<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/NCT04483414</url>
  </required_header>
  <id_info>
    <org_study_id>STU-2020-0488</org_study_id>
    <nct_id>NCT04483414</nct_id>
  </id_info>
  <brief_title>68Ga PSMA-11 PET/CT in Recurrent Prostate Cancer</brief_title>
  <official_title>The Role of 68Gallium PSMA-11 in Biochemical Recurrence in Prostate Cancer and in Known Metastatic Prostate Cancer and in the Evaluation of Treatment Response After Salvage Therapy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Dana Mathews</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Texas Southwestern Medical 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>
  </oversight_info>
  <brief_summary>
    <textblock>
      The goal of this research is to examine the ability of Gallium-68 (68Ga) Prostate-Specific&#xD;
      Membrane Antigen-11 (PSMA-11) positron emission tomography/computed tomography (PET/CT) to&#xD;
      detect sites of recurrent prostate cancer in patients with biochemical recurrence previously&#xD;
      treated with radical prostatectomy (RP) or external beam radiation (EBRT) and to assess&#xD;
      treatment response to subsequent salvage therapy.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      In developed countries, prostate cancer is the most common malignancy in men and the third&#xD;
      leading cause of death in men. Following primary therapy for prostate cancer, a substantial&#xD;
      number of patients will recur either locally in the pelvis or in extra pelvic locations.&#xD;
      Approximately 20-30% of patients' status post RP will recur and up to 60% patients treated&#xD;
      with EBRT will recur, as detected by rising serum levels of prostate specific antigen (PSA)&#xD;
      after original therapy. This phenomenon is referred to as biochemical recurrence (BCR), as&#xD;
      the elevated PSA usually occurs in advance of obvious clinical or radiologic evidence.&#xD;
&#xD;
      This study is designed to evaluate the performance of 68Ga PSMA-11 PET/CT in detecting the&#xD;
      location (localized versus extra pelvic) of BCR and advanced metastatic prostate cancer&#xD;
      compared to conventional imaging. In addition, we will evaluate its performance in assessing&#xD;
      interim and post salvage therapy response compared to conventional imaging, including pelvic&#xD;
      magnetic resonance imaging (MRI), computed tomography (CT), and bone scintigraphy.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Withdrawn</overall_status>
  <why_stopped>
    Study was closed since no participants were enrolled.&#xD;
  </why_stopped>
  <start_date type="Actual">March 19, 2021</start_date>
  <completion_date type="Actual">April 5, 2023</completion_date>
  <primary_completion_date type="Actual">April 5, 2023</primary_completion_date>
  <phase>Phase 2</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>
    <intervention_model_description>Unblinded, single arm imaging study</intervention_model_description>
    <primary_purpose>Diagnostic</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Location of recurrence</measure>
    <time_frame>Up to 3 years</time_frame>
    <description>Localized vs extra-pelvic recurrence will be determined for each patient based on 68Ga PSMA-11 PET/CT and standard-of-care radiological imaging.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Residual prostate cancer</measure>
    <time_frame>Up to 3 years</time_frame>
    <description>For imaging during or after salvage therapy, existence of residual prostate cancer will be determined for each patient on 68Ga PSMA-11 PET/CT and standard-of-care radiological imaging.</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">0</enrollment>
  <condition>Prostate Cancer</condition>
  <condition>Prostate Cancer Metastatic</condition>
  <condition>Prostate Cancer Metastatic to Bone</condition>
  <arm_group>
    <arm_group_label>Patients with suspected BCR or metastatic prostate cancer</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients with suspected BCR or metastatic prostate cancer</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>68Ga PSMA-11 injection</intervention_name>
    <description>Injection of 68Ga PSMA-11</description>
    <arm_group_label>Patients with suspected BCR or metastatic prostate cancer</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Positron Emission Tomography/Computed Tomography</intervention_name>
    <description>PET/CT scan after 68Ga PSMA-11 injection</description>
    <arm_group_label>Patients with suspected BCR or metastatic prostate cancer</arm_group_label>
    <other_name>PET/CT</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients with suspected BCR of prostate cancer following initial treatment with either&#xD;
             prostatectomy or definitive EBRT of the prostate or patients with known metastatic&#xD;
             prostate cancer who have failed systemic therapy.&#xD;
&#xD;
          -  Patients being considered for salvage therapy.&#xD;
&#xD;
          -  Patients must have an Eastern Cooperative Oncology Group (ECOG) performance status of&#xD;
             0-3.&#xD;
&#xD;
          -  Patients must be medically stable as judged by the patient's physician.&#xD;
&#xD;
          -  Patients must be able to lie still for 20-40 minutes for the PET/CT scans.&#xD;
&#xD;
          -  Ability to understand and the willingness to sign a written informed consent.&#xD;
&#xD;
          -  Patients with BCR and no known lesions should not be on antiandrogen therapy at the&#xD;
             time of scans. Patients with known metastases who are currently being treated with&#xD;
             anti-androgen therapy may remain on this medication.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients who have or have had a biopsy proven concurrent other malignancy, excluding&#xD;
             skin cancers.&#xD;
&#xD;
          -  Patients may not weigh more than the maximum weight limit for the PET /CT scanner&#xD;
             table (&gt; 200 kg or 440 pounds).&#xD;
&#xD;
          -  History of allergic reactions attributed to compounds of similar chemical or biologic&#xD;
             composition to 68Ga PSMA-11. Furosemide will not be administered to patients with&#xD;
             known allergy.&#xD;
&#xD;
          -  Patients must not be claustrophobic.&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <gender_based>Yes</gender_based>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Orhan K Oz, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>UT Southwestern Medical Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>UT Southwestern Medical Center</name>
      <address>
        <city>Dallas</city>
        <state>Texas</state>
        <zip>75390</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>May 2023</verification_date>
  <study_first_submitted>July 20, 2020</study_first_submitted>
  <study_first_submitted_qc>July 20, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 23, 2020</study_first_posted>
  <last_update_submitted>May 18, 2023</last_update_submitted>
  <last_update_submitted_qc>May 18, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">May 19, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>University of Texas Southwestern Medical Center</investigator_affiliation>
    <investigator_full_name>Dana Mathews</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <keyword>PET/CT</keyword>
  <keyword>prostate cancer</keyword>
  <keyword>Gallium-68</keyword>
  <keyword>PSMA-11</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <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>Gallium 68 PSMA-11</mesh_term>
  </intervention_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/NCT04483414
org study id: STU-2020-0488
nct id: NCT04483414
lead sponsor: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
The goal of this research is to examine the ability of Gallium-68 (68Ga) Prostate-Specific
      Membrane Antigen-11 (PSMA-11) positron emission tomography/computed tomography (PET/CT) to
      detect sites of recurrent prostate cancer in patients with biochemical recurrence previously
      treated with radical prostatectomy (RP) or external beam radiation (EBRT) and to assess
      treatment response to subsequent salvage therapy.
In developed countries, prostate cancer is the most common malignancy in men and the third
      leading cause of death in men. Following primary therapy for prostate cancer, a substantial
      number of patients will recur either locally in the pelvis or in extra pelvic locations.
      Approximately 20-30% of patients' status post RP will recur and up to 60% patients treated
      with EBRT will recur, as detected by rising serum levels of prostate specific antigen (PSA)
      after original therapy. This phenomenon is referred to as biochemical recurrence (BCR), as
      the elevated PSA usually occurs in advance of obvious clinical or radiologic evidence.

      This study is designed to evaluate the performance of 68Ga PSMA-11 PET/CT in detecting the
      location (localized versus extra pelvic) of BCR and advanced metastatic prostate cancer
      compared to conventional imaging. In addition, we will evaluate its performance in assessing
      interim and post salvage therapy response compared to conventional imaging, including pelvic
      magnetic resonance imaging (MRI), computed tomography (CT), and bone scintigraphy.
allocation: N/A
intervention model: Single Group Assignment
intervention model description: Unblinded, single arm imaging study
primary purpose: Diagnostic
masking: None (Open Label)
measure: Location of recurrence
time frame: Up to 3 years
description: Localized vs extra-pelvic recurrence will be determined for each patient based on 68Ga PSMA-11 PET/CT and standard-of-care radiological imaging.
measure: Residual prostate cancer
time frame: Up to 3 years
description: For imaging during or after salvage therapy, existence of residual prostate cancer will be determined for each patient on 68Ga PSMA-11 PET/CT and standard-of-care radiological imaging.
arm group label: Patients with suspected BCR or metastatic prostate cancer
arm group type: Experimental
description: Patients with suspected BCR or metastatic prostate cancer
intervention type: Drug
intervention name: 68Ga PSMA-11 injection
description: Injection of 68Ga PSMA-11
arm group label: Patients with suspected BCR or metastatic prostate cancer
intervention type: Procedure
intervention name: Positron Emission Tomography/Computed Tomography
description: PET/CT scan after 68Ga PSMA-11 injection
arm group label: Patients with suspected BCR or metastatic prostate cancer
other name: PET/CT
criteria: 
gender: Male
gender based: Yes
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Orhan K Oz, MD, PhD
role: Principal Investigator
affiliation: UT Southwestern Medical Center
facility: 
country: United States
responsible party type: Sponsor-Investigator
investigator affiliation: University of Texas Southwestern Medical Center
investigator full name: Dana Mathews
investigator title: Professor
mesh term: Prostatic Neoplasms
mesh term: Neoplasms
mesh term: Gallium 68 PSMA-11
sharing ipd: No