<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/NCT03035357</url>
  </required_header>
  <id_info>
    <org_study_id>2016-0566</org_study_id>
    <nct_id>NCT03035357</nct_id>
  </id_info>
  <brief_title>Neoadjuvant Listeria or Daratumumab in Prostate Cancer</brief_title>
  <official_title>A Pilot Presurgical Study of Daratumumab (CD38 Antagonist) in Men With High-Risk Localized Prostate Cancer Followed by Radical Prostatectomy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>M.D. Anderson Cancer Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Janssen-Cilag div. of Johnson&amp;Johnson SE</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>M.D. Anderson Cancer Center</source>
  <oversight_info>
    <has_dmc>No</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 clinical research study is to learn about biomarker changes in patients who&#xD;
      have primary prostate cancer after receiving Darzalex (daratumumab) and then have a&#xD;
      prostatectomy (the surgical removal of the prostate) as part of their standard care.&#xD;
      Biomarkers are found in the blood/tissue and may be related to your reaction to the study&#xD;
      drug.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Study Drug Administration:&#xD;
&#xD;
      If you are found to be eligible to take part in this study, you will receive daratumumab by&#xD;
      vein over about 1 hour 1 time a week during Weeks 1- 4.&#xD;
&#xD;
      Length of Study:&#xD;
&#xD;
      You may receive up to 4 doses of daratumumab. You will no longer be able to take the study&#xD;
      drug if the disease gets worse, if intolerable side effects occur, or if you are unable to&#xD;
      follow study directions.&#xD;
&#xD;
      Your participation on the study will be over after the Week 18 visit.&#xD;
&#xD;
      Study Visits:&#xD;
&#xD;
      Daratumumab treatment will interfere with blood type testing which is needed before blood&#xD;
      transfusions can be given. For this reason, a test to find out your blood type will be&#xD;
      performed before you receive daratumumab. You should carry the blood type card with you.&#xD;
&#xD;
      During Weeks 1 and 4:&#xD;
&#xD;
        -  You will have a physical exam&#xD;
&#xD;
        -  Blood (about 2 tablespoons) will be drawn for routine and blood typing.&#xD;
&#xD;
      During Weeks 2 and 3:&#xD;
&#xD;
        -  You will have a physical exam.&#xD;
&#xD;
        -  Blood (about 2 tablespoons) will be drawn for routine tests and for blood type testing.&#xD;
&#xD;
      During Week 6 (the week of your surgery):&#xD;
&#xD;
        -  You will have a physical exam&#xD;
&#xD;
        -  Blood (about 2 tablespoons) will be drawn for routine tests, including measurements of&#xD;
           your PSA and testosterone levels. Part of this sample will also be used for blood type&#xD;
           testing.&#xD;
&#xD;
        -  You will have surgery to remove your prostate. You will sign a separate consent form&#xD;
           explaining the procedure and its risks in more detail.&#xD;
&#xD;
      During Week 12, blood (about 2 tablespoons) will be drawn for routine tests, including&#xD;
      measurements of your PSA and testosterone levels.&#xD;
&#xD;
      Follow-Up:&#xD;
&#xD;
      At Week 18, you will come to the clinic and asked about any side effects and how you are&#xD;
      doing.&#xD;
&#xD;
      This is an investigational study. Daratumumab is FDA approved and commercially available to&#xD;
      treat multiple myeloma (MM). It is considered investigational to use daratumumab in patients&#xD;
      with prostate cancer.&#xD;
&#xD;
      The study doctor can explain how the study drug is designed to work.&#xD;
&#xD;
      Up to 15 participants will take part in this study. All will be enrolled at MD Anderson.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Withdrawn</overall_status>
  <why_stopped>
    PI's Request&#xD;
  </why_stopped>
  <start_date type="Anticipated">March 1, 2017</start_date>
  <completion_date type="Anticipated">March 1, 2019</completion_date>
  <primary_completion_date type="Anticipated">March 1, 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>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Biomarker Response of CD3 and CD68 Following Treatment with Daratumumab.</measure>
    <time_frame>Baseline and at 12 weeks after prostatectomy</time_frame>
    <description>Biomarker response if either CD3 or CD68 has a 1.5 fold increase at prostatectomy (after treatment) compared to baseline (pre-treatment).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of Adverse Events with Daratumumab (Adverse events as per CTCAE v4.03)</measure>
    <time_frame>4 weeks</time_frame>
    <description>Adverse events as per CTCAE v4.03.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">0</enrollment>
  <condition>Malignant Neoplasms of Male Genital Organs</condition>
  <condition>Prostate Cancer</condition>
  <arm_group>
    <arm_group_label>Daratumumab</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants receive Daratumumab by vein over about 1 hour 1 time a week during Weeks 1-4.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Daratumumab</intervention_name>
    <description>16 mg/kg by vein once weekly for a total of 4 doses.</description>
    <arm_group_label>Daratumumab</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Consent to MD Anderson laboratory protocol PA13-0291.&#xD;
&#xD;
          2. Histological documentation of adenocarcinoma of the prostate reviewed at MD Anderson&#xD;
             Cancer Center. Patients with small cell, neuroendocrine, or transitional cell&#xD;
             carcinomas are not eligible.&#xD;
&#xD;
          3. Patients with high-risk prostate cancer (at least 1 core with Gleason sum &gt;/=8) must&#xD;
             have at least three core biopsies involved with cancer (a minimum of 6 core biopsies,&#xD;
             must be obtained at baseline). A prostate biopsy within 3 months from screening is&#xD;
             allowed for entry requirements.&#xD;
&#xD;
          4. No evidence of metastatic disease as documented by technetium-99m (99mTc) bone scan&#xD;
             and by computed tomography (CT) or magnetic resonance imaging (MRI) scans.&#xD;
&#xD;
          5. Eugonadal state (serum testosterone &gt;150 ng/dL).&#xD;
&#xD;
          6. Localized or locally advanced disease deemed by the surgeon to be resectable. Patients&#xD;
             must be appropriate candidates for radical prostatectomy plus pelvic lymph node&#xD;
             dissection.&#xD;
&#xD;
          7. No prior treatment for prostate cancer including prior surgery (excluding&#xD;
             transurethral resection of the prostate [TURP]), cryoablation, pelvic lymph node&#xD;
             dissection, radiation therapy, hormonal therapy or chemotherapy.&#xD;
&#xD;
          8. Subject must be a man age &gt;/= 18 years of age.&#xD;
&#xD;
          9. To avoid risk of drug exposure through the ejaculate (even men with vasectomies),&#xD;
             subjects must use a condom during sexual activity while on study drug and for 3 months&#xD;
             following the last dose of study drug. If the subject is engaged in sexual activity&#xD;
             with a woman of childbearing potential, a condom is required along with another&#xD;
             effective contraceptive method consistent with local regulations regarding the use of&#xD;
             birth control methods for subjects participating in clinical studies and their&#xD;
             partners. Donation of sperm is not allowed while on study drug and for 3 months&#xD;
             following the last dose of study drug.&#xD;
&#xD;
         10. ECOG performance status (PS) grade of 0 or 1.&#xD;
&#xD;
         11. Clinical laboratory values at screening: a) Hemoglobin, platelet count, absolute&#xD;
             neutrophil count, absolute lymphocyte count within institutional normal limits.&#xD;
             Administration of growth factors or blood transfusions will not be allowed to confirm&#xD;
             eligibility b) Serum chemistries, renal and liver panels within institutional normal&#xD;
             limits or requirements for radical prostatectomy&#xD;
&#xD;
         12. Each subject must sign an informed consent form (ICF) indicating that he understands&#xD;
             the purpose of and procedures required for the study and is willing to participate in&#xD;
             the study.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Prior hormone therapy for prostate cancer including orchiectomy, antiandrogens,&#xD;
             ketoconazole, or estrogens (5-alpha reductase inhibitors allowed), or LHRH&#xD;
             agonists/antagonists.&#xD;
&#xD;
          2. Currently enrolled in another interventional study.&#xD;
&#xD;
          3. Concurrent treatment with systemic corticosteroids (prednisone dose &gt;10 mg per day or&#xD;
             equivalent) or other immunosuppressive drugs &lt;14 days prior to treatment initiation.&#xD;
             Steroids that are topical, inhaled, nasal (spray), or ophthalmic solution are&#xD;
             permitted.&#xD;
&#xD;
          4. History of or known or suspected autoimmune disease (exception(s): subjects with&#xD;
             vitiligo, resolved childhood atopic dermatitis, hypothyroidism, or hyperthyroidism&#xD;
             that is clinically euthyroid at screening are allowed).&#xD;
&#xD;
          5. Known evidence of an active infection requiring systemic therapy such as human&#xD;
             immunodeficiency virus (HIV), active hepatitis, or fungal infection.&#xD;
&#xD;
          6. History of clinically significant cardiovascular disease including, but not limited&#xD;
             to: a) Myocardial infarction or unstable angina &lt;/= 6 months prior to treatment&#xD;
             initiation b) Clinically significant cardiac arrhythmia c) Deep vein thrombosis,&#xD;
             pulmonary embolism, stroke &lt;/= 6 months prior to treatment initiation d) Congestive&#xD;
             heart failure (New York Heart Association class III-IV) e)Pericarditis/clinically&#xD;
             significant pericardial effusion f) Myocarditis g) Endocarditis&#xD;
&#xD;
          7. History of major implant(s) or device(s), including but not limited to: a) Prosthetic&#xD;
             heart valve(s) b) Artificial joints and prosthetics placed &lt;/= 12 months prior to&#xD;
             treatment initiation c) Current or prior history of infection or other clinically&#xD;
             significant adverse event associated with an exogenous implant or device that cannot&#xD;
             be removed&#xD;
&#xD;
          8. Other prior malignancy (exceptions: adequately treated basal cell or squamous cell&#xD;
             skin cancer, superficial bladder cancer, or any other cancer in situ currently in&#xD;
             complete remission) &lt;/= 2 years prior to enrollment.&#xD;
&#xD;
          9. Any condition that in the opinion of the investigator, would preclude participation in&#xD;
             this study.&#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>Sumit K. Subudhi, MD, PHD</last_name>
    <role>Principal Investigator</role>
    <affiliation>M.D. Anderson Cancer Center</affiliation>
  </overall_official>
  <removed_countries>
    <country>United States</country>
  </removed_countries>
  <link>
    <url>http://www.mdanderson.org</url>
    <description>University of Texas MD Anderson Cancer Center Website</description>
  </link>
  <verification_date>April 2017</verification_date>
  <study_first_submitted>January 26, 2017</study_first_submitted>
  <study_first_submitted_qc>January 27, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 30, 2017</study_first_posted>
  <last_update_submitted>April 20, 2017</last_update_submitted>
  <last_update_submitted_qc>April 20, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">April 21, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Malignant neoplasms of male genital organs</keyword>
  <keyword>Prostate cancer</keyword>
  <keyword>Adenocarcinoma of the prostate</keyword>
  <keyword>Daratumumab</keyword>
  <keyword>Biomarker response</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>
    <mesh_term>Genital Neoplasms, Male</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Daratumumab</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/NCT03035357
org study id: 2016-0566
nct id: NCT03035357
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
The goal of this clinical research study is to learn about biomarker changes in patients who
      have primary prostate cancer after receiving Darzalex (daratumumab) and then have a
      prostatectomy (the surgical removal of the prostate) as part of their standard care.
      Biomarkers are found in the blood/tissue and may be related to your reaction to the study
      drug.
Study Drug Administration:

      If you are found to be eligible to take part in this study, you will receive daratumumab by
      vein over about 1 hour 1 time a week during Weeks 1- 4.

      Length of Study:

      You may receive up to 4 doses of daratumumab. You will no longer be able to take the study
      drug if the disease gets worse, if intolerable side effects occur, or if you are unable to
      follow study directions.

      Your participation on the study will be over after the Week 18 visit.

      Study Visits:

      Daratumumab treatment will interfere with blood type testing which is needed before blood
      transfusions can be given. For this reason, a test to find out your blood type will be
      performed before you receive daratumumab. You should carry the blood type card with you.

      During Weeks 1 and 4:

        -  You will have a physical exam

        -  Blood (about 2 tablespoons) will be drawn for routine and blood typing.

      During Weeks 2 and 3:

        -  You will have a physical exam.

        -  Blood (about 2 tablespoons) will be drawn for routine tests and for blood type testing.

      During Week 6 (the week of your surgery):

        -  You will have a physical exam

        -  Blood (about 2 tablespoons) will be drawn for routine tests, including measurements of
           your PSA and testosterone levels. Part of this sample will also be used for blood type
           testing.

        -  You will have surgery to remove your prostate. You will sign a separate consent form
           explaining the procedure and its risks in more detail.

      During Week 12, blood (about 2 tablespoons) will be drawn for routine tests, including
      measurements of your PSA and testosterone levels.

      Follow-Up:

      At Week 18, you will come to the clinic and asked about any side effects and how you are
      doing.

      This is an investigational study. Daratumumab is FDA approved and commercially available to
      treat multiple myeloma (MM). It is considered investigational to use daratumumab in patients
      with prostate cancer.

      The study doctor can explain how the study drug is designed to work.

      Up to 15 participants will take part in this study. All will be enrolled at MD Anderson.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Biomarker Response of CD3 and CD68 Following Treatment with Daratumumab.
time frame: Baseline and at 12 weeks after prostatectomy
description: Biomarker response if either CD3 or CD68 has a 1.5 fold increase at prostatectomy (after treatment) compared to baseline (pre-treatment).
measure: Number of Adverse Events with Daratumumab (Adverse events as per CTCAE v4.03)
time frame: 4 weeks
description: Adverse events as per CTCAE v4.03.
arm group label: Daratumumab
arm group type: Experimental
description: Participants receive Daratumumab by vein over about 1 hour 1 time a week during Weeks 1-4.
intervention type: Drug
intervention name: Daratumumab
description: 16 mg/kg by vein once weekly for a total of 4 doses.
arm group label: Daratumumab
criteria: 
gender: Male
gender based: Yes
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Sumit K. Subudhi, MD, PHD
role: Principal Investigator
affiliation: M.D. Anderson Cancer Center
country: United States
url: http://www.mdanderson.org
description: University of Texas MD Anderson Cancer Center Website
responsible party type: Sponsor
mesh term: Prostatic Neoplasms
mesh term: Neoplasms
mesh term: Genital Neoplasms, Male
mesh term: Daratumumab