<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/NCT02254785</url>
  </required_header>
  <id_info>
    <org_study_id>OZM-054</org_study_id>
    <nct_id>NCT02254785</nct_id>
  </id_info>
  <brief_title>Cabazitaxel vs Abiraterone or Enzalutamide in Patients With Poor Prognosis Metastatic Castration-resistant Prostate Cancer</brief_title>
  <official_title>A Phase II, Randomized, Multi-center Study of Cabazitaxel Versus Abiraterone or Enzalutamide in Poor Prognosis-metastatic Castration-resistant Prostate Cancer</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>British Columbia Cancer Agency</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Sanofi</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
    <collaborator>
      <agency>Ozmosis Research Inc.</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>British Columbia Cancer Agency</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to assess and compare the clinical benefit rate in patients with&#xD;
      metastatic castrate-resistant prostate cancer and poor prognostic factors treated with&#xD;
      cabazitaxel or novel hormonal agents (abiraterone or enzalutamide) as initial therapy, to&#xD;
      determine which treatment is most active in this population. Clinical benefit rate is defined&#xD;
      as PSA or measurable radiological response of any duration or stable disease for &gt; or equal&#xD;
      to 12 weeks, in the absence of other indicators of progression.&#xD;
&#xD;
      There is option to cross-over onto the other arm if the patient progresses.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Active, not recruiting</last_known_status>
  <start_date>October 2014</start_date>
  <completion_date type="Anticipated">May 2020</completion_date>
  <primary_completion_date type="Anticipated">May 2020</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>Clinical benefit rate</measure>
    <time_frame>12 weeks or more</time_frame>
    <description>To assess and compare the clinical benefit rate in patients with mCRPC and poor prognostic factors treated with cabazitaxel or novel hormonal agents (abiraterone or enzalutamide) as initial therapy, to determine which treatment is most active in this population. Clinical benefit rate is defined as PSA or measurable radiological response of any duration or stable disease for greater than or equal to 12 weeks, in the absence of other indicators of progression.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Duration of treatment time to progression</measure>
    <time_frame>12 weeks until disease progression</time_frame>
    <description>To measure the treatment time before any type of progression (symptomatic, PSA, or radiological) between Arm A and Arm B</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Progression Free Survival</measure>
    <time_frame>12 weeks until disease progression</time_frame>
    <description>To measure the progression-free survival of metastatic castration-resistant prostate cancer patients following treatment with cabazitaxel or abiraterone/enzalutamide as initial therapy.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Overall Survival</measure>
    <time_frame>12 weeks until 2 years after last study visit</time_frame>
    <description>To measure the overall survival of metastatic castration-resistant prostate cancer patients following treatment with cabazitaxel or abiraterone/enzalutamide as initial therapy.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">120</enrollment>
  <condition>Metastatic Castration-Resistant Prostatic Cancer</condition>
  <arm_group>
    <arm_group_label>Cabazitaxel</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Abiraterone or enzalutamide</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>cabazitaxel</intervention_name>
    <description>Cabazitaxel 25mg/m2 intravenous every 3 weeks until disease progression</description>
    <arm_group_label>Cabazitaxel</arm_group_label>
    <other_name>Jevtana</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Abiraterone</intervention_name>
    <description>Abiraterone 1000mg daily (oral) until disease progression</description>
    <arm_group_label>Abiraterone or enzalutamide</arm_group_label>
    <other_name>Zytiga</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Enzalutamide 160mg daily (oral)</intervention_name>
    <description>Enzalutamide 160mg daily (oral) until disease progression</description>
    <arm_group_label>Abiraterone or enzalutamide</arm_group_label>
    <other_name>Xtandi</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Histological diagnosis of prostate adenocarcinoma.&#xD;
&#xD;
          -  Able and willing to provide informed consent and to comply with the study procedures&#xD;
&#xD;
          -  Age ≥18&#xD;
&#xD;
          -  Evidence of metastatic disease on a chest, abdominal, or pelvic CT scan and/or bone&#xD;
             scan within 6 weeks of registration&#xD;
&#xD;
          -  Castration resistant disease defined as evidence of radiological and/or PSA&#xD;
             progression despite castrate levels of testosterone (serum testosterone &lt; 50 ng/dL&#xD;
             (1.7 nmol/L)). For PSA progression, there must be at least 2 sequential rises at a&#xD;
             minimum of 1-week intervals. The first PSA value must be ≥ 2. (Prostate Cancer Working&#xD;
             Group 2 (PCWG2) criteria)&#xD;
&#xD;
          -  Poor prognosis disease as defined by any of the following:&#xD;
&#xD;
        the presence of liver metastases OR development of castration-resistance within 12 months&#xD;
        of orchiectomy or commencement of LHRH antagonist/agonist for metastatic disease OR the&#xD;
        presence of 4 or more of the following factors:&#xD;
&#xD;
          -  LDH &gt; ULN&#xD;
&#xD;
          -  ECOG Performance status (PS) 2&#xD;
&#xD;
          -  visceral metastatic disease&#xD;
&#xD;
          -  serum albumin less than or equal to 4 g/dL&#xD;
&#xD;
          -  ALP &gt; ULN&#xD;
&#xD;
          -  or &lt; 36 months from commencement of initial androgen deprivation therapy to study&#xD;
             enrollment&#xD;
&#xD;
          -  ECOG PS 0-2.&#xD;
&#xD;
          -  Adequate end-organ function within 14 days of registration:&#xD;
&#xD;
        Haemoglobin ≥ 90 g/L Neutrophils ≥ 1.5 x 109 /L Platelets ≥ 100 x 109/L AST &lt; 1.5 x ULN ALT&#xD;
        &lt; 1.5 x ULN Bilirubin ≤ 1.0 x ULN (exceptions for Gilbert's syndrome) Creatinine ≤ 1.5 x&#xD;
        ULN&#xD;
&#xD;
          -  At least 21 days have passed since completing radiotherapy (exception for&#xD;
             radiotherapy: at least 7 days since completing a single fraction of ≤ 800 cGy to a&#xD;
             restricted field or limited-field radiotherapy to non-marrow bearing area such as an&#xD;
             extremity or orbit) at the time of randomization.&#xD;
&#xD;
          -  At least 21 days have passed since receiving any investigational agent at the time of&#xD;
             registration.&#xD;
&#xD;
          -  At least 21 days have passed since major surgery.&#xD;
&#xD;
          -  Neuropathy ≤ grade 1 at the time of registration.&#xD;
&#xD;
          -  Has recovered from all therapy-related toxicity to ≤ grade 2 (except alopecia, anemia&#xD;
             and any signs or symptoms of androgen deprivation therapy) at the time of&#xD;
             registration.&#xD;
&#xD;
          -  Eligible for abiraterone acetate and/or enzalutamide as per standard of care&#xD;
             practices.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Histologic evidence of small cell/neuroendocrine prostate cancer.&#xD;
&#xD;
          -  Other chemotherapy regimen beyond one prior course of docetaxel.&#xD;
&#xD;
          -  Previously received treatment with cabazitaxel.&#xD;
&#xD;
          -  Received any prior next-generation anti-androgen (e.g. enzalutamide, ARN-509) or CYP&#xD;
             17 inhibitors (e.g. abiraterone, TAK-700).&#xD;
&#xD;
          -  Other condition, illness, psychiatric condition, or laboratory abnormality that may&#xD;
             increase the risk associated with administration of cabazitaxel, abiraterone or&#xD;
             enzalutamide, study participation, or may interfere with the interpretation of study&#xD;
             results and in the judgment of the investigator would make the patient inappropriate&#xD;
             for entry into this study.&#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>Kim N Chi, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>British Columbia Cancer Agency</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Box Hill Hospital</name>
      <address>
        <city>Box Hill</city>
        <state>Victoria</state>
        <zip>3128</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Monash Health-Monash Medical Centre</name>
      <address>
        <city>Clayton</city>
        <state>Victoria</state>
        <zip>3168</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Peter MacCallum Cancer Centre</name>
      <address>
        <city>Melbourne</city>
        <state>Victoria</state>
        <zip>3000</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Tom Baker Cancer Cantre</name>
      <address>
        <city>Calgary</city>
        <state>Alberta</state>
        <zip>T2N 4N2</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cross Cancer Institute</name>
      <address>
        <city>Edmonton</city>
        <state>Alberta</state>
        <zip>T6G 1Z2</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>BCCA - Kelowna</name>
      <address>
        <city>Kelowna</city>
        <state>British Columbia</state>
        <zip>V1Y 5J3</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>BCCA- Vancouver Center</name>
      <address>
        <city>Vancouver</city>
        <state>British Columbia</state>
        <zip>V5Z 4E6</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CancerCare Manitoba</name>
      <address>
        <city>Winnipeg</city>
        <state>Manitoba</state>
        <zip>R3E 0V9</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>QEII Health Sciences Centre</name>
      <address>
        <city>Halifax</city>
        <state>Nova Scotia</state>
        <zip>B3H 1V7</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Juravinski Cancer Centre</name>
      <address>
        <city>Hamilton</city>
        <state>Ontario</state>
        <zip>L8V 5C2</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Durham Regional Cancer Centre (Lakeridge Health)</name>
      <address>
        <city>Oshawa</city>
        <state>Ontario</state>
        <zip>L1G 2B9</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Ottawa Hospital Cancer Centre</name>
      <address>
        <city>Ottawa</city>
        <state>Ontario</state>
        <zip>K1H 8L6</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Princess Margaret Cancer Centre</name>
      <address>
        <city>Toronto</city>
        <state>Ontario</state>
        <zip>M5G 2M9</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Jewish General Hospital</name>
      <address>
        <city>Montreal</city>
        <state>Quebec</state>
        <zip>H3T 1E2</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Saskatoon Cancer Center</name>
      <address>
        <city>Saskatoon</city>
        <state>Saskatchewan</state>
        <zip>27N 4H4</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Australia</country>
    <country>Canada</country>
  </location_countries>
  <verification_date>December 2017</verification_date>
  <study_first_submitted>September 30, 2014</study_first_submitted>
  <study_first_submitted_qc>October 1, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 2, 2014</study_first_posted>
  <last_update_submitted>December 4, 2017</last_update_submitted>
  <last_update_submitted_qc>December 4, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">December 6, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>poor prognosis</keyword>
  <keyword>castrate-resistant prostate cancer</keyword>
  <keyword>cabazitaxel</keyword>
  <keyword>abiraterone</keyword>
  <keyword>enzalutamide</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Prostatic Neoplasms</mesh_term>
    <mesh_term>Prostatic Neoplasms, Castration-Resistant</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</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/NCT02254785
org study id: OZM-054
nct id: NCT02254785
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
The purpose of this study is to assess and compare the clinical benefit rate in patients with
      metastatic castrate-resistant prostate cancer and poor prognostic factors treated with
      cabazitaxel or novel hormonal agents (abiraterone or enzalutamide) as initial therapy, to
      determine which treatment is most active in this population. Clinical benefit rate is defined
      as PSA or measurable radiological response of any duration or stable disease for > or equal
      to 12 weeks, in the absence of other indicators of progression.

      There is option to cross-over onto the other arm if the patient progresses.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Clinical benefit rate
time frame: 12 weeks or more
description: To assess and compare the clinical benefit rate in patients with mCRPC and poor prognostic factors treated with cabazitaxel or novel hormonal agents (abiraterone or enzalutamide) as initial therapy, to determine which treatment is most active in this population. Clinical benefit rate is defined as PSA or measurable radiological response of any duration or stable disease for greater than or equal to 12 weeks, in the absence of other indicators of progression.
measure: Duration of treatment time to progression
time frame: 12 weeks until disease progression
description: To measure the treatment time before any type of progression (symptomatic, PSA, or radiological) between Arm A and Arm B
measure: Progression Free Survival
time frame: 12 weeks until disease progression
description: To measure the progression-free survival of metastatic castration-resistant prostate cancer patients following treatment with cabazitaxel or abiraterone/enzalutamide as initial therapy.
measure: Overall Survival
time frame: 12 weeks until 2 years after last study visit
description: To measure the overall survival of metastatic castration-resistant prostate cancer patients following treatment with cabazitaxel or abiraterone/enzalutamide as initial therapy.
arm group label: Cabazitaxel
arm group type: Experimental
arm group label: Abiraterone or enzalutamide
arm group type: Active Comparator
intervention type: Drug
intervention name: cabazitaxel
description: Cabazitaxel 25mg/m2 intravenous every 3 weeks until disease progression
arm group label: Cabazitaxel
other name: Jevtana
intervention type: Drug
intervention name: Abiraterone
description: Abiraterone 1000mg daily (oral) until disease progression
arm group label: Abiraterone or enzalutamide
other name: Zytiga
intervention type: Drug
intervention name: Enzalutamide 160mg daily (oral)
description: Enzalutamide 160mg daily (oral) until disease progression
arm group label: Abiraterone or enzalutamide
other name: Xtandi
criteria: 
gender: Male
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Kim N Chi, MD
role: Principal Investigator
affiliation: British Columbia Cancer Agency
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: Australia
country: Canada
responsible party type: Sponsor
mesh term: Prostatic Neoplasms
mesh term: Prostatic Neoplasms, Castration-Resistant