi-46 PET/CT)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients receive 68Ga-FAPi-46 IV and undergo PET/CT imaging over 20-50 minutes.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Computed Tomography</intervention_name>
    <description>Undergo PET/CT imaging</description>
    <arm_group_label>Basic Science (68Ga-FAPi-46 PET/CT)</arm_group_label>
    <other_name>CAT</other_name>
    <other_name>CAT Scan</other_name>
    <other_name>Computerized Axial Tomography</other_name>
    <other_name>Computerized Tomography</other_name>
    <other_name>CT</other_name>
    <other_name>CT Scan</other_name>
    <other_name>tomography</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Gallium Ga 68 FAPi-46</intervention_name>
    <description>Given IV</description>
    <arm_group_label>Basic Science (68Ga-FAPi-46 PET/CT)</arm_group_label>
    <other_name>68Ga-FAPi-46</other_name>
    <other_name>Gallium-68-FAPi-46</other_name>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Positron Emission Tomography</intervention_name>
    <description>Undergo PET/CT imaging</description>
    <arm_group_label>Basic Science (68Ga-FAPi-46 PET/CT)</arm_group_label>
    <other_name>Medical Imaging, Positron Emission Tomography</other_name>
    <other_name>PET</other_name>
    <other_name>PET Scan</other_name>
    <other_name>Positron Emission Tomography Scan</other_name>
    <other_name>Positron-Emission Tomography</other_name>
    <other_name>proton magnetic resonance spectroscopic imaging</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients who underwent a 68Ga-PSMA-11 PET/CT scan within 3 months of enrollment&#xD;
&#xD;
          -  Patients who are scheduled to undergo surgical excision or biopsy of a prostate cancer&#xD;
             primary, recurrent or metastatic lesion&#xD;
&#xD;
          -  Patients can provide written informed consent&#xD;
&#xD;
          -  Patients are able to remain still for duration of imaging procedure (up to one hour)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients with any new prostate therapy between the PSMA PET/CT and the FAP inhibitor&#xD;
             (FAPI) PET/CT&#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>Jeremie Calais</last_name>
    <role>Principal Investigator</role>
    <affiliation>UCLA / Jonsson Comprehensive Cancer Center</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Andrea Limon</last_name>
    <phone>310-206-7372</phone>
    <email>AndreaLimon@mednet.ucla.edu</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Ethan Lam</last_name>
    <phone>310-206-7372</phone>
    <email>eclam@mednet.ucla.edu</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>UCLA / Jonsson Comprehensive Cancer Center</name>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <zip>90095</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Andrea Limon</last_name>
      <phone>310-206-7372</phone>
      <email>AndreaLimon@mednet.ucla.edu</email>
    </contact>
    <contact_backup>
      <last_name>Ethan Lam</last_name>
      <phone>310-206-7372</phone>
      <email>eclam@mednet.ucla.edu.edu</email>
    </contact_backup>
    <investigator>
      <last_name>Jeremie Calais</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>July 2023</verification_date>
  <study_first_submitted>June 30, 2020</study_first_submitted>
  <study_first_submitted_qc>June 30, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 7, 2020</study_first_posted>
  <last_update_submitted>July 10, 2023</last_update_submitted>
  <last_update_submitted_qc>July 10, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">July 12, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Carcinoma</mesh_term>
    <mesh_term>Prostatic Neoplasms</mesh_term>
    <mesh_term>Neoplasms</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>FAPI-46</mesh_term>
  </intervention_browse>
  <!-- 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/NCT04457232
org study id: 20-000177
secondary id: NCI-2020-02712
secondary id: 20-000177
nct id: NCT04457232
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
is us export: No
This exploratory study investigates how a new imaging technique called FAPI PET/CT can
      determine where and to which degree the FAPI tracer (68Ga-FAPi-46) accumulates in normal and
      cancer tissues in patients with prostate cancer. Because some cancers take up 68Ga-FAPi-46 it
      can be seen with PET. FAP stands for Fibroblast Activation Protein. FAP is produced by cells
      that surround tumors. The function of FAP is not well understood but imaging studies have
      shown that FAP can be detected with FAPI PET/CT. Imaging FAP with FAPI PET/CT may in the
      future provide additional information about various cancers including prostate cancer.
PRIMARY OBJECTIVE:

      I. To define the biodistribution of gallium 68Ga-FAPi-46 in normal and cancer tissues of
      patients with prostate cancer.

      SECONDARY OBJECTIVES:

      I. To evaluate whether 68Ga-FAPi-46 and gallium Ga 68-labeled PSMA-11 (68Ga-PSMA-11)
      accumulation observed by positron emission tomography (PET) correlates with the amount of
      fibroblast activation protein (FAP) and prostate specific membrane antigen (PSMA) in excised
      cancer tissue, respectively.

      II. To assess the 68Ga-FAPI-46 biodistribution correlation with 68Ga-PSMA-11.

      OUTLINE:

      Patients receive 68Ga-FAPi-46 intravenously (IV) and undergo PET/computed tomography (CT)
      imaging over 20-50 minutes.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Basic Science
masking: None (Open Label)
measure: To define and document the biodistribution of gallium 68Ga-FAPi-46 in normal and cancer tissues of patients with prostate cancer
time frame: 60 minutes after tracer injection
description: To quantify tumor tissue and normal background organs positron emission tomography (PET) tracer uptake by semi-quantitative analysis (unit/metrics = standardized uptake values [SUV], SUVmean and SUVmax.
measure: To evaluate whether 68Ga-FAPi-46 accumulation observed by PET correlates with the amount of fibroblast activation protein (FAP) assessed by immunohistochemistry (IHC) in excised cancer tissue
time frame: Up to date of surgery (range 1-60 days)
description: 68Ga-FAPi-46 tumor SUVs will be correlated with FAP expression from surgically resected tumors. IHC will be scored with a semi-quantitative scoring system that accounts for staining intensity (0-2, where 0 is negative, 1 is weak, 2 is strong and eq. stands for equivocal). Correlations will be sought using least square regression analysis.
measure: To assess the 68Ga-FAPI-46 biodistribution correlation with 68Ga-PSMA-11 PET imaging
time frame: 60 minutes after tracer injection
description: The 68Ga-PSMA-11 and 68Ga-FAPI-46 tracer biodistribution will be described by mean and maximum standardized uptake values (SUVmean and SUVmax) and tested for correlation.
arm group label: Basic Science (68Ga-FAPi-46 PET/CT)
arm group type: Experimental
description: Patients receive 68Ga-FAPi-46 IV and undergo PET/CT imaging over 20-50 minutes.
intervention type: Procedure
intervention name: Computed Tomography
description: Undergo PET/CT imaging
arm group label: Basic Science (68Ga-FAPi-46 PET/CT)
other name: CAT
other name: CAT Scan
other name: Computerized Axial Tomography
other name: Computerized Tomography
other name: CT
other name: CT Scan
other name: tomography
intervention type: Other
intervention name: Gallium Ga 68 FAPi-46
description: Given IV
arm group label: Basic Science (68Ga-FAPi-46 PET/CT)
other name: 68Ga-FAPi-46
other name: Gallium-68-FAPi-46
intervention type: Procedure
intervention name: Positron Emission Tomography
description: Undergo PET/CT imaging
arm group label: Basic Science (68Ga-FAPi-46 PET/CT)
other name: Medical Imaging, Positron Emission Tomography
other name: PET
other name: PET Scan
other name: Positron Emission Tomography Scan
other name: Positron-Emission Tomography
other name: proton magnetic resonance spectroscopic imaging
criteria: 
gender: Male
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Jeremie Calais
role: Principal Investigator
affiliation: UCLA / Jonsson Comprehensive Cancer Center
last name: Andrea Limon
phone: 310-206-7372
email: AndreaLimon@mednet.ucla.edu
last name: Ethan Lam
phone: 310-206-7372
email: eclam@mednet.ucla.edu
facility: 
status: Recruiting
contact: 
contact backup: 
investigator: 
country: United States
responsible party type: Sponsor
mesh term: Carcinoma
mesh term: Prostatic Neoplasms
mesh term: Neoplasms
mesh term: FAPI-46