<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/NCT03768349</url>
  </required_header>
  <id_info>
    <org_study_id>18-006159</org_study_id>
    <nct_id>NCT03768349</nct_id>
    <nct_alias>NCT04144010</nct_alias>
  </id_info>
  <brief_title>PSMA and C-11 Choline PET in Patients With Biochemical Recurrence of Prostate Cancer</brief_title>
  <official_title>PSMA and C-11 Choline PET in Patients With Biochemical Recurrence of Prostate Cancer</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Mayo Clinic</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Mayo Clinic</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>
      Imaging and staging of prostate cancer is critical for surgical and treatment planning. In&#xD;
      this protocol we will image patients with suspected metastatic prostate cancer using&#xD;
      11C-Choline PET and Gallium-68 labeled HBED-CC PSMA (more commonly called 68Ga-PSMA-11) or&#xD;
      F-18 labeled PSMA 1007 in order to demonstrate their utility in detecting prostate cancer.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">January 3, 2019</start_date>
  <completion_date type="Anticipated">December 1, 2024</completion_date>
  <primary_completion_date type="Anticipated">February 3, 2024</primary_completion_date>
  <phase>Early Phase 1</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Diagnostic</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Tumor Detection on PET/CT</measure>
    <time_frame>12 Months post PET/CT</time_frame>
    <description>Positive predictive value on a per-patient and per-region-basis of PSMA and C-11 choline PET/CT for detection of tumor location confirmed by histopathology/biopsy or conventional imaging follow-up.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Impact of PSMA and C-11 choline PET on clinical management</measure>
    <time_frame>12 Months</time_frame>
    <description>Descriptive statistics will be used to evaluate the impact of PSMA and C-11 choline PET on clinical management</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of adverse events attributable to PSMA</measure>
    <time_frame>12 Months</time_frame>
    <description>Adverse events will be evaluated according to the Common Terminology Criteria for Adverse Events (CTCAE 5.0)</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">250</enrollment>
  <condition>Prostate Cancer</condition>
  <arm_group>
    <arm_group_label>PET/CT Ga-68 PSMA</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Ga-68 labeled PSMA-11 (or PSMA-HBED-CC) PET/CT</description>
  </arm_group>
  <arm_group>
    <arm_group_label>PET/CT F-18 Labeled PSMA 1007</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>F-18 Labeled PSMA 1007 PET/CT</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Ga-68 PSMA11</intervention_name>
    <description>Ga-68 PSMA11 PET/CT for detection of tumor location</description>
    <arm_group_label>PET/CT Ga-68 PSMA</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>F-18 PSMA 1007</intervention_name>
    <description>F-18 PSMA 1007 PET/CT for detection of tumor location</description>
    <arm_group_label>PET/CT F-18 Labeled PSMA 1007</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Histopathological proven prostate adenocarcinoma.&#xD;
&#xD;
          2. Rising PSA after definitive therapy with prostatectomy or radiation therapy (external&#xD;
             beam or brachytherapy).&#xD;
&#xD;
             a. Post radical prostatectomy (RP) - with or without radiation. i. PSA greater than or&#xD;
             equal to 0.2 ng/mL measured more than 12 weeks after RP. ii. &gt; 3 months post-surgery&#xD;
             b. Post-radiation therapy ASTRO-Phoenix consensus definition c. May or may not be&#xD;
             castrate resistant (list prior therapies)&#xD;
&#xD;
          3. Karnofsky performance status of 50 (or ECOG/WHO equivalent).&#xD;
&#xD;
          4. CT or as part of the PET study or performed within one month of PSMA PET.&#xD;
&#xD;
          5. Age &gt; 18.&#xD;
&#xD;
          6. Ability to understand a written informed consent document, and the willingness to sign&#xD;
             it.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Undergoing investigational therapy for prostate cancer.&#xD;
&#xD;
          2. Other ongoing treatments for prostate cancer including radiation therapy, chemotherapy&#xD;
             or androgen deprivation. Androgen deprivation within the last 4 months excluding&#xD;
             finasteride, dutasteride or other 5 alpha reductase inhibitors (excluding castrate&#xD;
             resistant subjects).&#xD;
&#xD;
          3. Unable to lie flat, still or tolerate a PET scan.&#xD;
&#xD;
          4. Prior history of any other malignancy within the last 2 years, other than skin basal&#xD;
             cell or cutaneous superficial squamous cell carcinoma that has not metastasized and&#xD;
             superficial bladder cancer.&#xD;
&#xD;
          5. Contraindication to furosemide administration including prior allergy or adverse&#xD;
             reaction to furosemide or sulfa drugs. (Note: This exclusion criteria can be removed&#xD;
             if Furosemide is omitted as part of the PET imaging protocol if a second-generation&#xD;
             scatter correction is available for the used PET device).&#xD;
&#xD;
          6. Absence of PSA and total testosterone tests within 4 weeks.&#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>Val Lowe, M.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Mayo Clinic</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Mayo Clinic</name>
      <address>
        <city>Rochester</city>
        <state>Minnesota</state>
        <zip>55905</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>September 2022</verification_date>
  <study_first_submitted>December 4, 2018</study_first_submitted>
  <study_first_submitted_qc>December 5, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 7, 2018</study_first_posted>
  <last_update_submitted>March 13, 2023</last_update_submitted>
  <last_update_submitted_qc>March 13, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">March 14, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Mayo Clinic</investigator_affiliation>
    <investigator_full_name>Val Lowe</investigator_full_name>
    <investigator_title>Prinicpal Investigator</investigator_title>
  </responsible_party>
  <keyword>Prostate Cancer</keyword>
  <keyword>PET/CT</keyword>
  <keyword>PSMA</keyword>
  <keyword>C-11 Choline</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Prostatic Neoplasms</mesh_term>
    <mesh_term>Recurrence</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Gallium 68 PSMA-11</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>The IPD data from this trial will be available to other researchers that will collate similar data from multiple sites to provide data to the FDA.</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Clinical Study Report (CSR)</ipd_info_type>
    <ipd_time_frame>After completion of the trial and IPD will be available for 2 years.</ipd_time_frame>
    <ipd_access_criteria>Researchers collating data from multiple sites for submission to the FDA will be provided access to the IPD.</ipd_access_criteria>
  </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/NCT03768349
org study id: 18-006159
nct id: NCT03768349
nct alias: NCT04144010
lead sponsor: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
Imaging and staging of prostate cancer is critical for surgical and treatment planning. In
      this protocol we will image patients with suspected metastatic prostate cancer using
      11C-Choline PET and Gallium-68 labeled HBED-CC PSMA (more commonly called 68Ga-PSMA-11) or
      F-18 labeled PSMA 1007 in order to demonstrate their utility in detecting prostate cancer.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Diagnostic
masking: None (Open Label)
measure: Tumor Detection on PET/CT
time frame: 12 Months post PET/CT
description: Positive predictive value on a per-patient and per-region-basis of PSMA and C-11 choline PET/CT for detection of tumor location confirmed by histopathology/biopsy or conventional imaging follow-up.
measure: Impact of PSMA and C-11 choline PET on clinical management
time frame: 12 Months
description: Descriptive statistics will be used to evaluate the impact of PSMA and C-11 choline PET on clinical management
measure: Incidence of adverse events attributable to PSMA
time frame: 12 Months
description: Adverse events will be evaluated according to the Common Terminology Criteria for Adverse Events (CTCAE 5.0)
arm group label: PET/CT Ga-68 PSMA
arm group type: Experimental
description: Ga-68 labeled PSMA-11 (or PSMA-HBED-CC) PET/CT
arm group label: PET/CT F-18 Labeled PSMA 1007
arm group type: Experimental
description: F-18 Labeled PSMA 1007 PET/CT
intervention type: Drug
intervention name: Ga-68 PSMA11
description: Ga-68 PSMA11 PET/CT for detection of tumor location
arm group label: PET/CT Ga-68 PSMA
intervention type: Drug
intervention name: F-18 PSMA 1007
description: F-18 PSMA 1007 PET/CT for detection of tumor location
arm group label: PET/CT F-18 Labeled PSMA 1007
criteria: 
gender: Male
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Val Lowe, M.D.
role: Principal Investigator
affiliation: Mayo Clinic
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Mayo Clinic
investigator full name: Val Lowe
investigator title: Prinicpal Investigator
mesh term: Prostatic Neoplasms
mesh term: Recurrence
mesh term: Gallium 68 PSMA-11
sharing ipd: Yes
ipd description: The IPD data from this trial will be available to other researchers that will collate similar data from multiple sites to provide data to the FDA.
ipd info type: Study Protocol
ipd info type: Clinical Study Report (CSR)
ipd time frame: After completion of the trial and IPD will be available for 2 years.
ipd access criteria: Researchers collating data from multiple sites for submission to the FDA will be provided access to the IPD.