xml: <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/NCT06015321</url>
    </required_header>
    <id_info>
      <org_study_id>2023-07-103</org_study_id>
      <nct_id>NCT06015321</nct_id>
    </id_info>
    <brief_title>An Open Label Phase II Study of First-Line Maintenance Enzalutamide Following Docetaxel Plus Androgen-Deprivation Therapy in Patients With Previously-Untreated, Metastatic, Castration-Naive Prostatic Adenocarcinoma</brief_title>
    <official_title>Open Label Trial of Maintenance Enzalutamide in CRPC</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Samsung Medical Center</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Samsung Medical Center</source>
    <oversight_info>
      <has_dmc>No</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        Although surgical or medical castration (i.e., androgen-deprivation therapy, ADT) is&#xD;
        considered standard treatment in metastatic castration-naïve PC (mCNPC) patients, current&#xD;
        guidelines have established the addition docetaxel or modern androgen receptor targeting&#xD;
        agents (ARTAs; abiraterone acetate or enzalutamide) to ADT as the standard of care for&#xD;
        patients with mCNPC [1,2]. One of the major challenges in the management of mCNPC includes&#xD;
        balancing the toxicity of first-line docetaxel with clinical benefit. Our previous clinical&#xD;
        studies suggested that the tolerability of docetaxel could be improved by using a biweekly&#xD;
        regimen [3,4], without compromising efficacy. There is a growing interest in maintenance&#xD;
        therapy as a strategy for prolonging the benefit of first-line therapy while minimizing&#xD;
        long-term toxicity. In phase III trials involving first-line enzalutamide in mCNPC (ENZAMET&#xD;
        and ARCHES), earlier treatment with docetaxel was permitted [5,6]. Based on these&#xD;
        considerations, we hypothesized that enzalutamide maintenance therapy would improve outcomes&#xD;
        in patients who had received first-line biweekly docetaxel plus ADT for mCNPC.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        1. Patients will receive docetaxel 40 mg/m2 IV every 2 weeks plus ADT. Docetaxel will be&#xD;
             repeated on an outpatient basis and continued until disease progression, unacceptable&#xD;
             toxicity, deterioration of clinical condition, patient refusal, or up to 6 to 8 cycles.&#xD;
             ADT includes commercially available GNRH agonists such as goserelin, leuprolide and&#xD;
             triptorelin, according to their market authorized approved label.&#xD;
  &#xD;
          2. After the receipt of 6 to 8 cycles of first-line docetaxel plus ADT, patients with no&#xD;
             evidence of disease progression (i.e., biochemical and clinical) will receive&#xD;
             enzalutamide 160 mg PO daily. Enzalutamide will be continued until disease progression&#xD;
             (i.e., development of mCRPC), unacceptable toxicity, deterioration of clinical&#xD;
             condition, patient refusal.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">October 1, 2023</start_date>
    <completion_date type="Anticipated">April 30, 2026</completion_date>
    <primary_completion_date type="Anticipated">October 31, 2025</primary_completion_date>
    <phase>Phase 2</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>N/A</allocation>
      <intervention_model>Single Group Assignment</intervention_model>
      <primary_purpose>Treatment</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Time-to-CRPC (biochemical or clinical)</measure>
      <time_frame>up tp 30months</time_frame>
      <description>RECIST v1.1 criteria will be used to assess patient response to treatment</description>
    </primary_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Anticipated">51</enrollment>
    <condition>Prostatic Adenocarcinoma</condition>
    <arm_group>
      <arm_group_label>Enzalutamide</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>First-Line Maintenance Enzalutamide Following Docetaxel plus Androgen-Deprivation Therapy in Patients with Previously-Untreated, Metastatic, Castration-Naïve Prostatic Adenocarcinoma</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Enzalutamide</intervention_name>
      <description>enzalutamide 160 mg PO daily</description>
      <arm_group_label>Enzalutamide</arm_group_label>
      <other_name>XtandiTM</other_name>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  For inclusion of a subject in the study, all of the following inclusion criteria must&#xD;
               be fulfilled:&#xD;
  &#xD;
                 1. Subject is a male at least 20 years of age.&#xD;
  &#xD;
                 2. Subject has a histologically or cytologically confirmed diagnosis of&#xD;
                    adenocarcinoma of prostate.&#xD;
  &#xD;
                 3. Subject has radiologic and clinical evidence of metastatic disease initially or&#xD;
                    after treatment for localized disease. They must have metastatic or progressive&#xD;
                    disease for which there is no further curative treatment available.&#xD;
  &#xD;
                 4. Subject has an ECOG performance status of 0 to 1.&#xD;
  &#xD;
                 5. Subject has a life expectancy of 3 months or more.&#xD;
  &#xD;
                 6. At least 4 weeks since the last surgical procedures or radiotherapy prior to&#xD;
                    enrolment. Subjects must have recovered to &lt;Grade 2 from all acute toxicities or&#xD;
                    toxicity must be deemed irreversible by the investigator.&#xD;
  &#xD;
                 7. Acceptable liver function:&#xD;
  &#xD;
                 8. Acceptable renal function&#xD;
  &#xD;
                 9. Acceptable hematologic status (without growth factor support or transfusion&#xD;
                    dependency):&#xD;
  &#xD;
                10. Subject must agree to use an adequate method of contraception (condom) if he is&#xD;
                    having sex with a woman of childbearing potential or with a woman who is&#xD;
                    pregnant.&#xD;
  &#xD;
                11. Written and voluntary informed consent understood, signed and dated.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
          For inclusion of a subject in the study, any of the following inclusion criteria must not&#xD;
          be fulfilled:&#xD;
  &#xD;
            1. Ongoing treatment with an anticancer agent not contemplated in this protocol&#xD;
  &#xD;
            2. Pathologic finding consistent with neuroendocrine or small cell carcinoma&#xD;
  &#xD;
            3. Any history of clinically relevant coronary artery disease or myocardial infarction&#xD;
               within the last 3 years, New York Heart Association (NYHA) grade III or greater&#xD;
               congestive heart failure, cerebrovascular attack within the prior year, or current&#xD;
               serious cardiac arrhythmia requiring medication except atrial fibrillation.&#xD;
  &#xD;
            4. Known uncontrolled brain, leptomeningeal or epidural metastases (unless treated and&#xD;
               well controlled for at least 4 weeks prior to Cycle 1 Day 1). Subjects that develop&#xD;
               brain metastasis during the study may have their treatment interrupted to receive a&#xD;
               course of cranial radiation and restart trial medication after a recovery period of at&#xD;
               least 1 week. High dose corticosteroids may be employed for the management of cranial&#xD;
               radiation but must be tapered off before resuming treatment.&#xD;
  &#xD;
            5. Non-tolerable &gt;Grade 2 neuropathy or evidence of unstable neurological symptoms within&#xD;
               4 weeks of Cycle 1 Day 1.&#xD;
  &#xD;
            6. Major surgery, other than diagnostic surgery, within 4 weeks prior to Cycle 1 Day 1,&#xD;
               without complete recovery.&#xD;
  &#xD;
            7. Active, uncontrolled bacterial, viral, or fungal infections, requiring systemic&#xD;
               therapy.&#xD;
  &#xD;
            8. Subjects who have exhibited allergic reactions to taxanes.&#xD;
  &#xD;
            9. Concomitant disease or condition that could interfere with the conduct of the study,&#xD;
               or that would, in the opinion of the Investigator, pose an unacceptable risk to the&#xD;
               subject in this study.&#xD;
  &#xD;
           10. The subject has legal incapacity or limited legal capacity. Dementia or significantly&#xD;
               altered mental status that would limit the understanding or rendering of informed&#xD;
               consent and compliance with the requirements of this protocol. Unwillingness or&#xD;
               inability to comply with the study protocol for any reason.&#xD;
        </textblock>
      </criteria>
      <gender>Male</gender>
      <gender_based>Yes</gender_based>
      <gender_description>Subject is a male at least 20 years of age</gender_description>
      <minimum_age>20 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>Sung Hee Lim, MD,Ph.D.</last_name>
      <phone>10-2018-9305</phone>
      <phone_ext>82</phone_ext>
      <email>sunghee1022.lim@samsung.com</email>
    </overall_contact>
    <location>
      <facility>
        <name>Samsung Medical Center</name>
        <address>
          <city>Seoul</city>
          <state>Korea</state>
          <zip>06531</zip>
          <country>Korea, Republic of</country>
        </address>
      </facility>
      <contact>
        <last_name>Mijin Lee</last_name>
        <phone>82-2-2008-4436</phone>
      </contact>
      <investigator>
        <last_name>Sung Hee Lim, MD, Ph.D.</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location_countries>
      <country>Korea, Republic of</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 23, 2023</study_first_submitted>
    <study_first_submitted_qc>August 23, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 29, 2023</study_first_posted>
    <last_update_submitted>August 23, 2023</last_update_submitted>
    <last_update_submitted_qc>August 23, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 29, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Samsung Medical Center</investigator_affiliation>
      <investigator_full_name>Sung Hee Lim</investigator_full_name>
      <investigator_title>Samsung Medical Center</investigator_title>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Adenocarcinoma</mesh_term>
      <mesh_term>Prostatic Neoplasms</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>Yes</sharing_ipd>
      <ipd_info_type>Clinical Study Report (CSR)</ipd_info_type>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06015321
  org study id: 2023-07-103
  nct id: NCT06015321
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  Although surgical or medical castration (i.e., androgen-deprivation therapy, ADT) is
        considered standard treatment in metastatic castration-naïve PC (mCNPC) patients, current
        guidelines have established the addition docetaxel or modern androgen receptor targeting
        agents (ARTAs; abiraterone acetate or enzalutamide) to ADT as the standard of care for
        patients with mCNPC [1,2]. One of the major challenges in the management of mCNPC includes
        balancing the toxicity of first-line docetaxel with clinical benefit. Our previous clinical
        studies suggested that the tolerability of docetaxel could be improved by using a biweekly
        regimen [3,4], without compromising efficacy. There is a growing interest in maintenance
        therapy as a strategy for prolonging the benefit of first-line therapy while minimizing
        long-term toxicity. In phase III trials involving first-line enzalutamide in mCNPC (ENZAMET
        and ARCHES), earlier treatment with docetaxel was permitted [5,6]. Based on these
        considerations, we hypothesized that enzalutamide maintenance therapy would improve outcomes
        in patients who had received first-line biweekly docetaxel plus ADT for mCNPC.
  1. Patients will receive docetaxel 40 mg/m2 IV every 2 weeks plus ADT. Docetaxel will be
             repeated on an outpatient basis and continued until disease progression, unacceptable
             toxicity, deterioration of clinical condition, patient refusal, or up to 6 to 8 cycles.
             ADT includes commercially available GNRH agonists such as goserelin, leuprolide and
             triptorelin, according to their market authorized approved label.
  
          2. After the receipt of 6 to 8 cycles of first-line docetaxel plus ADT, patients with no
             evidence of disease progression (i.e., biochemical and clinical) will receive
             enzalutamide 160 mg PO daily. Enzalutamide will be continued until disease progression
             (i.e., development of mCRPC), unacceptable toxicity, deterioration of clinical
             condition, patient refusal.
  allocation: N/A
  intervention model: Single Group Assignment
  primary purpose: Treatment
  masking: None (Open Label)
  measure: Time-to-CRPC (biochemical or clinical)
  time frame: up tp 30months
  description: RECIST v1.1 criteria will be used to assess patient response to treatment
  arm group label: Enzalutamide
  arm group type: Experimental
  description: First-Line Maintenance Enzalutamide Following Docetaxel plus Androgen-Deprivation Therapy in Patients with Previously-Untreated, Metastatic, Castration-Naïve Prostatic Adenocarcinoma
  intervention type: Drug
  intervention name: Enzalutamide
  description: enzalutamide 160 mg PO daily
  arm group label: Enzalutamide
  other name: XtandiTM
  criteria: 
  gender: Male
  gender based: Yes
  gender description: Subject is a male at least 20 years of age
  minimum age: 20 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Sung Hee Lim, MD,Ph.D.
  phone: 10-2018-9305
  phone ext: 82
  email: sunghee1022.lim@samsung.com
  facility: 
  contact: 
  investigator: 
  country: Korea, Republic of
  responsible party type: Principal Investigator
  investigator affiliation: Samsung Medical Center
  investigator full name: Sung Hee Lim
  investigator title: Samsung Medical Center
  mesh term: Adenocarcinoma
  mesh term: Prostatic Neoplasms
  sharing ipd: Yes
  ipd info type: Clinical Study Report (CSR)