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/NCT06029036</url>
    </required_header>
    <id_info>
      <org_study_id>22440</org_study_id>
      <nct_id>NCT06029036</nct_id>
    </id_info>
    <brief_title>A Phase II Neoadjuvant Study of Darolutamide Plus ADT in Men With Localized Prostate Cancer</brief_title>
    <official_title>A Phase II, Multi-center, Single-arm, Prospective Study of Darolutamide + ADT Prior to Radical Prostatectomy (RP) in High-risk/Very High-risk Localized Prostate Cancer</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Peking University First Hospital</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>Xijing Hospital of Air Force Military Medical University</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>Peking University First Hospital</source>
    <oversight_info>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        Scientific Rationale: High risk localized prostate cancer (PCa) is associated with higher&#xD;
        rates of biochemical recurrence, clinical recurrence, metastasis and PCa-specific death.&#xD;
        Novel hormone therapies(NHT) have shown a significant survival advantage with respect to&#xD;
        classical ADT in later stages of PCa and have already been investigated in neoadjuvant&#xD;
        setting.&#xD;
  &#xD;
        PURPOSE: To assess antitumor effect by measuring pathological tumor volume with pathological&#xD;
        downstaging following radical prostatectomy + pelvic lymph-node dissection (RP + PLND) for&#xD;
        high-risk localized prostate cancer patients.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">October 1, 2023</start_date>
    <completion_date type="Anticipated">July 31, 2026</completion_date>
    <primary_completion_date type="Anticipated">July 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>Rate of pathological downstaging</measure>
      <time_frame>6 months</time_frame>
      <description>Percentage of patients with tumor downstaging</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>pCR or MRD</measure>
      <time_frame>6 months</time_frame>
      <description>Pathologic complete response or Minimal Residual Disease(defined as overall diameter &lt;5 mm)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>PSM</measure>
      <time_frame>6 months</time_frame>
      <description>Percentage of patients with positive surgical margins</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Rate of peri-operative complications</measure>
      <time_frame>within 30 days of surgery</time_frame>
      <description>including delay in surgery, intra-operative complications, and postoperative complications</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Biochemical complete response</measure>
      <time_frame>6 months</time_frame>
      <description>PSA &lt;0.1ng/ml prior to RP</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>PSA undetectable rate</measure>
      <time_frame>12 months post-RP</time_frame>
      <description>PSA&lt;0.02 ng/ml</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>2-year biochemical progression-free survival, bPFS</measure>
      <time_frame>24 months post-RP</time_frame>
      <description>PSA&gt;0.2 ng/ml</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>AEs/SAEs</measure>
      <time_frame>Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first</time_frame>
      <description>The level of AEs defined by NCI-CTCAE v5.0. Safety assessments will be assessed and documented after initiation of study drug, regardless of relationship to study drug.</description>
    </secondary_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Anticipated">53</enrollment>
    <condition>Prostate Cancer</condition>
    <arm_group>
      <arm_group_label>Darolutamide + ADT</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Duration of treatment: 28-day cycle of darolutamide treatment and 6 cycles of neoadjuvant therapy.</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Darolutamide+ADT</intervention_name>
      <description>Drug: Darolutamide&#xD;
  Darolutamide 600 mg, (two 300 mg tablets) administered orally twice daily. Swallow tablets whole. Take Darolutamide with food.&#xD;
  Drug: ADT GnRH agonist per physicians' choice, orchiectomy is excluded</description>
      <arm_group_label>Darolutamide + ADT</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. Male ≥18 years of age.&#xD;
  &#xD;
            2. Able to Sign informed consent form independently.&#xD;
  &#xD;
            3. Non-metastatic adenocarcinoma of the prostate.&#xD;
  &#xD;
            4. Subjects must have as least one of the following features according to NCCN definition&#xD;
               of high-risk: Gleason score ≥8, or PSA &gt;20ng/ml,or≥clinical T3a.&#xD;
  &#xD;
            5. Subjects with pelvic lymph node involvement(N1) can be included.&#xD;
  &#xD;
            6. Candidate for radical prostatectomy with or without pelvic lymph node dissection as&#xD;
               per the investigator.&#xD;
  &#xD;
            7. Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0 or 1.&#xD;
  &#xD;
            8. Subjects must have normal organ and marrow function as defined below:&#xD;
  &#xD;
          Hemoglobin ≥ 9.0 g/dL;Absolute neutrophil count (ANC) ≥ 1,500/mcL; Platelets ≥ 100,000/mcL,&#xD;
          independent of transfusions/growth factors within 3 months of treatment start; Serum&#xD;
          potassium ≥ 3.5 mmol/L; Serum total bilirubin ≤ 2.0 x upper limit of normal (ULN) (except&#xD;
          in subjects with Gilbert's syndrome who have a total bilirubin &gt; 1.5 x ULN, measure direct&#xD;
          and indirect bilirubin and if direct bilirubin is ≤ 1.5 x ULN, subject may be&#xD;
          eligible);Aspartate aminotransferase (AST), alanine aminotransferase (ALT) ≤ 2.5 x&#xD;
          ULN;Serum albumin ≥ 3.0 g/dL;Serum creatinine &lt; 2.0 x ULN.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. Prostate cancer with neuroendocrine differentiation or small cell features&#xD;
  &#xD;
            2. Distant metastasis based on conventional imaging (clinical stage M1). Nodal disease&#xD;
               below the iliac bifurcation (clinical stage N1) is not an exclusion.&#xD;
  &#xD;
            3. History of prior systemic or local therapy for prostate cancer, including pelvic&#xD;
               radiation for prostate cancer.&#xD;
  &#xD;
            4. Subjects who are planning bilateral orchidectomy during the treatment period of the&#xD;
               study.&#xD;
  &#xD;
            5. Intolerable with darolutamide or ADT treatment.&#xD;
  &#xD;
            6. Candidates of other clinical trials.&#xD;
  &#xD;
            7. Any prior malignancy within 5 years.&#xD;
  &#xD;
            8. Complications include significant cardiovascular disease, active infection,&#xD;
               astrointestinal disorders, or any other complications that in the opinion of the&#xD;
               investigator.&#xD;
  &#xD;
            9. Any condition that in the opinion of the investigator would preclude participation in&#xD;
               this study.&#xD;
        </textblock>
      </criteria>
      <gender>Male</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>75 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>Zhisong He, MD</last_name>
      <phone>+8610-83572418</phone>
      <email>wyj7074@sohu.com</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Kaiwei Yang, MD</last_name>
      <phone>13811501435</phone>
      <email>13811501435@163.com</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Peking University First Hospital</name>
        <address>
          <city>Beijing</city>
          <country>China</country>
        </address>
      </facility>
      <contact>
        <last_name>Zhisong He, MD</last_name>
        <phone>+8610-83572418</phone>
        <email>wyj7074@sohu.com</email>
      </contact>
      <contact_backup>
        <last_name>Kaiwei Yang, MD</last_name>
        <phone>13811501435</phone>
        <email>13811501435@163.com</email>
      </contact_backup>
    </location>
    <location_countries>
      <country>China</country>
    </location_countries>
    <verification_date>March 2023</verification_date>
    <study_first_submitted>September 1, 2023</study_first_submitted>
    <study_first_submitted_qc>September 1, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 8, 2023</study_first_posted>
    <last_update_submitted>September 1, 2023</last_update_submitted>
    <last_update_submitted_qc>September 1, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 8, 2023</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>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </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/NCT06029036
  org study id: 22440
  nct id: NCT06029036
  lead sponsor: 
  collaborator: 
  collaborator: 
  is fda regulated drug: No
  is fda regulated device: No
  Scientific Rationale: High risk localized prostate cancer (PCa) is associated with higher
        rates of biochemical recurrence, clinical recurrence, metastasis and PCa-specific death.
        Novel hormone therapies(NHT) have shown a significant survival advantage with respect to
        classical ADT in later stages of PCa and have already been investigated in neoadjuvant
        setting.
  
        PURPOSE: To assess antitumor effect by measuring pathological tumor volume with pathological
        downstaging following radical prostatectomy + pelvic lymph-node dissection (RP + PLND) for
        high-risk localized prostate cancer patients.
  allocation: N/A
  intervention model: Single Group Assignment
  primary purpose: Treatment
  masking: None (Open Label)
  measure: Rate of pathological downstaging
  time frame: 6 months
  description: Percentage of patients with tumor downstaging
  measure: pCR or MRD
  time frame: 6 months
  description: Pathologic complete response or Minimal Residual Disease(defined as overall diameter <5 mm)
  measure: PSM
  time frame: 6 months
  description: Percentage of patients with positive surgical margins
  measure: Rate of peri-operative complications
  time frame: within 30 days of surgery
  description: including delay in surgery, intra-operative complications, and postoperative complications
  measure: Biochemical complete response
  time frame: 6 months
  description: PSA <0.1ng/ml prior to RP
  measure: PSA undetectable rate
  time frame: 12 months post-RP
  description: PSA<0.02 ng/ml
  measure: 2-year biochemical progression-free survival, bPFS
  time frame: 24 months post-RP
  description: PSA>0.2 ng/ml
  measure: AEs/SAEs
  time frame: Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first
  description: The level of AEs defined by NCI-CTCAE v5.0. Safety assessments will be assessed and documented after initiation of study drug, regardless of relationship to study drug.
  arm group label: Darolutamide + ADT
  arm group type: Experimental
  description: Duration of treatment: 28-day cycle of darolutamide treatment and 6 cycles of neoadjuvant therapy.
  intervention type: Drug
  intervention name: Darolutamide+ADT
  description: Drug: Darolutamide
  Darolutamide 600 mg, (two 300 mg tablets) administered orally twice daily. Swallow tablets whole. Take Darolutamide with food.
  Drug: ADT GnRH agonist per physicians' choice, orchiectomy is excluded
  arm group label: Darolutamide + ADT
  criteria: 
  gender: Male
  minimum age: 18 Years
  maximum age: 75 Years
  healthy volunteers: No
  last name: Zhisong He, MD
  phone: +8610-83572418
  email: wyj7074@sohu.com
  last name: Kaiwei Yang, MD
  phone: 13811501435
  email: 13811501435@163.com
  facility: 
  contact: 
  contact backup: 
  country: China
  responsible party type: Sponsor
  mesh term: Prostatic Neoplasms
  sharing ipd: No