<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/NCT04452136</url>
  </required_header>
  <id_info>
    <org_study_id>STUDY00020072</org_study_id>
    <secondary_id>STUDY00020073</secondary_id>
    <nct_id>NCT04452136</nct_id>
  </id_info>
  <brief_title>Expanded Access Protocol of 68Ga PSMA 11 PET Imaging of Prostate Cancer</brief_title>
  <official_title>68Ga PSMA-11 in Patients With Intermediate to High-risk Prostate Cancer Before Prostatectomy or With Biochemical Recurrence of Prostate Cancer.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Jeanne Link</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>OHSU Center of Radiochemistry Research</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Oregon Health and Science University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>OHSU Knight Cancer Institute</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>OHSU Knight Cancer Institute</source>
  <brief_summary>
    <textblock>
      This study provides expanded access to radiotracer Gallium 68 (68Ga)-prostate-specific&#xD;
      membrane antigen (PSMA)-HBED-CC (68Ga-PSMA-11) with Positron Emission Tomography (PET)&#xD;
      imaging for participants with intermediate and high risk prostate cancer before prostatectomy&#xD;
      or for suspected biochemical recurrence of their prostate cancer. Compared to conventional&#xD;
      imaging, 68Ga PSMA-HBED-CC might improve the ability to localize the sites of recurrent or&#xD;
      metastatic disease, which helps with surgical and other treatment planning.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      PRIMARY OBJECTIVE:&#xD;
&#xD;
      Provide participants with prostate cancer access to 68Ga PSMA-HBED-CC to localize the site of&#xD;
      potential metastatic or recurrent disease.&#xD;
&#xD;
      OUTLINE:&#xD;
&#xD;
      Eligible participants will be intravenously administered 68Ga PSMA-HBED-CC at a dose of 3-7&#xD;
      mCi (111 - 259 MBq), target 5 mCi. The estimated uptake time of the study agent is 75 minutes&#xD;
      ± 25 minutes. The targeted uptake time is 60 minutes, with an acceptable range of 50-100&#xD;
      minutes. Following the PET scan with the study agent, participants will undergo either&#xD;
      surgical management or treatment for metastatic disease in accordance with institutional&#xD;
      standards.&#xD;
&#xD;
      Patients will be observed for 2 hours after injection of the radiotracer, and will be&#xD;
      followed-up 1-3 days post injection with a phone call.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Approved for marketing</overall_status>
  <study_type>Expanded Access</study_type>
  <has_expanded_access>No</has_expanded_access>
  <expanded_access_info>
    <expanded_access_type_intermediate>Yes</expanded_access_type_intermediate>
  </expanded_access_info>
  <condition>Prostatic Neoplasms</condition>
  <condition>Prostatic Diseases</condition>
  <condition>Prostate Cancer</condition>
  <condition>Prostate Cancer Metastatic</condition>
  <condition>Prostate Cancer Recurrent</condition>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>68GA PSMA-HBED-CC</intervention_name>
    <description>Given IV</description>
    <other_name>68Ga-PSMA-11</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        PLANNED PROSTATECTOMY&#xD;
&#xD;
          -  Biopsy-proven prostate adenocarcinoma&#xD;
&#xD;
          -  Intermediate to high-risk disease, defined as one of the following factors: PSA &gt; 10,&#xD;
             T2b or greater, or a Gleason score of 7 or greater.&#xD;
&#xD;
          -  Planned prostatectomy with lymph node dissection&#xD;
&#xD;
          -  Must be treatment naïve (not have received neoadjuvant chemotherapy, radiation&#xD;
             therapy, hormonal therapy, androgen deprivation therapy, or focal ablation techniques&#xD;
             (e.g., HiFu)&#xD;
&#xD;
        BIOCHEMICAL RECURRENCE&#xD;
&#xD;
          -  Pathologically proven prostate adenocarcinoma. Rising PSA after definitive therapy&#xD;
             with prostatectomy or radiation therapy (external beam or brachytherapy).&#xD;
&#xD;
          -  If post-radical prostatectomy, PSA &gt; 0.2 ng/mL measured &gt; 6 weeks post-operatively and&#xD;
             confirmatory persistent PSA greater than 0.2 ng/mL (AUA recommendation for biochemical&#xD;
             recurrence).&#xD;
&#xD;
          -  If post-radiation therapy, PSA that is equal to or greater than a 2 mg/mL rise above&#xD;
             PSA nadir (ASTRO recommendation for biochemical recurrence).&#xD;
&#xD;
          -  No other malignancy within the past 2 years (skin basal cell or cutaneous superficial&#xD;
             squamous cell carcinoma or superficial bladder cancer are exempt from this criterion).&#xD;
&#xD;
        ALL&#xD;
&#xD;
          -  Karnofsky performance status (KPS) &gt;= 50 (ECOG/WHO 0, 1, or 2)&#xD;
&#xD;
          -  Not receiving any other investigational agents (i.e., unlabeled drugs or drugs under&#xD;
             an IND for initial efficacy investigations&#xD;
&#xD;
          -  Ability to understand and the willingness to provide informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  History of Stevens-Johnson syndrome&#xD;
&#xD;
          -  Known Paget's disease&#xD;
&#xD;
          -  Uncontrolled intercurrent illness including, but not limited to, ongoing or active&#xD;
             infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac&#xD;
             arrhythmia, or psychiatric illness/social situations that would limit compliance with&#xD;
             study requirements.&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
  </eligibility>
  <overall_official>
    <last_name>Nadine Mallak, M.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>OHSU Knight Cancer Institute</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>OHSU Knight Cancer Institute</name>
      <address>
        <city>Portland</city>
        <state>Oregon</state>
        <zip>97239</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>March 2022</verification_date>
  <study_first_submitted>June 25, 2020</study_first_submitted>
  <study_first_submitted_qc>June 29, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 30, 2020</study_first_posted>
  <last_update_submitted>March 11, 2022</last_update_submitted>
  <last_update_submitted_qc>March 11, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">March 14, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>OHSU Knight Cancer Institute</investigator_affiliation>
    <investigator_full_name>Jeanne Link</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Prostatic Neoplasms</mesh_term>
    <mesh_term>Prostatic Diseases</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>
  <!-- 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/NCT04452136
org study id: STUDY00020072
secondary id: STUDY00020073
nct id: NCT04452136
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
This study provides expanded access to radiotracer Gallium 68 (68Ga)-prostate-specific
      membrane antigen (PSMA)-HBED-CC (68Ga-PSMA-11) with Positron Emission Tomography (PET)
      imaging for participants with intermediate and high risk prostate cancer before prostatectomy
      or for suspected biochemical recurrence of their prostate cancer. Compared to conventional
      imaging, 68Ga PSMA-HBED-CC might improve the ability to localize the sites of recurrent or
      metastatic disease, which helps with surgical and other treatment planning.
PRIMARY OBJECTIVE:

      Provide participants with prostate cancer access to 68Ga PSMA-HBED-CC to localize the site of
      potential metastatic or recurrent disease.

      OUTLINE:

      Eligible participants will be intravenously administered 68Ga PSMA-HBED-CC at a dose of 3-7
      mCi (111 - 259 MBq), target 5 mCi. The estimated uptake time of the study agent is 75 minutes
      ± 25 minutes. The targeted uptake time is 60 minutes, with an acceptable range of 50-100
      minutes. Following the PET scan with the study agent, participants will undergo either
      surgical management or treatment for metastatic disease in accordance with institutional
      standards.

      Patients will be observed for 2 hours after injection of the radiotracer, and will be
      followed-up 1-3 days post injection with a phone call.
expanded access type intermediate: Yes
intervention type: Drug
intervention name: 68GA PSMA-HBED-CC
description: Given IV
other name: 68Ga-PSMA-11
criteria: 
gender: Male
minimum age: 18 Years
maximum age: N/A
last name: Nadine Mallak, M.D.
role: Principal Investigator
affiliation: OHSU Knight Cancer Institute
facility: 
country: United States
responsible party type: Sponsor-Investigator
investigator affiliation: OHSU Knight Cancer Institute
investigator full name: Jeanne Link
investigator title: Professor
mesh term: Prostatic Neoplasms
mesh term: Prostatic Diseases
mesh term: Gallium 68 PSMA-11