<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/NCT03780075</url>
  </required_header>
  <id_info>
    <org_study_id>PekingUMCH-NM019</org_study_id>
    <nct_id>NCT03780075</nct_id>
  </id_info>
  <brief_title>Lu177-EB-PSMA617 Radionuclide Treatment in Patients With Metastatic Castration-resistant Prostate Cancer</brief_title>
  <official_title>Lu177-EB-PSMA617 Prostate-Specific Membrane Antigen Inhibitor Therapy in Patients With Castration-Resistant Prostate Cancer</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Peking Union Medical College Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Institute for Biomedical Imaging and Bioengineering (NIBIB)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>Peking Union Medical College Hospital</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 prior studies, the investigators synthesized 177Lu-EB-PSMA-617 by conjugating a truncated&#xD;
      Evans Blue (EB) molecule and DOTA chelator onto PSMA-617 and labeled it with 177Lu to&#xD;
      increase the tumor accumulation and retention for radioligand therapy，and then the&#xD;
      investigators evaluated the dosimetry of 177Lu-EB-PSMA-617 and response to single low-dose&#xD;
      treatment in patients with metastatic castration-resistant prostate cancer(mCRPC). This study&#xD;
      was performed to evaluate the safety and therapy response to 177Lu-EB-PSMA-617 in patients&#xD;
      with mCRPC.&#xD;
&#xD;
      This is an open-label, randomized study. Different groups with doses of 1.11GBq (30 mCi),&#xD;
      2.00 GBq (54 mCi) and 3.7GBq (100 mCi)of 177Lu-EB -PSMA617 will be injected intravenously.&#xD;
      All patients will undergo 68Ga-PSMA PET/CT scans before and after the treatment.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Prostate cancer (PC) is the second most common cancer worldwide in men, with persistently&#xD;
      high numbers dying from this disease. Recent studies have demonstrated the possibility of&#xD;
      177Lu-PSMA-617 therapy as a viable treatment option in mCRPC. To increase tumor accumulation&#xD;
      and retention for radioligand therapy, and reduce dosage of 177Lu, the investigators&#xD;
      conjugated a truncated Evans blue (EB) molecule and DOTA chelator onto PSMA-617 (EB-PSMA-617)&#xD;
      and label it with 177Lu.&#xD;
&#xD;
      The study is open-label and patients will be divided into three groups and monitored&#xD;
      throughout the 6 to 10-month treatment period for survival, disease progression, and adverse&#xD;
      events to evaluate the safety and therapy response to the 177Lu-EB-PSMA-617.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">April 15, 2018</start_date>
  <completion_date type="Anticipated">December 1, 2022</completion_date>
  <primary_completion_date type="Actual">September 1, 2020</primary_completion_date>
  <phase>Phase 1</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change of the PSA and standardized uptake value of 68Ga-PSMA before and after the treatment in mCRPC</measure>
    <time_frame>1 year</time_frame>
    <description>The semiquantitative analysis will be performed by the same person for all the cases, and the standardized uptake in lesions will be measured.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Adverse events collection</measure>
    <time_frame>patients will be monitored throughout the whole treatment period. Patients will be followed up every 3 month until 1 year for a long-term follow-up period.</time_frame>
    <description>Adverse events after the treatment of patients will be followed and assessed</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Anticipated">50</enrollment>
  <condition>Metastatic Castration-resistant Prostate Cancer</condition>
  <arm_group>
    <arm_group_label>1.11GBq of 177Lu-EB-PSMA-617</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The patients were intravenously injected with the dose about 1.11GBq (30 mCi) of 177Lu-EB-PSMA617 and underwent 68Ga-PSMA PET/CT scans before and after the treatment.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>2.00 GBq of 177Lu-EB-PSMA-617</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The patients were intravenously injected with the dose about 2.00 GBq (54 mCi) of 177Lu-EB-PSMA-617 and underwent 68Ga-PSMA PET/CT scans before and after the treatment.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>3.70GBq of 177Lu-EB-PSMA-617</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The patients were intravenously injected with the dose about 3.70GBq (100 mCi) of 177Lu-EB-PSMA617 and underwent 68Ga-PSMA PET/CT scans before and after the treatment.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>1.11GBq of 177Lu-EB-PSMA-617</intervention_name>
    <description>Patients were intravenous injected with the dose about 1.11GBq (30 mCi) of 177Lu-EB-PSMA-617 every 8 weeks (±1 week) for a maximum of 3 cycles.</description>
    <arm_group_label>1.11GBq of 177Lu-EB-PSMA-617</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>2.00 GBq of 177Lu-EB-PSMA-617</intervention_name>
    <description>Patients were intravenous injected with the dose about 2.00 GBq (54 mCi) of 177Lu-EB-PSMA-617 every 8 weeks (±1 week) for a maximum of 3 cycles.</description>
    <arm_group_label>2.00 GBq of 177Lu-EB-PSMA-617</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>3.70GBq of 177Lu-EB-PSMA-617</intervention_name>
    <description>Patients were intravenous injected with the dose about 3.70GBq (100 mCi) of 177Lu-EB-PSMA-617 every 8 weeks (±1 week) for a maximum of 3 cycles.</description>
    <arm_group_label>3.70GBq of 177Lu-EB-PSMA-617</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  progressive metastatic castration-resistant prostate cancer that did not respond to&#xD;
             androgen-suppression therapy and/or systemic chemotherapy.&#xD;
&#xD;
          -  Distant metastases with high PSMA expression confirmed by 68Ga-PSMA PET/CT within one&#xD;
             week before the injection of 177Lu-EB-PSMA-617.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  a serum creatinine level of more than 150μmol per liter,&#xD;
&#xD;
          -  a hemoglobin level of less than 10.0 g/dl,&#xD;
&#xD;
          -  a white-cell count of less than 4.0× 109/L,&#xD;
&#xD;
          -  a platelet count of less than 100 × 109/L,&#xD;
&#xD;
          -  a total bilirubin level of more than 3 times the upper limit of the normal range,&#xD;
&#xD;
          -  a serum albumin level of more than 3.0 g per deciliter,&#xD;
&#xD;
          -  cardiac insufficiency including carcinoid heart valve disease,&#xD;
&#xD;
          -  a severe allergy or hypersensitivity to radiographic contrast material,&#xD;
&#xD;
          -  claustrophobia, and pregnancy or breastfeeding.&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Zhaohui Zhu, MD,PHD</last_name>
    <role>Study Chair</role>
    <affiliation>Peking Union Medical College Hospital, Chinese Academy of Medical Science</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Jie Zang, MD</last_name>
    <phone>+86 10 69154196</phone>
    <email>15901495106@163.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Peking Union Medical College Hospital</name>
      <address>
        <city>Beijing</city>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Jie Zang, MD</last_name>
      <email>15901495106@163.com</email>
    </contact>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>May 2022</verification_date>
  <study_first_submitted>December 17, 2018</study_first_submitted>
  <study_first_submitted_qc>December 17, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 19, 2018</study_first_posted>
  <last_update_submitted>May 6, 2022</last_update_submitted>
  <last_update_submitted_qc>May 6, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">May 12, 2022</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>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>177Lu-EB-PSMA-617</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/NCT03780075
org study id: PekingUMCH-NM019
nct id: NCT03780075
lead sponsor: 
collaborator: 
is fda regulated drug: No
is fda regulated device: No
In prior studies, the investigators synthesized 177Lu-EB-PSMA-617 by conjugating a truncated
      Evans Blue (EB) molecule and DOTA chelator onto PSMA-617 and labeled it with 177Lu to
      increase the tumor accumulation and retention for radioligand therapy，and then the
      investigators evaluated the dosimetry of 177Lu-EB-PSMA-617 and response to single low-dose
      treatment in patients with metastatic castration-resistant prostate cancer(mCRPC). This study
      was performed to evaluate the safety and therapy response to 177Lu-EB-PSMA-617 in patients
      with mCRPC.

      This is an open-label, randomized study. Different groups with doses of 1.11GBq (30 mCi),
      2.00 GBq (54 mCi) and 3.7GBq (100 mCi)of 177Lu-EB -PSMA617 will be injected intravenously.
      All patients will undergo 68Ga-PSMA PET/CT scans before and after the treatment.
Prostate cancer (PC) is the second most common cancer worldwide in men, with persistently
      high numbers dying from this disease. Recent studies have demonstrated the possibility of
      177Lu-PSMA-617 therapy as a viable treatment option in mCRPC. To increase tumor accumulation
      and retention for radioligand therapy, and reduce dosage of 177Lu, the investigators
      conjugated a truncated Evans blue (EB) molecule and DOTA chelator onto PSMA-617 (EB-PSMA-617)
      and label it with 177Lu.

      The study is open-label and patients will be divided into three groups and monitored
      throughout the 6 to 10-month treatment period for survival, disease progression, and adverse
      events to evaluate the safety and therapy response to the 177Lu-EB-PSMA-617.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Change of the PSA and standardized uptake value of 68Ga-PSMA before and after the treatment in mCRPC
time frame: 1 year
description: The semiquantitative analysis will be performed by the same person for all the cases, and the standardized uptake in lesions will be measured.
measure: Adverse events collection
time frame: patients will be monitored throughout the whole treatment period. Patients will be followed up every 3 month until 1 year for a long-term follow-up period.
description: Adverse events after the treatment of patients will be followed and assessed
arm group label: 1.11GBq of 177Lu-EB-PSMA-617
arm group type: Experimental
description: The patients were intravenously injected with the dose about 1.11GBq (30 mCi) of 177Lu-EB-PSMA617 and underwent 68Ga-PSMA PET/CT scans before and after the treatment.
arm group label: 2.00 GBq of 177Lu-EB-PSMA-617
arm group type: Experimental
description: The patients were intravenously injected with the dose about 2.00 GBq (54 mCi) of 177Lu-EB-PSMA-617 and underwent 68Ga-PSMA PET/CT scans before and after the treatment.
arm group label: 3.70GBq of 177Lu-EB-PSMA-617
arm group type: Experimental
description: The patients were intravenously injected with the dose about 3.70GBq (100 mCi) of 177Lu-EB-PSMA617 and underwent 68Ga-PSMA PET/CT scans before and after the treatment.
intervention type: Drug
intervention name: 1.11GBq of 177Lu-EB-PSMA-617
description: Patients were intravenous injected with the dose about 1.11GBq (30 mCi) of 177Lu-EB-PSMA-617 every 8 weeks (±1 week) for a maximum of 3 cycles.
arm group label: 1.11GBq of 177Lu-EB-PSMA-617
intervention type: Drug
intervention name: 2.00 GBq of 177Lu-EB-PSMA-617
description: Patients were intravenous injected with the dose about 2.00 GBq (54 mCi) of 177Lu-EB-PSMA-617 every 8 weeks (±1 week) for a maximum of 3 cycles.
arm group label: 2.00 GBq of 177Lu-EB-PSMA-617
intervention type: Drug
intervention name: 3.70GBq of 177Lu-EB-PSMA-617
description: Patients were intravenous injected with the dose about 3.70GBq (100 mCi) of 177Lu-EB-PSMA-617 every 8 weeks (±1 week) for a maximum of 3 cycles.
arm group label: 3.70GBq of 177Lu-EB-PSMA-617
criteria: 
gender: Male
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: No
last name: Zhaohui Zhu, MD,PHD
role: Study Chair
affiliation: Peking Union Medical College Hospital, Chinese Academy of Medical Science
last name: Jie Zang, MD
phone: +86 10 69154196
email: 15901495106@163.com
facility: 
status: Recruiting
contact: 
country: China
responsible party type: Sponsor
mesh term: Prostatic Neoplasms
mesh term: 177Lu-EB-PSMA-617