<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/NCT02256111</url>
  </required_header>
  <id_info>
    <org_study_id>Pro00053924</org_study_id>
    <nct_id>NCT02256111</nct_id>
  </id_info>
  <brief_title>EXTEND Exercise Trial</brief_title>
  <official_title>EXTEND: Safety and Efficacy of EXercise Training in Men Receiving ENzalutamide in Combination With Conventional Androgen Deprivation Therapy for Hormone Naïve Prostate Cancer</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Duke University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Duke University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study will examine the effect of supervised exercise training on cardiopulmonary&#xD;
      function in men receiving the combination of enzalutamide (ENZ) and androgen deprivation&#xD;
      therapy (ADT) for treatment of non-metastatic, hormone-naïve prostate cancer. No study to&#xD;
      date has examined the efficacy, tolerability, and safety of exercise training to prevent&#xD;
      and/or mitigate common adverse toxicities in men receiving combination androgen suppression&#xD;
      therapy for hormone-naïve prostate cancer.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">May 13, 2015</start_date>
  <completion_date type="Actual">July 17, 2018</completion_date>
  <primary_completion_date type="Actual">February 21, 2018</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in VO2peak in Usual Care Versus Exercise Training Arms</measure>
    <time_frame>From week 1 to week 17</time_frame>
    <description>Mean change in peak oxygen uptake (VO2peak) from week 1 to week 17 in the usual care and exercise training groups</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>17-week Change in Functional Capacity as Measured by Chair-stand Test</measure>
    <time_frame>Baseline to 17 weeks</time_frame>
    <description>Mean change in number of seconds to perform the chair-stand test between baseline and week 17. This test measures the time taken to complete 5 repetitions of the sit-to-stand maneuver from a chair without an arm rest at 43 cm in height and 47.5 cm in depth. This test provides an indicator of functional performance of lower body strength; quicker times indicate greater strength</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>17-week Change in Upper and Lower Extremity Maximal Muscular Strength</measure>
    <time_frame>Baseline to 17 weeks</time_frame>
    <description>Mean change in upper and lower extremity maximal muscular strength as measured by the voluntary one-repetition max (1-RM) and muscular endurance as measured by 70% of 1-RM between week 17 and baseline</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Effects on Serum Glucose</measure>
    <time_frame>Baseline to 17 weeks</time_frame>
    <description>Mean change in fasting serum glucose between week 17 and baseline.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in the Effect on Patient Reported Outcomes (PROs) of Interest Over Time</measure>
    <time_frame>Baseline to 17 weeks</time_frame>
    <description>Mean change in PROs aggregate score between week 17 and baseline. PROs include the FACT-Prostate (FACT-P, range 0 to 104), FACIT-Fatigue (FACIT-F, range 0 to 52), and the Godin Leisure Questionnaire. Higher scores indicate better quality of life.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Eligibility Rate</measure>
    <time_frame>29 months from study initiation</time_frame>
    <description>Eligibility rate is defined as the number of subjects found to be eligible divided by the number approached for the study. Note that ineligible subjects are not randomized. This is reported as a percent.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Acceptance Rate</measure>
    <time_frame>29 months from study initiation</time_frame>
    <description>Acceptance rate is defined as the number of patients agreeing to participate divided by total number randomized. This is reported as a percent.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Adherence Rate</measure>
    <time_frame>48 days</time_frame>
    <description>Adherence rate is defined as the percentage of days that each patient fulfilled the assigned exercise prescription of the 48 days. The median percentage is reported.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Attrition Rate</measure>
    <time_frame>16 weeks</time_frame>
    <description>Attrition rate is defined as the percent of subjects who complete the 16 week exercise training program. This outcome applies only to the exercise arm.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>17-week Change in Functional Capacity as Measured by Time Up and Go Test</measure>
    <time_frame>Baseline to 17 weeks</time_frame>
    <description>Mean change in number of seconds to complete the timed up and go test between week 17 and baseline. This test requires patients to stand up from a chair with armrests, walk 3m, turn around, return to the chair, and sit down</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>17-week Change in Functional Capacity as Measured by Six Minute Walk Test</measure>
    <time_frame>Baseline to 17 weeks</time_frame>
    <description>Mean change in distance covered during the six minute walk test between week 17 and baseline. This test requires patients to cover the longest distance possible in six minutes under the supervision of an exercise physiologist or designee.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>17-week Change in Muscle Cross-sectional Area (CSA)</measure>
    <time_frame>Baseline to 17 weeks</time_frame>
    <description>Mean change in muscle cross sectional area of the dominant quadricep, hamstring, and total mid-thigh between week 17 and baseline. Cross-sectional area was measured using magnetic resonance imaging with a 3.0T-scanner.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Effects on Serum Insulin</measure>
    <time_frame>Baseline to 17 weeks</time_frame>
    <description>Mean change in fasting serum insulin between week 17 and baseline.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Effects on Blood Hemoglobin (Hgb)</measure>
    <time_frame>Baseline to 17 weeks</time_frame>
    <description>Mean change in blood hemoglobin (Hgb) A1C between week 17 and baseline.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Effects on Body Composition</measure>
    <time_frame>Baseline to 17 weeks</time_frame>
    <description>Mean change in lean body mass and fat body mass between week 17 and baseline as measured by a DEXA Scan.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">26</enrollment>
  <condition>Non-metastatic, Hormone naïve Prostate Cancer</condition>
  <arm_group>
    <arm_group_label>ENZ+ADT+Usual care</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The usual care arm will receive treatment with enzalutamide with androgen deprivation therapy, with no supervised exercise training.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>ENZ+ADT+Exercise</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The ENZ+ADT+Exercise arm will receive treatment with enzalutamide plus androgen deprivation therapy along with supervised exercise training.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Enzalutamide</intervention_name>
    <arm_group_label>ENZ+ADT+Exercise</arm_group_label>
    <arm_group_label>ENZ+ADT+Usual care</arm_group_label>
    <other_name>Xtandi</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Androgen deprivation therapy</intervention_name>
    <arm_group_label>ENZ+ADT+Exercise</arm_group_label>
    <arm_group_label>ENZ+ADT+Usual care</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Supervised exercise training</intervention_name>
    <arm_group_label>ENZ+ADT+Exercise</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Male age ≥ 18 years.&#xD;
&#xD;
          2. Histologically-confirmed adenocarcinoma of the prostate.&#xD;
&#xD;
          3. Completion of appropriate prior treatment with local therapy (i.e., prostatectomy,&#xD;
             radiation therapy or equivalent), per NCCN Guidelines.&#xD;
&#xD;
          4. Detectable PSA, defined as PSA ≥0.01 ng/ml&#xD;
&#xD;
          5. Appropriate for treatment with ADT in the opinion of the treating physician.&#xD;
&#xD;
          6. Serum total testosterone ≥150 ng/dL (5.2 nmol/L).&#xD;
&#xD;
          7. ECOG performance status of ≤ 1 (Appendix A)&#xD;
&#xD;
          8. Planned treatment with castration therapy (GnRH agonist/antagonist) for ≥8 months.&#xD;
&#xD;
          9. Must not have any of the following absolute contraindications to cardiopulmonary&#xD;
             exercise testing and/or aerobic training as determined by the attending oncologist:&#xD;
&#xD;
             Absolute Contraindications&#xD;
&#xD;
               -  Acute myocardial Infarction (within 3-5 days of any planned study procedures)&#xD;
&#xD;
               -  Unstable angina&#xD;
&#xD;
               -  Uncontrolled arrhythmia causing symptoms or hemodynamic compromise&#xD;
&#xD;
               -  Recurrent syncope&#xD;
&#xD;
               -  Active endocarditis&#xD;
&#xD;
               -  Acute myocarditis or pericarditis&#xD;
&#xD;
               -  Symptomatic severe aortic stenosis&#xD;
&#xD;
               -  Uncontrolled heart failure&#xD;
&#xD;
               -  Acute (within 3 months) pulmonary embolus or pulmonary infarction&#xD;
&#xD;
               -  Thrombosis of lower extremities&#xD;
&#xD;
               -  Suspected dissecting aneurysm&#xD;
&#xD;
               -  Uncontrolled asthma&#xD;
&#xD;
               -  Pulmonary edema&#xD;
&#xD;
               -  Room air desaturation at rest &lt;85%&#xD;
&#xD;
               -  Respiratory failure&#xD;
&#xD;
               -  Acute non-cardiopulmonary disorders that may affect exercise performance or be&#xD;
                  aggravated by exercise (i.e. infection, renal failure, thyrotoxicosis)&#xD;
&#xD;
               -  Mental impairment leading to inability to cooperate.&#xD;
&#xD;
         10. Able to swallow enzalutamide and comply with study requirements.&#xD;
&#xD;
         11. Must be able to complete an acceptable cardiopulmonary exercise test (CPET) at&#xD;
             baseline (see Section 9), defined as at least one of the following:&#xD;
&#xD;
               -  Achieving a plateau in oxygen consumption concurrent with an increase in power&#xD;
                  output;&#xD;
&#xD;
               -  Respiratory exchange ratio ≥ 1.1 (RER);&#xD;
&#xD;
               -  Volitional exhaustion with a rating of perceived exertion ≥ 17 (RPE)&#xD;
&#xD;
         12. Must be able to complete an acceptable muscular strength test (assessed using&#xD;
             calculated one-repetition maximum (1-RM)) at baseline (see Section 9), in the opinion&#xD;
             of the fitness specialist, exercise physiologist, or trained designee administering&#xD;
             the test.&#xD;
&#xD;
         13. Life expectancy of ≥ 12 months.&#xD;
&#xD;
         14. Must use a condom if having sex with a pregnant woman.&#xD;
&#xD;
         15. Male subject and his female partner who is of childbearing potential must use 2&#xD;
             acceptable methods of birth control (one of which must include a condom as a barrier&#xD;
             method of contraception) starting at screening and continuing throughout the study&#xD;
             period and for 3 months after final study drug administration. Two acceptable methods&#xD;
             of birth control thus include the following:&#xD;
&#xD;
               -  Condom (barrier method of contraception); AND&#xD;
&#xD;
             One of the following is required:&#xD;
&#xD;
               -  Established use of oral, or injected or implanted hormonal method of&#xD;
                  contraception by the female partner;&#xD;
&#xD;
               -  Placement of an intrauterine device (IUD) or intrauterine system (IUS) by the&#xD;
                  female partner;&#xD;
&#xD;
               -  Additional barrier method: Occlusive cap (diaphragm or cervical/vault caps) with&#xD;
                  spermicidal foam/gel/film/cream/suppository by the female partner;&#xD;
&#xD;
               -  Tubal ligation in the female partner;&#xD;
&#xD;
               -  Vasectomy or other procedure resulting in infertility (e.g., bilateral&#xD;
                  orchiectomy), for more than 6 months&#xD;
&#xD;
         16. Subjects must have normal organ and marrow function as defined below:&#xD;
&#xD;
               -  absolute neutrophil count &gt;1,500/µL&#xD;
&#xD;
               -  platelets &gt;100,000/µL&#xD;
&#xD;
               -  total bilirubin &lt;2.5 X institutional upper limit of normal&#xD;
&#xD;
               -  AST(SGOT)/ALT(SGPT) &lt;2.5 X institutional upper limit of normal&#xD;
&#xD;
               -  Creatinine ≤ 2.0 OR creatinine clearance &gt;30 mL/min/1.73 m2 for subjects with&#xD;
                  creatinine levels above institutional normal.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Definite evidence of metastatic prostate cancer, in the opinion of the treating&#xD;
             physician. Pelvic and retroperitoneal lymph nodes &lt; 2.0 cm in short axis are allowed.&#xD;
&#xD;
          2. Subjects who have had treatments with GnRH agonists/antagonists and/or anti-androgens&#xD;
             within 1 year of randomization.&#xD;
&#xD;
          3. Use of herbal products that may have hormonal anti-prostate cancer activity and/or are&#xD;
             known to decrease PSA values (e.g., saw palmetto) or systemic corticosteroids for&#xD;
             prostate cancer within 4 weeks of day 29 visit (start of Enzalutamide and ADT).&#xD;
&#xD;
          4. Subjects who have had radiotherapy within 12 weeks prior to entering the study or&#xD;
             those who have not recovered from adverse events due to agents or therapies&#xD;
             administered for treatment of prostate cancer more than 4 weeks earlier (except&#xD;
             urinary, rectal, and sexual side effects related to prostatectomy or radiotherapy are&#xD;
             permitted)&#xD;
&#xD;
          5. Subjects who have had any surgical procedure (i.e. TURP, etc.) within 4 weeks prior to&#xD;
             entering the study.&#xD;
&#xD;
          6. Subjects who are receiving any other investigational agents.&#xD;
&#xD;
          7. Significant cardiovascular disease, including:&#xD;
&#xD;
               -  Symptomatic left ventricular dysfunction or known baseline left ventricular&#xD;
                  ejection fraction (LVEF) by multigated acquisition scan (MUGA) or echocardiogram&#xD;
                  (ECHO) of &lt; lower limit of institutional normal (LLN). &quot;Symptomatic&quot; is defined&#xD;
                  as New York Heart Association (NYHA) Class II or greater. Note: MUGA and ECHCO do&#xD;
                  NOT need to be measured to establish eligibility for this study.&#xD;
&#xD;
               -  Uncontrolled hypertension (in the opinion of the treating provider).&#xD;
&#xD;
               -  Myocardial infarction, severe angina, or unstable angina within 6 months prior to&#xD;
                  administration of first dose of study drug.&#xD;
&#xD;
               -  History of serious ventricular arrhythmia (i.e., ventricular tachycardia or&#xD;
                  ventricular fibrillation) within 12 months of first dose of study drug.&#xD;
&#xD;
               -  Uncontrolled cardiac arrhythmias.&#xD;
&#xD;
               -  Coronary or peripheral artery bypass graft within 6 months of first dose of study&#xD;
                  drug.&#xD;
&#xD;
               -  History of CVA, TIA, or rest claudication within 6 months of first dose of study&#xD;
                  drug.&#xD;
&#xD;
          8. Uncontrolled intercurrent illness including, but not limited to, ongoing or active&#xD;
             infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac&#xD;
             arrhythmia, or psychiatric illness/social situations that would limit compliance with&#xD;
             study requirements (in the opinion of the treating provider).&#xD;
&#xD;
          9. Subjects with any condition (e.g., gastrointestinal tract disease resulting in an&#xD;
             inability to take oral medication or a requirement for IV alimentation, prior surgical&#xD;
             procedures affecting absorption, or active peptic ulcer disease) that impairs the&#xD;
             ability to swallow and retain enzalutamide are excluded.&#xD;
&#xD;
         10. History of another invasive cancer within 5 years of randomization with the exceptions&#xD;
             of (a) non-melanoma skin cancers and (b) American Joint Committee on Cancer (AJCC)&#xD;
             Stage 0 or 1 cancers that have a remote probability of recurrence, in the opinion of&#xD;
             the treating physician, in consultation with the principal investigator.&#xD;
&#xD;
         11. Known or suspected brain metastasis or leptomeningeal disease.&#xD;
&#xD;
         12. History of seizure or any condition that may predispose to seizure (e.g., prior&#xD;
             cortical stroke, significant brain trauma) at any time in the past. Also, history of&#xD;
             loss of consciousness or transient ischemic attack within 12 months of the Day 1&#xD;
             visit.&#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>Michael Harrison, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Duke University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Memorial Sloan Kettering Cancer Center</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10017</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_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>March 2019</verification_date>
  <study_first_submitted>August 22, 2014</study_first_submitted>
  <study_first_submitted_qc>October 1, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 3, 2014</study_first_posted>
  <results_first_submitted>February 21, 2019</results_first_submitted>
  <results_first_submitted_qc>March 28, 2019</results_first_submitted_qc>
  <results_first_posted type="Actual">April 18, 2019</results_first_posted>
  <last_update_submitted>March 28, 2019</last_update_submitted>
  <last_update_submitted_qc>March 28, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">April 18, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Prostatic Neoplasms</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <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>October 24, 2017</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/11/NCT02256111/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>ENZ+ADT+Usual Care</title>
          <description>The usual care arm will receive treatment with enzalutamide with androgen deprivation therapy, with no supervised exercise training.&#xD;
Enzalutamide&#xD;
Androgen deprivation therapy</description>
        </group>
        <group group_id="P2">
          <title>ENZ+ADT+Exercise</title>
          <description>The ENZ+ADT+Exercise arm will receive treatment with enzalutamide plus androgen deprivation therapy along with supervised exercise training.&#xD;
Enzalutamide&#xD;
Androgen deprivation therapy&#xD;
Supervised exercise training</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="13"/>
                <participants group_id="P2" count="13"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="13"/>
                <participants group_id="P2" count="13"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>ENZ+ADT+Usual Care</title>
          <description>The usual care arm will receive treatment with enzalutamide with androgen deprivation therapy, with no supervised exercise training.&#xD;
Enzalutamide&#xD;
Androgen deprivation therapy</description>
        </group>
        <group group_id="B2">
          <title>ENZ+ADT+Exercise</title>
          <description>The ENZ+ADT+Exercise arm will receive treatment with enzalutamide plus androgen deprivation therapy along with supervised exercise training.&#xD;
Enzalutamide&#xD;
Androgen deprivation therapy&#xD;
Supervised exercise training</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="13"/>
            <count group_id="B2" value="13"/>
            <count group_id="B3" value="26"/>
          </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="64.37" spread="8.31"/>
                    <measurement group_id="B2" value="65.66" spread="8.11"/>
                    <measurement group_id="B3" value="65.01" spread="8.07"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="13"/>
                    <measurement group_id="B2" value="13"/>
                    <measurement group_id="B3" value="26"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Ethnicity (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="13"/>
                    <measurement group_id="B2" value="13"/>
                    <measurement group_id="B3" value="26"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="4"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="10"/>
                    <measurement group_id="B2" value="10"/>
                    <measurement group_id="B3" value="20"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Change in VO2peak in Usual Care Versus Exercise Training Arms</title>
        <description>Mean change in peak oxygen uptake (VO2peak) from week 1 to week 17 in the usual care and exercise training groups</description>
        <time_frame>From week 1 to week 17</time_frame>
        <group_list>
          <group group_id="O1">
            <title>ENZ+ADT+Usual Care</title>
            <description>The usual care arm will receive treatment with enzalutamide with androgen deprivation therapy, with no supervised exercise training.&#xD;
Enzalutamide&#xD;
Androgen deprivation therapy</description>
          </group>
          <group group_id="O2">
            <title>ENZ+ADT+Exercise</title>
            <description>The ENZ+ADT+Exercise arm will receive treatment with enzalutamide plus androgen deprivation therapy along with supervised exercise training.&#xD;
Enzalutamide&#xD;
Androgen deprivation therapy&#xD;
Supervised exercise training</description>
          </group>
        </group_list>
        <measure>
          <title>Change in VO2peak in Usual Care Versus Exercise Training Arms</title>
          <description>Mean change in peak oxygen uptake (VO2peak) from week 1 to week 17 in the usual care and exercise training groups</description>
          <units>mL/kg/min</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="13"/>
                <count group_id="O2" value="13"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-3.23" spread="5.02"/>
                    <measurement group_id="O2" value="-0.92" spread="2.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>17-week Change in Functional Capacity as Measured by Chair-stand Test</title>
        <description>Mean change in number of seconds to perform the chair-stand test between baseline and week 17. This test measures the time taken to complete 5 repetitions of the sit-to-stand maneuver from a chair without an arm rest at 43 cm in height and 47.5 cm in depth. This test provides an indicator of functional performance of lower body strength; quicker times indicate greater strength</description>
        <time_frame>Baseline to 17 weeks</time_frame>
        <population>One patient in the usual care arm did not complete the test at week 17</population>
        <group_list>
          <group group_id="O1">
            <title>ENZ+ADT+Usual Care</title>
            <description>The usual care arm will receive treatment with enzalutamide with androgen deprivation therapy, with no supervised exercise training.&#xD;
Enzalutamide&#xD;
Androgen deprivation therapy</description>
          </group>
          <group group_id="O2">
            <title>ENZ+ADT+Exercise</title>
            <description>The ENZ+ADT+Exercise arm will receive treatment with enzalutamide plus androgen deprivation therapy along with supervised exercise training.&#xD;
Enzalutamide&#xD;
Androgen deprivation therapy&#xD;
Supervised exercise training</description>
          </group>
        </group_list>
        <measure>
          <title>17-week Change in Functional Capacity as Measured by Chair-stand Test</title>
          <description>Mean change in number of seconds to perform the chair-stand test between baseline and week 17. This test measures the time taken to complete 5 repetitions of the sit-to-stand maneuver from a chair without an arm rest at 43 cm in height and 47.5 cm in depth. This test provides an indicator of functional performance of lower body strength; quicker times indicate greater strength</description>
          <population>One patient in the usual care arm did not complete the test at week 17</population>
          <units>seconds</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="12"/>
                <count group_id="O2" value="13"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.08" spread="2.29"/>
                    <measurement group_id="O2" value="-0.78" spread="1.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>17-week Change in Upper and Lower Extremity Maximal Muscular Strength</title>
        <description>Mean change in upper and lower extremity maximal muscular strength as measured by the voluntary one-repetition max (1-RM) and muscular endurance as measured by 70% of 1-RM between week 17 and baseline</description>
        <time_frame>Baseline to 17 weeks</time_frame>
        <population>1 patient out of 13 did not complete the 1-RM at baseline or week 17 in the usual care arm, and another did not complete the 70% 1-RM at week 17 out of 12</population>
        <group_list>
          <group group_id="O1">
            <title>ENZ+ADT+Usual Care</title>
            <description>The usual care arm will receive treatment with enzalutamide with androgen deprivation therapy, with no supervised exercise training.&#xD;
Enzalutamide&#xD;
Androgen deprivation therapy</description>
          </group>
          <group group_id="O2">
            <title>ENZ+ADT+Exercise</title>
            <description>The ENZ+ADT+Exercise arm will receive treatment with enzalutamide plus androgen deprivation therapy along with supervised exercise training.&#xD;
Enzalutamide&#xD;
Androgen deprivation therapy&#xD;
Supervised exercise training</description>
          </group>
        </group_list>
        <measure>
          <title>17-week Change in Upper and Lower Extremity Maximal Muscular Strength</title>
          <description>Mean change in upper and lower extremity maximal muscular strength as measured by the voluntary one-repetition max (1-RM) and muscular endurance as measured by 70% of 1-RM between week 17 and baseline</description>
          <population>1 patient out of 13 did not complete the 1-RM at baseline or week 17 in the usual care arm, and another did not complete the 70% 1-RM at week 17 out of 12</population>
          <units>pounds</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="12"/>
                <count group_id="O2" value="13"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Change in Leg Press 1-RM</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.67" spread="83.99"/>
                    <measurement group_id="O2" value="107.8" spread="105.75"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change in Leg Press 70% 1-RM</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10" spread="57.4"/>
                    <measurement group_id="O2" value="74.92" spread="74.05"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change in Chest Press 1-RM</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.08" spread="24.96"/>
                    <measurement group_id="O2" value="24.31" spread="24.99"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change in Chest Press 70% 1-RM</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.73" spread="13.93"/>
                    <measurement group_id="O2" value="17" spread="17.32"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change in Seated Row 1-RM</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.25" spread="20.86"/>
                    <measurement group_id="O2" value="14.85" spread="23.39"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change in Seated Row 70% 1-RM</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.27" spread="18.29"/>
                    <measurement group_id="O2" value="10.46" spread="16.47"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Effects on Serum Glucose</title>
        <description>Mean change in fasting serum glucose between week 17 and baseline.</description>
        <time_frame>Baseline to 17 weeks</time_frame>
        <population>Only 10 in the usual care and 8 in the exercise arm patients had glucose measurements at both baseline and week 17.</population>
        <group_list>
          <group group_id="O1">
            <title>ENZ+ADT+Usual Care</title>
            <description>The usual care arm will receive treatment with enzalutamide with androgen deprivation therapy, with no supervised exercise training.&#xD;
Enzalutamide&#xD;
Androgen deprivation therapy</description>
          </group>
          <group group_id="O2">
            <title>ENZ+ADT+Exercise</title>
            <description>The ENZ+ADT+Exercise arm will receive treatment with enzalutamide plus androgen deprivation therapy along with supervised exercise training.&#xD;
Enzalutamide&#xD;
Androgen deprivation therapy&#xD;
Supervised exercise training</description>
          </group>
        </group_list>
        <measure>
          <title>Effects on Serum Glucose</title>
          <description>Mean change in fasting serum glucose between week 17 and baseline.</description>
          <population>Only 10 in the usual care and 8 in the exercise arm patients had glucose measurements at both baseline and week 17.</population>
          <units>mg/dL</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="10"/>
                <count group_id="O2" value="8"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.3" spread="16.22"/>
                    <measurement group_id="O2" value="-1" spread="5.55"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in the Effect on Patient Reported Outcomes (PROs) of Interest Over Time</title>
        <description>Mean change in PROs aggregate score between week 17 and baseline. PROs include the FACT-Prostate (FACT-P, range 0 to 104), FACIT-Fatigue (FACIT-F, range 0 to 52), and the Godin Leisure Questionnaire. Higher scores indicate better quality of life.</description>
        <time_frame>Baseline to 17 weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>ENZ+ADT+Usual Care</title>
            <description>The usual care arm will receive treatment with enzalutamide with androgen deprivation therapy, with no supervised exercise training.&#xD;
Enzalutamide&#xD;
Androgen deprivation therapy</description>
          </group>
          <group group_id="O2">
            <title>ENZ+ADT+Exercise</title>
            <description>The ENZ+ADT+Exercise arm will receive treatment with enzalutamide plus androgen deprivation therapy along with supervised exercise training.&#xD;
Enzalutamide&#xD;
Androgen deprivation therapy&#xD;
Supervised exercise training</description>
          </group>
        </group_list>
        <measure>
          <title>Change in the Effect on Patient Reported Outcomes (PROs) of Interest Over Time</title>
          <description>Mean change in PROs aggregate score between week 17 and baseline. PROs include the FACT-Prostate (FACT-P, range 0 to 104), FACIT-Fatigue (FACIT-F, range 0 to 52), and the Godin Leisure Questionnaire. Higher scores indicate better quality of life.</description>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="13"/>
                <count group_id="O2" value="13"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>FACIT-Fatigue score</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-9.15" spread="11.25"/>
                    <measurement group_id="O2" value="-5" spread="4.88"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>FACT-Prostate Trial Outcome Index</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-11.61" spread="14.39"/>
                    <measurement group_id="O2" value="-5.38" spread="9.01"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Godin Leisure score</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.67" spread="26.2"/>
                    <measurement group_id="O2" value="9.33" spread="17.55"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Eligibility Rate</title>
        <description>Eligibility rate is defined as the number of subjects found to be eligible divided by the number approached for the study. Note that ineligible subjects are not randomized. This is reported as a percent.</description>
        <time_frame>29 months from study initiation</time_frame>
        <population>This overall number of participants analyzed reflects the total number of individuals approached for this study.</population>
        <group_list>
          <group group_id="O1">
            <title>Approached Subjects</title>
            <description>The usual care arm will receive treatment with enzalutamide with androgen deprivation therapy, with no supervised exercise training.&#xD;
Enzalutamide&#xD;
Androgen deprivation therapy</description>
          </group>
        </group_list>
        <measure>
          <title>Eligibility Rate</title>
          <description>Eligibility rate is defined as the number of subjects found to be eligible divided by the number approached for the study. Note that ineligible subjects are not randomized. This is reported as a percent.</description>
          <population>This overall number of participants analyzed reflects the total number of individuals approached for this study.</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="30"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="87"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Acceptance Rate</title>
        <description>Acceptance rate is defined as the number of patients agreeing to participate divided by total number randomized. This is reported as a percent.</description>
        <time_frame>29 months from study initiation</time_frame>
        <group_list>
          <group group_id="O1">
            <title>ENZ+ADT+Usual Care</title>
            <description>The usual care arm will receive treatment with enzalutamide with androgen deprivation therapy, with no supervised exercise training.&#xD;
Enzalutamide&#xD;
Androgen deprivation therapy</description>
          </group>
          <group group_id="O2">
            <title>ENZ+ADT+Exercise</title>
            <description>The ENZ+ADT+Exercise arm will receive treatment with enzalutamide plus androgen deprivation therapy along with supervised exercise training.&#xD;
Enzalutamide&#xD;
Androgen deprivation therapy&#xD;
Supervised exercise training</description>
          </group>
        </group_list>
        <measure>
          <title>Acceptance Rate</title>
          <description>Acceptance rate is defined as the number of patients agreeing to participate divided by total number randomized. This is reported as a percent.</description>
          <units>percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="13"/>
                <count group_id="O2" value="13"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="100"/>
                    <measurement group_id="O2" value="100"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Adherence Rate</title>
        <description>Adherence rate is defined as the percentage of days that each patient fulfilled the assigned exercise prescription of the 48 days. The median percentage is reported.</description>
        <time_frame>48 days</time_frame>
        <group_list>
          <group group_id="O1">
            <title>ENZ+ADT+Usual Care</title>
            <description>The usual care arm will receive treatment with enzalutamide with androgen deprivation therapy, with no supervised exercise training.&#xD;
Enzalutamide&#xD;
Androgen deprivation therapy</description>
          </group>
          <group group_id="O2">
            <title>ENZ+ADT+Exercise</title>
            <description>The ENZ+ADT+Exercise arm will receive treatment with enzalutamide plus androgen deprivation therapy along with supervised exercise training.&#xD;
Enzalutamide&#xD;
Androgen deprivation therapy&#xD;
Supervised exercise training</description>
          </group>
        </group_list>
        <measure>
          <title>Adherence Rate</title>
          <description>Adherence rate is defined as the percentage of days that each patient fulfilled the assigned exercise prescription of the 48 days. The median percentage is reported.</description>
          <units>percentage of days</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="13"/>
                <count group_id="O2" value="13"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="NA" lower_limit="NA" upper_limit="NA">Adherence rate does not apply to the usual care arm.</measurement>
                    <measurement group_id="O2" value="95.8" lower_limit="81.2" upper_limit="100"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Attrition Rate</title>
        <description>Attrition rate is defined as the percent of subjects who complete the 16 week exercise training program. This outcome applies only to the exercise arm.</description>
        <time_frame>16 weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>ENZ+ADT+Usual Care</title>
            <description>The usual care arm will receive treatment with enzalutamide with androgen deprivation therapy, with no supervised exercise training.&#xD;
Enzalutamide&#xD;
Androgen deprivation therapy</description>
          </group>
          <group group_id="O2">
            <title>ENZ+ADT+Exercise</title>
            <description>The ENZ+ADT+Exercise arm will receive treatment with enzalutamide plus androgen deprivation therapy along with supervised exercise training.&#xD;
Enzalutamide&#xD;
Androgen deprivation therapy&#xD;
Supervised exercise training</description>
          </group>
        </group_list>
        <measure>
          <title>Attrition Rate</title>
          <description>Attrition rate is defined as the percent of subjects who complete the 16 week exercise training program. This outcome applies only to the exercise arm.</description>
          <units>percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="13"/>
                <count group_id="O2" value="13"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="NA">Attrition rate does not apply to the usual care arm.</measurement>
                    <measurement group_id="O2" value="100"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>17-week Change in Functional Capacity as Measured by Time Up and Go Test</title>
        <description>Mean change in number of seconds to complete the timed up and go test between week 17 and baseline. This test requires patients to stand up from a chair with armrests, walk 3m, turn around, return to the chair, and sit down</description>
        <time_frame>Baseline to 17 weeks</time_frame>
        <population>One patient in the usual care arm did not complete the test at week 17</population>
        <group_list>
          <group group_id="O1">
            <title>ENZ+ADT+Usual Care</title>
            <description>The usual care arm will receive treatment with enzalutamide with androgen deprivation therapy, with no supervised exercise training.&#xD;
Enzalutamide&#xD;
Androgen deprivation therapy</description>
          </group>
          <group group_id="O2">
            <title>ENZ+ADT+Exercise</title>
            <description>The ENZ+ADT+Exercise arm will receive treatment with enzalutamide plus androgen deprivation therapy along with supervised exercise training.&#xD;
Enzalutamide&#xD;
Androgen deprivation therapy&#xD;
Supervised exercise training</description>
          </group>
        </group_list>
        <measure>
          <title>17-week Change in Functional Capacity as Measured by Time Up and Go Test</title>
          <description>Mean change in number of seconds to complete the timed up and go test between week 17 and baseline. This test requires patients to stand up from a chair with armrests, walk 3m, turn around, return to the chair, and sit down</description>
          <population>One patient in the usual care arm did not complete the test at week 17</population>
          <units>seconds</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="12"/>
                <count group_id="O2" value="13"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.33" spread="1.07"/>
                    <measurement group_id="O2" value="0.08" spread="0.95"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>17-week Change in Functional Capacity as Measured by Six Minute Walk Test</title>
        <description>Mean change in distance covered during the six minute walk test between week 17 and baseline. This test requires patients to cover the longest distance possible in six minutes under the supervision of an exercise physiologist or designee.</description>
        <time_frame>Baseline to 17 weeks</time_frame>
        <population>Two patients in the usual care arm did not complete the test at both baseline and week 17</population>
        <group_list>
          <group group_id="O1">
            <title>ENZ+ADT+Usual Care</title>
            <description>The usual care arm will receive treatment with enzalutamide with androgen deprivation therapy, with no supervised exercise training.&#xD;
Enzalutamide&#xD;
Androgen deprivation therapy</description>
          </group>
          <group group_id="O2">
            <title>ENZ+ADT+Exercise</title>
            <description>The ENZ+ADT+Exercise arm will receive treatment with enzalutamide plus androgen deprivation therapy along with supervised exercise training.&#xD;
Enzalutamide&#xD;
Androgen deprivation therapy&#xD;
Supervised exercise training</description>
          </group>
        </group_list>
        <measure>
          <title>17-week Change in Functional Capacity as Measured by Six Minute Walk Test</title>
          <description>Mean change in distance covered during the six minute walk test between week 17 and baseline. This test requires patients to cover the longest distance possible in six minutes under the supervision of an exercise physiologist or designee.</description>
          <population>Two patients in the usual care arm did not complete the test at both baseline and week 17</population>
          <units>meters</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="11"/>
                <count group_id="O2" value="13"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-32.02" spread="58.47"/>
                    <measurement group_id="O2" value="42" spread="60.26"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>17-week Change in Muscle Cross-sectional Area (CSA)</title>
        <description>Mean change in muscle cross sectional area of the dominant quadricep, hamstring, and total mid-thigh between week 17 and baseline. Cross-sectional area was measured using magnetic resonance imaging with a 3.0T-scanner.</description>
        <time_frame>Baseline to 17 weeks</time_frame>
        <population>Only 10 in the usual care and 8 in the exercise arm patients had cross-sectional area measurements performed at both measurement time points.</population>
        <group_list>
          <group group_id="O1">
            <title>ENZ+ADT+Usual Care</title>
            <description>The usual care arm will receive treatment with enzalutamide with androgen deprivation therapy, with no supervised exercise training.&#xD;
Enzalutamide&#xD;
Androgen deprivation therapy</description>
          </group>
          <group group_id="O2">
            <title>ENZ+ADT+Exercise</title>
            <description>The ENZ+ADT+Exercise arm will receive treatment with enzalutamide plus androgen deprivation therapy along with supervised exercise training.&#xD;
Enzalutamide&#xD;
Androgen deprivation therapy&#xD;
Supervised exercise training</description>
          </group>
        </group_list>
        <measure>
          <title>17-week Change in Muscle Cross-sectional Area (CSA)</title>
          <description>Mean change in muscle cross sectional area of the dominant quadricep, hamstring, and total mid-thigh between week 17 and baseline. Cross-sectional area was measured using magnetic resonance imaging with a 3.0T-scanner.</description>
          <population>Only 10 in the usual care and 8 in the exercise arm patients had cross-sectional area measurements performed at both measurement time points.</population>
          <units>cm^2</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="10"/>
                <count group_id="O2" value="8"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Change in quadricep CSA</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-4.84" spread="4.03"/>
                    <measurement group_id="O2" value="-4.03" spread="3.24"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change in hamstring CSA</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-4.8" spread="5.32"/>
                    <measurement group_id="O2" value="-5.09" spread="4.04"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change in total mid-thigh CSA</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-9.43" spread="6.12"/>
                    <measurement group_id="O2" value="-9.12" spread="7.01"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Effects on Serum Insulin</title>
        <description>Mean change in fasting serum insulin between week 17 and baseline.</description>
        <time_frame>Baseline to 17 weeks</time_frame>
        <population>Only 10 in the usual care and 8 in the exercise arm patients had insulin measurements at both baseline and week 17.</population>
        <group_list>
          <group group_id="O1">
            <title>ENZ+ADT+Usual Care</title>
            <description>The usual care arm will receive treatment with enzalutamide with androgen deprivation therapy, with no supervised exercise training.&#xD;
Enzalutamide&#xD;
Androgen deprivation therapy</description>
          </group>
          <group group_id="O2">
            <title>ENZ+ADT+Exercise</title>
            <description>The ENZ+ADT+Exercise arm will receive treatment with enzalutamide plus androgen deprivation therapy along with supervised exercise training.&#xD;
Enzalutamide&#xD;
Androgen deprivation therapy&#xD;
Supervised exercise training</description>
          </group>
        </group_list>
        <measure>
          <title>Effects on Serum Insulin</title>
          <description>Mean change in fasting serum insulin between week 17 and baseline.</description>
          <population>Only 10 in the usual care and 8 in the exercise arm patients had insulin measurements at both baseline and week 17.</population>
          <units>u[iU]/mL</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="10"/>
                <count group_id="O2" value="8"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.61" spread="5.06"/>
                    <measurement group_id="O2" value="0" spread="11.05"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Effects on Blood Hemoglobin (Hgb)</title>
        <description>Mean change in blood hemoglobin (Hgb) A1C between week 17 and baseline.</description>
        <time_frame>Baseline to 17 weeks</time_frame>
        <population>Only 10 in the usual care and 8 in the exercise arm patients had Hgb measurements at both baseline and week 17.</population>
        <group_list>
          <group group_id="O1">
            <title>ENZ+ADT+Usual Care</title>
            <description>The usual care arm will receive treatment with enzalutamide with androgen deprivation therapy, with no supervised exercise training.&#xD;
Enzalutamide&#xD;
Androgen deprivation therapy</description>
          </group>
          <group group_id="O2">
            <title>ENZ+ADT+Exercise</title>
            <description>The ENZ+ADT+Exercise arm will receive treatment with enzalutamide plus androgen deprivation therapy along with supervised exercise training.&#xD;
Enzalutamide&#xD;
Androgen deprivation therapy&#xD;
Supervised exercise training</description>
          </group>
        </group_list>
        <measure>
          <title>Effects on Blood Hemoglobin (Hgb)</title>
          <description>Mean change in blood hemoglobin (Hgb) A1C between week 17 and baseline.</description>
          <population>Only 10 in the usual care and 8 in the exercise arm patients had Hgb measurements at both baseline and week 17.</population>
          <units>percentage of glycated hemoglobin</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="10"/>
                <count group_id="O2" value="8"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.04" spread="0.39"/>
                    <measurement group_id="O2" value="1.15" spread="2.81"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Effects on Body Composition</title>
        <description>Mean change in lean body mass and fat body mass between week 17 and baseline as measured by a DEXA Scan.</description>
        <time_frame>Baseline to 17 weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>ENZ+ADT+Usual Care</title>
            <description>The usual care arm will receive treatment with enzalutamide with androgen deprivation therapy, with no supervised exercise training.&#xD;
Enzalutamide&#xD;
Androgen deprivation therapy</description>
          </group>
          <group group_id="O2">
            <title>ENZ+ADT+Exercise</title>
            <description>The ENZ+ADT+Exercise arm will receive treatment with enzalutamide plus androgen deprivation therapy along with supervised exercise training.&#xD;
Enzalutamide&#xD;
Androgen deprivation therapy&#xD;
Supervised exercise training</description>
          </group>
        </group_list>
        <measure>
          <title>Effects on Body Composition</title>
          <description>Mean change in lean body mass and fat body mass between week 17 and baseline as measured by a DEXA Scan.</description>
          <units>g</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="13"/>
                <count group_id="O2" value="13"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Change in lean body mass</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-3087.92" spread="3799.02"/>
                    <measurement group_id="O2" value="-2094.42" spread="2407.27"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change in fat body mass</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2949.36" spread="3944.65"/>
                    <measurement group_id="O2" value="-121.45" spread="2435.41"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>37 weeks</time_frame>
      <desc>Adverse events were collected using Common Terminology Criteria for Adverse Events (CTCAE version 4.0)</desc>
      <group_list>
        <group group_id="E1">
          <title>ENZ+ADT+Usual Care</title>
          <description>The usual care arm will receive treatment with enzalutamide with androgen deprivation therapy, with no supervised exercise training.&#xD;
Enzalutamide&#xD;
Androgen deprivation therapy</description>
        </group>
        <group group_id="E2">
          <title>ENZ+ADT+Exercise</title>
          <description>The ENZ+ADT+Exercise arm will receive treatment with enzalutamide plus androgen deprivation therapy along with supervised exercise training.&#xD;
Enzalutamide&#xD;
Androgen deprivation therapy&#xD;
Supervised exercise training</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="13"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="13"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="13"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Acute coronary syndrome</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="13"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Cardiac disorders - Other, Specify: RIGHT CORONARY ARTERY STENOSIS (90% OCCULUSION)</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="13"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="13"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Colonic obstruction</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="13"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="13"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Neoplasms benign, malignant and unspecified (incl cysts and polyps)</title>
            <event_list>
              <event>
                <sub_title>Other, Specify: SURGICAL PROCEDURE FOR INVASIVE ADENOCARCINOMA OF COLON</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="13"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="13"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Surgical and medical procedures</title>
            <event_list>
              <event>
                <sub_title>Surgical and medical procedures - Other, Specify: INGUINAL HERNIA REPAIR, LAPAROSCOPIC</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="13"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="13"/>
              </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="13" subjects_at_risk="13"/>
                <counts group_id="E2" subjects_affected="13" subjects_at_risk="13"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Other, Specify: ABNORMAL ECG</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="13"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Other, Specify: ST DEPRESSION</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="13"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Chest pain - cardiac</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="13"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Palpitations</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="13"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Sinus bradycardia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="13"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Ear and labyrinth disorders</title>
            <event_list>
              <event>
                <sub_title>Tinnitus</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="13"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="13"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Abdominal pain</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="13"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Bloating</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="13"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Diarrhea</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="13"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Dry mouth</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="13"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Dyspepsia</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="13"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Flatulence</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="13"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Other, Specify: &quot;BURPING&quot;</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="13"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Other, Specify: STOMACH SPASMS</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="13"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Gingival pain</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Nausea</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="13"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Oral pain</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Stomach pain</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="13"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Toothache</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="13"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Vomiting</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="13"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="13"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Chills</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Fatigue</sub_title>
                <counts group_id="E1" subjects_affected="11" subjects_at_risk="13"/>
                <counts group_id="E2" subjects_affected="10" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Flu like symptoms</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Irritability</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="13"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Localized edema</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="13"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Malaise</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Non-cardiac chest pain</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Pain</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="13"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="13"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Other, Specify: SURGICAL WOUND INFECTION FOLLOWING HERNIA REPAIR</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="13"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Mucosal infection</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="13"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Sinusitis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="13"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="13"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Fall</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="13"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Alanine aminotransferase increased</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="13"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Aspartate aminotransferase increased</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="13"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Weight gain</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="13"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Weight loss</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="13"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="13"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Dehydration</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="13"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Hypercalcemia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="13"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Hyperkalemia</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="13"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Hyponatremia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="13"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="13"/>
              </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="13"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Arthritis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Generalized muscle weakness</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="13"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Other, Specify: LEG SPASMS</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="13"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Other, Specify: MUSCLE CRAMPS</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="13"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Other, Specify: WEAKNESS IN EXTREMITIES</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="13"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Myalgia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="13"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Neck pain</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="13"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Pain in extremity</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="13"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="13"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Cognitive disturbance</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="13"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Concentration impairment</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="13"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Dizziness</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="13"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Dysarthria</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="13"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Dysgeusia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="13"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Hypersomnia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="13"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Memory impairment</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="13"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Other, Specify: INTERMITTENT SLEEP DISTURBANCE</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="13"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Other, Specify: VIVID DREAMS</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Paresthesia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Tremor</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="13"/>
              </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="13"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Anxiety</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="13"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Depression</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Insomnia</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="13"/>
                <counts group_id="E2" subjects_affected="6" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Libido decreased</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Other, Specify: MOODY</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="13"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Other, Specify: SLEEP DISTURBANCE - NIGHTMARES</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="13"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Restlessness</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="13"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="13"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>Other, Specify: TROUBLE STARTING STREAM</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Urinary frequency</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="13"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Urinary incontinence</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="13"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Urinary tract pain</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Urinary urgency</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="13"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="13"/>
              </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="0" subjects_at_risk="13"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Gynecomastia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="13"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Other, Specify: ERECTION LASTING 14-16 HOURS, NON-PAINFUL.</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="13"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="13"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Dyspnea</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="13"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Hoarseness</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Nasal congestion</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="13"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Postnasal drip</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="13"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="13"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Alopecia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="13"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Dry skin</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="13"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Pruritus</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Rash maculo-papular</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="13"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Other, Specify: ABDOMINAL RASH</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Other, Specify: NIGHT SWEATS</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="13"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Other, Specify: PENIS LESION</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Other, Specify: PUBIC HAIR LOSS (R/T RADIATION THERAPY)</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="13"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="13"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Surgical and medical procedures</title>
            <event_list>
              <event>
                <sub_title>Other, Specify: NUMBNESS IN LOWER RIGHT LIP</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="13"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Hot flashes</sub_title>
                <counts group_id="E1" subjects_affected="12" subjects_at_risk="13"/>
                <counts group_id="E2" subjects_affected="13" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Hypertension</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="13"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Hypotension</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="13"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Other, Specify</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="13"/>
              </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>Michael Harrison, MD</name_or_title>
      <organization>Duke University</organization>
      <phone>919-668-4615</phone>
      <email>michael.harrison@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/NCT02256111
org study id: Pro00053924
nct id: NCT02256111
lead sponsor: 
has dmc: No
This study will examine the effect of supervised exercise training on cardiopulmonary
      function in men receiving the combination of enzalutamide (ENZ) and androgen deprivation
      therapy (ADT) for treatment of non-metastatic, hormone-naïve prostate cancer. No study to
      date has examined the efficacy, tolerability, and safety of exercise training to prevent
      and/or mitigate common adverse toxicities in men receiving combination androgen suppression
      therapy for hormone-naïve prostate cancer.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Change in VO2peak in Usual Care Versus Exercise Training Arms
time frame: From week 1 to week 17
description: Mean change in peak oxygen uptake (VO2peak) from week 1 to week 17 in the usual care and exercise training groups
measure: 17-week Change in Functional Capacity as Measured by Chair-stand Test
time frame: Baseline to 17 weeks
description: Mean change in number of seconds to perform the chair-stand test between baseline and week 17. This test measures the time taken to complete 5 repetitions of the sit-to-stand maneuver from a chair without an arm rest at 43 cm in height and 47.5 cm in depth. This test provides an indicator of functional performance of lower body strength; quicker times indicate greater strength
measure: 17-week Change in Upper and Lower Extremity Maximal Muscular Strength
time frame: Baseline to 17 weeks
description: Mean change in upper and lower extremity maximal muscular strength as measured by the voluntary one-repetition max (1-RM) and muscular endurance as measured by 70% of 1-RM between week 17 and baseline
measure: Effects on Serum Glucose
time frame: Baseline to 17 weeks
description: Mean change in fasting serum glucose between week 17 and baseline.
measure: Change in the Effect on Patient Reported Outcomes (PROs) of Interest Over Time
time frame: Baseline to 17 weeks
description: Mean change in PROs aggregate score between week 17 and baseline. PROs include the FACT-Prostate (FACT-P, range 0 to 104), FACIT-Fatigue (FACIT-F, range 0 to 52), and the Godin Leisure Questionnaire. Higher scores indicate better quality of life.
measure: Eligibility Rate
time frame: 29 months from study initiation
description: Eligibility rate is defined as the number of subjects found to be eligible divided by the number approached for the study. Note that ineligible subjects are not randomized. This is reported as a percent.
measure: Acceptance Rate
time frame: 29 months from study initiation
description: Acceptance rate is defined as the number of patients agreeing to participate divided by total number randomized. This is reported as a percent.
measure: Adherence Rate
time frame: 48 days
description: Adherence rate is defined as the percentage of days that each patient fulfilled the assigned exercise prescription of the 48 days. The median percentage is reported.
measure: Attrition Rate
time frame: 16 weeks
description: Attrition rate is defined as the percent of subjects who complete the 16 week exercise training program. This outcome applies only to the exercise arm.
measure: 17-week Change in Functional Capacity as Measured by Time Up and Go Test
time frame: Baseline to 17 weeks
description: Mean change in number of seconds to complete the timed up and go test between week 17 and baseline. This test requires patients to stand up from a chair with armrests, walk 3m, turn around, return to the chair, and sit down
measure: 17-week Change in Functional Capacity as Measured by Six Minute Walk Test
time frame: Baseline to 17 weeks
description: Mean change in distance covered during the six minute walk test between week 17 and baseline. This test requires patients to cover the longest distance possible in six minutes under the supervision of an exercise physiologist or designee.
measure: 17-week Change in Muscle Cross-sectional Area (CSA)
time frame: Baseline to 17 weeks
description: Mean change in muscle cross sectional area of the dominant quadricep, hamstring, and total mid-thigh between week 17 and baseline. Cross-sectional area was measured using magnetic resonance imaging with a 3.0T-scanner.
measure: Effects on Serum Insulin
time frame: Baseline to 17 weeks
description: Mean change in fasting serum insulin between week 17 and baseline.
measure: Effects on Blood Hemoglobin (Hgb)
time frame: Baseline to 17 weeks
description: Mean change in blood hemoglobin (Hgb) A1C between week 17 and baseline.
measure: Effects on Body Composition
time frame: Baseline to 17 weeks
description: Mean change in lean body mass and fat body mass between week 17 and baseline as measured by a DEXA Scan.
arm group label: ENZ+ADT+Usual care
arm group type: Experimental
description: The usual care arm will receive treatment with enzalutamide with androgen deprivation therapy, with no supervised exercise training.
arm group label: ENZ+ADT+Exercise
arm group type: Experimental
description: The ENZ+ADT+Exercise arm will receive treatment with enzalutamide plus androgen deprivation therapy along with supervised exercise training.
intervention type: Drug
intervention name: Enzalutamide
arm group label: ENZ+ADT+Exercise
arm group label: ENZ+ADT+Usual care
other name: Xtandi
intervention type: Drug
intervention name: Androgen deprivation therapy
arm group label: ENZ+ADT+Exercise
arm group label: ENZ+ADT+Usual care
intervention type: Behavioral
intervention name: Supervised exercise training
arm group label: ENZ+ADT+Exercise
criteria: 
gender: Male
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Michael Harrison, MD
role: Principal Investigator
affiliation: Duke University
facility: 
facility: 
country: United States
responsible party type: Sponsor
mesh term: Prostatic Neoplasms
mesh term: Androgens
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 