<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/NCT04409288</url>
  </required_header>
  <id_info>
    <org_study_id>56021927PCR3012</org_study_id>
    <nct_id>NCT04409288</nct_id>
  </id_info>
  <brief_title>Patient Preference of Apalutamide Versus Enzalutamide in Patients With Recurrent or Metastatic Hormone-Sensitive Prostate Cancer</brief_title>
  <official_title>Patient Preference of Apalutamide Versus Enzalutamide in Patients With Recurrent or Metastatic Hormone-Sensitive Prostate Cancer: An Open-label, Randomized, Cross-Over Trial.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Chinese University of Hong Kong</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Janssen, LP</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Chinese University of Hong Kong</source>
  <oversight_info>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>Yes</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is a prospective, open-label, randomized, controlled, cross-over trial assessing patient&#xD;
      preference for apalutamide versus enzalutamide in 146 male patients with recurrent or&#xD;
      metastatic hormone-sensitive prostate cancer. The primary objective is to investigate whether&#xD;
      there is any difference in patient preference between apalutamide and enzalutamide in&#xD;
      patients with recurrent or metastatic hormone-sensitive prostate cancer.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a prospective, open-label, randomized, controlled, cross-over trial assessing patient&#xD;
      preference for apalutamide versus enzalutamide in 146 male patients with recurrent or&#xD;
      metastatic hormone-sensitive prostate cancer The primary outcome is patient preference, which&#xD;
      serves as an indicator covering different aspects of treatment-related effects, and this&#xD;
      would be most important in a patient's perspective. The quality of life, psychological and&#xD;
      cognitive changes following apalutamide and enzalutamide in a comprehensive manner will be&#xD;
      investigated.&#xD;
&#xD;
      Patient will receive two 12-weeks treatment periods with a 5-week wash-out period between the&#xD;
      treatment periods. Patients will receive Apalutamide and Enzulutamide sequentially. Patient,&#xD;
      physician and caregiver preferences will be assessed at the end of the second treatment&#xD;
      period. Other secondary outcomes on health-related quality of life measures, psychological&#xD;
      assessment scores and cognitive assessment scores shall be assessed before and the end of&#xD;
      first treatment and second treatment period.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">July 20, 2020</start_date>
  <completion_date type="Anticipated">December 31, 2023</completion_date>
  <primary_completion_date type="Anticipated">July 31, 2023</primary_completion_date>
  <phase>Phase 3</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Crossover Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Patient Preference Questionnaire</measure>
    <time_frame>Week 29 (at the end of second treatment)</time_frame>
    <description>This Patient Preference Questionnaire consists of 4 questions, assessing the patients preference on Apalutamide verse Enzalutamide, the factors that had an influence on their treatment preference, the most important reason for their preference and the side effect of first treatment and second treatment.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>The side effect profile as assessed Patient Preference Questionnaire</measure>
    <time_frame>Baseline to week 29 (the end of the study)</time_frame>
    <description>In Patient Preference Questionnaire, participants completed a sideffect checklist.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Physician Preference Questionnaire</measure>
    <time_frame>Week 29 (at the end of second treatment)</time_frame>
    <description>This Physician Preference Questionnaire consists of 3 questions, assessing the physicians preference on Apalutamide verse Enzalutamide, the factors that had an influence on their treatment preference, the most important reason for their preference.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Caregiver Preference Questionnaire</measure>
    <time_frame>Week 29 (at the end of second treatment)</time_frame>
    <description>This Caregiver Preference Questionnaire consists of 3 questions, assessing the caregivers preference on Apalutamide verse Enzalutamide, the factors that had an influence on their treatment preference, the most important reason for their preference.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The Functional Assessment of Cancer Therapy-Prostate Questionnaire (FACT-P)</measure>
    <time_frame>Week 0 (before start of first treatment period), Week 12 (end of first treatment period), week 17 (before start of second treatment period) and Week 29 (end of second treatment period).</time_frame>
    <description>This is a 39-item questionnaire assessing five domains including Physical Well-Being, Social and Family Well-Being, Emotional Well-Being, Functional Well-Being and Prostate Cancer Subscale.The higher the score, the better the QOL</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality of life measured by EurolQol instrument (EQ-5D-5L)</measure>
    <time_frame>Week 0 (before start of first treatment period), Week 12 (end of first treatment period), week 17 (before start of second treatment period) and Week 29 (end of second treatment period</time_frame>
    <description>This questionnaire consists of two parts, namely the EQ-5D-5L Descriptive System and the EQ Visual Analog Scale, the higher the score the better in quality of life</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>FACT-Cognitive Function Version 3 (FACT-Cog)</measure>
    <time_frame>Week 0 (before start of first treatment period), Week 12 (end of first treatment period), week 17 (before start of second treatment period) and Week 29 (end of second treatment period</time_frame>
    <description>This is a well-established 37-item questionnaire assessing patients' perceived cognitive impairments, perceived cognitive abilities, noticeability or comments from others, and impact of cognitive changes on quality of life. The higher the score, the better the QOL.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Brief Fatigue Inventory (BFI)</measure>
    <time_frame>Week 0 (before start of first treatment period), Week 12 (end of first treatment period), week 17 (before start of second treatment period) and Week 29 (end of second treatment period</time_frame>
    <description>This is a well-established 9-item questionnaire assessing patients' degree of fatigue.The higher the score, the higher fatigue level</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">146</enrollment>
  <condition>Prostate Cancer</condition>
  <arm_group>
    <arm_group_label>Group A</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Apalutamide followed by Enzalutamide Study participants will receive 12 weeks of oral apalutamide (240mg) daily, followed by five weeks of washout period, and then 12 weeks of oral enzalutamide (160mg) daily.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group B</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Enzalutamide followed by Apalutamide Study participants will receive 12 weeks of oral enzalutamide (160mg) daily, followed by five weeks of washout period, and then 12 weeks of oral apalutamide (240mg) daily.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Apalutamide</intervention_name>
    <description>Androgen receptor inhibitor.</description>
    <arm_group_label>Group A</arm_group_label>
    <arm_group_label>Group B</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Enzalutamide</intervention_name>
    <description>Androgern receptor inhibitor</description>
    <arm_group_label>Group A</arm_group_label>
    <arm_group_label>Group B</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. 18 years old or above with informed consent&#xD;
&#xD;
          2. Histological diagnosis of adenocarcinoma of the prostate without neuroendocrine&#xD;
             differentiation, signet cell, or small cell features&#xD;
&#xD;
          3. Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2&#xD;
&#xD;
          4. Androgen deprivation therapy started at least 28 days prior to randomization&#xD;
&#xD;
          5. Patients should be having one of the following diseases and treatment conditions:&#xD;
&#xD;
               1. Recurrent prostate cancer following radical prostatectomy or radiotherapy, which&#xD;
                  do not fall into high-risk or high-volume categories&#xD;
&#xD;
               2. Metastatic hormone-sensitive prostate cancer, which do not fall into high-risk or&#xD;
                  high-volume categories&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Patients with high-volume metastatic hormone-sensitive prostate cancer, defined by the&#xD;
             presence of visceral metastases or four or more bone lesions with at least one beyond&#xD;
             the vertebral bodies and pelvis&#xD;
&#xD;
          2. Patients with high-risk metastatic hormone-sensitive prostate cancer, defined by&#xD;
             having at least two of the three following factors - a Gleason score above 7, having&#xD;
             at least 3 bone metastasis or presence of measurable visceral metastasis&#xD;
&#xD;
          3. Presence of brain metastasis&#xD;
&#xD;
          4. Use of bisphosphonate or denosumab within 28 days prior to randomization&#xD;
&#xD;
          5. Use of older anti-androgens, including flutamide and bicalutamide, for flare&#xD;
             protection, within 28 days prior to randomization&#xD;
&#xD;
          6. Prior use of chemotherapy, immunotherapy, radiopharmaceutical agents, CYP17 inhibitors&#xD;
             (e.g. abiraterone acetate), enzalutamide or apalutamide for the treatment of prostate&#xD;
             cancer or prior participation in a clinical trial of an investigational agent that&#xD;
             inhibits the androgen receptor or androgen synthesis&#xD;
&#xD;
          7. History of seizure or any condition that may predispose to seizure (e.g., neurological&#xD;
             disorder, prior cortical stroke or significant brain trauma)&#xD;
&#xD;
          8. Use of an investigational agent within 4 weeks of randomization&#xD;
&#xD;
          9. Hypersensitivity reaction to the active pharmaceutical ingredient&#xD;
&#xD;
         10. Clinically significant cardiovascular disease including the following:&#xD;
&#xD;
               1. Myocardial infarction within 6 months before screening;&#xD;
&#xD;
               2. Uncontrolled angina within 3 months before screening;&#xD;
&#xD;
               3. Congestive heart failure New York Heart Association class 3 or 4, or a history of&#xD;
                  congestive heart failure New York Heart Association class 3 or 4, unless a&#xD;
                  screening echocardiogram or multigated acquisition scan performed within 3 months&#xD;
                  before randomization demonstrates a left ventricular ejection fraction ≥ 50%;&#xD;
&#xD;
               4. History of clinically significant ventricular arrhythmias (e.g. sustained&#xD;
                  ventricular tachycardia, ventricular fibrillation, torsades de pointes);&#xD;
&#xD;
               5. History of Mobitz II second-degree or third-degree heart block without a&#xD;
                  permanent pacemaker in place;&#xD;
&#xD;
               6. Hypotension as indicated by systolic blood pressure &lt; 86 millimeters of mercury&#xD;
                  (mm Hg) at screening;&#xD;
&#xD;
               7. Bradycardia as indicated by a heart rate of &lt; 45 beats per minute on the&#xD;
                  screening electrocardiogram and on physical examination;&#xD;
&#xD;
               8. Uncontrolled hypertension as indicated by systolic blood pressure &gt; 170 mm Hg or&#xD;
                  diastolic blood pressure &gt; 105 mm Hg at screening&#xD;
&#xD;
         11. Gastrointestinal disorder affecting absorption (e.g., gastrectomy, active peptic ulcer&#xD;
             disease within 3 months before randomization)&#xD;
&#xD;
         12. Major surgery within 28 days of randomization&#xD;
&#xD;
         13. Any concurrent disease, infection, or comorbid condition that interferes with the&#xD;
             ability of the patient to participate in the trial, which places the patient at undue&#xD;
             risk, or complicates the interpretation of data, in the opinion of the investigator&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <gender_based>Yes</gender_based>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Chi Fai NG, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Chinese University of Hong Kong</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Chi Fai NG, MD</last_name>
    <phone>35052625</phone>
    <email>ngcf@surgery.cuhk.edu.hk</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Pui Tak LAI, BN</last_name>
    <phone>35051663</phone>
    <email>francolai@surgery.cuhk.edu.hk</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Prince of Wales Hospital</name>
      <address>
        <city>Shatin</city>
        <country>Hong Kong</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Chi Fai NG, MD</last_name>
      <phone>3505 2625</phone>
      <email>ngcf@surgery.cuhk.edu.hk</email>
    </contact>
  </location>
  <location_countries>
    <country>Hong Kong</country>
  </location_countries>
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  <verification_date>February 2023</verification_date>
  <study_first_submitted>May 27, 2020</study_first_submitted>
  <study_first_submitted_qc>May 27, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 1, 2020</study_first_posted>
  <last_update_submitted>February 8, 2023</last_update_submitted>
  <last_update_submitted_qc>February 8, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">February 10, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Chinese University of Hong Kong</investigator_affiliation>
    <investigator_full_name>Chi Fai NG</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <keyword>Patient Preference</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Prostatic Neoplasms</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT04409288
org study id: 56021927PCR3012
nct id: NCT04409288
lead sponsor: 
collaborator: 
is fda regulated drug: Yes
is fda regulated device: No
is us export: Yes
This is a prospective, open-label, randomized, controlled, cross-over trial assessing patient
      preference for apalutamide versus enzalutamide in 146 male patients with recurrent or
      metastatic hormone-sensitive prostate cancer. The primary objective is to investigate whether
      there is any difference in patient preference between apalutamide and enzalutamide in
      patients with recurrent or metastatic hormone-sensitive prostate cancer.
This is a prospective, open-label, randomized, controlled, cross-over trial assessing patient
      preference for apalutamide versus enzalutamide in 146 male patients with recurrent or
      metastatic hormone-sensitive prostate cancer The primary outcome is patient preference, which
      serves as an indicator covering different aspects of treatment-related effects, and this
      would be most important in a patient's perspective. The quality of life, psychological and
      cognitive changes following apalutamide and enzalutamide in a comprehensive manner will be
      investigated.

      Patient will receive two 12-weeks treatment periods with a 5-week wash-out period between the
      treatment periods. Patients will receive Apalutamide and Enzulutamide sequentially. Patient,
      physician and caregiver preferences will be assessed at the end of the second treatment
      period. Other secondary outcomes on health-related quality of life measures, psychological
      assessment scores and cognitive assessment scores shall be assessed before and the end of
      first treatment and second treatment period.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Patient Preference Questionnaire
time frame: Week 29 (at the end of second treatment)
description: This Patient Preference Questionnaire consists of 4 questions, assessing the patients preference on Apalutamide verse Enzalutamide, the factors that had an influence on their treatment preference, the most important reason for their preference and the side effect of first treatment and second treatment.
measure: The side effect profile as assessed Patient Preference Questionnaire
time frame: Baseline to week 29 (the end of the study)
description: In Patient Preference Questionnaire, participants completed a sideffect checklist.
measure: Physician Preference Questionnaire
time frame: Week 29 (at the end of second treatment)
description: This Physician Preference Questionnaire consists of 3 questions, assessing the physicians preference on Apalutamide verse Enzalutamide, the factors that had an influence on their treatment preference, the most important reason for their preference.
measure: Caregiver Preference Questionnaire
time frame: Week 29 (at the end of second treatment)
description: This Caregiver Preference Questionnaire consists of 3 questions, assessing the caregivers preference on Apalutamide verse Enzalutamide, the factors that had an influence on their treatment preference, the most important reason for their preference.
measure: The Functional Assessment of Cancer Therapy-Prostate Questionnaire (FACT-P)
time frame: Week 0 (before start of first treatment period), Week 12 (end of first treatment period), week 17 (before start of second treatment period) and Week 29 (end of second treatment period).
description: This is a 39-item questionnaire assessing five domains including Physical Well-Being, Social and Family Well-Being, Emotional Well-Being, Functional Well-Being and Prostate Cancer Subscale.The higher the score, the better the QOL
measure: Quality of life measured by EurolQol instrument (EQ-5D-5L)
time frame: Week 0 (before start of first treatment period), Week 12 (end of first treatment period), week 17 (before start of second treatment period) and Week 29 (end of second treatment period
description: This questionnaire consists of two parts, namely the EQ-5D-5L Descriptive System and the EQ Visual Analog Scale, the higher the score the better in quality of life
measure: FACT-Cognitive Function Version 3 (FACT-Cog)
time frame: Week 0 (before start of first treatment period), Week 12 (end of first treatment period), week 17 (before start of second treatment period) and Week 29 (end of second treatment period
description: This is a well-established 37-item questionnaire assessing patients' perceived cognitive impairments, perceived cognitive abilities, noticeability or comments from others, and impact of cognitive changes on quality of life. The higher the score, the better the QOL.
measure: Brief Fatigue Inventory (BFI)
time frame: Week 0 (before start of first treatment period), Week 12 (end of first treatment period), week 17 (before start of second treatment period) and Week 29 (end of second treatment period
description: This is a well-established 9-item questionnaire assessing patients' degree of fatigue.The higher the score, the higher fatigue level
arm group label: Group A
arm group type: Experimental
description: Apalutamide followed by Enzalutamide Study participants will receive 12 weeks of oral apalutamide (240mg) daily, followed by five weeks of washout period, and then 12 weeks of oral enzalutamide (160mg) daily.
arm group label: Group B
arm group type: Experimental
description: Enzalutamide followed by Apalutamide Study participants will receive 12 weeks of oral enzalutamide (160mg) daily, followed by five weeks of washout period, and then 12 weeks of oral apalutamide (240mg) daily.
intervention type: Drug
intervention name: Apalutamide
description: Androgen receptor inhibitor.
arm group label: Group A
arm group label: Group B
intervention type: Drug
intervention name: Enzalutamide
description: Androgern receptor inhibitor
arm group label: Group A
arm group label: Group B
criteria: 
gender: Male
gender based: Yes
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Chi Fai NG, MD
role: Principal Investigator
affiliation: Chinese University of Hong Kong
last name: Chi Fai NG, MD
phone: 35052625
email: ngcf@surgery.cuhk.edu.hk
last name: Pui Tak LAI, BN
phone: 35051663
email: francolai@surgery.cuhk.edu.hk
facility: 
status: Recruiting
contact: 
country: Hong Kong
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responsible party type: Principal Investigator
investigator affiliation: Chinese University of Hong Kong
investigator full name: Chi Fai NG
investigator title: Professor
mesh term: Prostatic Neoplasms
sharing ipd: No