xml: <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/NCT06011304</url>
    </required_header>
    <id_info>
      <org_study_id>BJK-ZX-STM-2202-GK</org_study_id>
      <nct_id>NCT06011304</nct_id>
    </id_info>
    <brief_title>Study of 18F-Florastamin PET/CT Imaging in Patients With at Least Intermediate Risk Prostate Cancer</brief_title>
    <official_title>A Phase III, Open-Label, Multi-center Clinical Study to Assess the Diagnostic Performance and Safety of 18F-Florastamin PET/CT Imaging in Patients With at Least Intermediate Risk Prostate Cancer</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>HTA Co., Ltd.</agency>
        <agency_class>Industry</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>HTA Co., Ltd.</source>
    <oversight_info>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        In this study, 18F-Florastamin PET/CT will be performed in patients with at least&#xD;
        intermediate risk prostate cancer, to assess the diagnostic performance and safety of&#xD;
        18F-Florastamin PET/CT imaging.&#xD;
  &#xD;
        This study will first carry out the pilot study (including pharmacokinetics and radiation&#xD;
        dosimetry).&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Recruiting</overall_status>
    <start_date type="Anticipated">August 2023</start_date>
    <completion_date type="Anticipated">January 2025</completion_date>
    <primary_completion_date type="Anticipated">November 2024</primary_completion_date>
    <phase>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>Specificity</measure>
      <time_frame>Within 28 days following 18F-Florastamin PET/CT</time_frame>
      <description>The specificity of 18F-Florastamin PET/CT in patients with negative pelvic lymph node metastasis compared with the histopathology.&#xD;
  The subjects underwent RP (radical prostatectomy) with PLND (pelvic lymph node dissection) within 28 days after the administration of 18F-Florastamin Injection. The histopathology results of the pelvic lymph node tissue collected from the subjects will be used as the standard of truth for this study.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Sensitivity</measure>
      <time_frame>Within 28 days following 18F-Florastamin PET/CT</time_frame>
      <description>The sensitivity of 18F-Florastamin PET/CT in patients with positive pelvic lymph node metastasis compared with the histopathology.</description>
    </secondary_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Anticipated">267</enrollment>
    <condition>Prostate Cancer</condition>
    <arm_group>
      <arm_group_label>18F-Florastamin Injection</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>[18F]Florastamin Injection</intervention_name>
      <description>The subjects who participate in phase 3 study will be intravenously injected with [18F]Florastamin Injection and undergo PET/CT scan at 110 min after the injection.&#xD;
  Subjects who participate in pilot study will be intravenously injected with [18F]Florastamin Injection and undergo PET/CT scan at 5 min, 30 min, 60 min, 110 min, 160 min after the injection.</description>
      <arm_group_label>18F-Florastamin Injection</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. Subjects fully understood the content, process, and potential risks of the study and&#xD;
               voluntarily signed an informed consent form (ICF).&#xD;
  &#xD;
            2. Male subjects aged 18 or older.&#xD;
  &#xD;
            3. Subjects with histopathological diagnosis of prostate adenocarcinoma.&#xD;
  &#xD;
            4. According to clinical judgment, radical prostatectomy and pelvic lymph node dissection&#xD;
               (which can include patients with localized, regional lymph node metastasis or&#xD;
               oligometastatic prostate cancer) are planned, and there is no surgical&#xD;
               contraindication.&#xD;
  &#xD;
            5. If it is localized prostate cancer, according to the Prostate Cancer Diagnosis and&#xD;
               Treatment Guidelines of 2021 Chinese Society of Clinical Oncology, it is necessary to&#xD;
               meet any of the following criteria:&#xD;
  &#xD;
               Intermediate Risk: Has at least one intermediate risk factor: T2b-T2c; Gleason pattern&#xD;
               2 or 3; PSA 10-20 ng/mL, and does not include feature of high-risk or very-high-risk&#xD;
               groups.&#xD;
  &#xD;
               High Risk: Has no very-high-risk features and has at least one high-risk feature: T3a;&#xD;
               Gleason Grade Group 4 or 5; PSA &gt;20 ng/mL.&#xD;
  &#xD;
               Very High Risk: Has at least one of the following: T3b-T4; Primary Gleason pattern 5;&#xD;
               More than 4 punctures with Gleason Grade Group 4 or 5.&#xD;
  &#xD;
            6. ECOG score 0 or 1.&#xD;
  &#xD;
            7. Subjects who meet the following conditions in hematology, renal function, and liver&#xD;
               function:&#xD;
  &#xD;
                 -  Platelet count&gt;100 * 10^9/L&#xD;
  &#xD;
                 -  Urea nitrogen and creatinine&lt;1.5 times upper limits of normal&#xD;
  &#xD;
                 -  AST and ALT&lt;2.5 times upper limits of normal.&#xD;
  &#xD;
            8. Expected survival time ≥ 6 months.&#xD;
  &#xD;
            9. Subjects and their partners must use effective contraceptive measurements and avoid&#xD;
               sperm donation from the date of signing ICF to 3 months after administration.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. Subjects who have participated in other interventional clinical trials before signing&#xD;
               ICF and were within the 5 half-lives of the investigational drug, or who are currently&#xD;
               participating in other interventional clinical trials or have participated in clinical&#xD;
               trials of radioactive drugs within 1 year before signing ICF and have been&#xD;
               discontinued for less than 3 months until the signing date of ICF.&#xD;
  &#xD;
            2. Intravenous injection of iodinated contrast medium within 24 hours, or any&#xD;
               high-density oral contrast medium (Such as barium sulfate. Oral water contrast is&#xD;
               acceptable, such as compound meglumine diatrizoate oral liquid) within 5 days, prior&#xD;
               to study drug administration.&#xD;
  &#xD;
            3. Subjects administered any high energy (&gt;300 KeV) gamma-emitting radioisotope within&#xD;
               five physical half-lives prior to study drug administration.&#xD;
  &#xD;
            4. Patients with prior androgen deprivation therapy or any other neoadjuvant agent.&#xD;
  &#xD;
            5. The investigator determines that there are any medical diseases or other conditions&#xD;
               that affect the safety or compliance of the subjects.&#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_contact>
      <last_name>Wei Fan</last_name>
      <phone>+86 13602883007</phone>
      <email>fanwei@sysucc.org.cn</email>
    </overall_contact>
    <location>
      <facility>
        <name>Sun Yat-sen University Cancer Center</name>
        <address>
          <city>Guangzhou</city>
          <country>China</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Wei Fan</last_name>
        <phone>+8613602883007</phone>
        <email>fanwei@sysucc.org.cn</email>
      </contact>
    </location>
    <location_countries>
      <country>China</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 21, 2023</study_first_submitted>
    <study_first_submitted_qc>August 21, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 25, 2023</study_first_posted>
    <last_update_submitted>August 21, 2023</last_update_submitted>
    <last_update_submitted_qc>August 21, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 25, 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>Prostatic Neoplasms</mesh_term>
    </condition_browse>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06011304
  org study id: BJK-ZX-STM-2202-GK
  nct id: NCT06011304
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  In this study, 18F-Florastamin PET/CT will be performed in patients with at least
        intermediate risk prostate cancer, to assess the diagnostic performance and safety of
        18F-Florastamin PET/CT imaging.
  
        This study will first carry out the pilot study (including pharmacokinetics and radiation
        dosimetry).
  allocation: N/A
  intervention model: Single Group Assignment
  primary purpose: Diagnostic
  masking: None (Open Label)
  measure: Specificity
  time frame: Within 28 days following 18F-Florastamin PET/CT
  description: The specificity of 18F-Florastamin PET/CT in patients with negative pelvic lymph node metastasis compared with the histopathology.
  The subjects underwent RP (radical prostatectomy) with PLND (pelvic lymph node dissection) within 28 days after the administration of 18F-Florastamin Injection. The histopathology results of the pelvic lymph node tissue collected from the subjects will be used as the standard of truth for this study.
  measure: Sensitivity
  time frame: Within 28 days following 18F-Florastamin PET/CT
  description: The sensitivity of 18F-Florastamin PET/CT in patients with positive pelvic lymph node metastasis compared with the histopathology.
  arm group label: 18F-Florastamin Injection
  arm group type: Experimental
  intervention type: Drug
  intervention name: [18F]Florastamin Injection
  description: The subjects who participate in phase 3 study will be intravenously injected with [18F]Florastamin Injection and undergo PET/CT scan at 110 min after the injection.
  Subjects who participate in pilot study will be intravenously injected with [18F]Florastamin Injection and undergo PET/CT scan at 5 min, 30 min, 60 min, 110 min, 160 min after the injection.
  arm group label: 18F-Florastamin Injection
  criteria: 
  gender: Male
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Wei Fan
  phone: +86 13602883007
  email: fanwei@sysucc.org.cn
  facility: 
  status: Recruiting
  contact: 
  country: China
  responsible party type: Sponsor
  mesh term: Prostatic Neoplasms