<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/NCT01696877</url>
  </required_header>
  <id_info>
    <org_study_id>J1265</org_study_id>
    <secondary_id>NA_00073453</secondary_id>
    <nct_id>NCT01696877</nct_id>
  </id_info>
  <brief_title>A Neoadjuvant Study of Androgen Ablation Combined With Cyclophosphamide and GVAX Vaccine for Localized Prostate Cancer</brief_title>
  <official_title>A Neoadjuvant Immunologic Study of Androgen Deprivation Therapy Combined With a Granulocytemacrophage-colony Stimulating Factor F-secreting Allogeneic Prostate Cancer Vaccine and Low-dose Cyclophosphamide in Men With High-risk Localized Prostate Cancer Undergoing Radical Prostatectomy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>David H. Koch Charitable Foundation</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>BioSante Pharmaceuticals</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This research is being done to see if an investigational prostate cancer vaccine, called&#xD;
      GVAX, can safely be given together with a single intravenous injection of a drug called&#xD;
      cyclophosphamide to men that will undergo surgery to remove their cancerous prostate glands&#xD;
      who have also received standard hormonal therapy.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Cancer immunotherapy refers broadly to approaches which attempt to treat cancer by activating&#xD;
      immune responses directed against malignant tissue. Prostate GVAX is an allogeneic cell-based&#xD;
      prostate cancer vaccine composed of two irradiated cell lines (PC3 and LNCaP) that have been&#xD;
      genetically modified to secrete granulocyte-macrophage colony-stimulating factor&#xD;
      (granulocytemacrophage-colony stimulating factor). The release of&#xD;
      granulocytemacrophage-colony stimulating factor by these modified tumor cells serves to&#xD;
      recruit dendritic cells which then present tumor antigens to T-cells, thus initiating&#xD;
      antitumor immune responses.&#xD;
&#xD;
      However, abundant preclinical data show that, when used alone, cell-based immunotherapy is&#xD;
      unable to break specific T-cell tolerance in tumor-bearing hosts. Studies in an autochthonous&#xD;
      prostate cancer mouse model have shown that giving low-dose cyclophosphamide prior to a&#xD;
      cell-based granulocytemacrophage-colony stimulating factor-secreting vaccine abrogates immune&#xD;
      tolerance through augmentation of CD8+ T cell infiltration in the prostate, transient&#xD;
      depletion of regulatory T cells (Tregs), and increased expression of dendritic cell&#xD;
      maturation markers. Enhancement of antitumor immunity has also been observed in other&#xD;
      preclinical models where cyclophosphamide was given in sequence with&#xD;
      granulocytemacrophage-colony stimulating factor-secreting immunotherapy for the treatment of&#xD;
      breast and pancreatic cancers. These preclinical data are supported by early-phase clinical&#xD;
      trials combining GVAX with low-dose cyclophosphamide in pancreatic and breast cancers.&#xD;
&#xD;
      Furthermore, emerging evidence suggests that androgen deprivation therapy (ADT) itself has&#xD;
      profound effects on the host immune system, resulting in thymic regeneration and enhancement&#xD;
      of antitumor immunity. In addition, preclinical and clinical studies demonstrate that ADT&#xD;
      augments prostate cancer-specific immune responses induced by immunotherapy, suggesting that&#xD;
      ADT may act synergistically with immunotherapy. Based on data from mouse models as well as&#xD;
      human clinical trials, it has been suggested that prostate cancer immunotherapy may be most&#xD;
      effective when administered in the setting of an androgen-suppressed environment.&#xD;
&#xD;
      Building on these findings, investigators have designed a study to assess the use of ADT&#xD;
      given alone or administered following immunization with low-dose cyclophosphamide and&#xD;
      prostate GVAX, in patients undergoing radical prostatectomy. Investigators aim (1) to&#xD;
      determine whether ADT is immunogenic in men with localized prostate cancer by evaluating&#xD;
      T-cell infiltration in harvested prostate glands; (2) to determine whether administering ADT&#xD;
      after low-dose cyclophosphamide and prostate GVAX augments immune infiltration into the&#xD;
      prostate gland; and (3) to investigate whether this combinatorial immuno-hormonal approach is&#xD;
      safe and feasible. Investigators hypothesize that the combination of ADT and&#xD;
      cyclophosphamide/GVAX will produce significantly greater antitumor immune responses than&#xD;
      would ADT used alone.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 18, 2013</start_date>
  <completion_date type="Actual">December 18, 2018</completion_date>
  <primary_completion_date type="Actual">August 2017</primary_completion_date>
  <phase>Phase 1/Phase 2</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>Intraprostatic CD8+ T Cell Infiltration</measure>
    <time_frame>2 years</time_frame>
    <description>CD8+ T cell infiltration (quantified as log[CD8 density]) into the prostate from harvested prostate glands in men with localized prostate cancer receiving neoadjuvant Androgen deprivation therapy alone (2 weeks prior to surgery), or cyclophosphamide and GVAX followed by Androgen deprivation therapy, (with cyclophosphamide/GVAX administered 4 weeks prior to prostatectomy, and Androgen deprivation therapy administered 2 weeks prior to prostatectomy).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Intraprostatic CD4+ T Cell and Treg Infiltration</measure>
    <time_frame>2 years</time_frame>
    <description>Number of participants with CD4+ T cell and Treg infiltration into the prostate.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quantification of Tissue Androgen Concentrations</measure>
    <time_frame>2 years</time_frame>
    <description>Tissue androgen concentrations (testosterone, dihydrotestosterone), and androgen receptor (AR) protein expression in prostate specimens</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quantification of Markers of Apoptosis</measure>
    <time_frame>2 years</time_frame>
    <description>Amount of apoptosis (activated caspase 3) and proliferation (Ki-67) in prostate tumor specimens</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pathological Complete Responses</measure>
    <time_frame>2 years</time_frame>
    <description>Number of participants with pathological complete response (pCR)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Serum Antibodies to Prostate-associated Antigens</measure>
    <time_frame>2 years</time_frame>
    <description>Number of participants with generation of novel antibodies to prostate-associated antigens in the serum of patients, after the initiation of protocol therapy</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Prostate-specific Antigen Response Rate</measure>
    <time_frame>2 years</time_frame>
    <description>Number of participants with Prostate-specific antigen response</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants Without Prostate Specific Antigen Recurrence at 24 Months After Surgery</measure>
    <time_frame>2 years</time_frame>
    <description>Percentage of participants in each arm who were free of prostate specific antigen recurrence (i.e. prostate specific antigen remained undetectable after prostatectomy) at 24 months after undergoing surgery.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">29</enrollment>
  <condition>Prostate Cancer Adenocarcinoma in Situ</condition>
  <arm_group>
    <arm_group_label>Degarelix</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Degarelix will be administered as three 80 mg subcutaneous injections, for a total dose of 240 mg at 14 (±3) days prior to surgery. A telephone follow-up interview (or an in-person clinic visit) to evaluate for adverse events will occur 28 (±21) days after prostatectomy. Patients will then be followed by their urologists according to standard institutional practices, but will require prostate-specific antigen evaluations every 3 (±1) months during year 1 and every 6 (±2) months during years 2-3.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Cyclophosphamide, GVAX and Degarelix</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Cyclophosphamide will be given at a dose of 200 mg/m2 as a single intravenous infusion. 1 day later, prostate GVAX will be administered as five 0.8-mL intradermal injections of PC3 (2.5 × 108 cells) and five 0.5-mL intradermal injections of LNCaP (2.5 × 108 cells), for a total dose of 5 × 108 cells. On day 14, Degarelix will be administered as three 80 mg subcutaneous injections, for a total dose of 240 mg.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>degarelix acetate</intervention_name>
    <description>Degarelix Acetate is a gonadotropin-releasing hormone (GnRH) receptor antagonist. It works by decreasing the amount of testosterone in the body,which the tumor needs to grow.</description>
    <arm_group_label>Cyclophosphamide, GVAX and Degarelix</arm_group_label>
    <arm_group_label>Degarelix</arm_group_label>
    <other_name>Firmagon</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Cyclophosphamide</intervention_name>
    <description>Cyclophosphamide as a potent enhancer of immune responses to GVAX. cyclophosphamide is used as an immune suppressor in many autoimmune disorders.</description>
    <arm_group_label>Cyclophosphamide, GVAX and Degarelix</arm_group_label>
    <other_name>Cytoxan</other_name>
    <other_name>Neosar</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>GVAX</intervention_name>
    <description>GVAX is granulocytemacrophage -colony stimulating factor -secreting allogeneic cell-based vaccine as immunotherapy for prostate cancer</description>
    <arm_group_label>Cyclophosphamide, GVAX and Degarelix</arm_group_label>
    <other_name>granulocytemacrophage -colony stimulating factor -secreting cell-based (PC3/LNCaP)immunotherapy</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Histologically confirmed adenocarcinoma of the prostate (clinical stage T1c-T3b, N0,&#xD;
             M0) without involvement of lymph nodes, bone, or visceral organs&#xD;
&#xD;
          -  Initial prostate biopsy is available for central pathologic review, and is confirmed&#xD;
             to show at least 2 positive cores and a maximum Gleason sum of ≥ 7&#xD;
&#xD;
          -  Radical prostatectomy has been scheduled at Johns Hopkins Hospital&#xD;
&#xD;
          -  Age ≥ 21 years&#xD;
&#xD;
          -  Eastern Cooperative Oncology Group performance status 0-1, or Karnofsky score ≥ 70%&#xD;
&#xD;
          -  Adequate bone marrow, hepatic, and renal function:&#xD;
&#xD;
               -  White Blood Count &gt; 3,000 cells/mm3&#xD;
&#xD;
               -  Absolute neutrophil count &gt; 1,500 cells/mm3&#xD;
&#xD;
               -  Hemoglobin &gt; 9.0 g/dL&#xD;
&#xD;
               -  Platelet count &gt; 100,000 cells/mm3&#xD;
&#xD;
               -  Serum creatinine &lt; 2.0 mg/dL&#xD;
&#xD;
               -  Serum bilirubin &lt; 2 mg/dL&#xD;
&#xD;
               -  Alanine aminotransferase &lt; 2 × upper limit of normal (ULN)&#xD;
&#xD;
               -  Aspartate aminotransferase &lt; 2 × ULN&#xD;
&#xD;
               -  Alkaline phosphatase &lt; 2 × ULN&#xD;
&#xD;
          -  Willingness to provide written informed consent and HIPAA authorization for the&#xD;
             release of personal health information, and the ability to comply with the study&#xD;
             requirements (note: HIPAA authorization will be included in the informed consent)&#xD;
&#xD;
          -  Willingness to use barrier contraception from the time of cyclophosphamide and/or GVAX&#xD;
             administration until the time of prostatectomy.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Presence of known lymph node involvement or distant metastases&#xD;
&#xD;
          -  Other histologic types of prostate cancers such as ductal, sarcomatous, lymphoma,&#xD;
             small cell, and neuroendocrine tumors&#xD;
&#xD;
          -  Prior radiation therapy, hormonal therapy, biologic therapy, or chemotherapy for&#xD;
             prostate cancer&#xD;
&#xD;
          -  Prior immunotherapy/vaccine therapy for prostate cancer&#xD;
&#xD;
          -  Previous or concurrent use of cyclophosphamide&#xD;
&#xD;
          -  Concomitant treatment with other hormonal therapy or 5a-reductase inhibitors&#xD;
&#xD;
          -  Current use of systemic corticosteroids or use of corticosteroids within 4 weeks of&#xD;
             enrollment (inhaled corticosteroids for asthma or Chronic obstructive pulmonary&#xD;
             disease are permitted)&#xD;
&#xD;
          -  Use of experimental agents for prostate cancer within the past 3 months&#xD;
&#xD;
          -  Known allergy to cyclophosphamide or G-colony stimulating factor&#xD;
             /granulocytemacrophage-colony stimulating factor&#xD;
&#xD;
          -  Known hypersensitivity to materials of bovine origin (e.g. fetal bovine serum), or&#xD;
             other components of GVAX which include Dimethyl sulfoxide and hydroxyethyl starch as&#xD;
             well as small amounts of porcine trypsin and DNase&#xD;
&#xD;
          -  History or presence of autoimmune disease requiring systemic immunosuppression&#xD;
             (including but not limited to: inflammatory bowel disease, systemic lupus&#xD;
             erythematosus, vasculitis, rheumatoid arthritis, scleroderma, multiple sclerosis,&#xD;
             hemolytic anemia, Sjögren syndrome, and sarcoidosis)&#xD;
&#xD;
          -  Other concurrent malignancies, with the exception of non-melanoma skin cancers and&#xD;
             superficial bladder cancer&#xD;
&#xD;
          -  Uncontrolled major active infectious, cardiovascular, pulmonary, hematologic, or&#xD;
             psychiatric illnesses that would make the patient a poor study candidate&#xD;
&#xD;
          -  Known prior or current history of HIV and/or hepatitis B/C&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>21 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Emmanual Antonarakis, M.D</last_name>
    <role>Principal Investigator</role>
    <affiliation>Johns Hopkins University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins</name>
      <address>
        <city>Baltimore</city>
        <state>Maryland</state>
        <zip>21231</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>March 2019</verification_date>
  <study_first_submitted>September 14, 2012</study_first_submitted>
  <study_first_submitted_qc>September 27, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 1, 2012</study_first_posted>
  <results_first_submitted>September 28, 2018</results_first_submitted>
  <results_first_submitted_qc>October 31, 2018</results_first_submitted_qc>
  <results_first_posted type="Actual">November 1, 2018</results_first_posted>
  <last_update_submitted>March 18, 2019</last_update_submitted>
  <last_update_submitted_qc>March 18, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">March 28, 2019</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>
    <mesh_term>Adenocarcinoma in Situ</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Cyclophosphamide</mesh_term>
    <mesh_term>Molgramostim</mesh_term>
    <mesh_term>Sargramostim</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>November 30, 2012</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/77/NCT01696877/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Degarelix</title>
          <description>Degarelix will be administered as three 80 mg subcutaneous injections, for a total dose of 240 mg at 14 (±3) days prior to surgery. A telephone follow-up interview (or an in-person clinic visit) to evaluate for adverse events will occur 28 (±21) days after prostatectomy. Patients will then be followed by their urologists according to standard institutional practices, but will require prostate-specific antigen evaluations every 3 (±1) months during year 1 and every 6 (±2) months during years 2-3.&#xD;
degarelix acetate: Degarelix Acetate is a gonadotropin-releasing hormone (GnRH) receptor antagonist. It works by decreasing the amount of testosterone in the body,which the tumor needs to grow.</description>
        </group>
        <group group_id="P2">
          <title>Cyclophosphamide, GVAX and Degarelix</title>
          <description>Cyclophosphamide will be given at a dose of 200 mg/m2 as a single intravenous infusion. 1 day later, prostate GVAX will be administered as five 0.8-mL intradermal injections of PC3 (2.5 × 108 cells) and five 0.5-mL intradermal injections of LNCaP (2.5 × 108 cells), for a total dose of 5 × 108 cells. On day 14, Degarelix will be administered as three 80 mg subcutaneous injections, for a total dose of 240 mg.&#xD;
degarelix acetate: Degarelix Acetate is a gonadotropin-releasing hormone (GnRH) receptor antagonist. It works by decreasing the amount of testosterone in the body,which the tumor needs to grow.&#xD;
Cyclophosphamide: Cyclophosphamide as a potent enhancer of immune responses to GVAX. cyclophosphamide is used as an immune suppressor in many autoimmune disorders.&#xD;
GVAX: GVAX is granulocytemacrophage-colony stimulating factor -secreting allogeneic cell-based vaccine as immunotherapy for prostate cancer</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="15"/>
                <participants group_id="P2" count="14"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="15"/>
                <participants group_id="P2" count="13"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Adverse Event</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>Only participants who were randomized and underwent prostatectomy.</population>
      <group_list>
        <group group_id="B1">
          <title>Degarelix</title>
          <description>Degarelix will be administered as three 80 mg subcutaneous injections, for a total dose of 240 mg at 14 (±3) days prior to surgery. A telephone follow-up interview (or an in-person clinic visit) to evaluate for adverse events will occur 28 (±21) days after prostatectomy. Patients will then be followed by their urologists according to standard institutional practices, but will require prostate-specific antigen evaluations every 3 (±1) months during year 1 and every 6 (±2) months during years 2-3.&#xD;
degarelix acetate: Degarelix Acetate is a gonadotropin-releasing hormone (GnRH) receptor antagonist. It works by decreasing the amount of testosterone in the body,which the tumor needs to grow.</description>
        </group>
        <group group_id="B2">
          <title>Cyclophosphamide, GVAX and Degarelix</title>
          <description>Cyclophosphamide will be given at a dose of 200 mg/m2 as a single intravenous infusion. 1 day later, prostate GVAX will be administered as five 0.8-mL intradermal injections of PC3 (2.5 × 108 cells) and five 0.5-mL intradermal injections of LNCaP (2.5 × 108 cells), for a total dose of 5 × 108 cells. On day 14, Degarelix will be administered as three 80 mg subcutaneous injections, for a total dose of 240 mg.&#xD;
degarelix acetate: Degarelix Acetate is a gonadotropin-releasing hormone (GnRH) receptor antagonist. It works by decreasing the amount of testosterone in the body,which the tumor needs to grow.&#xD;
Cyclophosphamide: Cyclophosphamide as a potent enhancer of immune responses to GVAX. cyclophosphamide is used as an immune suppressor in many autoimmune disorders.&#xD;
GVAX: GVAX is granulocytemacrophage-colony stimulating factor -secreting allogeneic cell-based vaccine as immunotherapy for prostate cancer</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="15"/>
            <count group_id="B2" value="14"/>
            <count group_id="B3" value="29"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>&lt;=18 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="12"/>
                    <measurement group_id="B2" value="12"/>
                    <measurement group_id="B3" value="24"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="15"/>
                    <measurement group_id="B2" value="14"/>
                    <measurement group_id="B3" value="29"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="15"/>
                    <measurement group_id="B2" value="12"/>
                    <measurement group_id="B3" value="27"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="15"/>
                    <measurement group_id="B2" value="14"/>
                    <measurement group_id="B3" value="29"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Intraprostatic CD8+ T Cell Infiltration</title>
        <description>CD8+ T cell infiltration (quantified as log[CD8 density]) into the prostate from harvested prostate glands in men with localized prostate cancer receiving neoadjuvant Androgen deprivation therapy alone (2 weeks prior to surgery), or cyclophosphamide and GVAX followed by Androgen deprivation therapy, (with cyclophosphamide/GVAX administered 4 weeks prior to prostatectomy, and Androgen deprivation therapy administered 2 weeks prior to prostatectomy).</description>
        <time_frame>2 years</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Degarelix</title>
            <description>Degarelix will be administered as three 80 mg subcutaneous injections, for a total dose of 240 mg at 14 (±3) days prior to surgery. A telephone follow-up interview (or an in-person clinic visit) to evaluate for adverse events will occur 28 (±21) days after prostatectomy. Patients will then be followed by their urologists according to standard institutional practices, but will require prostate-specific antigen evaluations every 3 (±1) months during year 1 and every 6 (±2) months during years 2-3.&#xD;
degarelix acetate: Degarelix Acetate is a gonadotropin-releasing hormone (GnRH) receptor antagonist. It works by decreasing the amount of testosterone in the body,which the tumor needs to grow.</description>
          </group>
          <group group_id="O2">
            <title>Cyclophosphamide, GVAX and Degarelix</title>
            <description>Cyclophosphamide will be given at a dose of 200 mg/m2 as a single intravenous infusion. 1 day later, prostate GVAX will be administered as five 0.8-mL intradermal injections of PC3 (2.5 × 108 cells) and five 0.5-mL intradermal injections of LNCaP (2.5 × 108 cells), for a total dose of 5 × 108 cells. On day 14, Degarelix will be administered as three 80 mg subcutaneous injections, for a total dose of 240 mg.&#xD;
degarelix acetate: Degarelix Acetate is a gonadotropin-releasing hormone (GnRH) receptor antagonist. It works by decreasing the amount of testosterone in the body,which the tumor needs to grow.&#xD;
Cyclophosphamide: Cyclophosphamide as a potent enhancer of immune responses to GVAX. cyclophosphamide is used as an immune suppressor in many autoimmune disorders.&#xD;
GVAX: GVAX is granulocytemacrophage-colony stimulating factor -secreting allogeneic cell-based vaccine as immunotherapy for prostate cancer</description>
          </group>
        </group_list>
        <measure>
          <title>Intraprostatic CD8+ T Cell Infiltration</title>
          <description>CD8+ T cell infiltration (quantified as log[CD8 density]) into the prostate from harvested prostate glands in men with localized prostate cancer receiving neoadjuvant Androgen deprivation therapy alone (2 weeks prior to surgery), or cyclophosphamide and GVAX followed by Androgen deprivation therapy, (with cyclophosphamide/GVAX administered 4 weeks prior to prostatectomy, and Androgen deprivation therapy administered 2 weeks prior to prostatectomy).</description>
          <units>log10 (cells/mm^2)</units>
          <param>Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="15"/>
                <count group_id="O2" value="13"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="204.81" lower_limit="120.67" upper_limit="288.95"/>
                    <measurement group_id="O2" value="263.33" lower_limit="129.4" upper_limit="397.25"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Intraprostatic CD4+ T Cell and Treg Infiltration</title>
        <description>Number of participants with CD4+ T cell and Treg infiltration into the prostate.</description>
        <time_frame>2 years</time_frame>
        <population>Data was not collected for this outcome measure</population>
        <group_list>
          <group group_id="O1">
            <title>Degarelix</title>
            <description>Degarelix will be administered as three 80 mg subcutaneous injections, for a total dose of 240 mg at 14 (±3) days prior to surgery. A telephone follow-up interview (or an in-person clinic visit) to evaluate for adverse events will occur 28 (±21) days after prostatectomy. Patients will then be followed by their urologists according to standard institutional practices, but will require prostate-specific antigen evaluations every 3 (±1) months during year 1 and every 6 (±2) months during years 2-3.&#xD;
degarelix acetate: Degarelix Acetate is a gonadotropin-releasing hormone (GnRH) receptor antagonist. It works by decreasing the amount of testosterone in the body,which the tumor needs to grow.</description>
          </group>
          <group group_id="O2">
            <title>Cyclophosphamide, GVAX and Degarelix</title>
            <description>Cyclophosphamide will be given at a dose of 200 mg/m2 as a single intravenous infusion. 1 day later, prostate GVAX will be administered as five 0.8-mL intradermal injections of PC3 (2.5 × 108 cells) and five 0.5-mL intradermal injections of LNCaP (2.5 × 108 cells), for a total dose of 5 × 108 cells. On day 14, Degarelix will be administered as three 80 mg subcutaneous injections, for a total dose of 240 mg.&#xD;
degarelix acetate: Degarelix Acetate is a gonadotropin-releasing hormone (GnRH) receptor antagonist. It works by decreasing the amount of testosterone in the body,which the tumor needs to grow.&#xD;
Cyclophosphamide: Cyclophosphamide as a potent enhancer of immune responses to GVAX. cyclophosphamide is used as an immune suppressor in many autoimmune disorders.&#xD;
GVAX: GVAX is granulocytemacrophage -colony stimulating factor -secreting allogeneic cell-based vaccine as immunotherapy for prostate cancer</description>
          </group>
        </group_list>
        <measure>
          <title>Intraprostatic CD4+ T Cell and Treg Infiltration</title>
          <description>Number of participants with CD4+ T cell and Treg infiltration into the prostate.</description>
          <population>Data was not collected for this outcome measure</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Quantification of Tissue Androgen Concentrations</title>
        <description>Tissue androgen concentrations (testosterone, dihydrotestosterone), and androgen receptor (AR) protein expression in prostate specimens</description>
        <time_frame>2 years</time_frame>
        <population>Data was not collected for this outcome measure</population>
        <group_list>
          <group group_id="O1">
            <title>Degarelix</title>
            <description>Degarelix will be administered as three 80 mg subcutaneous injections, for a total dose of 240 mg at 14 (±3) days prior to surgery. A telephone follow-up interview (or an in-person clinic visit) to evaluate for adverse events will occur 28 (±21) days after prostatectomy. Patients will then be followed by their urologists according to standard institutional practices, but will require prostate-specific antigen evaluations every 3 (±1) months during year 1 and every 6 (±2) months during years 2-3.&#xD;
degarelix acetate: Degarelix Acetate is a gonadotropin-releasing hormone (GnRH) receptor antagonist. It works by decreasing the amount of testosterone in the body,which the tumor needs to grow.</description>
          </group>
          <group group_id="O2">
            <title>Cyclophosphamide, GVAX and Degarelix</title>
            <description>Cyclophosphamide will be given at a dose of 200 mg/m2 as a single intravenous infusion. 1 day later, prostate GVAX will be administered as five 0.8-mL intradermal injections of PC3 (2.5 × 108 cells) and five 0.5-mL intradermal injections of LNCaP (2.5 × 108 cells), for a total dose of 5 × 108 cells. On day 14, Degarelix will be administered as three 80 mg subcutaneous injections, for a total dose of 240 mg.&#xD;
degarelix acetate: Degarelix Acetate is a gonadotropin-releasing hormone (GnRH) receptor antagonist. It works by decreasing the amount of testosterone in the body,which the tumor needs to grow.&#xD;
Cyclophosphamide: Cyclophosphamide as a potent enhancer of immune responses to GVAX. cyclophosphamide is used as an immune suppressor in many autoimmune disorders.&#xD;
GVAX: GVAX is granulocytemacrophage-colony stimulating factor -secreting allogeneic cell-based vaccine as immunotherapy for prostate cancer</description>
          </group>
        </group_list>
        <measure>
          <title>Quantification of Tissue Androgen Concentrations</title>
          <description>Tissue androgen concentrations (testosterone, dihydrotestosterone), and androgen receptor (AR) protein expression in prostate specimens</description>
          <population>Data was not collected for this outcome measure</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Quantification of Markers of Apoptosis</title>
        <description>Amount of apoptosis (activated caspase 3) and proliferation (Ki-67) in prostate tumor specimens</description>
        <time_frame>2 years</time_frame>
        <population>Data was not collected for this outcome measure</population>
        <group_list>
          <group group_id="O1">
            <title>Degarelix</title>
            <description>Degarelix will be administered as three 80 mg subcutaneous injections, for a total dose of 240 mg at 14 (±3) days prior to surgery. A telephone follow-up interview (or an in-person clinic visit) to evaluate for adverse events will occur 28 (±21) days after prostatectomy. Patients will then be followed by their urologists according to standard institutional practices, but will require prostate-specific antigen evaluations every 3 (±1) months during year 1 and every 6 (±2) months during years 2-3.&#xD;
degarelix acetate: Degarelix Acetate is a gonadotropin-releasing hormone (GnRH) receptor antagonist. It works by decreasing the amount of testosterone in the body,which the tumor needs to grow.</description>
          </group>
          <group group_id="O2">
            <title>Cyclophosphamide, GVAX and Degarelix</title>
            <description>Cyclophosphamide will be given at a dose of 200 mg/m2 as a single intravenous infusion. 1 day later, prostate GVAX will be administered as five 0.8-mL intradermal injections of PC3 (2.5 × 108 cells) and five 0.5-mL intradermal injections of LNCaP (2.5 × 108 cells), for a total dose of 5 × 108 cells. On day 14, Degarelix will be administered as three 80 mg subcutaneous injections, for a total dose of 240 mg.&#xD;
degarelix acetate: Degarelix Acetate is a gonadotropin-releasing hormone (GnRH) receptor antagonist. It works by decreasing the amount of testosterone in the body,which the tumor needs to grow.&#xD;
Cyclophosphamide: Cyclophosphamide as a potent enhancer of immune responses to GVAX. cyclophosphamide is used as an immune suppressor in many autoimmune disorders.&#xD;
GVAX: GVAX is granulocytemacrophage-colony stimulating factor -secreting allogeneic cell-based vaccine as immunotherapy for prostate cancer</description>
          </group>
        </group_list>
        <measure>
          <title>Quantification of Markers of Apoptosis</title>
          <description>Amount of apoptosis (activated caspase 3) and proliferation (Ki-67) in prostate tumor specimens</description>
          <population>Data was not collected for this outcome measure</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Pathological Complete Responses</title>
        <description>Number of participants with pathological complete response (pCR)</description>
        <time_frame>2 years</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Degarelix</title>
            <description>Degarelix will be administered as three 80 mg subcutaneous injections, for a total dose of 240 mg at 14 (±3) days prior to surgery. A telephone follow-up interview (or an in-person clinic visit) to evaluate for adverse events will occur 28 (±21) days after prostatectomy. Patients will then be followed by their urologists according to standard institutional practices, but will require prostate-specific antigen evaluations every 3 (±1) months during year 1 and every 6 (±2) months during years 2-3.&#xD;
degarelix acetate: Degarelix Acetate is a gonadotropin-releasing hormone (GnRH) receptor antagonist. It works by decreasing the amount of testosterone in the body,which the tumor needs to grow.</description>
          </group>
          <group group_id="O2">
            <title>Cyclophosphamide, GVAX and Degarelix</title>
            <description>Cyclophosphamide will be given at a dose of 200 mg/m2 as a single intravenous infusion. 1 day later, prostate GVAX will be administered as five 0.8-mL intradermal injections of PC3 (2.5 × 108 cells) and five 0.5-mL intradermal injections of LNCaP (2.5 × 108 cells), for a total dose of 5 × 108 cells. On day 14, Degarelix will be administered as three 80 mg subcutaneous injections, for a total dose of 240 mg.&#xD;
degarelix acetate: Degarelix Acetate is a gonadotropin-releasing hormone (GnRH) receptor antagonist. It works by decreasing the amount of testosterone in the body,which the tumor needs to grow.&#xD;
Cyclophosphamide: Cyclophosphamide as a potent enhancer of immune responses to GVAX. cyclophosphamide is used as an immune suppressor in many autoimmune disorders.&#xD;
GVAX: GVAX is Granulocyte-macrophage-colony stimulating factor-secreting allogeneic cell-based vaccine as immunotherapy for prostate cancer</description>
          </group>
        </group_list>
        <measure>
          <title>Pathological Complete Responses</title>
          <description>Number of participants with pathological complete response (pCR)</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="15"/>
                <count group_id="O2" value="13"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Serum Antibodies to Prostate-associated Antigens</title>
        <description>Number of participants with generation of novel antibodies to prostate-associated antigens in the serum of patients, after the initiation of protocol therapy</description>
        <time_frame>2 years</time_frame>
        <population>Data was not collected for this outcome measure</population>
        <group_list>
          <group group_id="O1">
            <title>Degarelix</title>
            <description>Degarelix will be administered as three 80 mg subcutaneous injections, for a total dose of 240 mg at 14 (±3) days prior to surgery. A telephone follow-up interview (or an in-person clinic visit) to evaluate for adverse events will occur 28 (±21) days after prostatectomy. Patients will then be followed by their urologists according to standard institutional practices, but will require prostate-specific antigen evaluations every 3 (±1) months during year 1 and every 6 (±2) months during years 2-3.&#xD;
degarelix acetate: Degarelix Acetate is a gonadotropin-releasing hormone (GnRH) receptor antagonist. It works by decreasing the amount of testosterone in the body,which the tumor needs to grow.</description>
          </group>
          <group group_id="O2">
            <title>Cyclophosphamide, GVAX and Degarelix</title>
            <description>Cyclophosphamide will be given at a dose of 200 mg/m2 as a single intravenous infusion. 1 day later, prostate GVAX will be administered as five 0.8-mL intradermal injections of PC3 (2.5 × 108 cells) and five 0.5-mL intradermal injections of LNCaP (2.5 × 108 cells), for a total dose of 5 × 108 cells. On day 14, Degarelix will be administered as three 80 mg subcutaneous injections, for a total dose of 240 mg.&#xD;
degarelix acetate: Degarelix Acetate is a gonadotropin-releasing hormone (GnRH) receptor antagonist. It works by decreasing the amount of testosterone in the body,which the tumor needs to grow.&#xD;
Cyclophosphamide: Cyclophosphamide as a potent enhancer of immune responses to GVAX. cyclophosphamide is used as an immune suppressor in many autoimmune disorders.&#xD;
GVAX: GVAX is granulocytemacrophage-colony stimulating factor -secreting allogeneic cell-based vaccine as immunotherapy for prostate cancer</description>
          </group>
        </group_list>
        <measure>
          <title>Serum Antibodies to Prostate-associated Antigens</title>
          <description>Number of participants with generation of novel antibodies to prostate-associated antigens in the serum of patients, after the initiation of protocol therapy</description>
          <population>Data was not collected for this outcome measure</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Prostate-specific Antigen Response Rate</title>
        <description>Number of participants with Prostate-specific antigen response</description>
        <time_frame>2 years</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Degarelix</title>
            <description>Degarelix will be administered as three 80 mg subcutaneous injections, for a total dose of 240 mg at 14 (±3) days prior to surgery. A telephone follow-up interview (or an in-person clinic visit) to evaluate for adverse events will occur 28 (±21) days after prostatectomy. Patients will then be followed by their urologists according to standard institutional practices, but will require prostate-specific antigen evaluations every 3 (±1) months during year 1 and every 6 (±2) months during years 2-3.&#xD;
degarelix acetate: Degarelix Acetate is a gonadotropin-releasing hormone (GnRH) receptor antagonist. It works by decreasing the amount of testosterone in the body,which the tumor needs to grow.</description>
          </group>
          <group group_id="O2">
            <title>Cyclophosphamide, GVAX and Degarelix</title>
            <description>Cyclophosphamide will be given at a dose of 200 mg/m2 as a single intravenous infusion. 1 day later, prostate GVAX will be administered as five 0.8-mL intradermal injections of PC3 (2.5 × 108 cells) and five 0.5-mL intradermal injections of LNCaP (2.5 × 108 cells), for a total dose of 5 × 108 cells. On day 14, Degarelix will be administered as three 80 mg subcutaneous injections, for a total dose of 240 mg.&#xD;
degarelix acetate: Degarelix Acetate is a gonadotropin-releasing hormone (GnRH) receptor antagonist. It works by decreasing the amount of testosterone in the body,which the tumor needs to grow.&#xD;
Cyclophosphamide: Cyclophosphamide as a potent enhancer of immune responses to GVAX. cyclophosphamide is used as an immune suppressor in many autoimmune disorders.&#xD;
GVAX: GVAX is granulocytemacrophage-colony stimulating factor -secreting allogeneic cell-based vaccine as immunotherapy for prostate cancer</description>
          </group>
        </group_list>
        <measure>
          <title>Prostate-specific Antigen Response Rate</title>
          <description>Number of participants with Prostate-specific antigen response</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="15"/>
                <count group_id="O2" value="13"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="13"/>
                    <measurement group_id="O2" value="11"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants Without Prostate Specific Antigen Recurrence at 24 Months After Surgery</title>
        <description>Percentage of participants in each arm who were free of prostate specific antigen recurrence (i.e. prostate specific antigen remained undetectable after prostatectomy) at 24 months after undergoing surgery.</description>
        <time_frame>2 years</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Degarelix</title>
            <description>Degarelix will be administered as three 80 mg subcutaneous injections, for a total dose of 240 mg at 14 (±3) days prior to surgery. A telephone follow-up interview (or an in-person clinic visit) to evaluate for adverse events will occur 28 (±21) days after prostatectomy. Patients will then be followed by their urologists according to standard institutional practices, but will require prostate-specific antigen evaluations every 3 (±1) months during year 1 and every 6 (±2) months during years 2-3.&#xD;
degarelix acetate: Degarelix Acetate is a gonadotropin-releasing hormone (GnRH) receptor antagonist. It works by decreasing the amount of testosterone in the body,which the tumor needs to grow.</description>
          </group>
          <group group_id="O2">
            <title>Cyclophosphamide, GVAX and Degarelix</title>
            <description>Cyclophosphamide will be given at a dose of 200 mg/m2 as a single intravenous infusion. 1 day later, prostate GVAX will be administered as five 0.8-mL intradermal injections of PC3 (2.5 × 108 cells) and five 0.5-mL intradermal injections of LNCaP (2.5 × 108 cells), for a total dose of 5 × 108 cells. On day 14, Degarelix will be administered as three 80 mg subcutaneous injections, for a total dose of 240 mg.&#xD;
degarelix acetate: Degarelix Acetate is a gonadotropin-releasing hormone (GnRH) receptor antagonist. It works by decreasing the amount of testosterone in the body,which the tumor needs to grow.&#xD;
Cyclophosphamide: Cyclophosphamide as a potent enhancer of immune responses to GVAX. cyclophosphamide is used as an immune suppressor in many autoimmune disorders.&#xD;
GVAX: GVAX is granulocytemacrophage-colony stimulating factor -secreting allogeneic cell-based vaccine as immunotherapy for prostate cancer</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants Without Prostate Specific Antigen Recurrence at 24 Months After Surgery</title>
          <description>Percentage of participants in each arm who were free of prostate specific antigen recurrence (i.e. prostate specific antigen remained undetectable after prostatectomy) at 24 months after undergoing surgery.</description>
          <units>percentage of participants</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="15"/>
                <count group_id="O2" value="13"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="38" lower_limit="19" upper_limit="74"/>
                    <measurement group_id="O2" value="66" lower_limit="43" upper_limit="100"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Participants were assessed for adverse events after receiving study drug and before prostatectomy as well as doing each follow up visit after prostatectomy up to 3 years.</time_frame>
      <desc>An adverse event (AE) is defined as any untoward medical occurrence (symptom, sign, illness or experience) that develops or worsens in a research patient during a clinical study or within 30 days post-treatment, regardless of causality.</desc>
      <group_list>
        <group group_id="E1">
          <title>Degarelix</title>
          <description>Degarelix will be administered as three 80 mg subcutaneous injections, for a total dose of 240 mg at 14 (±3) days prior to surgery. A telephone follow-up interview (or an in-person clinic visit) to evaluate for adverse events will occur 28 (±21) days after prostatectomy. Patients will then be followed by their urologists according to standard institutional practices, but will require prostate-specific antigen evaluations every 3 (±1) months during year 1 and every 6 (±2) months during years 2-3.&#xD;
degarelix acetate: Degarelix Acetate is a gonadotropin-releasing hormone (GnRH) receptor antagonist. It works by decreasing the amount of testosterone in the body,which the tumor needs to grow.</description>
        </group>
        <group group_id="E2">
          <title>Cyclophosphamide, GVAX and Degarelix</title>
          <description>Cyclophosphamide will be given at a dose of 200 mg/m2 as a single intravenous infusion. 1 day later, prostate GVAX will be administered as five 0.8-mL intradermal injections of PC3 (2.5 × 108 cells) and five 0.5-mL intradermal injections of LNCaP (2.5 × 108 cells), for a total dose of 5 × 108 cells. On day 14, Degarelix will be administered as three 80 mg subcutaneous injections, for a total dose of 240 mg.&#xD;
degarelix acetate: Degarelix Acetate is a gonadotropin-releasing hormone (GnRH) receptor antagonist. It works by decreasing the amount of testosterone in the body,which the tumor needs to grow.&#xD;
Cyclophosphamide: Cyclophosphamide as a potent enhancer of immune responses to GVAX. cyclophosphamide is used as an immune suppressor in many autoimmune disorders.&#xD;
GVAX: GVAX is GM-CSF-secreting allogeneic cell-based vaccine as immunotherapy for prostate cancer</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>CTCAE (4.0)</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="14"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="14"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Stroke</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="14"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Hematoma</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="14"/>
              </event>
              <event>
                <sub_title>Thromboembolic event</sub_title>
                <description>Pulmonary embolism</description>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="14"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <default_vocab>CTCAE (4.0)</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="15" subjects_at_risk="15"/>
                <counts group_id="E2" subjects_affected="14" subjects_at_risk="14"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Blood and lymphatic system disorders</title>
            <event_list>
              <event>
                <sub_title>Anemia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="14"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>atrial fibrillation</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="14"/>
              </event>
              <event>
                <sub_title>Atrial flutter</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="14"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Eye disorders</title>
            <event_list>
              <event>
                <sub_title>Eye disorders - Other,</sub_title>
                <description>soreness around eyes</description>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="14"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Diarrhea</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="15"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="14"/>
              </event>
              <event>
                <sub_title>Constipation</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="14"/>
              </event>
              <event>
                <sub_title>Abdominal pain</sub_title>
                <description>lower abdominal pain</description>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="15"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="14"/>
              </event>
              <event>
                <sub_title>Oral dysesthesia</sub_title>
                <description>swollen tongue</description>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="14"/>
              </event>
              <event>
                <sub_title>Constipation</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="14"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Fatigue</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="15"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="14"/>
              </event>
              <event>
                <sub_title>Injection site reaction</sub_title>
                <description>erythema bilateral legs</description>
                <counts group_id="E1" events="22" subjects_affected="8" subjects_at_risk="15"/>
                <counts group_id="E2" events="50" subjects_affected="12" subjects_at_risk="14"/>
              </event>
              <event>
                <sub_title>Fever</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="14"/>
              </event>
              <event>
                <sub_title>Chills</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="14"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Immune system disorders</title>
            <event_list>
              <event>
                <sub_title>Allergic reaction</sub_title>
                <description>allergic reaction/erythema</description>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E2" events="15" subjects_affected="6" subjects_at_risk="14"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Urinary tract infection</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="14"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Alkaline Phosphatase</sub_title>
                <description>Increased Alkaline Phosphatase</description>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="14"/>
              </event>
              <event>
                <sub_title>Creatinine increased</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="14"/>
              </event>
              <event>
                <sub_title>Aspartate aminotransferase increased</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="15"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="14"/>
              </event>
              <event>
                <sub_title>Alanine aminotransferase increased</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="14"/>
              </event>
              <event>
                <sub_title>Blood bilirubin increased</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="14"/>
              </event>
              <event>
                <sub_title>Weight gain</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="14"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Hypertriglyceridemia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="14"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Generalized muscle weakness</sub_title>
                <description>muscle soreness (legs)</description>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="15"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="14"/>
              </event>
              <event>
                <sub_title>Arthralgia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E2" events="6" subjects_affected="3" subjects_at_risk="14"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Facial nerve disorder</sub_title>
                <description>facial nerve disorder (Bell's Palsy)</description>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="14"/>
              </event>
              <event>
                <sub_title>Lethargy</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="14"/>
              </event>
              <event>
                <sub_title>Peripheral sensory neuropathy</sub_title>
                <description>peri-oral numbness</description>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E2" events="3" subjects_affected="2" subjects_at_risk="14"/>
              </event>
              <event>
                <sub_title>Paresthesia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="14"/>
              </event>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="14"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Insomnia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="14"/>
              </event>
              <event>
                <sub_title>Restlessness</sub_title>
                <description>restless/ anxious</description>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="14"/>
              </event>
              <event>
                <sub_title>Anxiety</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="14"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>Urinary Incontinence</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="15"/>
                <counts group_id="E2" events="11" subjects_affected="10" subjects_at_risk="14"/>
              </event>
              <event>
                <sub_title>Cystitis noninfective</sub_title>
                <description>nocturia</description>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E2" events="3" subjects_affected="2" subjects_at_risk="14"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Reproductive system and breast disorders</title>
            <event_list>
              <event>
                <sub_title>Premature menopause</sub_title>
                <description>hot flashes</description>
                <counts group_id="E1" events="7" subjects_affected="7" subjects_at_risk="15"/>
                <counts group_id="E2" events="8" subjects_affected="8" subjects_at_risk="14"/>
              </event>
              <event>
                <sub_title>Erectile dysfunction</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E2" events="8" subjects_affected="7" subjects_at_risk="14"/>
              </event>
              <event>
                <sub_title>Perineal pain</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="14"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Allergic rhinitis</sub_title>
                <description>nasal congestion</description>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="14"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Bullous dermatitis</sub_title>
                <description>Shingles (right side of body)</description>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="14"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Thromboembolic event</sub_title>
                <description>pulmonary embolism</description>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="14"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>All Principal Investigators ARE employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Emmanuel S. Antonarakis, M.D., principal investigator</name_or_title>
      <organization>Johns Hopkins University</organization>
      <phone>443-287-0553</phone>
      <email>eantona1@jhmi.edu</email>
    </point_of_contact>
  </clinical_results>
</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/NCT01696877
org study id: J1265
secondary id: NA_00073453
nct id: NCT01696877
lead sponsor: 
collaborator: 
collaborator: 
has dmc: Yes
This research is being done to see if an investigational prostate cancer vaccine, called
      GVAX, can safely be given together with a single intravenous injection of a drug called
      cyclophosphamide to men that will undergo surgery to remove their cancerous prostate glands
      who have also received standard hormonal therapy.
Cancer immunotherapy refers broadly to approaches which attempt to treat cancer by activating
      immune responses directed against malignant tissue. Prostate GVAX is an allogeneic cell-based
      prostate cancer vaccine composed of two irradiated cell lines (PC3 and LNCaP) that have been
      genetically modified to secrete granulocyte-macrophage colony-stimulating factor
      (granulocytemacrophage-colony stimulating factor). The release of
      granulocytemacrophage-colony stimulating factor by these modified tumor cells serves to
      recruit dendritic cells which then present tumor antigens to T-cells, thus initiating
      antitumor immune responses.

      However, abundant preclinical data show that, when used alone, cell-based immunotherapy is
      unable to break specific T-cell tolerance in tumor-bearing hosts. Studies in an autochthonous
      prostate cancer mouse model have shown that giving low-dose cyclophosphamide prior to a
      cell-based granulocytemacrophage-colony stimulating factor-secreting vaccine abrogates immune
      tolerance through augmentation of CD8+ T cell infiltration in the prostate, transient
      depletion of regulatory T cells (Tregs), and increased expression of dendritic cell
      maturation markers. Enhancement of antitumor immunity has also been observed in other
      preclinical models where cyclophosphamide was given in sequence with
      granulocytemacrophage-colony stimulating factor-secreting immunotherapy for the treatment of
      breast and pancreatic cancers. These preclinical data are supported by early-phase clinical
      trials combining GVAX with low-dose cyclophosphamide in pancreatic and breast cancers.

      Furthermore, emerging evidence suggests that androgen deprivation therapy (ADT) itself has
      profound effects on the host immune system, resulting in thymic regeneration and enhancement
      of antitumor immunity. In addition, preclinical and clinical studies demonstrate that ADT
      augments prostate cancer-specific immune responses induced by immunotherapy, suggesting that
      ADT may act synergistically with immunotherapy. Based on data from mouse models as well as
      human clinical trials, it has been suggested that prostate cancer immunotherapy may be most
      effective when administered in the setting of an androgen-suppressed environment.

      Building on these findings, investigators have designed a study to assess the use of ADT
      given alone or administered following immunization with low-dose cyclophosphamide and
      prostate GVAX, in patients undergoing radical prostatectomy. Investigators aim (1) to
      determine whether ADT is immunogenic in men with localized prostate cancer by evaluating
      T-cell infiltration in harvested prostate glands; (2) to determine whether administering ADT
      after low-dose cyclophosphamide and prostate GVAX augments immune infiltration into the
      prostate gland; and (3) to investigate whether this combinatorial immuno-hormonal approach is
      safe and feasible. Investigators hypothesize that the combination of ADT and
      cyclophosphamide/GVAX will produce significantly greater antitumor immune responses than
      would ADT used alone.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Intraprostatic CD8+ T Cell Infiltration
time frame: 2 years
description: CD8+ T cell infiltration (quantified as log[CD8 density]) into the prostate from harvested prostate glands in men with localized prostate cancer receiving neoadjuvant Androgen deprivation therapy alone (2 weeks prior to surgery), or cyclophosphamide and GVAX followed by Androgen deprivation therapy, (with cyclophosphamide/GVAX administered 4 weeks prior to prostatectomy, and Androgen deprivation therapy administered 2 weeks prior to prostatectomy).
measure: Intraprostatic CD4+ T Cell and Treg Infiltration
time frame: 2 years
description: Number of participants with CD4+ T cell and Treg infiltration into the prostate.
measure: Quantification of Tissue Androgen Concentrations
time frame: 2 years
description: Tissue androgen concentrations (testosterone, dihydrotestosterone), and androgen receptor (AR) protein expression in prostate specimens
measure: Quantification of Markers of Apoptosis
time frame: 2 years
description: Amount of apoptosis (activated caspase 3) and proliferation (Ki-67) in prostate tumor specimens
measure: Pathological Complete Responses
time frame: 2 years
description: Number of participants with pathological complete response (pCR)
measure: Serum Antibodies to Prostate-associated Antigens
time frame: 2 years
description: Number of participants with generation of novel antibodies to prostate-associated antigens in the serum of patients, after the initiation of protocol therapy
measure: Prostate-specific Antigen Response Rate
time frame: 2 years
description: Number of participants with Prostate-specific antigen response
measure: Percentage of Participants Without Prostate Specific Antigen Recurrence at 24 Months After Surgery
time frame: 2 years
description: Percentage of participants in each arm who were free of prostate specific antigen recurrence (i.e. prostate specific antigen remained undetectable after prostatectomy) at 24 months after undergoing surgery.
arm group label: Degarelix
arm group type: Active Comparator
description: Degarelix will be administered as three 80 mg subcutaneous injections, for a total dose of 240 mg at 14 (±3) days prior to surgery. A telephone follow-up interview (or an in-person clinic visit) to evaluate for adverse events will occur 28 (±21) days after prostatectomy. Patients will then be followed by their urologists according to standard institutional practices, but will require prostate-specific antigen evaluations every 3 (±1) months during year 1 and every 6 (±2) months during years 2-3.
arm group label: Cyclophosphamide, GVAX and Degarelix
arm group type: Experimental
description: Cyclophosphamide will be given at a dose of 200 mg/m2 as a single intravenous infusion. 1 day later, prostate GVAX will be administered as five 0.8-mL intradermal injections of PC3 (2.5 × 108 cells) and five 0.5-mL intradermal injections of LNCaP (2.5 × 108 cells), for a total dose of 5 × 108 cells. On day 14, Degarelix will be administered as three 80 mg subcutaneous injections, for a total dose of 240 mg.
intervention type: Drug
intervention name: degarelix acetate
description: Degarelix Acetate is a gonadotropin-releasing hormone (GnRH) receptor antagonist. It works by decreasing the amount of testosterone in the body,which the tumor needs to grow.
arm group label: Cyclophosphamide, GVAX and Degarelix
arm group label: Degarelix
other name: Firmagon
intervention type: Drug
intervention name: Cyclophosphamide
description: Cyclophosphamide as a potent enhancer of immune responses to GVAX. cyclophosphamide is used as an immune suppressor in many autoimmune disorders.
arm group label: Cyclophosphamide, GVAX and Degarelix
other name: Cytoxan
other name: Neosar
intervention type: Drug
intervention name: GVAX
description: GVAX is granulocytemacrophage -colony stimulating factor -secreting allogeneic cell-based vaccine as immunotherapy for prostate cancer
arm group label: Cyclophosphamide, GVAX and Degarelix
other name: granulocytemacrophage -colony stimulating factor -secreting cell-based (PC3/LNCaP)immunotherapy
criteria: 
gender: Male
minimum age: 21 Years
maximum age: N/A
healthy volunteers: No
last name: Emmanual Antonarakis, M.D
role: Principal Investigator
affiliation: Johns Hopkins University
facility: 
country: United States
responsible party type: Sponsor
mesh term: Prostatic Neoplasms
mesh term: Adenocarcinoma in Situ
mesh term: Cyclophosphamide
mesh term: Molgramostim
mesh term: Sargramostim
sharing ipd: No
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 