<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/NCT01735396</url>
  </required_header>
  <id_info>
    <org_study_id>GCO 12-1727</org_study_id>
    <nct_id>NCT01735396</nct_id>
  </id_info>
  <brief_title>Abiraterone Acetate Trial in African American Prostate Cancer Patients</brief_title>
  <official_title>A Pilot Study of Abiraterone Acetate in African American/Black Patients With Castration Resistant Prostate Cancer</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Icahn School of Medicine at Mount Sinai</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Icahn School of Medicine at Mount Sinai</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is a pilot study of abiraterone acetate in African American/Black patients with&#xD;
      castration-resistant prostate cancer. The primary objective is to determine the correlation&#xD;
      between germline polymorphisms and antitumor activity (as defined by a decline in PSA of ≥&#xD;
      30%) in African American patients with castration-resistant prostate cancer treated with&#xD;
      abiraterone acetate. Patients will receive abiraterone acetate until the time of disease&#xD;
      progression, in the absence of prohibitive toxicities. Patients will be followed for disease&#xD;
      progression and survival.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    poor accrual&#xD;
  </why_stopped>
  <start_date>December 2012</start_date>
  <completion_date type="Actual">March 2016</completion_date>
  <primary_completion_date type="Actual">March 2016</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number of Participants With ≥ 30% Change in PSA</measure>
    <time_frame>baseline and 12 weeks</time_frame>
    <description>The primary objective of this study is to determine a correlation between inherited genetic polymorphisms and antitumor activity (as defined by a decline in PSA of ≥ 30%) in AA patients with castration-resistant prostate cancer treated with Abiraterone. The primary endpoint is the percent change in PSA from baseline to 12 weeks. A decline of ≥ 30% will be correlated with germline SNPs.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Response Assessment</measure>
    <time_frame>up to 12 weeks</time_frame>
    <description>Post-treatment changes in measurable disease by RECIST - Response Evaluation Criteria in Solid Tumors Complete Response (CR): Disappearance of all target lesions Partial Response (PR): At least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started Progressive Disease (PD): At least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to Progression</measure>
    <time_frame>up to 12 weeks</time_frame>
    <description>post-treatment changes in measurable disease by time to disease progression (as per PCWG2 guidelines)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Bone Scan</measure>
    <time_frame>up to 12 weeks</time_frame>
    <description>post-treatment changes in bone scans (as per PCWG2 guidelines) (&quot;no new lesions&quot; versus &quot;new lesions.&quot;)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Safety of Abiraterone</measure>
    <time_frame>up to 12 weeks</time_frame>
    <description>To determine the safety of abiraterone Adverse events as defined by CTCAE v4. Number of participants with serious adverse events grade 4 or 5</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Testosterone</measure>
    <time_frame>up to 12 weeks</time_frame>
    <description>Post-treatment changes in testosterone</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">11</enrollment>
  <condition>Prostate Cancer</condition>
  <arm_group>
    <arm_group_label>Abiraterone Acetate</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Abiraterone acetate 1000mg orally daily until the time of disease progression, in the absence of prohibitive toxicities.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Abiraterone Acetate</intervention_name>
    <description>Abiraterone acetate 1000 mg orally daily (supplied as four 250 mg tablets) and prednisone 5 mg orally twice daily</description>
    <arm_group_label>Abiraterone Acetate</arm_group_label>
    <other_name>Zytiga</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  1. Have signed an informed consent document indicating that the subjects understands&#xD;
             the purpose of and procedures required for the study and are willing to participate in&#xD;
             the study&#xD;
&#xD;
          -  Be willing/able to adhere to the prohibitions and restrictions specified in this&#xD;
             protocol&#xD;
&#xD;
          -  Written Authorization for Use and Release of Health and Research Study Information&#xD;
&#xD;
          -  African American or Black (by self identification)&#xD;
&#xD;
          -  Male aged 18 years and above&#xD;
&#xD;
          -  Histologically or cytologically confirmed adenocarcinoma of the prostate&#xD;
&#xD;
          -  Metastatic disease documented by standard imaging&#xD;
&#xD;
          -  Progressive prostate cancer based on either rising PSA, new bone metastases, or&#xD;
             progression of measurable disease according to PCWG2 12 guidelines.&#xD;
&#xD;
          -  Patients in either of the following clinical states will be eligible for enrollment:&#xD;
&#xD;
             i. No prior chemotherapy; ii. Patients previously treated with 1-2 prior chemotherapy&#xD;
             regimens permitted, one of which must have been included docetaxel&#xD;
&#xD;
          -  Surgically or medically castrated, with testosterone levels of &lt; 50 ng/dl.&#xD;
&#xD;
          -  Patients previously treated with an anti-androgen must demonstrate progression off of&#xD;
             the anti-androgen.&#xD;
&#xD;
          -  Eastern Cooperative Oncology Group (ECOG) Performance Status of ≤ 2&#xD;
&#xD;
          -  Have a baseline serum potassium of ≥ 3.5 mEq/L&#xD;
&#xD;
          -  Have aspartate aminotransferase (AST), alanine aminotransferase (ALT), and bilirubin&#xD;
             levels &lt; 1.5 x ULN&#xD;
&#xD;
          -  Have a serum albumin of ≥ 3.0 g/dL&#xD;
&#xD;
          -  Total bilirubin ≤ 1.5 x ULN&#xD;
&#xD;
          -  Have a platelet count of ≥ 100,000/μL&#xD;
&#xD;
          -  Have an absolute neutrophil count of &gt; 1500 cell/mm3&#xD;
&#xD;
          -  Have a calculated creatinine clearance ≥ 60 mL/min&#xD;
&#xD;
          -  Have a hemoglobin of ≥ 9.0 g/dL&#xD;
&#xD;
          -  Able to swallow the study drug as a whole tablet&#xD;
&#xD;
          -  Willing to take abiraterone acetate on an empty stomach; no food should be consumed at&#xD;
             least two hours before and for at least one hour after the dose of abiraterone acetate&#xD;
             is taken&#xD;
&#xD;
          -  Patients who have partners of childbearing potential must be willing to use a method&#xD;
             of birth control with adequate barrier protection as determined to be acceptable by&#xD;
             the principal investigator during the study and for 1 week after last dose of&#xD;
             abiraterone acetate&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Active infection or other medical condition that would make prednisone/prednisolone&#xD;
             (corticosteroid) use contraindicated&#xD;
&#xD;
          -  Known brain metastasis&#xD;
&#xD;
          -  Uncontrolled hypertension (systolic BP ≥ 160 mmHg or diastolic BP ≥ 95 mmHg) Patients&#xD;
             with a history of hypertension are allowed provided blood pressure is controlled by&#xD;
             anti-hypertensive treatment&#xD;
&#xD;
          -  Active or symptomatic viral hepatitis or chronic liver disease&#xD;
&#xD;
          -  History of pituitary or adrenal dysfunction&#xD;
&#xD;
          -  Clinically significant heart disease as evidenced by myocardial infarction, or&#xD;
             arterial thrombotic events in the past 6 months, severe or unstable angina, or New&#xD;
             York Heart Association (NYHA) Class III-IV heart disease or cardiac ejection fraction&#xD;
             measurement of &lt; 50% at baseline&#xD;
&#xD;
          -  Administration of an investigational therapeutic within 30 days of screening&#xD;
&#xD;
          -  Have any condition that, in the opinion of the investigator, would compromise the&#xD;
             well-being of the subject or the study or prevent the subject from meeting or&#xD;
             performing study requirements&#xD;
&#xD;
          -  Have poorly controlled diabetes&#xD;
&#xD;
          -  Have a history of gastrointestinal disorders (medical disorders or extensive surgery)&#xD;
             that may interfere with the absorption of the study agents&#xD;
&#xD;
          -  Have a pre-existing condition that warrants long-term corticosteroid use in excess of&#xD;
             study dose&#xD;
&#xD;
          -  Have known allergies, hypersensitivity, or intolerance to abiraterone acetate or&#xD;
             prednisone or their excipients&#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>Matthew Galsky, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Icahn School of Medicine at Mount Sinai</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Icahn School of Medicine at Mount Sinai</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10029</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Queens Cancer Center, Queens Hospital</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>11432</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>http://www.mssm.edu/research/institutes/tisch-cancer-institute</url>
    <description>Mt. Sinai Tisch Cancer Institute</description>
  </link>
  <verification_date>April 2017</verification_date>
  <study_first_submitted>November 24, 2012</study_first_submitted>
  <study_first_submitted_qc>November 27, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 28, 2012</study_first_posted>
  <results_first_submitted>April 4, 2017</results_first_submitted>
  <results_first_submitted_qc>April 4, 2017</results_first_submitted_qc>
  <results_first_posted type="Actual">May 12, 2017</results_first_posted>
  <last_update_submitted>April 4, 2017</last_update_submitted>
  <last_update_submitted_qc>April 4, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">May 12, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Icahn School of Medicine at Mount Sinai</investigator_affiliation>
    <investigator_full_name>Matthew Galsky</investigator_full_name>
    <investigator_title>Associate Professor</investigator_title>
  </responsible_party>
  <keyword>African American men</keyword>
  <keyword>metastatic prostate cancer</keyword>
  <keyword>castration resistant</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Prostatic Neoplasms</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Abiraterone Acetate</mesh_term>
  </intervention_browse>

  <clinical_results>

    <participant_flow>
      <recruitment_details>Recruitment began in Dec 2012, with enrollment from April 2014 to March 2016.</recruitment_details>
      <group_list>
        <group group_id="P1">
          <title>Abiraterone Acetate</title>
          <description>Abiraterone acetate 1000mg orally daily until the time of disease progression, in the absence of prohibitive toxicities.&#xD;
Abiraterone Acetate: Abiraterone acetate 1000 mg orally daily (supplied as four 250 mg tablets) and prednisone 5 mg orally twice daily</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="11"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="10"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>not evaluable</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Abiraterone Acetate</title>
          <description>Abiraterone Acetate: Abiraterone acetate 1000 mg orally daily (supplied as four 250 mg tablets) and prednisone 5 mg orally twice daily</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="11"/>
          </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="66" lower_limit="54" upper_limit="78"/>
                  </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_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="11"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Number of prior systemic therapies</title>
          <units>prior therapies</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="3" lower_limit="1" upper_limit="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Performance Status: ECOG</title>
          <description>ECOG (Eastern Cooperative Oncology Group) Performance Status:&#xD;
0= Fully active; 1=restricted in physically strenuous activity but ambulatory, light work; 2= ambulatory and capable of self care, but no any work activities; 3= capable of only limited self care; 4 = completely disabled, 5= dead</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>ECOG 0</title>
                  <measurement_list>
                    <measurement group_id="B1" value="8"/>
                  </measurement_list>
                </category>
                <category>
                  <title>ECOG 1</title>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Number of Participants With ≥ 30% Change in PSA</title>
        <description>The primary objective of this study is to determine a correlation between inherited genetic polymorphisms and antitumor activity (as defined by a decline in PSA of ≥ 30%) in AA patients with castration-resistant prostate cancer treated with Abiraterone. The primary endpoint is the percent change in PSA from baseline to 12 weeks. A decline of ≥ 30% will be correlated with germline SNPs.</description>
        <time_frame>baseline and 12 weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Abiraterone Acetate</title>
            <description>Abiraterone Acetate: Abiraterone acetate 1000 mg orally daily (supplied as four 250 mg tablets) and prednisone 5 mg orally twice daily</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With ≥ 30% Change in PSA</title>
          <description>The primary objective of this study is to determine a correlation between inherited genetic polymorphisms and antitumor activity (as defined by a decline in PSA of ≥ 30%) in AA patients with castration-resistant prostate cancer treated with Abiraterone. The primary endpoint is the percent change in PSA from baseline to 12 weeks. A decline of ≥ 30% will be correlated with germline SNPs.</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="10"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Response Assessment</title>
        <description>Post-treatment changes in measurable disease by RECIST - Response Evaluation Criteria in Solid Tumors Complete Response (CR): Disappearance of all target lesions Partial Response (PR): At least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started Progressive Disease (PD): At least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions</description>
        <time_frame>up to 12 weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Abiraterone Acetate</title>
            <description>Abiraterone Acetate: Abiraterone acetate 1000 mg orally daily (supplied as four 250 mg tablets) and prednisone 5 mg orally twice daily</description>
          </group>
        </group_list>
        <measure>
          <title>Response Assessment</title>
          <description>Post-treatment changes in measurable disease by RECIST - Response Evaluation Criteria in Solid Tumors Complete Response (CR): Disappearance of all target lesions Partial Response (PR): At least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started Progressive Disease (PD): At least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions</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="10"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>PR</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>SD</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Time to Progression</title>
        <description>post-treatment changes in measurable disease by time to disease progression (as per PCWG2 guidelines)</description>
        <time_frame>up to 12 weeks</time_frame>
        <population>data not collected</population>
        <group_list>
          <group group_id="O1">
            <title>Abiraterone Acetate</title>
            <description>Abiraterone Acetate: Abiraterone acetate 1000 mg orally daily (supplied as four 250 mg tablets) and prednisone 5 mg orally twice daily</description>
          </group>
        </group_list>
        <measure>
          <title>Time to Progression</title>
          <description>post-treatment changes in measurable disease by time to disease progression (as per PCWG2 guidelines)</description>
          <population>data not collected</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Bone Scan</title>
        <description>post-treatment changes in bone scans (as per PCWG2 guidelines) (&quot;no new lesions&quot; versus &quot;new lesions.&quot;)</description>
        <time_frame>up to 12 weeks</time_frame>
        <population>data not collected</population>
        <group_list>
          <group group_id="O1">
            <title>Abiraterone Acetate</title>
            <description>Abiraterone Acetate: Abiraterone acetate 1000 mg orally daily (supplied as four 250 mg tablets) and prednisone 5 mg orally twice daily</description>
          </group>
        </group_list>
        <measure>
          <title>Bone Scan</title>
          <description>post-treatment changes in bone scans (as per PCWG2 guidelines) (&quot;no new lesions&quot; versus &quot;new lesions.&quot;)</description>
          <population>data not collected</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Safety of Abiraterone</title>
        <description>To determine the safety of abiraterone Adverse events as defined by CTCAE v4. Number of participants with serious adverse events grade 4 or 5</description>
        <time_frame>up to 12 weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Abiraterone Acetate</title>
            <description>Abiraterone Acetate: Abiraterone acetate 1000 mg orally daily (supplied as four 250 mg tablets) and prednisone 5 mg orally twice daily</description>
          </group>
        </group_list>
        <measure>
          <title>Safety of Abiraterone</title>
          <description>To determine the safety of abiraterone Adverse events as defined by CTCAE v4. Number of participants with serious adverse events grade 4 or 5</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="10"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Testosterone</title>
        <description>Post-treatment changes in testosterone</description>
        <time_frame>up to 12 weeks</time_frame>
        <population>data not collected</population>
        <group_list>
          <group group_id="O1">
            <title>Abiraterone Acetate</title>
            <description>Abiraterone Acetate: Abiraterone acetate 1000 mg orally daily (supplied as four 250 mg tablets) and prednisone 5 mg orally twice daily</description>
          </group>
        </group_list>
        <measure>
          <title>Testosterone</title>
          <description>Post-treatment changes in testosterone</description>
          <population>data not collected</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <group_list>
        <group group_id="E1">
          <title>Abiraterone Acetate</title>
          <description>Abiraterone Acetate: Abiraterone acetate 1000 mg orally daily (supplied as four 250 mg tablets) and prednisone 5 mg orally twice daily</description>
        </group>
      </group_list>
      <serious_events>
        <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="10"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="10"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="10" subjects_at_risk="10"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Blood and lymphatic system disorders</title>
            <event_list>
              <event>
                <sub_title>Platelet count decreased</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Lymphocyte count decreased</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="10"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Fatigue</sub_title>
                <counts group_id="E1" subjects_affected="7" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Hot flashes</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Nausea</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Vomiting</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Cough</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Diarrhea</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Anorexia</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="10"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Hypocalcemia</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Hypokalemia</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Alkaline phosphatase level increased</sub_title>
                <counts group_id="E1" subjects_affected="7" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Hypophosphatemia</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Hyperglycemia</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Hypoalbuminemia</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Aspartate aminotransferase level increased</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Alanine aminotransferase level increased</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="10"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Muscle weakness in lower limb</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Back pain</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="10"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>Urinary incontinence</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="10"/>
              </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>Dr. Matthew David Galsky</name_or_title>
      <organization>Tisch Cancer Center, Icahn School of Medicine at Mount Sinai</organization>
      <phone>212-689-5412</phone>
      <email>matthew.galsky@mssm.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/NCT01735396
org study id: GCO 12-1727
nct id: NCT01735396
lead sponsor: 
has dmc: Yes
This is a pilot study of abiraterone acetate in African American/Black patients with
      castration-resistant prostate cancer. The primary objective is to determine the correlation
      between germline polymorphisms and antitumor activity (as defined by a decline in PSA of ≥
      30%) in African American patients with castration-resistant prostate cancer treated with
      abiraterone acetate. Patients will receive abiraterone acetate until the time of disease
      progression, in the absence of prohibitive toxicities. Patients will be followed for disease
      progression and survival.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Number of Participants With ≥ 30% Change in PSA
time frame: baseline and 12 weeks
description: The primary objective of this study is to determine a correlation between inherited genetic polymorphisms and antitumor activity (as defined by a decline in PSA of ≥ 30%) in AA patients with castration-resistant prostate cancer treated with Abiraterone. The primary endpoint is the percent change in PSA from baseline to 12 weeks. A decline of ≥ 30% will be correlated with germline SNPs.
measure: Response Assessment
time frame: up to 12 weeks
description: Post-treatment changes in measurable disease by RECIST - Response Evaluation Criteria in Solid Tumors Complete Response (CR): Disappearance of all target lesions Partial Response (PR): At least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started Progressive Disease (PD): At least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions
measure: Time to Progression
time frame: up to 12 weeks
description: post-treatment changes in measurable disease by time to disease progression (as per PCWG2 guidelines)
measure: Bone Scan
time frame: up to 12 weeks
description: post-treatment changes in bone scans (as per PCWG2 guidelines) ("no new lesions" versus "new lesions.")
measure: Safety of Abiraterone
time frame: up to 12 weeks
description: To determine the safety of abiraterone Adverse events as defined by CTCAE v4. Number of participants with serious adverse events grade 4 or 5
measure: Testosterone
time frame: up to 12 weeks
description: Post-treatment changes in testosterone
arm group label: Abiraterone Acetate
arm group type: Experimental
description: Abiraterone acetate 1000mg orally daily until the time of disease progression, in the absence of prohibitive toxicities.
intervention type: Drug
intervention name: Abiraterone Acetate
description: Abiraterone acetate 1000 mg orally daily (supplied as four 250 mg tablets) and prednisone 5 mg orally twice daily
arm group label: Abiraterone Acetate
other name: Zytiga
criteria: 
gender: Male
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Matthew Galsky, MD
role: Principal Investigator
affiliation: Icahn School of Medicine at Mount Sinai
facility: 
facility: 
country: United States
url: http://www.mssm.edu/research/institutes/tisch-cancer-institute
description: Mt. Sinai Tisch Cancer Institute
responsible party type: Principal Investigator
investigator affiliation: Icahn School of Medicine at Mount Sinai
investigator full name: Matthew Galsky
investigator title: Associate Professor
mesh term: Prostatic Neoplasms
mesh term: Abiraterone Acetate
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 