<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/NCT01717053</url>
  </required_header>
  <id_info>
    <org_study_id>Pro00044071</org_study_id>
    <nct_id>NCT01717053</nct_id>
  </id_info>
  <brief_title>Abiraterone, Radiotherapy and Short-Term Androgen Deprivation in Unfavorable Localized Prostate Cancer</brief_title>
  <official_title>A Phase II Trial of Abiraterone Acetate, Radiotherapy and Short-Term Androgen Deprivation in Men With Unfavorable Risk Localized Prostate Cancer</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Duke University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Janssen Pharmaceuticals</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Duke University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The addition of abiraterone acetate to standard treatment of radiotherapy and short-term&#xD;
      androgen deprivation will increase the frequency of undetectable PSA.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a single arm two-site study of 37 men with unfavorable prostate cancer (defined as&#xD;
      having a single high risk factor). Patients will concurrently initiate 6 months of&#xD;
      standard-of-care GNRH agonist therapy and once daily abiraterone acetate/prednisone. After 2&#xD;
      months of lead-in hormonal treatment, definitive standard-of-care prostate/seminal vesicle&#xD;
      radiotherapy will be delivered, to a total dose of 75-80 Gy.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 17, 2014</start_date>
  <completion_date type="Actual">August 31, 2021</completion_date>
  <primary_completion_date type="Actual">August 24, 2017</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>Percentage of Patients With Undetectable PSA (Prostate-Specific Antigen) at 1 Year</measure>
    <time_frame>1 year</time_frame>
    <description>The percentage of patients with undetectable PSA after 1 year will be calculated. Undetectable PSA is defined as a measurement of &lt;0.1 ng/mL.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Time to PSA Nadir</measure>
    <time_frame>1 year</time_frame>
    <description>The median time in months to the lowest PSA value from the start of study therapy.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>PSA Nadir Value</measure>
    <time_frame>1 year, 2 years</time_frame>
    <description>The lowest PSA value from the start of study therapy.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants With Biochemical Progression-free Survival (BPFS)</measure>
    <time_frame>36 and 48 months</time_frame>
    <description>Disease progression defined as Phoenix RTOG definition of nadir PSA + 2ng/ml or initiation of salvage therapy not imaging. The two outcomes use different measures (biochemical as measured by PSA increase vs radiographic as measured by imaging), yielding different results in this case.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Metastasis or Systemic Therapy</measure>
    <time_frame>up to 5 years (60 months)</time_frame>
    <description>Time to either imaging indicating metastasis or beginning a new systemic therapy. This is a distinctly different measure from number 4 above. The two outcomes use different measures (biochemical as measured by PSA increase vs radiographic as measured by imaging), yielding different results in this case.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Testosterone Recovery</measure>
    <time_frame>up to 5 years</time_frame>
    <description>Time to testosterone recovery</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>PSA &lt; 1.5ng/ml in Setting of Non-castrate Testosterone</measure>
    <time_frame>1 year, 2 years, 3 years, 4 years, 5 years</time_frame>
    <description>Percentage of men with 1, 2, 3, 4 and 5 year PSA &lt; 1.5ng/ml in setting of non-castrate testosterone.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Safety and Tolerability</measure>
    <time_frame>6 months</time_frame>
    <description>The number of patients experiencing an adverse event of at least grade 3 that is possibly, probably, or definitely related to study therapy per CTCAE version 4.0.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">37</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, Radiotherapy and Short Term Androgen Deprivation. Prednisone will be prescribed concurrently with Abiraterone acetate.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Abiraterone acetate</intervention_name>
    <description>1000 mg orally once a day for 6 months.</description>
    <arm_group_label>Abiraterone acetate</arm_group_label>
    <other_name>Zytiga</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Androgen deprivation</intervention_name>
    <description>LHRH analog (at discretion of treating physician) will be administered over 6 months (for example, leuprolide acetate 22.5mg IM or goserelin acetate 10.8mg SC given every 3 months for 2 doses).</description>
    <arm_group_label>Abiraterone acetate</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Radiation</intervention_type>
    <intervention_name>Radiation Therapy</intervention_name>
    <description>Daily (Monday-Friday) for 8 weeks, final dose of 75-80 Gy</description>
    <arm_group_label>Abiraterone acetate</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Prednisone</intervention_name>
    <description>5 mg tablet once daily for 6 months.</description>
    <arm_group_label>Abiraterone acetate</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  One of the following high risk criteria:&#xD;
&#xD;
          -  Gleason Score 7 with PSA ≤ 20 ng/ml and clinical T1-2, or&#xD;
&#xD;
          -  Gleason Score 8-10, PSA ≤ 20 ng/ml and clinical T1-2a, or&#xD;
&#xD;
          -  PSA 10.1-40 ng/ml with GS &lt; 7 and clinical T1-2, or&#xD;
&#xD;
          -  Clinical T3 with Gleason Score &lt; 7 and PSA ≤ 10 ng/ml.&#xD;
&#xD;
          -  ECOG Performance Status ≤ 1&#xD;
&#xD;
          -  Digital rectal exam within 90 days of registration on study&#xD;
&#xD;
          -  CBC with differential with adequate bone marrow function defined as follows:&#xD;
&#xD;
          -  Absolute neutrophil count (ANC) ≥ 1,500 cells/mm3, Platelets &gt; 100,000/µL and&#xD;
             Hemoglobin ≥ 9g/dL&#xD;
&#xD;
          -  Serum potassium ≥ 3.5 mEq/L&#xD;
&#xD;
          -  Serum albumin &gt; 3.0 g/dl&#xD;
&#xD;
          -  Total bilirubin &lt; 1.5 X of institutional upper limit of normal (ULN)&#xD;
&#xD;
          -  AST(SGOT)/ALT(SGPT) &lt; 1.5 X ULN&#xD;
&#xD;
          -  Calculated creatinine clearance &gt; 60 mL/min&#xD;
&#xD;
          -  Age &gt; 18 years&#xD;
&#xD;
          -  Able to swallow a whole tablet and take abiraterone acetate on an empty stomach&#xD;
             (defined as no food for two hours before and one hour after abiraterone acetate&#xD;
             ingestion)&#xD;
&#xD;
          -  Ability to understand and sign a written informed consent document&#xD;
&#xD;
          -  Written authorization for use and release of health and research study information has&#xD;
             been obtained&#xD;
&#xD;
          -  Be willing/able to adhere to the prohibitions and restrictions specified in this&#xD;
             protocol&#xD;
&#xD;
          -  Subjects who have partners of childbearing potential must be willing to use a method&#xD;
             of birth control with adequate barrier protections as determined acceptable by the&#xD;
             principal investigator during the study and for 1 week after the last dose of&#xD;
             abiraterone acetate.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Bone, visceral or soft tissue metastasis, including lymph nodes (&gt;2 cm in longest&#xD;
             diameter)&#xD;
&#xD;
          -  Prior therapy for prostate cancer [Exceptions: LHRH agonist or antagonist may have&#xD;
             been initiated within 30 days prior to enrollment. Bicalutamide may have been given&#xD;
             within 60 days of enrollment as long as it has been stopped at least 7 days before&#xD;
             enrollment and total duration was no longer than 30 days. This is to allow enrollment&#xD;
             of those who have been given bicalutamide as a bridge for LHRH agonist/antagonist. It&#xD;
             is highly unlikely a short non-overlapping course of bicalutamide will interact with&#xD;
             abiraterone acetate in a measurable way. Previous alpha-reductase inhibitor use&#xD;
             allowed IF patient has not been taking for at least 30 days prior to abiraterone&#xD;
             acetate initiation, OR if alpha reductase inhibitor was not used as a primary&#xD;
             treatment of prostate cancer and the PSA on alpha-reductase inhibitor remains within&#xD;
             eligibility when doubled. ]&#xD;
&#xD;
          -  Known serum testosterone ≤ 150 ng/dl or symptoms of hypogonadism (fatigue, hot&#xD;
             flashes, hair loss, loss of muscle mass, osteoporosis, low libido, depression) prior&#xD;
             to ADT initiation not explained by other medical co-morbidity OR history of&#xD;
             testosterone supplement. If questionable, serum testosterone level greater than 150&#xD;
             ng/dl can be used to exclude hypogonadism.&#xD;
&#xD;
          -  Previous malignancy within 3 years other than non-melanomatous skin cancer and&#xD;
             non-muscle invasive bladder cancer&#xD;
&#xD;
          -  Previous pelvic radiotherapy that would prevent prostate/SV irradiation&#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 therapy&#xD;
&#xD;
          -  History of gastrointestinal disorders that may interfere with the absorption of study&#xD;
             drug (including gastric bypass surgery)&#xD;
&#xD;
          -  Concurrent spironolactone use&#xD;
&#xD;
          -  Significant concurrent medical condition that would make prednisone/prednisolone use&#xD;
             contraindicated or would interfere with the patient's ability to participate in the&#xD;
             trial&#xD;
&#xD;
          -  Receiving any investigational agents currently or within 30 days prior to study&#xD;
             screening&#xD;
&#xD;
          -  Prior demonstrated hypersensitivity, intolerance or allergy to abiraterone acetate,&#xD;
             prednisone or their excipients&#xD;
&#xD;
          -  Active co-morbidity, defined as follows:&#xD;
&#xD;
               -  Chronic liver disease with cirrhosis (Child-Pugh B or C) or active hepatitis B or&#xD;
                  C&#xD;
&#xD;
               -  History of pituitary or adrenal dysfunction&#xD;
&#xD;
               -  Poorly controlled diabetes mellitus (A1c &gt;9% or history of complications&#xD;
                  including peripheral neuropathy, end organ damage, hospitalization, amputation)&#xD;
&#xD;
               -  Poorly controlled glaucoma&#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&#xD;
                  New York Heart Association (NYHA) Class III-IV heart disease or known cardiac&#xD;
                  ejection fraction measurement of &lt; 50% at baseline.&#xD;
&#xD;
               -  Clinical evidence of active infection of any type, including active or&#xD;
                  symptomatic viral hepatitis.&#xD;
&#xD;
               -  Known immune deficiency and/or HIV-positive patients&#xD;
&#xD;
               -  Any medical condition that warrants long-term corticosteroid use in excess of&#xD;
                  study dose&#xD;
&#xD;
          -  Patients taking strong CYP3A4 inducers (e.g., phenytoin, carbamazepine, rifampin,&#xD;
             rifabutin, rifapentine, phenobarbital)&#xD;
&#xD;
          -  Any condition that in the opinion of the Principal Investigator, would compromise the&#xD;
             well-being of the subject or the study or prevent the subject from meeting or&#xD;
             performing the study requirements&#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>Daniel George, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Duke University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Durham Regional Hospital</name>
      <address>
        <city>Durham</city>
        <state>North Carolina</state>
        <zip>27704</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Duke University Medical Center</name>
      <address>
        <city>Durham</city>
        <state>North Carolina</state>
        <zip>27710</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>MD Anderson Cancer Center</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77030</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>October 2022</verification_date>
  <study_first_submitted>October 26, 2012</study_first_submitted>
  <study_first_submitted_qc>October 26, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 30, 2012</study_first_posted>
  <results_first_submitted>August 23, 2018</results_first_submitted>
  <results_first_submitted_qc>August 23, 2018</results_first_submitted_qc>
  <results_first_posted type="Actual">September 24, 2018</results_first_posted>
  <last_update_submitted>October 6, 2022</last_update_submitted>
  <last_update_submitted_qc>October 6, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">October 10, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Prostatic Neoplasms</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Prednisone</mesh_term>
    <mesh_term>Abiraterone Acetate</mesh_term>
    <mesh_term>Androgens</mesh_term>
  </intervention_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>April 25, 2017</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/53/NCT01717053/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Abiraterone+Radiotherapy+ADT</title>
          <description>Abiraterone Acetate, Radiotherapy and Short Term Androgen Deprivation. Prednisone will be prescribed concurrently with Abiraterone acetate.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="37"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="33"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="4"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Abiraterone+Radiotherapy+ADT</title>
          <description>Abiraterone Acetate, Radiotherapy and Short Term Androgen Deprivation. Prednisone will be prescribed concurrently with Abiraterone acetate.</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="37"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="66.0" spread="5.3"/>
                  </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="37"/>
                  </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_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="37"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" 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_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="6"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="31"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Percentage of Patients With Undetectable PSA (Prostate-Specific Antigen) at 1 Year</title>
        <description>The percentage of patients with undetectable PSA after 1 year will be calculated. Undetectable PSA is defined as a measurement of &lt;0.1 ng/mL.</description>
        <time_frame>1 year</time_frame>
        <population>This analysis includes all patients that completed protocol therapy.</population>
        <group_list>
          <group group_id="O1">
            <title>Abiraterone+Radiotherapy+ADT</title>
            <description>Abiraterone Acetate, Radiotherapy and Short Term Androgen Deprivation. Prednisone will be prescribed concurrently with Abiraterone acetate.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Patients With Undetectable PSA (Prostate-Specific Antigen) at 1 Year</title>
          <description>The percentage of patients with undetectable PSA after 1 year will be calculated. Undetectable PSA is defined as a measurement of &lt;0.1 ng/mL.</description>
          <population>This analysis includes all patients that completed protocol therapy.</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="33"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="54.54"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Time to PSA Nadir</title>
        <description>The median time in months to the lowest PSA value from the start of study therapy.</description>
        <time_frame>1 year</time_frame>
        <population>This analysis includes all patients that completed protocol therapy.</population>
        <group_list>
          <group group_id="O1">
            <title>Abiraterone+Radiotherapy+ADT</title>
            <description>Abiraterone Acetate, Radiotherapy and Short Term Androgen Deprivation. Prednisone will be prescribed concurrently with Abiraterone acetate.</description>
          </group>
        </group_list>
        <measure>
          <title>Time to PSA Nadir</title>
          <description>The median time in months to the lowest PSA value from the start of study therapy.</description>
          <population>This analysis includes all patients that completed protocol therapy.</population>
          <units>months</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="33"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8.9" lower_limit="2.9" upper_limit="39.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>PSA Nadir Value</title>
        <description>The lowest PSA value from the start of study therapy.</description>
        <time_frame>1 year, 2 years</time_frame>
        <population>This analysis includes all patients that completed protocol therapy.</population>
        <group_list>
          <group group_id="O1">
            <title>Abiraterone+Radiotherapy+ADT</title>
            <description>Abiraterone Acetate, Radiotherapy and Short Term Androgen Deprivation. Prednisone will be prescribed concurrently with Abiraterone acetate.</description>
          </group>
        </group_list>
        <measure>
          <title>PSA Nadir Value</title>
          <description>The lowest PSA value from the start of study therapy.</description>
          <population>This analysis includes all patients that completed protocol therapy.</population>
          <units>ng/mL</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="33"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Year 1</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.03" lower_limit="0" upper_limit="0.44"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Year 2</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.03" lower_limit="0" upper_limit="0.36"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants With Biochemical Progression-free Survival (BPFS)</title>
        <description>Disease progression defined as Phoenix RTOG definition of nadir PSA + 2ng/ml or initiation of salvage therapy not imaging. The two outcomes use different measures (biochemical as measured by PSA increase vs radiographic as measured by imaging), yielding different results in this case.</description>
        <time_frame>36 and 48 months</time_frame>
        <population>Men with unfavorable prostate cancer (defined as having a single high risk factor)</population>
        <group_list>
          <group group_id="O1">
            <title>Abiraterone Acetate</title>
            <description>Abiraterone Acetate, Radiotherapy and Short Term Androgen Deprivation. Prednisone will be prescribed concurrently with Abiraterone acetate.&#xD;
Abiraterone acetate: 1000 mg orally once a day for 6 months.&#xD;
Androgen deprivation: LHRH analog (at discretion of treating physician) will be administered over 6 months (for example, leuprolide acetate 22.5mg IM or goserelin acetate 10.8mg SC given every 3 months for 2 doses).&#xD;
Radiation Therapy: Daily (Monday-Friday) for 8 weeks, final dose of 75-80 Gy&#xD;
Prednisone: 5 mg tablet once daily for 6 months.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With Biochemical Progression-free Survival (BPFS)</title>
          <description>Disease progression defined as Phoenix RTOG definition of nadir PSA + 2ng/ml or initiation of salvage therapy not imaging. The two outcomes use different measures (biochemical as measured by PSA increase vs radiographic as measured by imaging), yielding different results in this case.</description>
          <population>Men with unfavorable prostate cancer (defined as having a single high risk factor)</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="33"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>36 months</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="96.96"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>48 months</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="96.96"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Metastasis or Systemic Therapy</title>
        <description>Time to either imaging indicating metastasis or beginning a new systemic therapy. This is a distinctly different measure from number 4 above. The two outcomes use different measures (biochemical as measured by PSA increase vs radiographic as measured by imaging), yielding different results in this case.</description>
        <time_frame>up to 5 years (60 months)</time_frame>
        <population>Men with unfavorable prostate cancer (defined ad having a single high risk factor)</population>
        <group_list>
          <group group_id="O1">
            <title>Abiraterone Acetate</title>
            <description>Abiraterone Acetate, Radiotherapy and Short Term Androgen Deprivation. Prednisone will be prescribed concurrently with Abiraterone acetate.&#xD;
Abiraterone acetate: 1000 mg orally once a day for 6 months.&#xD;
Androgen deprivation: LHRH analog (at discretion of treating physician) will be administered over 6 months (for example, leuprolide acetate 22.5mg IM or goserelin acetate 10.8mg SC given every 3 months for 2 doses).&#xD;
Radiation Therapy: Daily (Monday-Friday) for 8 weeks, final dose of 75-80 Gy&#xD;
Prednisone: 5 mg tablet once daily for 6 months.</description>
          </group>
        </group_list>
        <measure>
          <title>Metastasis or Systemic Therapy</title>
          <description>Time to either imaging indicating metastasis or beginning a new systemic therapy. This is a distinctly different measure from number 4 above. The two outcomes use different measures (biochemical as measured by PSA increase vs radiographic as measured by imaging), yielding different results in this case.</description>
          <population>Men with unfavorable prostate cancer (defined ad having a single high risk factor)</population>
          <units>months</units>
          <param>Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="33"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="60" lower_limit="NA" upper_limit="NA">Insufficient number of participants with events.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Testosterone Recovery</title>
        <description>Time to testosterone recovery</description>
        <time_frame>up to 5 years</time_frame>
        <population>Men with unfavorable prostate cancer (defined ad having a single high risk factor)</population>
        <group_list>
          <group group_id="O1">
            <title>Abiraterone Acetate</title>
            <description>Abiraterone Acetate, Radiotherapy and Short Term Androgen Deprivation. Prednisone will be prescribed concurrently with Abiraterone acetate.&#xD;
Abiraterone acetate: 1000 mg orally once a day for 6 months.&#xD;
Androgen deprivation: LHRH analog (at discretion of treating physician) will be administered over 6 months (for example, leuprolide acetate 22.5mg IM or goserelin acetate 10.8mg SC given every 3 months for 2 doses).&#xD;
Radiation Therapy: Daily (Monday-Friday) for 8 weeks, final dose of 75-80 Gy&#xD;
Prednisone: 5 mg tablet once daily for 6 months.</description>
          </group>
        </group_list>
        <measure>
          <title>Testosterone Recovery</title>
          <description>Time to testosterone recovery</description>
          <population>Men with unfavorable prostate cancer (defined ad having a single high risk factor)</population>
          <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="37"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9.2" lower_limit="9" upper_limit="12.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>PSA &lt; 1.5ng/ml in Setting of Non-castrate Testosterone</title>
        <description>Percentage of men with 1, 2, 3, 4 and 5 year PSA &lt; 1.5ng/ml in setting of non-castrate testosterone.</description>
        <time_frame>1 year, 2 years, 3 years, 4 years, 5 years</time_frame>
        <population>Men with unfavorable prostate cancer (defined as having a single high risk factor)</population>
        <group_list>
          <group group_id="O1">
            <title>Abiraterone+Radiotherapy+ADT</title>
            <description>Abiraterone Acetate, Radiotherapy and Short Term Androgen Deprivation. Prednisone will be prescribed concurrently with Abiraterone acetate.</description>
          </group>
        </group_list>
        <measure>
          <title>PSA &lt; 1.5ng/ml in Setting of Non-castrate Testosterone</title>
          <description>Percentage of men with 1, 2, 3, 4 and 5 year PSA &lt; 1.5ng/ml in setting of non-castrate testosterone.</description>
          <population>Men with unfavorable prostate cancer (defined as having a single high risk factor)</population>
          <units>percentage of patients</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="33"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>1 year</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="100"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>2 years</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="100"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>3 years</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="90.91"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>4 years</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="90.91"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>5 years</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="90.91"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Safety and Tolerability</title>
        <description>The number of patients experiencing an adverse event of at least grade 3 that is possibly, probably, or definitely related to study therapy per CTCAE version 4.0.</description>
        <time_frame>6 months</time_frame>
        <population>This analysis includes all patients that completed protocol therapy.</population>
        <group_list>
          <group group_id="O1">
            <title>Abiraterone+Radiotherapy+ADT</title>
            <description>Abiraterone Acetate, Radiotherapy and Short Term Androgen Deprivation. Prednisone will be prescribed concurrently with Abiraterone acetate.</description>
          </group>
        </group_list>
        <measure>
          <title>Safety and Tolerability</title>
          <description>The number of patients experiencing an adverse event of at least grade 3 that is possibly, probably, or definitely related to study therapy per CTCAE version 4.0.</description>
          <population>This analysis includes all patients that completed protocol therapy.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="33"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="12"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>6 months</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Abiraterone+Radiotherapy+ADT</title>
          <description>Abiraterone Acetate, Radiotherapy and Short Term Androgen Deprivation. Prednisone will be prescribed concurrently with Abiraterone acetate.</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>CTCAE (4.0)</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="37"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Fever</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="37"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Pain in extremity</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="37"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Neoplasms benign, malignant and unspecified (incl cysts and polyps)</title>
            <event_list>
              <event>
                <sub_title>Other, specify: Malignant melanoma</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="37"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Psychiatric disorders - Other, specify</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="37"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>Acute kidney injury</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="37"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Respiratory, thoracic and mediastinal disorders - Other, specify: Bilateral pleural effusion</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="37"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <default_vocab>CTCAE (4.0)</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="36" subjects_at_risk="37"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Blood and lymphatic system disorders</title>
            <event_list>
              <event>
                <sub_title>Anemia</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="37"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Atrial fibrillation</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Cardiac disorders - Other, specify: Irregular heart beats</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Chest pain - cardiac</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Palpitations</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="37"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Ear and labyrinth disorders</title>
            <event_list>
              <event>
                <sub_title>Ear and labyrinth disorders - Other, specify: &quot;&quot;slight off balance and fluid in ears&quot;&quot;</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Ear and labyrinth disorders - Other, specify: Slight off balance</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Ear pain</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Vertigo</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="37"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Eye disorders</title>
            <event_list>
              <event>
                <sub_title>Blurred vision</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Dry eye</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Eye disorders - Other, specify: Left eye &quot;&quot;stye with morning crustiness&quot;&quot;</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="37"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Abdominal distension</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Colitis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Constipation</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Diarrhea</sub_title>
                <counts group_id="E1" subjects_affected="10" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Dry mouth</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Dyspepsia</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Esophageal pain</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Fecal incontinence</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Flatulence</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Gastrointestinal disorders - Other, specify: Bowel urgency</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Gastrointestinal disorders - Other, specify: Guaiac positive stools</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Gastrointestinal disorders - Other, specify: Intermittent &quot;&quot;mucous loose stool&quot;&quot;</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Gastrointestinal disorders - Other, specify: Pt reports intermittent frank red blood on stool</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Gastrointestinal disorders - Other, specify: diverticulitis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Gastrointestinal disorders - Other, specify: intermittent rectal bleeding</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Gastrointestinal disorders - Other, specify: urgency with bowels</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Gingival pain</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Hemorrhoids</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Nausea</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Oral pain</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Rectal pain</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Toothache</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Vomiting</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="37"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Edema limbs</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Fatigue</sub_title>
                <counts group_id="E1" subjects_affected="24" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>General disorders and administration site conditions - Other, specify: Injury left hand</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>General disorders and administration site conditions - Other, specify: Occasional cramping</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>General disorders and administration site conditions - Other, specify: Perineal pain</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Injection site reaction</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Irritability</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Neck edema</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Non-cardiac chest pain</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Pain</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="37"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Infections and infestations - Other, specify: C diff colitis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Tooth infection</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Urinary tract infection</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="37"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Bruising</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Burn</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Fall</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Injury, poisoning and procedural complications - Other, specify:Chigger bite</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Injury, poisoning and procedural complications - Other, specify: Injury to Right Shin</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Injury, poisoning and procedural complications - Other, specify: face injury</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="37"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Alanine aminotransferase increased</sub_title>
                <counts group_id="E1" subjects_affected="12" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Alkaline phosphatase increased</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Aspartate aminotransferase increased</sub_title>
                <counts group_id="E1" subjects_affected="13" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Blood bilirubin increased</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Creatinine increased</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Investigations - Other, specify: Blood Urea Nitrogen 20(7-18); 20 (8-20)</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Investigations - Other, specify: Blood Urea Nitrogen 21 (8-20)</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Investigations - Other, specify: Blood Urea Nitrogen 23 (7-18); 20 (8-20)</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Investigations - Other, specify: Blood urea nitrogen 28;18</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Investigations - Other, specify: CO2 level (carbon dioxide) 31</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Investigations - Other, specify: CO2 level (carbon dioxide)31</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Investigations - Other, specify: CO2 level (carbon dioxide)31 (23-30)</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Investigations - Other, specify: Decreased ALT, &lt;12 (7-56)</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Investigations - Other, specify: Elevated CO2 (Carbon Dioxide) level at 31 (23-30)</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Investigations - Other, specify: Elevated Total Bilirubin</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Investigations - Other, specify: Elevated Total Bilirubin, decreased at 1.5</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Investigations - Other, specify: Increased Albumin 5.0 (3.5-4.7)</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Investigations - Other, specify: Increased CO2 (carbon dioxide) level, 31</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Investigations - Other, specify: Low Chloride 96 (98-108)</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Investigations - Other, specify: Low Chloride 97;on 3/31- 96 (98-108)</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Investigations - Other, specify: Low serum creatinine, 0.66</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Investigations - Other, specify: Minimally increased @ 32 (23-30)</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Investigations - Other, specify: Serum Carbon Dioxide Level 32;28 (23-30)</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Investigations - Other, specify: Serum Carbon Dioxide Level 34;29 (23-30)</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Investigations - Other, specify: Weight loss, 83.7 kg (88 kg on 6/4/15)</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Platelet count decreased</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Urine output decreased</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Weight gain</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Weight loss</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>White blood cell decreased</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="37"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Acidosis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Anorexia</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Hyperglycemia</sub_title>
                <counts group_id="E1" subjects_affected="8" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Hyperkalemia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Hypocalcemia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Hypokalemia</sub_title>
                <counts group_id="E1" subjects_affected="8" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Hyponatremia</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Metabolism and nutrition disorders - Other, specify: Possible mineralcorticoid excess (hypokalemia)</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Metabolism and nutrition disorders - Other, specify: elevated ALT/AST</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Metabolism and nutrition disorders - Other, specify: low Total Protein level- 5.8 (6.1-8.1)</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="37"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Arthralgia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Back pain</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Chest wall pain</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Musculoskeletal and connective tissue disorder - Other, specify: Chronic left hip/sciatica pain</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Musculoskeletal and connective tissue disorder - Other, specify: Decreased strength &amp; endurance</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Musculoskeletal and connective tissue disorder - Other, specify: L4-L5 procedure on 8/4/15</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Musculoskeletal and connective tissue disorder - Other, specify: Right Lower Extremity leg spasm</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Musculoskeletal and connective tissue disorder - Other, specify: Right flank pain</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Musculoskeletal and connective tissue disorder - Other, specify: bursitis, left knee</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Musculoskeletal and connective tissue disorder - Other, specify: restless legs</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Pain in extremity</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="37"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Dizziness</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Dysgeusia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Memory impairment</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Nervous system disorders - Other, specify: Chronic sciatic back pain</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Nervous system disorders - Other, specify: Pre-treatment, chronic sciatic back pain</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Nervous system disorders - Other, specify: lightheaded, when standing</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Paresthesia</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Presyncope</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Somnolence</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="37"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Agitation</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Anxiety</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Depression</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Insomnia</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Libido decreased</sub_title>
                <counts group_id="E1" subjects_affected="6" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Psychiatric disorders - Other, specify</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Restlessness</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="37"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>Cystitis noninfective</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Hematuria</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Renal and urinary disorders - Other, specify: Dysuria</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Renal and urinary disorders - Other, specify: Increased urination</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Renal and urinary disorders - Other, specify: Nocturia</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Renal and urinary disorders - Other, specify: Slow urinary stream</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Renal and urinary disorders - Other, specify: Urinary hesistancy</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Renal and urinary disorders - Other, specify: Urinary hesitancy</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Renal and urinary disorders - Other, specify: Weak urinary stream</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Renal and urinary disorders - Other, specify: nocturia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Renal and urinary disorders - Other, specify: weak stream</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Urinary frequency</sub_title>
                <counts group_id="E1" subjects_affected="20" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Urinary incontinence</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Urinary retention</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Urinary tract pain</sub_title>
                <counts group_id="E1" subjects_affected="6" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Urinary urgency</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="37"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Reproductive system and breast disorders</title>
            <event_list>
              <event>
                <sub_title>Erectile dysfunction</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Gynecomastia</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Perineal pain</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="37"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Cough</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Dyspnea</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Laryngeal inflammation</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Nasal congestion</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Pleural effusion</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Postnasal drip</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Productive cough</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Respiratory, thoracic and mediastinal disorders - Other, specify: Dry nose</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Sleep apnea</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Sore throat</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="37"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Dry skin</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Erythema multiforme</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Pruritus</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Rash maculo-papular</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Skin and subcutaneous tissue disorders - Other, specify:</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Skin and subcutaneous tissue disorders - Other, specify: Basal cell carcinoma of left ear</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Skin and subcutaneous tissue disorders - Other, specify: Melanoma of lower back</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Skin and subcutaneous tissue disorders - Other, specify: Melanoma of right shoulder</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Skin and subcutaneous tissue disorders - Other, specify: Soft non-tender area on lower leg</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Skin and subcutaneous tissue disorders - Other, specify: skin pallor, pale</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="37"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Hot flashes</sub_title>
                <counts group_id="E1" subjects_affected="28" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Hypertension</sub_title>
                <counts group_id="E1" subjects_affected="22" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Vascular disorders - Other, specify: Facial petechiae &quot;&quot;from force of vomiting&quot;&quot; per pt</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="37"/>
              </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. Bridget Koontz</name_or_title>
      <organization>Duke University</organization>
      <phone>919-668-5213</phone>
      <email>bridget.koontz@duke.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/NCT01717053
org study id: Pro00044071
nct id: NCT01717053
lead sponsor: 
collaborator: 
has dmc: No
The addition of abiraterone acetate to standard treatment of radiotherapy and short-term
      androgen deprivation will increase the frequency of undetectable PSA.
This is a single arm two-site study of 37 men with unfavorable prostate cancer (defined as
      having a single high risk factor). Patients will concurrently initiate 6 months of
      standard-of-care GNRH agonist therapy and once daily abiraterone acetate/prednisone. After 2
      months of lead-in hormonal treatment, definitive standard-of-care prostate/seminal vesicle
      radiotherapy will be delivered, to a total dose of 75-80 Gy.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Percentage of Patients With Undetectable PSA (Prostate-Specific Antigen) at 1 Year
time frame: 1 year
description: The percentage of patients with undetectable PSA after 1 year will be calculated. Undetectable PSA is defined as a measurement of <0.1 ng/mL.
measure: Time to PSA Nadir
time frame: 1 year
description: The median time in months to the lowest PSA value from the start of study therapy.
measure: PSA Nadir Value
time frame: 1 year, 2 years
description: The lowest PSA value from the start of study therapy.
measure: Percentage of Participants With Biochemical Progression-free Survival (BPFS)
time frame: 36 and 48 months
description: Disease progression defined as Phoenix RTOG definition of nadir PSA + 2ng/ml or initiation of salvage therapy not imaging. The two outcomes use different measures (biochemical as measured by PSA increase vs radiographic as measured by imaging), yielding different results in this case.
measure: Metastasis or Systemic Therapy
time frame: up to 5 years (60 months)
description: Time to either imaging indicating metastasis or beginning a new systemic therapy. This is a distinctly different measure from number 4 above. The two outcomes use different measures (biochemical as measured by PSA increase vs radiographic as measured by imaging), yielding different results in this case.
measure: Testosterone Recovery
time frame: up to 5 years
description: Time to testosterone recovery
measure: PSA < 1.5ng/ml in Setting of Non-castrate Testosterone
time frame: 1 year, 2 years, 3 years, 4 years, 5 years
description: Percentage of men with 1, 2, 3, 4 and 5 year PSA < 1.5ng/ml in setting of non-castrate testosterone.
measure: Safety and Tolerability
time frame: 6 months
description: The number of patients experiencing an adverse event of at least grade 3 that is possibly, probably, or definitely related to study therapy per CTCAE version 4.0.
arm group label: Abiraterone acetate
arm group type: Experimental
description: Abiraterone Acetate, Radiotherapy and Short Term Androgen Deprivation. Prednisone will be prescribed concurrently with Abiraterone acetate.
intervention type: Drug
intervention name: Abiraterone acetate
description: 1000 mg orally once a day for 6 months.
arm group label: Abiraterone acetate
other name: Zytiga
intervention type: Drug
intervention name: Androgen deprivation
description: LHRH analog (at discretion of treating physician) will be administered over 6 months (for example, leuprolide acetate 22.5mg IM or goserelin acetate 10.8mg SC given every 3 months for 2 doses).
arm group label: Abiraterone acetate
intervention type: Radiation
intervention name: Radiation Therapy
description: Daily (Monday-Friday) for 8 weeks, final dose of 75-80 Gy
arm group label: Abiraterone acetate
intervention type: Drug
intervention name: Prednisone
description: 5 mg tablet once daily for 6 months.
arm group label: Abiraterone acetate
criteria: 
gender: Male
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Daniel George, MD
role: Principal Investigator
affiliation: Duke University
facility: 
facility: 
facility: 
country: United States
responsible party type: Sponsor
mesh term: Prostatic Neoplasms
mesh term: Prednisone
mesh term: Abiraterone Acetate
mesh term: Androgens
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 