<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/NCT01706458</url>
  </required_header>
  <id_info>
    <org_study_id>CO11816</org_study_id>
    <secondary_id>A534260</secondary_id>
    <secondary_id>SMPH/MEDICINE/MEDICINE*H</secondary_id>
    <secondary_id>NCI-2012-02026</secondary_id>
    <secondary_id>2012-0352</secondary_id>
    <nct_id>NCT01706458</nct_id>
  </id_info>
  <brief_title>Provenge With or Without pTVG-HP DNA Booster Vaccine in Prostate Cancer</brief_title>
  <official_title>Pilot Trial of Sipuleucel-T, With or Without pTVG-HP DNA Booster Vaccine, in Patients With Castrate-Resistant, Metastatic Prostate Cancer</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Wisconsin, Madison</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Dendreon</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Wisconsin, Madison</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This randomized pilot clinical trial studies sipuleucel-T with or without deoxyribonucleic&#xD;
      acid (DNA) vaccine therapy in treating patients with prostate cancer that has not responded&#xD;
      to previous treatment with hormones and has spread to other places in the body. Vaccines may&#xD;
      help the body build an effective immune response to kill tumor cells. It is not yet known&#xD;
      whether giving sipuleucel-T vaccine works better with or without DNA vaccine therapy in&#xD;
      treating prostate cancer.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">May 20, 2013</start_date>
  <completion_date type="Actual">August 13, 2020</completion_date>
  <primary_completion_date type="Actual">June 12, 2017</primary_completion_date>
  <phase>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>Number of Participants With Immune Response Following Treatment</measure>
    <time_frame>12 months</time_frame>
    <description>The primary immunological goal of this study was to determine whether booster immunizations with a DNA vaccine encoding PAP could augment the number of PAP-specific effector and memory T cells following treatment with sipuleucel-T, or prolong the duration of detectable T-cell response. All subjects received a tetanus booster immunization prior to beginning the immunization series, providing a separate test of an individual's immune responsiveness. Responses to PSA, a non-target prostate specific protein, were concurrently evaluated, as were responses to GM-CSF, a component of the PA2024 fusion protein used in the preparation of sipuleucel-T.Samples were evaluated for antigen-specific IFNy or granzyme B secretion by ELISPOT, and the detection of statistically significant antigen-specific responses, that were at least 3-fold over the baseline value, and detectable more than once post-treatment, were used to define immune response to a particular antigen.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Progression-free Survival</measure>
    <time_frame>12 months</time_frame>
    <description>Percentage of patients without radiographic progression at 12 months.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to Radiographic Disease Progression</measure>
    <time_frame>12 months</time_frame>
    <description>Time to radiographic progression using staging obtained at month 3 as baseline for evaluation.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Measure Prostate-specific Antigen (PSA) Doubling Time</measure>
    <time_frame>12 months</time_frame>
    <description>PSA doubling times were calculated from PSA values obtained up to 6 months from day 1 of study treatment. An increase in the PSA doubling time to at least double the baseline value will be defined as a PSA doubling time &quot;response&quot;.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Overall Survival: Median Time to Death From Any Cause</measure>
    <time_frame>up to approximately 5 years</time_frame>
    <description>Overall survival is defined as the time interval from randomization to death from any cause or to the last follow-up in censored patients.</description>
  </other_outcome>
  <other_outcome>
    <measure>Number of Circulating Tumor Cells</measure>
    <time_frame>6 months</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>PAP-specific Antibody and T-cell Immune Responses Following Treatment With Sipuleucel-T and DNA Vaccine</measure>
    <time_frame>12 months</time_frame>
    <description>A response resulting from immunization was defined as a PAP-specific response detectable more than once post-treatment that was both significant (compared to media only control), at least 3-fold higher than the pre-treatment value, and with a frequency&gt; 1:100,000 PBMC. An antibody response was defined as any increase in titer over baseline.</description>
  </other_outcome>
  <other_outcome>
    <measure>Logistic Regression Analysis Will be Conducted to Evaluate Whether PAP-specific Immune Response is Associated With Prolonged (1-year) Progression-free Survival.</measure>
    <time_frame>12 months</time_frame>
    <description>Not performed because no progression free survival at one year.</description>
  </other_outcome>
  <other_outcome>
    <measure>Logistic Regression Analysis Will be Conducted to Evaluate Whether Baseline Immune Responses Predict for Immune Responses Elicited/Augmented Following Treatment With Sipuleucel-T +/- DNA Vaccine.</measure>
    <time_frame>12 months</time_frame>
    <description>Not performed because no progression free survival at one year.</description>
  </other_outcome>
  <other_outcome>
    <measure>The Detection of Antigen Spread to Other Prostate Associated Antigens, and the Identification of Specific Antigens Recognized, Will be Analyzed Descriptively.</measure>
    <time_frame>12 months</time_frame>
    <description>Not performed because no progression free survival at one year.</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">18</enrollment>
  <condition>Prostate Cancer</condition>
  <arm_group>
    <arm_group_label>sipuleucel-T</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Patients receive sipuleucel-T IV on weeks 0, 2, and 4.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>sipuleucel-T with DNA Vaccine</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients receive sipuleucel-T as patients in arm I and pTVG-HP plasmid DNA vaccine ID on weeks 6, 8, 10, and 12, and then at 6 and 9 months.</description>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>sipuleucel-T</intervention_name>
    <description>Given IV</description>
    <arm_group_label>sipuleucel-T</arm_group_label>
    <arm_group_label>sipuleucel-T with DNA Vaccine</arm_group_label>
    <other_name>Provenge</other_name>
  </intervention>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>DNA Vaccine</intervention_name>
    <description>Given ID</description>
    <arm_group_label>sipuleucel-T with DNA Vaccine</arm_group_label>
    <other_name>pTVG-HP with rhGM-CSF</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Histologically confirmed diagnosis of prostate cancer (adenocarcinoma of the prostate)&#xD;
&#xD;
          -  Metastatic disease as evidenced by the presence of soft tissue and/or bone metastases&#xD;
             on imaging studies (computed tomography [CT] of abdomen/pelvis, bone scintigraphy)&#xD;
&#xD;
          -  Castrate-resistant disease, defined as follows:&#xD;
&#xD;
               -  All patients must have received standard of care androgen deprivation treatment&#xD;
                  before trial entry (surgical castration versus gonadotropin-releasing hormone&#xD;
                  [GnRH] analogue or antagonist treatment), and subjects receiving GnRH analogue or&#xD;
                  antagonist must continue this treatment throughout the time on this study&#xD;
&#xD;
               -  Patients may have been treated previously with a nonsteroidal antiandrogen, with&#xD;
                  evidence of disease progression subsequently; subjects must be off use of&#xD;
                  anti-androgen for at least 4 weeks (for flutamide) or 6 weeks (for bicalutamide&#xD;
                  or nilutamide) prior to registration&#xD;
&#xD;
                  ** Subjects who demonstrate an anti-androgen withdrawal response, defined as a &gt;=&#xD;
                  25% decline in PSA within 4-6 week of stopping a nonsteroidal antiandrogen are&#xD;
                  not eligible until the PSA rises above the nadir observed after antiandrogen&#xD;
                  withdrawal&#xD;
&#xD;
               -  Castration levels of testosterone (&lt; 50 ng/dL) within 2 weeks of registration&#xD;
&#xD;
          -  Progressive disease while receiving androgen deprivation therapy defined by any one of&#xD;
             the following as per the Prostate Cancer Clinical Trials Working Group 2 (PCWG2) bone&#xD;
             scan criteria or Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 during or&#xD;
             after completing last therapy:&#xD;
&#xD;
               -  PSA: at least two consecutive rises in serum PSA, obtained at a minimum of 1-week&#xD;
                  intervals, and each value &gt;= 2.0 ng/mL&#xD;
&#xD;
               -  Measurable disease: &gt;= 50% increase in the sum of the cross products of all&#xD;
                  measurable lesions or the development of new measurable lesions; the short axis&#xD;
                  of a target lymph node must be at least 15 mm by spiral CT to be considered a&#xD;
                  target lesion&#xD;
&#xD;
               -  Non-measurable (bone) disease: the appearance of two or more new areas of uptake&#xD;
                  on bone scan consistent with metastatic disease compared to previous imaging&#xD;
                  during castration therapy; the increased uptake of pre-existing lesions on bone&#xD;
                  scan will not be taken to constitute progression, and ambiguous results must be&#xD;
                  confirmed by other imaging modalities (e.g. X-ray, CT or magnetic resonance&#xD;
                  imaging [MRI])&#xD;
&#xD;
          -  Must have &gt;= 3 serum PSA values obtained over at least a 12 week period of time prior&#xD;
             to registration, including the day of screening, to calculate a PSA doubling time;&#xD;
             Note: PSA's are not required to be obtained at the same laboratory; use all PSA values&#xD;
             that have been done in last 6 months to calculate PSA doubling time&#xD;
&#xD;
          -  Life expectancy of at least 6 months&#xD;
&#xD;
          -  Patients must have an Eastern Cooperative Oncology Group (ECOG) performance status of&#xD;
             0, 1, or 2&#xD;
&#xD;
          -  White blood cell &gt;= 2000/mm^3&#xD;
&#xD;
          -  Absolute neutrophil count &gt;= 1000/mm^3&#xD;
&#xD;
          -  Hemoglobin (HgB) &gt;= 9.0 mg/dL&#xD;
&#xD;
          -  Platelets &gt;= 100,000/mm^3&#xD;
&#xD;
          -  Creatinine =&lt; 2.0 mg/dL&#xD;
&#xD;
          -  Aspartate aminotransferase (AST), alanine aminotransferase (ALT) =&lt; 2.5 x&#xD;
             institutional upper limit of normal&#xD;
&#xD;
          -  Negative serology tests for human immunodeficiency virus (HIV) 1 and 2, and for active&#xD;
             hepatitis B or hepatitis C, within 14 days of first peripheral blood collection for&#xD;
             sipuleucel-T&#xD;
&#xD;
          -  Patients must be at least 4 weeks from any prior treatments and have recovered (to &lt;&#xD;
             grade 2) from acute toxicity attributed to this prior treatment&#xD;
&#xD;
          -  Patients must be informed of the experimental nature of the study and its potential&#xD;
             risks, and must sign an Institutional Review Board (IRB)-approved written informed&#xD;
             consent form indicating such an understanding&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Small cell or other variant prostate cancer histology&#xD;
&#xD;
          -  Patients may not be receiving other investigational agents or be receiving concurrent&#xD;
             anticancer therapy other than androgen deprivation&#xD;
&#xD;
          -  Symptomatic metastatic disease, as defined by the need for opioid analgesics for the&#xD;
             treatment of pain attributed to a prostate cancer metastatic lesion; patients&#xD;
             receiving opioids must receive approval from the principal investigator (PI) for&#xD;
             eligibility&#xD;
&#xD;
          -  Patients may not have been treated with prior sipuleucel-T&#xD;
&#xD;
          -  Treatment with any of the following medications within 28 days of registration, or&#xD;
             while on study, is prohibited:&#xD;
&#xD;
               -  Systemic corticosteroids (at doses over the equivalent of 1 mg prednisone daily);&#xD;
                  inhaled, intranasal or topical corticosteroids are acceptable&#xD;
&#xD;
               -  Prostate cancer (PC)-SPES&#xD;
&#xD;
               -  Saw palmetto&#xD;
&#xD;
               -  Megestrol&#xD;
&#xD;
               -  Ketoconazole&#xD;
&#xD;
               -  5-alpha-reductase inhibitors-patients already taking 5-alpha-reductase inhibitors&#xD;
                  prior to 28 days prior to registration may stay on these agents throughout the&#xD;
                  course of therapy, but these should not be started while patients are on study&#xD;
&#xD;
               -  Diethyl stilbestrol&#xD;
&#xD;
               -  Abiraterone&#xD;
&#xD;
               -  Any other hormonal agent or supplement being used with the intent of cancer&#xD;
                  treatment&#xD;
&#xD;
          -  External beam radiation therapy within 4 weeks of registration is prohibited, or&#xD;
             anticipated need for radiation therapy (e.g. imminent pathological fracture or spinal&#xD;
             cord compression) within 3 months of registration&#xD;
&#xD;
          -  Major surgery within 4 weeks of registration is prohibited&#xD;
&#xD;
          -  Prior cytotoxic chemotherapy (e.g. docetaxel, mitoxantrone, cabazitaxel) within 6&#xD;
             months of registration is prohibited&#xD;
&#xD;
          -  Patients with a history of life-threatening autoimmune disease&#xD;
&#xD;
          -  Patients who have undergone splenectomy&#xD;
&#xD;
          -  Patients must not have other active malignancies other than non-melanoma skin cancers&#xD;
             or carcinoma in situ of the bladder; subjects with a history of other cancers who have&#xD;
             been adequately treated and have been recurrence-free for &gt;= 3 years are eligible&#xD;
&#xD;
          -  Patients with known brain metastases&#xD;
&#xD;
          -  Any antibiotic therapy or evidence of infection within 1 week of registration&#xD;
&#xD;
          -  Any other medical intervention or condition, which, in the opinion of the PI could&#xD;
             compromise patient safety or adherence with the study requirements&#xD;
&#xD;
          -  Patients cannot have concurrent enrollment on other phase I, II, or III&#xD;
             investigational treatment studies&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Douglas McNeel, M.D., PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Wisconsin, Madison</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Wisconsin Carbone Cancer Center</name>
      <address>
        <city>Madison</city>
        <state>Wisconsin</state>
        <zip>53792</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>http://www.uwhealth.org/uw-carbone-cancer-center/cancer/10252</url>
    <description>University of Wisconsin Carbone Cancer Center</description>
  </link>
  <results_reference>
    <citation>Wargowski E, Johnson LE, Eickhoff JC, Delmastro L, Staab MJ, Liu G, McNeel DG. Prime-boost vaccination targeting prostatic acid phosphatase (PAP) in patients with metastatic castration-resistant prostate cancer (mCRPC) using Sipuleucel-T and a DNA vaccine. J Immunother Cancer. 2018 Mar 13;6(1):21. doi: 10.1186/s40425-018-0333-y.</citation>
    <PMID>29534736</PMID>
  </results_reference>
  <verification_date>May 2021</verification_date>
  <study_first_submitted>October 9, 2012</study_first_submitted>
  <study_first_submitted_qc>October 11, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 15, 2012</study_first_posted>
  <results_first_submitted>May 17, 2018</results_first_submitted>
  <results_first_submitted_qc>June 19, 2018</results_first_submitted_qc>
  <results_first_posted type="Actual">July 17, 2018</results_first_posted>
  <last_update_submitted>June 15, 2021</last_update_submitted>
  <last_update_submitted_qc>June 15, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">June 18, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Vaccine</keyword>
  <keyword>pTVG-HP</keyword>
  <keyword>Prostate Cancer</keyword>
  <keyword>Castrate Resistant</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Prostatic Neoplasms</mesh_term>
  </condition_browse>
  <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>September 5, 2015</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/58/NCT01706458/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Sipuleucel-T</title>
          <description>Patients receive sipuleucel-T IV on weeks 0, 2, and 4.&#xD;
sipuleucel-T: Given IV</description>
        </group>
        <group group_id="P2">
          <title>Sipuleucel-T With DNA Vaccine</title>
          <description>Patients receive sipuleucel-T as patients in arm I and pTVG-HP plasmid DNA vaccine ID on weeks 6, 8, 10, and 12, and then at 6 and 9 months.&#xD;
sipuleucel-T: Given IV&#xD;
DNA Vaccine: Given ID</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="9"/>
                <participants group_id="P2" count="9"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="6"/>
                <participants group_id="P2" count="5"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="3"/>
                <participants group_id="P2" count="4"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Physician Decision</title>
              <participants_list>
                <participants group_id="P1" count="3"/>
                <participants group_id="P2" count="4"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>Male patients, histological diagnosis of prostate adenocarcinoma and PSA recurrence following castration were eligible, provided they had evidence of metastatic disease by CT of abdomen/pelvis or bone scintigraphy. Progressive disease following last treatment required, per Prostate Cancer Working Group 2 criteria. 4 weeks from prior treatment.</population>
      <group_list>
        <group group_id="B1">
          <title>Sipuleucel-T</title>
          <description>Patients receive sipuleucel-T IV on weeks 0, 2, and 4.&#xD;
sipuleucel-T: Given IV</description>
        </group>
        <group group_id="B2">
          <title>Sipuleucel-T With DNA Vaccine</title>
          <description>Patients receive sipuleucel-T as patients in arm I and pTVG-HP plasmid DNA vaccine ID on weeks 6, 8, 10, and 12, and then at 6 and 9 months.&#xD;
sipuleucel-T: Given IV&#xD;
DNA Vaccine: Given ID</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="9"/>
            <count group_id="B2" value="9"/>
            <count group_id="B3" value="18"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="75" lower_limit="67" upper_limit="82"/>
                    <measurement group_id="B2" value="72" lower_limit="66" upper_limit="85"/>
                    <measurement group_id="B3" value="74" lower_limit="66" upper_limit="85"/>
                  </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="9"/>
                    <measurement group_id="B2" value="9"/>
                    <measurement group_id="B3" value="18"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Ethnicity (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Hispanic or Latino</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>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="9"/>
                    <measurement group_id="B2" value="9"/>
                    <measurement group_id="B3" value="18"/>
                  </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>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="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="9"/>
                    <measurement group_id="B2" value="9"/>
                    <measurement group_id="B3" value="18"/>
                  </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>ECOG Performance Status</title>
          <description>The ECOG Performance Status describes a patient's level of function:&#xD;
0. is fully active, performance without restriction,&#xD;
is restricted in physically strenuous activity, ambulatory and able to carry out light or sedentary work,&#xD;
is ambulatory and capable of selfcare but unable to carry out work activities, up and about more that 50% of waking hours,&#xD;
is capable of limited selfcare; confined to bed or chair more than 50% of waking hours,&#xD;
is completely disabled; no selfcare, confined to bed or chair,&#xD;
is deceased</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>0</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="9"/>
                    <measurement group_id="B2" value="8"/>
                    <measurement group_id="B3" value="17"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>1</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Gleason score</title>
          <description>The Gleason Score is a grading system for prostate cancer severity. It is defined on a scale of 1-5 where 1 is low-grade tumor cells and 5 is high-grade tumor cells.&#xD;
Pathologists assign two Gleason grades to a biopsy; one for the predominant pattern and another for the second most predominant pattern. The two grades are added together to determine the Gleason Score (ultimately a number between 2 and 10). Scores of 2-4 tend to indicate less aggressive cancers, and 7-10 indicate more aggressive cancers.</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>&lt; 7</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>7</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                    <measurement group_id="B2" value="4"/>
                    <measurement group_id="B3" value="7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>8</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>&gt;/= 9</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="5"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Unknown</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Metastatic sites</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>Visceral</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Bone</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="5"/>
                    <measurement group_id="B3" value="7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Distant lymph nodes</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="6"/>
                    <measurement group_id="B2" value="4"/>
                    <measurement group_id="B3" value="10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Baseline PSA (ng/mL)</title>
          <units>ng/mL</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="32.6" lower_limit="4.17" upper_limit="1090"/>
                    <measurement group_id="B2" value="11.2" lower_limit="2.09" upper_limit="68.4"/>
                    <measurement group_id="B3" value="16.25" lower_limit="2.09" upper_limit="1090"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Baseline PSA doubling time (months)</title>
          <units>months</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="2.8" lower_limit="1.4" upper_limit="63.9"/>
                    <measurement group_id="B2" value="2.2" lower_limit="1.0" upper_limit="25.8"/>
                    <measurement group_id="B3" value="2.55" lower_limit="1.0" upper_limit="63.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Number of Participants With Immune Response Following Treatment</title>
        <description>The primary immunological goal of this study was to determine whether booster immunizations with a DNA vaccine encoding PAP could augment the number of PAP-specific effector and memory T cells following treatment with sipuleucel-T, or prolong the duration of detectable T-cell response. All subjects received a tetanus booster immunization prior to beginning the immunization series, providing a separate test of an individual's immune responsiveness. Responses to PSA, a non-target prostate specific protein, were concurrently evaluated, as were responses to GM-CSF, a component of the PA2024 fusion protein used in the preparation of sipuleucel-T.Samples were evaluated for antigen-specific IFNy or granzyme B secretion by ELISPOT, and the detection of statistically significant antigen-specific responses, that were at least 3-fold over the baseline value, and detectable more than once post-treatment, were used to define immune response to a particular antigen.</description>
        <time_frame>12 months</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Sipuleucel-T</title>
            <description>Patients receive sipuleucel-T IV on weeks 0, 2, and 4.&#xD;
sipuleucel-T: Given IV</description>
          </group>
          <group group_id="O2">
            <title>Sipuleucel-T With DNA Vaccine</title>
            <description>Patients receive sipuleucel-T as patients in arm I and pTVG-HP plasmid DNA vaccine ID on weeks 6, 8, 10, and 12, and then at 6 and 9 months.&#xD;
sipuleucel-T: Given IV&#xD;
DNA Vaccine: Given ID</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Immune Response Following Treatment</title>
          <description>The primary immunological goal of this study was to determine whether booster immunizations with a DNA vaccine encoding PAP could augment the number of PAP-specific effector and memory T cells following treatment with sipuleucel-T, or prolong the duration of detectable T-cell response. All subjects received a tetanus booster immunization prior to beginning the immunization series, providing a separate test of an individual's immune responsiveness. Responses to PSA, a non-target prostate specific protein, were concurrently evaluated, as were responses to GM-CSF, a component of the PA2024 fusion protein used in the preparation of sipuleucel-T.Samples were evaluated for antigen-specific IFNy or granzyme B secretion by ELISPOT, and the detection of statistically significant antigen-specific responses, that were at least 3-fold over the baseline value, and detectable more than once post-treatment, were used to define immune response to a particular antigen.</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="9"/>
                <count group_id="O2" value="9"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6"/>
                    <measurement group_id="O2" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Progression-free Survival</title>
        <description>Percentage of patients without radiographic progression at 12 months.</description>
        <time_frame>12 months</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Sipuleucel-T</title>
            <description>Patients receive sipuleucel-T IV on weeks 0, 2, and 4.&#xD;
sipuleucel-T: Given IV</description>
          </group>
          <group group_id="O2">
            <title>Sipuleucel-T With DNA Vaccine</title>
            <description>Patients receive sipuleucel-T as patients in arm I and pTVG-HP plasmid DNA vaccine ID on weeks 6, 8, 10, and 12, and then at 6 and 9 months.&#xD;
sipuleucel-T: Given IV&#xD;
DNA Vaccine: Given ID</description>
          </group>
        </group_list>
        <measure>
          <title>Progression-free Survival</title>
          <description>Percentage of patients without radiographic progression at 12 months.</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="9"/>
                <count group_id="O2" value="9"/>
              </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>Time to Radiographic Disease Progression</title>
        <description>Time to radiographic progression using staging obtained at month 3 as baseline for evaluation.</description>
        <time_frame>12 months</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Sipuleucel-T</title>
            <description>Patients receive sipuleucel-T IV on weeks 0, 2, and 4.&#xD;
sipuleucel-T: Given IV</description>
          </group>
          <group group_id="O2">
            <title>Sipuleucel-T With DNA Vaccine</title>
            <description>Patients receive sipuleucel-T as patients in arm I and pTVG-HP plasmid DNA vaccine ID on weeks 6, 8, 10, and 12, and then at 6 and 9 months.&#xD;
sipuleucel-T: Given IV&#xD;
DNA Vaccine: Given ID</description>
          </group>
        </group_list>
        <measure>
          <title>Time to Radiographic Disease Progression</title>
          <description>Time to radiographic progression using staging obtained at month 3 as baseline for evaluation.</description>
          <units>days</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="9"/>
                <count group_id="O2" value="9"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="161" lower_limit="85" upper_limit="259"/>
                    <measurement group_id="O2" value="164" lower_limit="85" upper_limit="343"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Measure Prostate-specific Antigen (PSA) Doubling Time</title>
        <description>PSA doubling times were calculated from PSA values obtained up to 6 months from day 1 of study treatment. An increase in the PSA doubling time to at least double the baseline value will be defined as a PSA doubling time &quot;response&quot;.</description>
        <time_frame>12 months</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Sipuleucel-T</title>
            <description>Patients receive sipuleucel-T IV on weeks 0, 2, and 4.&#xD;
sipuleucel-T: Given IV</description>
          </group>
          <group group_id="O2">
            <title>Sipuleucel-T With DNA Vaccine</title>
            <description>Patients receive sipuleucel-T as patients in arm I and pTVG-HP plasmid DNA vaccine ID on weeks 6, 8, 10, and 12, and then at 6 and 9 months.&#xD;
sipuleucel-T: Given IV&#xD;
DNA Vaccine: Given ID</description>
          </group>
        </group_list>
        <measure>
          <title>Measure Prostate-specific Antigen (PSA) Doubling Time</title>
          <description>PSA doubling times were calculated from PSA values obtained up to 6 months from day 1 of study treatment. An increase in the PSA doubling time to at least double the baseline value will be defined as a PSA doubling time &quot;response&quot;.</description>
          <units>months</units>
          <param>Median</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="9"/>
                <count group_id="O2" value="9"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.5" lower_limit="1.1" upper_limit="8.8"/>
                    <measurement group_id="O2" value="2.6" lower_limit="1.7" upper_limit="3.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Overall Survival: Median Time to Death From Any Cause</title>
        <description>Overall survival is defined as the time interval from randomization to death from any cause or to the last follow-up in censored patients.</description>
        <time_frame>up to approximately 5 years</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Sipuleucel-T</title>
            <description>Patients receive sipuleucel-T IV on weeks 0, 2, and 4.&#xD;
sipuleucel-T: Given IV</description>
          </group>
          <group group_id="O2">
            <title>Sipuleucel-T With DNA Vaccine</title>
            <description>Patients receive sipuleucel-T as patients in arm I and pTVG-HP plasmid DNA vaccine ID on weeks 6, 8, 10, and 12, and then at 6 and 9 months.&#xD;
sipuleucel-T: Given IV&#xD;
DNA Vaccine: Given ID</description>
          </group>
        </group_list>
        <measure>
          <title>Overall Survival: Median Time to Death From Any Cause</title>
          <description>Overall survival is defined as the time interval from randomization to death from any cause or to the last follow-up in censored patients.</description>
          <units>months</units>
          <param>Median</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="9"/>
                <count group_id="O2" value="9"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="32.3" lower_limit="7.7" upper_limit="66.7"/>
                    <measurement group_id="O2" value="29.6" lower_limit="14.6" upper_limit="46.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>0.9060</p_value>
            <method>Log Rank</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Number of Circulating Tumor Cells</title>
        <time_frame>6 months</time_frame>
        <population>This outcome measure was not determined because there was no progression free survival at one-year.</population>
        <group_list>
          <group group_id="O1">
            <title>Sipuleucel-T</title>
            <description>Patients receive sipuleucel-T IV on weeks 0, 2, and 4.&#xD;
sipuleucel-T: Given IV</description>
          </group>
          <group group_id="O2">
            <title>Sipuleucel-T With DNA Vaccine</title>
            <description>Patients receive sipuleucel-T as patients in arm I and pTVG-HP plasmid DNA vaccine ID on weeks 6, 8, 10, and 12, and then at 6 and 9 months.&#xD;
sipuleucel-T: Given IV&#xD;
DNA Vaccine: Given ID</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Circulating Tumor Cells</title>
          <population>This outcome measure was not determined because there was no progression free survival at one-year.</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>Other Pre-specified</type>
        <title>PAP-specific Antibody and T-cell Immune Responses Following Treatment With Sipuleucel-T and DNA Vaccine</title>
        <description>A response resulting from immunization was defined as a PAP-specific response detectable more than once post-treatment that was both significant (compared to media only control), at least 3-fold higher than the pre-treatment value, and with a frequency&gt; 1:100,000 PBMC. An antibody response was defined as any increase in titer over baseline.</description>
        <time_frame>12 months</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Sipuleucel-T</title>
            <description>Patients receive sipuleucel-T IV on weeks 0, 2, and 4.&#xD;
sipuleucel-T: Given IV</description>
          </group>
          <group group_id="O2">
            <title>Sipuleucel-T With DNA Vaccine</title>
            <description>Patients receive sipuleucel-T as patients in arm I and pTVG-HP plasmid DNA vaccine ID on weeks 6, 8, 10, and 12, and then at 6 and 9 months.&#xD;
sipuleucel-T: Given IV&#xD;
DNA Vaccine: Given ID</description>
          </group>
        </group_list>
        <measure>
          <title>PAP-specific Antibody and T-cell Immune Responses Following Treatment With Sipuleucel-T and DNA Vaccine</title>
          <description>A response resulting from immunization was defined as a PAP-specific response detectable more than once post-treatment that was both significant (compared to media only control), at least 3-fold higher than the pre-treatment value, and with a frequency&gt; 1:100,000 PBMC. An antibody response was defined as any increase in titer over baseline.</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="9"/>
                <count group_id="O2" value="9"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Interferon Gamma Response</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                    <measurement group_id="O2" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Granzyme B</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                    <measurement group_id="O2" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Antibody Response</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                    <measurement group_id="O2" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Logistic Regression Analysis Will be Conducted to Evaluate Whether PAP-specific Immune Response is Associated With Prolonged (1-year) Progression-free Survival.</title>
        <description>Not performed because no progression free survival at one year.</description>
        <time_frame>12 months</time_frame>
        <population>This outcome measure was not determined because there was no progression free survival at one-year.</population>
        <group_list>
          <group group_id="O1">
            <title>Sipuleucel-T</title>
            <description>Patients receive sipuleucel-T IV on weeks 0, 2, and 4.&#xD;
sipuleucel-T: Given IV</description>
          </group>
          <group group_id="O2">
            <title>Sipuleucel-T With DNA Vaccine</title>
            <description>Patients receive sipuleucel-T as patients in arm I and pTVG-HP plasmid DNA vaccine ID on weeks 6, 8, 10, and 12, and then at 6 and 9 months.&#xD;
sipuleucel-T: Given IV&#xD;
DNA Vaccine: Given ID</description>
          </group>
        </group_list>
        <measure>
          <title>Logistic Regression Analysis Will be Conducted to Evaluate Whether PAP-specific Immune Response is Associated With Prolonged (1-year) Progression-free Survival.</title>
          <description>Not performed because no progression free survival at one year.</description>
          <population>This outcome measure was not determined because there was no progression free survival at one-year.</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>Other Pre-specified</type>
        <title>Logistic Regression Analysis Will be Conducted to Evaluate Whether Baseline Immune Responses Predict for Immune Responses Elicited/Augmented Following Treatment With Sipuleucel-T +/- DNA Vaccine.</title>
        <description>Not performed because no progression free survival at one year.</description>
        <time_frame>12 months</time_frame>
        <population>This outcome measure was not determined because there was no progression-free survival at one-year.</population>
        <group_list>
          <group group_id="O1">
            <title>Sipuleucel-T</title>
            <description>Patients receive sipuleucel-T IV on weeks 0, 2, and 4.&#xD;
sipuleucel-T: Given IV</description>
          </group>
          <group group_id="O2">
            <title>Sipuleucel-T With DNA Vaccine</title>
            <description>Patients receive sipuleucel-T as patients in arm I and pTVG-HP plasmid DNA vaccine ID on weeks 6, 8, 10, and 12, and then at 6 and 9 months.&#xD;
sipuleucel-T: Given IV&#xD;
DNA Vaccine: Given ID</description>
          </group>
        </group_list>
        <measure>
          <title>Logistic Regression Analysis Will be Conducted to Evaluate Whether Baseline Immune Responses Predict for Immune Responses Elicited/Augmented Following Treatment With Sipuleucel-T +/- DNA Vaccine.</title>
          <description>Not performed because no progression free survival at one year.</description>
          <population>This outcome measure was not determined because there was no progression-free survival at one-year.</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>Other Pre-specified</type>
        <title>The Detection of Antigen Spread to Other Prostate Associated Antigens, and the Identification of Specific Antigens Recognized, Will be Analyzed Descriptively.</title>
        <description>Not performed because no progression free survival at one year.</description>
        <time_frame>12 months</time_frame>
        <population>This outcome measure was not determined because there was no progression free survival at one-year.</population>
        <group_list>
          <group group_id="O1">
            <title>Sipuleucel-T</title>
            <description>Patients receive sipuleucel-T IV on weeks 0, 2, and 4.&#xD;
sipuleucel-T: Given IV</description>
          </group>
          <group group_id="O2">
            <title>Sipuleucel-T With DNA Vaccine</title>
            <description>Patients receive sipuleucel-T as patients in arm I and pTVG-HP plasmid DNA vaccine ID on weeks 6, 8, 10, and 12, and then at 6 and 9 months.&#xD;
sipuleucel-T: Given IV&#xD;
DNA Vaccine: Given ID</description>
          </group>
        </group_list>
        <measure>
          <title>The Detection of Antigen Spread to Other Prostate Associated Antigens, and the Identification of Specific Antigens Recognized, Will be Analyzed Descriptively.</title>
          <description>Not performed because no progression free survival at one year.</description>
          <population>This outcome measure was not determined because there was no progression free survival at one-year.</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_list>

    <reported_events>
      <time_frame>Overall, patients were followed for a mean of 24 months.</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Sipuleucel-T</title>
          <description>Patients receive sipuleucel-T IV on weeks 0, 2, and 4.&#xD;
sipuleucel-T: Given IV</description>
        </group>
        <group group_id="E2">
          <title>Sipuleucel-T With DNA Vaccine</title>
          <description>Patients receive sipuleucel-T as patients in arm I and pTVG-HP plasmid DNA vaccine ID on weeks 6, 8, 10, and 12, and then at 6 and 9 months.&#xD;
sipuleucel-T: Given IV&#xD;
DNA Vaccine: Given ID</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>NCI CTCAE v3</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="5" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="8" subjects_at_risk="9"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="9"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Fall</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="9"/>
              </event>
              <event>
                <sub_title>Fracture</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="9"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>Urinary tract obstruction</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="9"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Surgical and medical procedures</title>
            <event_list>
              <event>
                <sub_title>Surgical and medical procedures - Other, specify</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="9"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Hematoma</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="9"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <default_vocab>NCI CTCAE v3</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="9" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="9" subjects_at_risk="9"/>
              </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="9"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="9"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Nausea</sub_title>
                <counts group_id="E1" events="3" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E2" events="4" subjects_affected="4" subjects_at_risk="9"/>
              </event>
              <event>
                <sub_title>Abdominal Pain</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="9"/>
              </event>
              <event>
                <sub_title>Constipation</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="9"/>
              </event>
              <event>
                <sub_title>Diarrhea</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" events="3" subjects_affected="1" subjects_at_risk="9"/>
              </event>
              <event>
                <sub_title>Gastrointestinal disorders - Other, specify</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="9"/>
              </event>
              <event>
                <sub_title>Vomiting</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="9"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Chills</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="9"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="9"/>
              </event>
              <event>
                <sub_title>Fatigue</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="9"/>
                <counts group_id="E2" events="5" subjects_affected="3" subjects_at_risk="9"/>
              </event>
              <event>
                <sub_title>Fever</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="9"/>
              </event>
              <event>
                <sub_title>Non-cardiac chest pain</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="9"/>
              </event>
              <event>
                <sub_title>Injection site reaction</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" events="6" subjects_affected="4" subjects_at_risk="9"/>
              </event>
              <event>
                <sub_title>Localized edema</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="9"/>
              </event>
              <event>
                <sub_title>Malaise</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="9"/>
              </event>
              <event>
                <sub_title>Pain</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" events="3" subjects_affected="1" subjects_at_risk="9"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Sinusitis</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="9"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="9"/>
              </event>
              <event>
                <sub_title>Tooth infection</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="9"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Fall</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="9"/>
              </event>
              <event>
                <sub_title>Fracture</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="9"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>White blood cell decreased</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="9"/>
              </event>
              <event>
                <sub_title>Alkaline phosphatase increased</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="9"/>
              </event>
              <event>
                <sub_title>Platelet count decreased</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="9"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Anorexia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="9"/>
              </event>
              <event>
                <sub_title>Dehydration</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="9"/>
              </event>
              <event>
                <sub_title>Hypokalemia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="9"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Back pain</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E2" events="4" subjects_affected="4" subjects_at_risk="9"/>
              </event>
              <event>
                <sub_title>Bone pain</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="9"/>
              </event>
              <event>
                <sub_title>Arthralgia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="9"/>
              </event>
              <event>
                <sub_title>Arthritis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="9"/>
              </event>
              <event>
                <sub_title>Flank pain</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="9"/>
              </event>
              <event>
                <sub_title>Generalized muscle weakness</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="9"/>
              </event>
              <event>
                <sub_title>Myalgia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="9"/>
              </event>
              <event>
                <sub_title>Neck pain</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="9"/>
              </event>
              <event>
                <sub_title>Pain in extremity</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" events="3" subjects_affected="2" subjects_at_risk="9"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Heahache</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="9"/>
              </event>
              <event>
                <sub_title>Peripheral sensory neuropathy</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="9"/>
              </event>
              <event>
                <sub_title>Presyncope</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" events="2" subjects_affected="1" subjects_at_risk="9"/>
              </event>
              <event>
                <sub_title>Vasovagal reaction</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="9"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Insomnia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="9"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>Urinary tract obstruction</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="9"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Reproductive system and breast disorders</title>
            <event_list>
              <event>
                <sub_title>Pelvic pain</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="9"/>
              </event>
              <event>
                <sub_title>Testicular pain</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="9"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Cough</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="9"/>
              </event>
              <event>
                <sub_title>Dyspnea</sub_title>
                <counts group_id="E1" events="2" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="9"/>
              </event>
              <event>
                <sub_title>Postnasal drip</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="9"/>
              </event>
              <event>
                <sub_title>Hoarseness</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="9"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Skin and subcutaneous tissue disorders - Other, specify</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="9"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Surgical and medical procedures</title>
            <event_list>
              <event>
                <sub_title>Surgical and medical procedures - Other, specify</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="9"/>
              </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="9"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="9"/>
              </event>
              <event>
                <sub_title>Hypertension</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="9"/>
              </event>
              <event>
                <sub_title>Hot flashes</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="9"/>
              </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>Mary Jane Staab - Program Manager</name_or_title>
      <organization>UWCCC</organization>
      <phone>608-262-4304</phone>
      <email>mjs@medicine.wisc.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/NCT01706458
org study id: CO11816
secondary id: A534260
secondary id: SMPH/MEDICINE/MEDICINE*H
secondary id: NCI-2012-02026
secondary id: 2012-0352
nct id: NCT01706458
lead sponsor: 
collaborator: 
has dmc: Yes
This randomized pilot clinical trial studies sipuleucel-T with or without deoxyribonucleic
      acid (DNA) vaccine therapy in treating patients with prostate cancer that has not responded
      to previous treatment with hormones and has spread to other places in the body. Vaccines may
      help the body build an effective immune response to kill tumor cells. It is not yet known
      whether giving sipuleucel-T vaccine works better with or without DNA vaccine therapy in
      treating prostate cancer.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Number of Participants With Immune Response Following Treatment
time frame: 12 months
description: The primary immunological goal of this study was to determine whether booster immunizations with a DNA vaccine encoding PAP could augment the number of PAP-specific effector and memory T cells following treatment with sipuleucel-T, or prolong the duration of detectable T-cell response. All subjects received a tetanus booster immunization prior to beginning the immunization series, providing a separate test of an individual's immune responsiveness. Responses to PSA, a non-target prostate specific protein, were concurrently evaluated, as were responses to GM-CSF, a component of the PA2024 fusion protein used in the preparation of sipuleucel-T.Samples were evaluated for antigen-specific IFNy or granzyme B secretion by ELISPOT, and the detection of statistically significant antigen-specific responses, that were at least 3-fold over the baseline value, and detectable more than once post-treatment, were used to define immune response to a particular antigen.
measure: Progression-free Survival
time frame: 12 months
description: Percentage of patients without radiographic progression at 12 months.
measure: Time to Radiographic Disease Progression
time frame: 12 months
description: Time to radiographic progression using staging obtained at month 3 as baseline for evaluation.
measure: Measure Prostate-specific Antigen (PSA) Doubling Time
time frame: 12 months
description: PSA doubling times were calculated from PSA values obtained up to 6 months from day 1 of study treatment. An increase in the PSA doubling time to at least double the baseline value will be defined as a PSA doubling time "response".
measure: Overall Survival: Median Time to Death From Any Cause
time frame: up to approximately 5 years
description: Overall survival is defined as the time interval from randomization to death from any cause or to the last follow-up in censored patients.
measure: Number of Circulating Tumor Cells
time frame: 6 months
measure: PAP-specific Antibody and T-cell Immune Responses Following Treatment With Sipuleucel-T and DNA Vaccine
time frame: 12 months
description: A response resulting from immunization was defined as a PAP-specific response detectable more than once post-treatment that was both significant (compared to media only control), at least 3-fold higher than the pre-treatment value, and with a frequency> 1:100,000 PBMC. An antibody response was defined as any increase in titer over baseline.
measure: Logistic Regression Analysis Will be Conducted to Evaluate Whether PAP-specific Immune Response is Associated With Prolonged (1-year) Progression-free Survival.
time frame: 12 months
description: Not performed because no progression free survival at one year.
measure: Logistic Regression Analysis Will be Conducted to Evaluate Whether Baseline Immune Responses Predict for Immune Responses Elicited/Augmented Following Treatment With Sipuleucel-T +/- DNA Vaccine.
time frame: 12 months
description: Not performed because no progression free survival at one year.
measure: The Detection of Antigen Spread to Other Prostate Associated Antigens, and the Identification of Specific Antigens Recognized, Will be Analyzed Descriptively.
time frame: 12 months
description: Not performed because no progression free survival at one year.
arm group label: sipuleucel-T
arm group type: Active Comparator
description: Patients receive sipuleucel-T IV on weeks 0, 2, and 4.
arm group label: sipuleucel-T with DNA Vaccine
arm group type: Experimental
description: Patients receive sipuleucel-T as patients in arm I and pTVG-HP plasmid DNA vaccine ID on weeks 6, 8, 10, and 12, and then at 6 and 9 months.
intervention type: Biological
intervention name: sipuleucel-T
description: Given IV
arm group label: sipuleucel-T
arm group label: sipuleucel-T with DNA Vaccine
other name: Provenge
intervention type: Biological
intervention name: DNA Vaccine
description: Given ID
arm group label: sipuleucel-T with DNA Vaccine
other name: pTVG-HP with rhGM-CSF
criteria: 
gender: Male
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Douglas McNeel, M.D., PhD
role: Principal Investigator
affiliation: University of Wisconsin, Madison
facility: 
country: United States
url: http://www.uwhealth.org/uw-carbone-cancer-center/cancer/10252
description: University of Wisconsin Carbone Cancer Center
citation: Wargowski E, Johnson LE, Eickhoff JC, Delmastro L, Staab MJ, Liu G, McNeel DG. Prime-boost vaccination targeting prostatic acid phosphatase (PAP) in patients with metastatic castration-resistant prostate cancer (mCRPC) using Sipuleucel-T and a DNA vaccine. J Immunother Cancer. 2018 Mar 13;6(1):21. doi: 10.1186/s40425-018-0333-y.
PMID: 29534736
responsible party type: Sponsor
mesh term: Prostatic Neoplasms
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 