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/NCT05983783</url>
    </required_header>
    <id_info>
      <org_study_id>2023-SR-376</org_study_id>
      <nct_id>NCT05983783</nct_id>
    </id_info>
    <brief_title>Comparing the Efficacy and Safety of Rezvilutamide+ADT+Docetaxel Versus Rezvilutamide +ADT in the mHSPC</brief_title>
    <official_title>A Prospective Randomized Controlled Study Comparing the Efficacy and Safety of Rezvilutamide+ADT+Docetaxel Versus Rezvilutamide +ADT in the Treatment of Patients With Metastatic Hormone-sensitive Prostate Cancer (mHSPC)</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>The First Affiliated Hospital with Nanjing Medical University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>The First Affiliated Hospital with Nanjing Medical University</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>
        Evaluate whether the combination of Rezvilutamide and androgen deprivation therapy (ADT) with&#xD;
        docetaxel improves overall survival (OS) in patients with metastatic hormone-sensitive&#xD;
        prostate cancer (mHSPC) compared to the combination of Rezvilutamide and ADT.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        To investigate the value of chemotherapy in the treatment of high-burden of mHSPC on the&#xD;
        background of next-genertion of AR inhibitors.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">August 1, 2023</start_date>
    <completion_date type="Anticipated">December 31, 2027</completion_date>
    <primary_completion_date type="Anticipated">December 31, 2025</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>Parallel Assignment</intervention_model>
      <primary_purpose>Treatment</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>rPFS</measure>
      <time_frame>36 months</time_frame>
      <description>radiographic Progression-Free Survival</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>prostate-specific antigen (PSA) response rate</measure>
      <time_frame>36 months</time_frame>
      <description>percentage of patients with a decreasing PSA following the regimens discussed above</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>time to castration-resistant prostate cancer (CRPC)</measure>
      <time_frame>36 months</time_frame>
      <description>time to PSA progression</description>
    </secondary_outcome>
    <other_outcome>
      <measure>time to next bone-related event</measure>
      <time_frame>36 months</time_frame>
      <description>Including bone structure, pain, etc.</description>
    </other_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">200</enrollment>
    <condition>Metastatic Prostate Cancer</condition>
    <condition>Hormone Sensitive Prostate Cancer</condition>
    <condition>Chemotherapy Effect</condition>
    <arm_group>
      <arm_group_label>Rezvilutamide+ADT+Docetaxel</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Rezvilutamide: 240 mg (3 tablets of 80 mg each) orally once daily (QD), can be taken with or without food.&#xD;
  Docetaxel 6 cycles</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Rezvilutamide+ADT</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>Rezvilutamide: 240 mg (3 tablets of 80 mg each) orally once daily (QD), can be taken with or without food.</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Docetaxel</intervention_name>
      <description>This is Triple drug regimen for mHSPC</description>
      <arm_group_label>Rezvilutamide+ADT+Docetaxel</arm_group_label>
      <other_name>Rezvilutamide</other_name>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Rezvilutamide</intervention_name>
      <description>This is doubling drug regimen for mHSPC</description>
      <arm_group_label>Rezvilutamide+ADT</arm_group_label>
      <other_name>ADT</other_name>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. Males aged ≥40 years and ≤80 years.&#xD;
  &#xD;
            2. Histologically or cytologically confirmed prostate adenocarcinoma.&#xD;
  &#xD;
            3. Metastatic disease.&#xD;
  &#xD;
            4. Eligible for ADT and Docetaxel.&#xD;
  &#xD;
            5. Started or not started first-generation androgen deprivation therapy (ADT), but not&#xD;
               exceeding 12 weeks before randomization.&#xD;
  &#xD;
            6. ECOG score of 0 or 1.&#xD;
  &#xD;
            7. Laboratory tests meet the following requirements:&#xD;
  &#xD;
                 -  Hematology: neutrophils ≥1.5×10^9/L, platelets ≥100×10^9/L, hemoglobin ≥9g/dL.&#xD;
  &#xD;
                 -  Renal function: serum creatinine ≤1.5× upper limit of normal (ULN).&#xD;
  &#xD;
                 -  Liver function: aspartate aminotransferase (AST) and alanine aminotransferase&#xD;
                    (ALT) ≤2.5× ULN, total bilirubin (TBIL) ≤1.5× ULN.&#xD;
  &#xD;
                 -  Coagulation function: international normalized ratio (INR) &lt;1.5.&#xD;
  &#xD;
            8. Study subjects: Patients with mHSPC have a confirmed pathology of prostate&#xD;
               adenocarcinoma with high tumor burden, which is defined by having at least one of the&#xD;
               following conditions:&#xD;
  &#xD;
          1) Bone scan showing ≥4 bone metastatic lesions (with at least one site outside the pelvis&#xD;
          or spine).&#xD;
  &#xD;
          2) CT/MRI revealing visceral metastatic lesions (excluding lymph nodes).&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
          Patients who meet any of the following criteria are not eligible to participate in this&#xD;
          study:&#xD;
  &#xD;
            1. Prior use of LHRH agonists/antagonists; second-generation androgen receptor (AR)&#xD;
               inhibitors such as enzalutamide, ARN-509, darolutamide (ODM-201), or other&#xD;
               investigational AR inhibitors; CYP17 enzyme inhibitors such as abiraterone acetate or&#xD;
               oral ketoconazole for anti-tumor treatment of prostate cancer; chemotherapy or&#xD;
               immunotherapy for prostate cancer prior to randomization.&#xD;
  &#xD;
            2. Received radiation therapy/radiopharmaceutical treatment within 2 weeks before&#xD;
               randomization.&#xD;
  &#xD;
            3. Any of the following conditions within 6 months before randomization: stroke,&#xD;
               myocardial infarction, severe/unstable angina pectoris, coronary artery/peripheral&#xD;
               artery bypass surgery, congestive heart failure (New York Heart Association class III&#xD;
               or IV).&#xD;
  &#xD;
            4. Previous malignancy, except adequately treated basal cell carcinoma or squamous cell&#xD;
               carcinoma of the skin or superficial bladder cancer not invading the deeper muscle&#xD;
               layer (i.e., pTis, pTa, and pT1) and any other cancer in complete remission for at&#xD;
               least 5 years before randomization.&#xD;
  &#xD;
            5. Gastrointestinal diseases or procedures that are expected to significantly interfere&#xD;
               with the absorption of study treatment.&#xD;
  &#xD;
            6. Inability to take oral medication.&#xD;
        </textblock>
      </criteria>
      <gender>Male</gender>
      <minimum_age>40 Years</minimum_age>
      <maximum_age>80 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Lixxin Hua</last_name>
      <role>Principal Investigator</role>
      <affiliation>Urology Dpt, First Affiliated Hospital of Nanjing Medical University</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Shangqian Wang, M.D., Ph.D.</last_name>
      <phone>+862568303186</phone>
      <email>wsq5501@126.com</email>
    </overall_contact>
    <location>
      <facility>
        <name>Urology dpt, First Affiliated Hospital of Nanjing Medical University</name>
        <address>
          <city>Nanjing</city>
          <state>Jiangsu</state>
          <zip>210029</zip>
          <country>China</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Shangqian Wang, M.D.,PhD.</last_name>
        <phone>68303186</phone>
        <email>wsq5501@126.com</email>
      </contact>
      <investigator>
        <last_name>Lixin Hua, M.D.</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location_countries>
      <country>China</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 2, 2023</study_first_submitted>
    <study_first_submitted_qc>August 2, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 9, 2023</study_first_posted>
    <last_update_submitted>August 2, 2023</last_update_submitted>
    <last_update_submitted_qc>August 2, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 9, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>The First Affiliated Hospital with Nanjing Medical University</investigator_affiliation>
      <investigator_full_name>Hua Lixin</investigator_full_name>
      <investigator_title>M.D.</investigator_title>
    </responsible_party>
    <keyword>Rezvilutamide</keyword>
    <keyword>mHPSC</keyword>
    <keyword>chemotherapy</keyword>
    <keyword>Androgen deprivation therapy</keyword>
    <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>Docetaxel</mesh_term>
    </intervention_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <provided_document_section>
      <provided_document>
        <document_type>Study Protocol and Informed Consent Form</document_type>
        <document_has_protocol>Yes</document_has_protocol>
        <document_has_icf>Yes</document_has_icf>
        <document_has_sap>No</document_has_sap>
        <document_date>August 2, 2023</document_date>
        <document_url>https://ClinicalTrials.gov/ProvidedDocs/83/NCT05983783/Prot_ICF_000.pdf</document_url>
      </provided_document>
    </provided_document_section>
    <!-- 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/NCT05983783
  org study id: 2023-SR-376
  nct id: NCT05983783
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  Evaluate whether the combination of Rezvilutamide and androgen deprivation therapy (ADT) with
        docetaxel improves overall survival (OS) in patients with metastatic hormone-sensitive
        prostate cancer (mHSPC) compared to the combination of Rezvilutamide and ADT.
  To investigate the value of chemotherapy in the treatment of high-burden of mHSPC on the
        background of next-genertion of AR inhibitors.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: None (Open Label)
  measure: rPFS
  time frame: 36 months
  description: radiographic Progression-Free Survival
  measure: prostate-specific antigen (PSA) response rate
  time frame: 36 months
  description: percentage of patients with a decreasing PSA following the regimens discussed above
  measure: time to castration-resistant prostate cancer (CRPC)
  time frame: 36 months
  description: time to PSA progression
  measure: time to next bone-related event
  time frame: 36 months
  description: Including bone structure, pain, etc.
  arm group label: Rezvilutamide+ADT+Docetaxel
  arm group type: Experimental
  description: Rezvilutamide: 240 mg (3 tablets of 80 mg each) orally once daily (QD), can be taken with or without food.
  Docetaxel 6 cycles
  arm group label: Rezvilutamide+ADT
  arm group type: Active Comparator
  description: Rezvilutamide: 240 mg (3 tablets of 80 mg each) orally once daily (QD), can be taken with or without food.
  intervention type: Drug
  intervention name: Docetaxel
  description: This is Triple drug regimen for mHSPC
  arm group label: Rezvilutamide+ADT+Docetaxel
  other name: Rezvilutamide
  intervention type: Drug
  intervention name: Rezvilutamide
  description: This is doubling drug regimen for mHSPC
  arm group label: Rezvilutamide+ADT
  other name: ADT
  criteria: 
  gender: Male
  minimum age: 40 Years
  maximum age: 80 Years
  healthy volunteers: No
  last name: Lixxin Hua
  role: Principal Investigator
  affiliation: Urology Dpt, First Affiliated Hospital of Nanjing Medical University
  last name: Shangqian Wang, M.D., Ph.D.
  phone: +862568303186
  email: wsq5501@126.com
  facility: 
  status: Recruiting
  contact: 
  investigator: 
  country: China
  responsible party type: Principal Investigator
  investigator affiliation: The First Affiliated Hospital with Nanjing Medical University
  investigator full name: Hua Lixin
  investigator title: M.D.
  mesh term: Prostatic Neoplasms
  mesh term: Hypersensitivity
  mesh term: Docetaxel
  sharing ipd: No
  provided document: 