<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/NCT03827473</url>
  </required_header>
  <id_info>
    <org_study_id>HCI115099</org_study_id>
    <nct_id>NCT03827473</nct_id>
  </id_info>
  <brief_title>Docetaxel or Abiraterone Acetate With ADT in Treating Patients With Metastatic Hormone Sensitive Prostate Cancer</brief_title>
  <acronym>ACADEMIC</acronym>
  <official_title>ACADEMIC: A Randomized Phase II Clinical Trial of ADT Combined With Abiraterone or Docetaxel in Metastatic Hormone Sensitive Prostate Cancer</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Utah</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Utah</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      This phase II trial studies how well docetaxel or abiraterone acetate work when combined with&#xD;
      androgen deprivation therapy (ADT) in treating patients with hormone sensitive prostate&#xD;
      cancer that has spread to other parts of the body. Drugs used in chemotherapy, such as&#xD;
      docetaxel and abiraterone acetate, work in different ways to stop the growth of tumor cells,&#xD;
      either by killing the cells, by stopping them from dividing, or by stopping them from&#xD;
      spreading. Antihormone therapy, such as ADT may lessen the amount of androgen made by the&#xD;
      body. It is not yet known whether docetaxel or abiraterone acetate work better when combined&#xD;
      with ADT in treating patients with hormone sensitive prostate cancer.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      PRIMARY OBJECTIVES:&#xD;
&#xD;
      I. To assess the impact of abiraterone acetate (abiraterone) and docetaxel on total quality&#xD;
      of life between screening and month 12 of the study.&#xD;
&#xD;
      SECONDARY OBJECTIVES:&#xD;
&#xD;
      I. To assess prostate specific androgen (PSA) response rates across the entire population and&#xD;
      compared between groups.&#xD;
&#xD;
      II. To assess impact of abiraterone and docetaxel on additional quality of life measurements&#xD;
      and quality of life trends throughout the duration of the study.&#xD;
&#xD;
      III. To assess the potential clinical efficacy between treatment groups.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    The trial was closed because the changing standard of care landscape, making this trial not&#xD;
    impactful anymore.&#xD;
  </why_stopped>
  <start_date type="Actual">February 8, 2019</start_date>
  <completion_date type="Actual">July 31, 2019</completion_date>
  <primary_completion_date type="Actual">July 31, 2019</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 Quality of Life - FACT-P</measure>
    <time_frame>Planned for up to one year, but actual was 3 months</time_frame>
    <description>The impact of abiraterone acetate and docetaxel on health related quality of life will be assessed every 3 months from screening to month 12 of treatment or follow-up. The scale used will be the Functional Assessment of Cancer Therapy-Prostate (FACT-P) scale. The total score ranges from 0 to 156, with higher scores indicating a higher quality of life. The primary endpoint was intended to be quality of life at 12 months, but since no participants completed 12 months of treatment/follow-up, scores at baseline and 3 months are reported instead.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Prostate-specific Antigen (PSA) Response</measure>
    <time_frame>Planned for up to 18 months, but actual was 3 months</time_frame>
    <description>PSA evaluations will occur every 3 months while on study. PSA response is defined as a reduction in PSA value of greater than or equal to 90% from baseline, reported as a count of participants who had a PSA response on the study.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Quality of Life - FACT/GOG-NTX</measure>
    <time_frame>Planned for up to 18 months, but actual was 3 months</time_frame>
    <description>Quality of Life questionnaires will be done every 3 months while participants are on treatment. The scale used will be the Functional Assessment of Cancer Therapy (FACT)/Gynecologic Oncology Group (GOG)-Neurotoxicity (NTX) (FACT/GOG-NTX) scale (version 4). FACT/GOG-NTX total score ranges from 0 to 152, with higher scores indicating a higher quality of life.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Quality of Life - PROMIS Fatigue</measure>
    <time_frame>Planned for up to 18 months, but actual was 3 months</time_frame>
    <description>Quality of Life questionnaires will be done every 3 months while participants are on treatment. The scale used will be the Patient-Reported Outcomes Measurement Information System (PROMIS) Fatigue scale. Total raw scores range from 7 to 35, with higher scores indicating a higher level of fatigue.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Prostate Specific Antigen Progression Free Survival (PSA-PFS)</measure>
    <time_frame>Planned up to 18 months, but actual was 3 months</time_frame>
    <description>Prostate Specific Antigen (PSA) will be measured every three months while on study. PSA Progression Free Survival (PSA-PSF) will be reported as the number of participants who have not demonstrated PSA progression by the end of the follow-up period. PSA progression is defined by meeting the following criteria: 1) an increase in PSA of greater than or equal to 25% from baseline or nadir, AND 2) an increase in PSA of at least 2 ng/dL, AND 3) the increase is confirmed at least 3 weeks later. This analysis was planned for up to 18 months following study enrollment, but the only participant enrolled on the study was only followed for 3 months.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">1</enrollment>
  <condition>Castration-Sensitive Prostate Carcinoma</condition>
  <condition>Metastatic Prostatic Adenocarcinoma</condition>
  <condition>Stage IV Prostate Cancer</condition>
  <condition>Stage IVA Prostate Cancer</condition>
  <condition>Stage IVB Prostate Cancer</condition>
  <arm_group>
    <arm_group_label>Arm A (ADT, docetaxel)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants receive androgen deprivation therapy (ADT) per standard of care and docetaxel IV over 1 hour on day 1. Treatment repeats every 21 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Arm B (ADT, abiraterone acetate, prednisone)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants receive androgen deprivation therapy (ADT) per standard of care, abiraterone acetate PO daily, and prednisone PO twice daily. Treatment continues in the absence of disease progression or unacceptable toxicity.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Abiraterone Acetate</intervention_name>
    <description>Given PO</description>
    <arm_group_label>Arm B (ADT, abiraterone acetate, prednisone)</arm_group_label>
    <other_name>CB7630</other_name>
    <other_name>Zytiga</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Antiandrogen Therapy</intervention_name>
    <description>Given per standard of care</description>
    <arm_group_label>Arm A (ADT, docetaxel)</arm_group_label>
    <arm_group_label>Arm B (ADT, abiraterone acetate, prednisone)</arm_group_label>
    <other_name>ADT</other_name>
    <other_name>Androgen Deprivation Therapy</other_name>
    <other_name>Anti-androgen Therapy</other_name>
    <other_name>Anti-androgen Treatment</other_name>
    <other_name>Antiandrogen Treatment</other_name>
    <other_name>Hormone Deprivation Therapy</other_name>
    <other_name>Hormone-Deprivation Therapy</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Docetaxel</intervention_name>
    <description>Given IV</description>
    <arm_group_label>Arm A (ADT, docetaxel)</arm_group_label>
    <other_name>Docecad</other_name>
    <other_name>RP56976</other_name>
    <other_name>Taxotere</other_name>
    <other_name>Taxotere Injection Concentrate</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Prednisone</intervention_name>
    <description>Given PO</description>
    <arm_group_label>Arm B (ADT, abiraterone acetate, prednisone)</arm_group_label>
    <other_name>.delta.1-Cortisone</other_name>
    <other_name>1, 2-Dehydrocortisone</other_name>
    <other_name>Adasone</other_name>
    <other_name>Cortancyl</other_name>
    <other_name>Dacortin</other_name>
    <other_name>DeCortin</other_name>
    <other_name>Decortisyl</other_name>
    <other_name>Decorton</other_name>
    <other_name>Delta 1-Cortisone</other_name>
    <other_name>Delta-Dome</other_name>
    <other_name>Deltacortene</other_name>
    <other_name>Deltacortisone</other_name>
    <other_name>Deltadehydrocortisone</other_name>
    <other_name>Deltasone</other_name>
    <other_name>Deltison</other_name>
    <other_name>Deltra</other_name>
    <other_name>Econosone</other_name>
    <other_name>Lisacort</other_name>
    <other_name>Meprosona-F</other_name>
    <other_name>Metacortandracin</other_name>
    <other_name>Meticorten</other_name>
    <other_name>Ofisolona</other_name>
    <other_name>Orasone</other_name>
    <other_name>Panafcort</other_name>
    <other_name>Panasol-S</other_name>
    <other_name>Paracort</other_name>
    <other_name>PRED</other_name>
    <other_name>Predicor</other_name>
    <other_name>Predicorten</other_name>
    <other_name>Prednicen-M</other_name>
    <other_name>Prednicort</other_name>
    <other_name>Prednidib</other_name>
    <other_name>Prednilonga</other_name>
    <other_name>Predniment</other_name>
    <other_name>Prednisonum</other_name>
    <other_name>Prednitone</other_name>
    <other_name>Promifen</other_name>
    <other_name>Servisone</other_name>
    <other_name>SK-Prednisone</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Quality-of-Life Assessment</intervention_name>
    <description>Ancillary studies</description>
    <arm_group_label>Arm A (ADT, docetaxel)</arm_group_label>
    <arm_group_label>Arm B (ADT, abiraterone acetate, prednisone)</arm_group_label>
    <other_name>Quality of Life Assessment</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Questionnaire Administration</intervention_name>
    <description>Ancillary studies</description>
    <arm_group_label>Arm A (ADT, docetaxel)</arm_group_label>
    <arm_group_label>Arm B (ADT, abiraterone acetate, prednisone)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Histologically diagnosed adenocarcinoma of the prostate.&#xD;
&#xD;
          -  Radiographically confirmed metastatic disease prior to patient enrollment. Metastatic&#xD;
             disease can be confirmed based on conventional imaging (CT, MRI, nuclear medicine bone&#xD;
             scan) or molecular imaging (fluciclovine-positron emission tomography (PET)/CT,&#xD;
             prostate-specific membrane antigen (PSMA)-PET/CT, Choline-PET/CT etc).&#xD;
&#xD;
          -  Eastern Cooperative Oncology Group (ECOG) performance status =&lt; 2.&#xD;
&#xD;
          -  Absolute neutrophil count (ANC) &gt;= 1.5 k/uL.&#xD;
&#xD;
          -  Platelets &gt;= 100 k/uL.&#xD;
&#xD;
          -  Hemoglobin &gt;= 9 g/dL.&#xD;
&#xD;
          -  Serum total bilirubin =&lt; 1.5 times upper limit of normal (ULN) OR direct bilirubin =&lt;&#xD;
             ULN for subjects with total bilirubin &gt;= 1.5 x ULN.&#xD;
&#xD;
          -  Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) =&lt; 2.5 x ULN OR =&lt;&#xD;
             4 x ULN for subjects with liver metastases.&#xD;
&#xD;
          -  Creatinine &lt; 1.5 x ULN OR&#xD;
&#xD;
          -  Creatinine clearance &gt; 50 mL/min for subject with creatinine levels &gt; 1.5 x ULN by&#xD;
             Cockcroft-Gault formula or standard institutional practice.&#xD;
&#xD;
          -  Highly effective method of contraception for both male and female partners of subjects&#xD;
             throughout the study and for at least 3 months after last study treatment&#xD;
             administration if the risk of conception exists.&#xD;
&#xD;
          -  Able to provide informed consent and willing to sign an approved consent form that&#xD;
             conforms to federal and institutional guidelines.&#xD;
&#xD;
          -  Recovery to baseline or =&lt; grade 1 Common Terminology Criteria for Adverse Events&#xD;
             (CTCAE) version (v)5.0 from toxicities related to any prior treatments, unless adverse&#xD;
             event (AE)(s) are clinically nonsignificant and/or stable on supportive therapy as&#xD;
             defined by the treating physician.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  No prior abiraterone or docetaxel therapy for metastatic hormone sensitive prostate&#xD;
             cancer. Prior therapy with ADT or first generation anti-androgen receptor therapy&#xD;
             (example: bicalutamide) is allowed.&#xD;
&#xD;
          -  Completed any hormone therapy for localized prostate cancer and have recovery of&#xD;
             testosterone (i.e. testosterone level is &gt;50ng/dL).&#xD;
&#xD;
          -  Patients have a histologic diagnosis of small cell prostate cancer or pure squamous&#xD;
             cell prostate cancer.&#xD;
&#xD;
          -  Known brain metastases or cranial epidural disease unless adequately treated with&#xD;
             radiotherapy and/or surgery (including radiosurgery) and stable for at least 4 weeks&#xD;
             before first dose of study treatment. Eligible subjects must be neurologically&#xD;
             asymptomatic and without corticosteroid treatment at the time of first dose of study&#xD;
             treatment.&#xD;
&#xD;
          -  The subject has uncontrolled, significant intercurrent or recent illness including,&#xD;
             but not limited to, the following conditions:&#xD;
&#xD;
               -  Cardiovascular disorders:&#xD;
&#xD;
                    -  Congestive heart failure New York Heart Association class 3 or 4, unstable&#xD;
                       angina pectoris, serious cardiac arrhythmias within 3 months of study&#xD;
                       enrollment.&#xD;
&#xD;
                    -  Uncontrolled hypertension defined as sustained blood pressure (BP) &gt; 170 mm&#xD;
                       Hg systolic or &gt; 100 mm Hg diastolic despite optimal antihypertensive&#xD;
                       treatment.&#xD;
&#xD;
                    -  Stroke (including transient ischemic attack (TIA)), myocardial infarction&#xD;
                       (MI), or other ischemic event, or arterial thromboembolic event within 3&#xD;
                       months before first dose.&#xD;
&#xD;
               -  Other clinically significant disorders that would preclude safe study&#xD;
                  participation. As defined by the treating physician.&#xD;
&#xD;
          -  Known history of testing positive for human immunodeficiency virus (HIV) and cluster&#xD;
             of differentiation 4 (CD4) count is below 200 or known acquired immunodeficiency&#xD;
             syndrome diagnosis.&#xD;
&#xD;
          -  Known history of hepatitis B virus (HBV) or hepatitis C virus (HCV) infection at&#xD;
             screening (positive HBV surface antigen or detectable HCV ribonucleic acid [RNA] if&#xD;
             anti-HCV antibody screening test positive) and a detectable viral count at screening.&#xD;
&#xD;
          -  Use of live virus vaccine within 4 weeks of the first dose of treatment or planned use&#xD;
             while on trial for the duration of potential docetaxel treatment. Live vaccine use is&#xD;
             acceptable after chemotherapy or for patients randomized to the abiraterone arm. There&#xD;
             are no restrictions on inactive viruses.&#xD;
&#xD;
          -  Known prior severe hypersensitivity to investigational product or any component in its&#xD;
             formulations (National Cancer Institute [NCI] CTCAE v5.0 grade &gt;= 3).&#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>Benjamin Maughan, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Huntsman Cancer Institute/ University of Utah</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Huntsman Cancer Institute/University of Utah</name>
      <address>
        <city>Salt Lake City</city>
        <state>Utah</state>
        <zip>84112</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>January 29, 2019</study_first_submitted>
  <study_first_submitted_qc>January 30, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 1, 2019</study_first_posted>
  <results_first_submitted>June 5, 2020</results_first_submitted>
  <results_first_submitted_qc>June 5, 2020</results_first_submitted_qc>
  <results_first_posted type="Actual">June 25, 2020</results_first_posted>
  <last_update_submitted>June 5, 2020</last_update_submitted>
  <last_update_submitted_qc>June 5, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 25, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Prostatic Neoplasms</mesh_term>
    <mesh_term>Hypersensitivity</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Ascorbic Acid</mesh_term>
    <mesh_term>Prednisone</mesh_term>
    <mesh_term>Cortisone</mesh_term>
    <mesh_term>Docetaxel</mesh_term>
    <mesh_term>Abiraterone Acetate</mesh_term>
    <mesh_term>Methyltestosterone</mesh_term>
    <mesh_term>Hormones</mesh_term>
    <mesh_term>Estrogens, Conjugated (USP)</mesh_term>
    <mesh_term>Androgens</mesh_term>
    <mesh_term>Androgen Antagonists</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>March 13, 2019</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/73/NCT03827473/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Arm A (ADT, Docetaxel)</title>
          <description>Participants receive androgen deprivation therapy (ADT) per standard of care and docetaxel IV over 1 hour on day 1. Treatment repeats every 21 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity.</description>
        </group>
        <group group_id="P2">
          <title>Arm B (ADT, Abiraterone)</title>
          <description>Participants receive androgen deprivation therapy (ADT) per standard of care, abiraterone acetate PO daily, and prednisone PO twice daily. Treatment continues in the absence of disease progression or unacceptable toxicity.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>Because only one participant enrolled, the baseline characteristics were not provided to protect the identify and privacy of the participant.</population>
      <group_list>
        <group group_id="B1">
          <title>Arm A (ADT, Docetaxel)</title>
          <description>Participants receive ADT per standard of care and docetaxel IV over 1 hour on day 1. Treatment repeats every 21 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity.</description>
        </group>
        <group group_id="B2">
          <title>Arm B (ADT, Abiraterone)</title>
          <description>Participants receive ADT per standard of care, abiraterone acetate PO daily, and prednisone PO twice daily. Treatment continues in the absence of disease progression or unacceptable toxicity.</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="0"/>
            <count group_id="B2" value="0"/>
            <count group_id="B3" value="0"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>&lt;=18 years</title>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Age</title>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                </category>
                <category>
                  <title>Male</title>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Ethnicity (NIH/OMB)</title>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Hispanic or Latino</title>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                </category>
                <category>
                  <title>Asian</title>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                </category>
                <category>
                  <title>Black or African American</title>
                </category>
                <category>
                  <title>White</title>
                </category>
                <category>
                  <title>More than one race</title>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Change in Quality of Life - FACT-P</title>
        <description>The impact of abiraterone acetate and docetaxel on health related quality of life will be assessed every 3 months from screening to month 12 of treatment or follow-up. The scale used will be the Functional Assessment of Cancer Therapy-Prostate (FACT-P) scale. The total score ranges from 0 to 156, with higher scores indicating a higher quality of life. The primary endpoint was intended to be quality of life at 12 months, but since no participants completed 12 months of treatment/follow-up, scores at baseline and 3 months are reported instead.</description>
        <time_frame>Planned for up to one year, but actual was 3 months</time_frame>
        <population>There were no participants on Arm B to analyze.</population>
        <group_list>
          <group group_id="O1">
            <title>Arm A (ADT, Docetaxel)</title>
            <description>Participants receive ADT per standard of care and docetaxel IV over 1 hour on day 1. Treatment repeats every 21 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity.</description>
          </group>
          <group group_id="O2">
            <title>Arm B (ADT, Abiraterone)</title>
            <description>Participants receive ADT per standard of care, abiraterone acetate PO daily, and prednisone PO twice daily. Treatment continues in the absence of disease progression or unacceptable toxicity.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Quality of Life - FACT-P</title>
          <description>The impact of abiraterone acetate and docetaxel on health related quality of life will be assessed every 3 months from screening to month 12 of treatment or follow-up. The scale used will be the Functional Assessment of Cancer Therapy-Prostate (FACT-P) scale. The total score ranges from 0 to 156, with higher scores indicating a higher quality of life. The primary endpoint was intended to be quality of life at 12 months, but since no participants completed 12 months of treatment/follow-up, scores at baseline and 3 months are reported instead.</description>
          <population>There were no participants on Arm B to analyze.</population>
          <units>score on a scale</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="1"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline Score</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="139.83"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 3 Score</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="127"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Prostate-specific Antigen (PSA) Response</title>
        <description>PSA evaluations will occur every 3 months while on study. PSA response is defined as a reduction in PSA value of greater than or equal to 90% from baseline, reported as a count of participants who had a PSA response on the study.</description>
        <time_frame>Planned for up to 18 months, but actual was 3 months</time_frame>
        <population>There were no participants on Arm B to analyze.</population>
        <group_list>
          <group group_id="O1">
            <title>Arm A (ADT, Docetaxel)</title>
            <description>Participants receive ADT per standard of care and docetaxel IV over 1 hour on day 1. Treatment repeats every 21 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity.</description>
          </group>
          <group group_id="O2">
            <title>Arm B (ADT, Abiraterone)</title>
            <description>Participants receive ADT per standard of care, abiraterone acetate PO daily, and prednisone PO twice daily. Treatment continues in the absence of disease progression or unacceptable toxicity.</description>
          </group>
        </group_list>
        <measure>
          <title>Prostate-specific Antigen (PSA) Response</title>
          <description>PSA evaluations will occur every 3 months while on study. PSA response is defined as a reduction in PSA value of greater than or equal to 90% from baseline, reported as a count of participants who had a PSA response on the study.</description>
          <population>There were no participants on Arm B to analyze.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="1"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Quality of Life - FACT/GOG-NTX</title>
        <description>Quality of Life questionnaires will be done every 3 months while participants are on treatment. The scale used will be the Functional Assessment of Cancer Therapy (FACT)/Gynecologic Oncology Group (GOG)-Neurotoxicity (NTX) (FACT/GOG-NTX) scale (version 4). FACT/GOG-NTX total score ranges from 0 to 152, with higher scores indicating a higher quality of life.</description>
        <time_frame>Planned for up to 18 months, but actual was 3 months</time_frame>
        <population>There were no participants on Arm B to analyze.</population>
        <group_list>
          <group group_id="O1">
            <title>Arm A (ADT, Docetaxel)</title>
            <description>Participants receive ADT per standard of care and docetaxel IV over 1 hour on day 1. Treatment repeats every 21 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity.</description>
          </group>
          <group group_id="O2">
            <title>Arm B (ADT, Abiraterone)</title>
            <description>Participants receive ADT per standard of care, abiraterone acetate PO daily, and prednisone PO twice daily. Treatment continues in the absence of disease progression or unacceptable toxicity.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Quality of Life - FACT/GOG-NTX</title>
          <description>Quality of Life questionnaires will be done every 3 months while participants are on treatment. The scale used will be the Functional Assessment of Cancer Therapy (FACT)/Gynecologic Oncology Group (GOG)-Neurotoxicity (NTX) (FACT/GOG-NTX) scale (version 4). FACT/GOG-NTX total score ranges from 0 to 152, with higher scores indicating a higher quality of life.</description>
          <population>There were no participants on Arm B to analyze.</population>
          <units>score on a scale</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="1"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline Score</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="131.83"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 3 Score</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="126"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Quality of Life - PROMIS Fatigue</title>
        <description>Quality of Life questionnaires will be done every 3 months while participants are on treatment. The scale used will be the Patient-Reported Outcomes Measurement Information System (PROMIS) Fatigue scale. Total raw scores range from 7 to 35, with higher scores indicating a higher level of fatigue.</description>
        <time_frame>Planned for up to 18 months, but actual was 3 months</time_frame>
        <population>There were no participants on Arm B to analyze.</population>
        <group_list>
          <group group_id="O1">
            <title>Arm A (ADT, Docetaxel)</title>
            <description>Participants receive ADT per standard of care and docetaxel IV over 1 hour on day 1. Treatment repeats every 21 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity.</description>
          </group>
          <group group_id="O2">
            <title>Arm B (ADT, Abiraterone)</title>
            <description>Participants receive ADT per standard of care, abiraterone acetate PO daily, and prednisone PO twice daily. Treatment continues in the absence of disease progression or unacceptable toxicity.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Quality of Life - PROMIS Fatigue</title>
          <description>Quality of Life questionnaires will be done every 3 months while participants are on treatment. The scale used will be the Patient-Reported Outcomes Measurement Information System (PROMIS) Fatigue scale. Total raw scores range from 7 to 35, with higher scores indicating a higher level of fatigue.</description>
          <population>There were no participants on Arm B to analyze.</population>
          <units>score on a scale</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="1"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline Score</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 3 Score</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="16"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Prostate Specific Antigen Progression Free Survival (PSA-PFS)</title>
        <description>Prostate Specific Antigen (PSA) will be measured every three months while on study. PSA Progression Free Survival (PSA-PSF) will be reported as the number of participants who have not demonstrated PSA progression by the end of the follow-up period. PSA progression is defined by meeting the following criteria: 1) an increase in PSA of greater than or equal to 25% from baseline or nadir, AND 2) an increase in PSA of at least 2 ng/dL, AND 3) the increase is confirmed at least 3 weeks later. This analysis was planned for up to 18 months following study enrollment, but the only participant enrolled on the study was only followed for 3 months.</description>
        <time_frame>Planned up to 18 months, but actual was 3 months</time_frame>
        <population>There were no participants on Arm B to be analyzed.</population>
        <group_list>
          <group group_id="O1">
            <title>Arm A (ADT, Docetaxel)</title>
            <description>Participants receive ADT per standard of care and docetaxel IV over 1 hour on day 1. Treatment repeats every 21 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity.</description>
          </group>
          <group group_id="O2">
            <title>Arm B (ADT, Abiraterone)</title>
            <description>Participants receive ADT per standard of care, abiraterone acetate PO daily, and prednisone PO twice daily. Treatment continues in the absence of disease progression or unacceptable toxicity.</description>
          </group>
        </group_list>
        <measure>
          <title>Prostate Specific Antigen Progression Free Survival (PSA-PFS)</title>
          <description>Prostate Specific Antigen (PSA) will be measured every three months while on study. PSA Progression Free Survival (PSA-PSF) will be reported as the number of participants who have not demonstrated PSA progression by the end of the follow-up period. PSA progression is defined by meeting the following criteria: 1) an increase in PSA of greater than or equal to 25% from baseline or nadir, AND 2) an increase in PSA of at least 2 ng/dL, AND 3) the increase is confirmed at least 3 weeks later. This analysis was planned for up to 18 months following study enrollment, but the only participant enrolled on the study was only followed for 3 months.</description>
          <population>There were no participants on Arm B to be analyzed.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="1"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Planned for up to 18 months, but due to low enrollment and early participant discontinuation, the actual time frame was 3 months.</time_frame>
      <desc>Information about adverse events, whether volunteered by the subject, discovered by investigator questioning, or detected through physical examination, lab test or other means, were abstracted from clinic notes and recorded in the participant's study chart. The safety profile for the drugs involved in this study have been characterized extensively in previous clinical trials and standard clinical contexts. As such, safety data collection for this study was limited to ≥ Grade 3 adverse events.</desc>
      <group_list>
        <group group_id="E1">
          <title>Arm A (ADT, Docetaxel)</title>
          <description>Participants receive ADT per standard of care and docetaxel IV over 1 hour on day 1. Treatment repeats every 21 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity.</description>
        </group>
        <group group_id="E2">
          <title>Arm B (ADT, Abiraterone)</title>
          <description>Participants receive ADT per standard of care, abiraterone acetate PO daily, and prednisone PO twice daily. Treatment continues in the absence of disease progression or unacceptable toxicity.</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="0"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="0"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="0"/>
              </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>Data Manager</name_or_title>
      <organization>Huntsman Cancer Institute Research Compliance Office</organization>
      <phone>8015850601</phone>
      <email>compliance@hci.utah.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/NCT03827473
org study id: HCI115099
nct id: NCT03827473
lead sponsor: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
is us export: No
This phase II trial studies how well docetaxel or abiraterone acetate work when combined with
      androgen deprivation therapy (ADT) in treating patients with hormone sensitive prostate
      cancer that has spread to other parts of the body. Drugs used in chemotherapy, such as
      docetaxel and abiraterone acetate, work in different ways to stop the growth of tumor cells,
      either by killing the cells, by stopping them from dividing, or by stopping them from
      spreading. Antihormone therapy, such as ADT may lessen the amount of androgen made by the
      body. It is not yet known whether docetaxel or abiraterone acetate work better when combined
      with ADT in treating patients with hormone sensitive prostate cancer.
PRIMARY OBJECTIVES:

      I. To assess the impact of abiraterone acetate (abiraterone) and docetaxel on total quality
      of life between screening and month 12 of the study.

      SECONDARY OBJECTIVES:

      I. To assess prostate specific androgen (PSA) response rates across the entire population and
      compared between groups.

      II. To assess impact of abiraterone and docetaxel on additional quality of life measurements
      and quality of life trends throughout the duration of the study.

      III. To assess the potential clinical efficacy between treatment groups.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Change in Quality of Life - FACT-P
time frame: Planned for up to one year, but actual was 3 months
description: The impact of abiraterone acetate and docetaxel on health related quality of life will be assessed every 3 months from screening to month 12 of treatment or follow-up. The scale used will be the Functional Assessment of Cancer Therapy-Prostate (FACT-P) scale. The total score ranges from 0 to 156, with higher scores indicating a higher quality of life. The primary endpoint was intended to be quality of life at 12 months, but since no participants completed 12 months of treatment/follow-up, scores at baseline and 3 months are reported instead.
measure: Prostate-specific Antigen (PSA) Response
time frame: Planned for up to 18 months, but actual was 3 months
description: PSA evaluations will occur every 3 months while on study. PSA response is defined as a reduction in PSA value of greater than or equal to 90% from baseline, reported as a count of participants who had a PSA response on the study.
measure: Change in Quality of Life - FACT/GOG-NTX
time frame: Planned for up to 18 months, but actual was 3 months
description: Quality of Life questionnaires will be done every 3 months while participants are on treatment. The scale used will be the Functional Assessment of Cancer Therapy (FACT)/Gynecologic Oncology Group (GOG)-Neurotoxicity (NTX) (FACT/GOG-NTX) scale (version 4). FACT/GOG-NTX total score ranges from 0 to 152, with higher scores indicating a higher quality of life.
measure: Change in Quality of Life - PROMIS Fatigue
time frame: Planned for up to 18 months, but actual was 3 months
description: Quality of Life questionnaires will be done every 3 months while participants are on treatment. The scale used will be the Patient-Reported Outcomes Measurement Information System (PROMIS) Fatigue scale. Total raw scores range from 7 to 35, with higher scores indicating a higher level of fatigue.
measure: Prostate Specific Antigen Progression Free Survival (PSA-PFS)
time frame: Planned up to 18 months, but actual was 3 months
description: Prostate Specific Antigen (PSA) will be measured every three months while on study. PSA Progression Free Survival (PSA-PSF) will be reported as the number of participants who have not demonstrated PSA progression by the end of the follow-up period. PSA progression is defined by meeting the following criteria: 1) an increase in PSA of greater than or equal to 25% from baseline or nadir, AND 2) an increase in PSA of at least 2 ng/dL, AND 3) the increase is confirmed at least 3 weeks later. This analysis was planned for up to 18 months following study enrollment, but the only participant enrolled on the study was only followed for 3 months.
arm group label: Arm A (ADT, docetaxel)
arm group type: Experimental
description: Participants receive androgen deprivation therapy (ADT) per standard of care and docetaxel IV over 1 hour on day 1. Treatment repeats every 21 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity.
arm group label: Arm B (ADT, abiraterone acetate, prednisone)
arm group type: Experimental
description: Participants receive androgen deprivation therapy (ADT) per standard of care, abiraterone acetate PO daily, and prednisone PO twice daily. Treatment continues in the absence of disease progression or unacceptable toxicity.
intervention type: Drug
intervention name: Abiraterone Acetate
description: Given PO
arm group label: Arm B (ADT, abiraterone acetate, prednisone)
other name: CB7630
other name: Zytiga
intervention type: Drug
intervention name: Antiandrogen Therapy
description: Given per standard of care
arm group label: Arm A (ADT, docetaxel)
arm group label: Arm B (ADT, abiraterone acetate, prednisone)
other name: ADT
other name: Androgen Deprivation Therapy
other name: Anti-androgen Therapy
other name: Anti-androgen Treatment
other name: Antiandrogen Treatment
other name: Hormone Deprivation Therapy
other name: Hormone-Deprivation Therapy
intervention type: Drug
intervention name: Docetaxel
description: Given IV
arm group label: Arm A (ADT, docetaxel)
other name: Docecad
other name: RP56976
other name: Taxotere
other name: Taxotere Injection Concentrate
intervention type: Drug
intervention name: Prednisone
description: Given PO
arm group label: Arm B (ADT, abiraterone acetate, prednisone)
other name: .delta.1-Cortisone
other name: 1, 2-Dehydrocortisone
other name: Adasone
other name: Cortancyl
other name: Dacortin
other name: DeCortin
other name: Decortisyl
other name: Decorton
other name: Delta 1-Cortisone
other name: Delta-Dome
other name: Deltacortene
other name: Deltacortisone
other name: Deltadehydrocortisone
other name: Deltasone
other name: Deltison
other name: Deltra
other name: Econosone
other name: Lisacort
other name: Meprosona-F
other name: Metacortandracin
other name: Meticorten
other name: Ofisolona
other name: Orasone
other name: Panafcort
other name: Panasol-S
other name: Paracort
other name: PRED
other name: Predicor
other name: Predicorten
other name: Prednicen-M
other name: Prednicort
other name: Prednidib
other name: Prednilonga
other name: Predniment
other name: Prednisonum
other name: Prednitone
other name: Promifen
other name: Servisone
other name: SK-Prednisone
intervention type: Other
intervention name: Quality-of-Life Assessment
description: Ancillary studies
arm group label: Arm A (ADT, docetaxel)
arm group label: Arm B (ADT, abiraterone acetate, prednisone)
other name: Quality of Life Assessment
intervention type: Other
intervention name: Questionnaire Administration
description: Ancillary studies
arm group label: Arm A (ADT, docetaxel)
arm group label: Arm B (ADT, abiraterone acetate, prednisone)
criteria: 
gender: Male
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Benjamin Maughan, MD
role: Principal Investigator
affiliation: Huntsman Cancer Institute/ University of Utah
facility: 
country: United States
responsible party type: Sponsor
mesh term: Prostatic Neoplasms
mesh term: Hypersensitivity
mesh term: Ascorbic Acid
mesh term: Prednisone
mesh term: Cortisone
mesh term: Docetaxel
mesh term: Abiraterone Acetate
mesh term: Methyltestosterone
mesh term: Hormones
mesh term: Estrogens, Conjugated (USP)
mesh term: Androgens
mesh term: Androgen Antagonists
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 