<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/NCT03307460</url>
  </required_header>
  <id_info>
    <org_study_id>AK-2017-PC-1</org_study_id>
    <secondary_id>2017-002276-37</secondary_id>
    <nct_id>NCT03307460</nct_id>
  </id_info>
  <brief_title>uPAR-PET/MRI in Patients With Prostate Cancer for Evaluation of Tumor Aggressiveness</brief_title>
  <official_title>Phase II Trial: uPAR-PET/MR in Patients With Newly Diagnosed Prostate Cancer; Non-invasive Characterization of Tumor Aggressiveness</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Rigshospitalet, Denmark</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Rigshospitalet, Denmark</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Prospective study to evaluate the value of uPAR-targeted PET/MR scan using the tracer&#xD;
      68Ga-NOTA-AE105 in patients with newly diagnosed prostate cancer&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Prostate cancer is one of the most frequent types of cancer in men. The characteristics of&#xD;
      the disease varies significantly among patients where some have an indolent type of cancer,&#xD;
      from which they will never experience symptoms while others have highly aggressive malignant&#xD;
      disease that requires prompt therapeutic action.&#xD;
&#xD;
      Treatment of localized prostate cancer is based on a risk stratification, where patients are&#xD;
      either offered therapy with curative intent - surgery or radiotherapy - or in case of&#xD;
      low-risk disease an &quot;active surveillance&quot; strategy can be advised. In active surveillance the&#xD;
      disease is monitored by PSA measurement, repeated biopsies and digital rectal examination.&#xD;
      Some patients progress during active surveillance to a higher risk classification, which may&#xD;
      lead to selection of active therapy.&#xD;
&#xD;
      The aim of this study is to investigate positron emission tomography (PET) with the&#xD;
      radiolabelled tracer 68Ga-NOTA-AE105, combined with magnetic resonance imaging (MRI) in&#xD;
      patients with newly diagnosed prostate cancer. 68Ga-NOTA-AE105 targets the receptor&#xD;
      urokinase-type plasminogen activator receptor (uPAR), which is a known marker for aggressive&#xD;
      disease in prostate cancer.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Active, not recruiting</last_known_status>
  <start_date type="Actual">November 21, 2017</start_date>
  <completion_date type="Anticipated">April 1, 2022</completion_date>
  <primary_completion_date type="Actual">October 11, 2019</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>
    <primary_purpose>Diagnostic</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Correlation with Gleason Score</measure>
    <time_frame>3 months after PET/MRI</time_frame>
    <description>Correlate the uptake of 68Ga-NOTA-AE105 with Gleason Score obtained from biopsy material.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Prognostic value</measure>
    <time_frame>3 years from PET/MRI</time_frame>
    <description>Evaluate the prognostic value of uPAR PET/MRI in patients with prostate cancer either undergoing therapy with curative intent or active surveillance.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Diagnostic accuracy in staging lymph nodes</measure>
    <time_frame>3 months from PET/MRI</time_frame>
    <description>Evaluate the diagnostic accuracy of uPAR PET/MRI in identifying regional lymph node metastases in patients with newly diagnosed prostate cancer</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">52</enrollment>
  <condition>Prostate Cancer</condition>
  <arm_group>
    <arm_group_label>uPAR PET/MRI</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>68Ga-NOTA-AE105 is injected once for performing a PET/MRI scan</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>68Ga-NOTA-AE105</intervention_name>
    <description>PET/MRI scan</description>
    <arm_group_label>uPAR PET/MRI</arm_group_label>
    <other_name>PET/MRI</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Histologically verified prostate cancer&#xD;
&#xD;
          -  Capable of understanding written information and giving informed consent&#xD;
&#xD;
          -  Planned to enter active surveillance strategy or undergo therapy with curative intent&#xD;
             (surgery or radiotherapy)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Obesity (Body weight over 140 kg)&#xD;
&#xD;
          -  Known allergy to 68-Ga-NOTA-AE105&#xD;
&#xD;
          -  Metallic components in the body that contradicts MRI scan&#xD;
&#xD;
          -  Severe claustrophobia making the person unable to complete an MRI scan&#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>Marie Ø Fosboel, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Rigshospitalet, Department of Clinical Physiology, Nuclear Medicine &amp; PET</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Rigshospitalet</name>
      <address>
        <city>Copenhagen</city>
        <zip>2100</zip>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Denmark</country>
  </location_countries>
  <verification_date>November 2020</verification_date>
  <study_first_submitted>October 6, 2017</study_first_submitted>
  <study_first_submitted_qc>October 6, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">October 11, 2017</study_first_posted>
  <last_update_submitted>November 20, 2020</last_update_submitted>
  <last_update_submitted_qc>November 20, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">November 23, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Rigshospitalet, Denmark</investigator_affiliation>
    <investigator_full_name>Marie Øbro Fosbøl</investigator_full_name>
    <investigator_title>Medical doctor</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>Aggression</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <pending_results>
    <submitted>October 10, 2022</submitted>
    <returned>August 29, 2023</returned>
  </pending_results>
  <!-- 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/NCT03307460
org study id: AK-2017-PC-1
secondary id: 2017-002276-37
nct id: NCT03307460
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Prospective study to evaluate the value of uPAR-targeted PET/MR scan using the tracer
      68Ga-NOTA-AE105 in patients with newly diagnosed prostate cancer
Prostate cancer is one of the most frequent types of cancer in men. The characteristics of
      the disease varies significantly among patients where some have an indolent type of cancer,
      from which they will never experience symptoms while others have highly aggressive malignant
      disease that requires prompt therapeutic action.

      Treatment of localized prostate cancer is based on a risk stratification, where patients are
      either offered therapy with curative intent - surgery or radiotherapy - or in case of
      low-risk disease an "active surveillance" strategy can be advised. In active surveillance the
      disease is monitored by PSA measurement, repeated biopsies and digital rectal examination.
      Some patients progress during active surveillance to a higher risk classification, which may
      lead to selection of active therapy.

      The aim of this study is to investigate positron emission tomography (PET) with the
      radiolabelled tracer 68Ga-NOTA-AE105, combined with magnetic resonance imaging (MRI) in
      patients with newly diagnosed prostate cancer. 68Ga-NOTA-AE105 targets the receptor
      urokinase-type plasminogen activator receptor (uPAR), which is a known marker for aggressive
      disease in prostate cancer.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Diagnostic
masking: None (Open Label)
measure: Correlation with Gleason Score
time frame: 3 months after PET/MRI
description: Correlate the uptake of 68Ga-NOTA-AE105 with Gleason Score obtained from biopsy material.
measure: Prognostic value
time frame: 3 years from PET/MRI
description: Evaluate the prognostic value of uPAR PET/MRI in patients with prostate cancer either undergoing therapy with curative intent or active surveillance.
measure: Diagnostic accuracy in staging lymph nodes
time frame: 3 months from PET/MRI
description: Evaluate the diagnostic accuracy of uPAR PET/MRI in identifying regional lymph node metastases in patients with newly diagnosed prostate cancer
arm group label: uPAR PET/MRI
arm group type: Experimental
description: 68Ga-NOTA-AE105 is injected once for performing a PET/MRI scan
intervention type: Drug
intervention name: 68Ga-NOTA-AE105
description: PET/MRI scan
arm group label: uPAR PET/MRI
other name: PET/MRI
criteria: 
gender: Male
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Marie Ø Fosboel, MD
role: Principal Investigator
affiliation: Rigshospitalet, Department of Clinical Physiology, Nuclear Medicine & PET
facility: 
country: Denmark
responsible party type: Principal Investigator
investigator affiliation: Rigshospitalet, Denmark
investigator full name: Marie Øbro Fosbøl
investigator title: Medical doctor
mesh term: Prostatic Neoplasms
mesh term: Aggression
sharing ipd: Undecided
submitted: October 10, 2022
returned: August 29, 2023