<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/NCT03241537</url>
  </required_header>
  <id_info>
    <org_study_id>SMC2015-11-139-002</org_study_id>
    <nct_id>NCT03241537</nct_id>
  </id_info>
  <brief_title>COHORT Trial in Clinical Pelivc Lymph Node Metastatic Prostate Cancer</brief_title>
  <official_title>Open Label, Randomized Phase III Trial of Hormone Therapy Alone Versus COmbined HOrmone With Radiation Therapy in Clinical Pelvic Lymph Node Metastatic Prostate Cancer (COHORT Trial)</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>Yes</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>
      In local advanced prostate cancer patients with clinically positive metastatic regional lymph&#xD;
      node, the optimal treatment is still unanswered. For these patients, radiotherapy combined&#xD;
      with hormonal therapy or hormonal therapy alone are recommended. Recently, the reports from&#xD;
      NCCB and SEER data showed that radiotherapy combined with hormonal therapy have better&#xD;
      survivals than hormonal therapy alone.&#xD;
&#xD;
      This randomized phase III trial compare hormonal therapy alone with combined hormone with&#xD;
      radiotherapy in clinically pelvic lymph node metastatic prostate cancer.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">January 15, 2016</start_date>
  <completion_date type="Anticipated">December 14, 2026</completion_date>
  <primary_completion_date type="Anticipated">December 31, 2022</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>Comparison of recurrence-free survival between two treatment groups</measure>
    <time_frame>5-year</time_frame>
    <description>expected 5-year recurrence-free survival were 40% in hormonal therapy alone group and more than 80% in hormonal therapy combined with radiotherapy</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Comparison of toxicities between two treatment groups</measure>
    <time_frame>5-year</time_frame>
    <description>Compare adverse events accroding to CTCAE V4.0 between hormonal therapy alone group and hormonal therapy combined with radiotherapy group</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Comparison of quality of lifl between two treatment groups</measure>
    <time_frame>5-year</time_frame>
    <description>Compare quality of life accroding to Expanded prostate cancer index composite_Korean between hormonal therapy alone group and hormonal therapy combined with radiotherapy group</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Comparison of overall survival between two treatment groups</measure>
    <time_frame>5-year</time_frame>
    <description>Compare overall survival between hormonal therapy alone group and hormonal therapy combined with radiotherapy group</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Comparison of clinical failure free survival between two treatment groups</measure>
    <time_frame>5-year</time_frame>
    <description>Compare clinical failure free survival between hormonal therapy alone group and hormonal therapy combined with radiotherapy group</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Comparison of cause-specific survival between two treatment groups</measure>
    <time_frame>5-year</time_frame>
    <description>Compare cause-specific survival between hormonal therapy alone group and hormonal therapy combined with radiotherapy group</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">61</enrollment>
  <condition>Prostate Neoplasm</condition>
  <arm_group>
    <arm_group_label>Hormonal therapy alone</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>total androgen ablation or antiandrogen therapy alone for 2-3 years</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Hormonal therapy with radiotherapy</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>total androgen ablation or antiandrogen therapy for 2-3 years combined with radiotherapy on whole pelvis</description>
  </arm_group>
  <intervention>
    <intervention_type>Radiation</intervention_type>
    <intervention_name>Intensity modulated radiotherapy</intervention_name>
    <arm_group_label>Hormonal therapy with radiotherapy</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  pathologically confirmed prostate cancer within 6 months for study enrollment&#xD;
&#xD;
          -  Clincally enlarged pelvic lymph node ((short axis 0.5 cm ≤) in imaging studies (CT,&#xD;
             MRI, PET-CT) at diagnosis and partial response or complete remission of enlarged lymph&#xD;
             nodes according to RECIST v1.1 after hormonal therapy for 2-3 months 3. age 20 ≤ 4.&#xD;
             ECOG performance status 0-1 5. Optimal hematologic profiles within 6 months for study&#xD;
             enrollment&#xD;
&#xD;
          -  Absolute neutrophil count (ANC) ≥ 1500 cells/mm3&#xD;
&#xD;
          -  Platelets ≥ 50,000 cells/mm3&#xD;
&#xD;
          -  Hemoglobin ≥ 8.0 g/dl 6. Optimal kidney function within 6 months for study enrollment&#xD;
&#xD;
          -  Creatinine &lt; 2.0 ng/dL 7. Optimal liver functions within 6 months for study enrollment&#xD;
&#xD;
          -  total bilirubin &lt; 1.5 X maximum normal value&#xD;
&#xD;
          -  alanine aminotransferase or aspartate aminotransferase &lt; 2.5 X maximum normal value&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. combined with distant metastasis (retroperitoneal lymph node, bone,...)&#xD;
&#xD;
          2. previous history of antiandrogen therapy within 6 months of study enrollment&#xD;
&#xD;
          3. previous history of definitive prostate cancer treatment such as prostatectomy&#xD;
&#xD;
          4. previous history of pelvic radiotherapy&#xD;
&#xD;
          5. previous history of other cancer treatment except for skin cancer and theroid cancer&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Won Park, M.D.,Ph.D</last_name>
    <role>Principal Investigator</role>
    <affiliation>Korean Radiation Oncology Group</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Samsung Medical Center</name>
      <address>
        <city>Seoul</city>
        <zip>06351</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <verification_date>July 2022</verification_date>
  <study_first_submitted>July 27, 2017</study_first_submitted>
  <study_first_submitted_qc>August 1, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 7, 2017</study_first_posted>
  <last_update_submitted>July 7, 2022</last_update_submitted>
  <last_update_submitted_qc>July 7, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">July 11, 2022</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>


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/NCT03241537
org study id: SMC2015-11-139-002
nct id: NCT03241537
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
In local advanced prostate cancer patients with clinically positive metastatic regional lymph
      node, the optimal treatment is still unanswered. For these patients, radiotherapy combined
      with hormonal therapy or hormonal therapy alone are recommended. Recently, the reports from
      NCCB and SEER data showed that radiotherapy combined with hormonal therapy have better
      survivals than hormonal therapy alone.

      This randomized phase III trial compare hormonal therapy alone with combined hormone with
      radiotherapy in clinically pelvic lymph node metastatic prostate cancer.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Comparison of recurrence-free survival between two treatment groups
time frame: 5-year
description: expected 5-year recurrence-free survival were 40% in hormonal therapy alone group and more than 80% in hormonal therapy combined with radiotherapy
measure: Comparison of toxicities between two treatment groups
time frame: 5-year
description: Compare adverse events accroding to CTCAE V4.0 between hormonal therapy alone group and hormonal therapy combined with radiotherapy group
measure: Comparison of quality of lifl between two treatment groups
time frame: 5-year
description: Compare quality of life accroding to Expanded prostate cancer index composite_Korean between hormonal therapy alone group and hormonal therapy combined with radiotherapy group
measure: Comparison of overall survival between two treatment groups
time frame: 5-year
description: Compare overall survival between hormonal therapy alone group and hormonal therapy combined with radiotherapy group
measure: Comparison of clinical failure free survival between two treatment groups
time frame: 5-year
description: Compare clinical failure free survival between hormonal therapy alone group and hormonal therapy combined with radiotherapy group
measure: Comparison of cause-specific survival between two treatment groups
time frame: 5-year
description: Compare cause-specific survival between hormonal therapy alone group and hormonal therapy combined with radiotherapy group
arm group label: Hormonal therapy alone
arm group type: No Intervention
description: total androgen ablation or antiandrogen therapy alone for 2-3 years
arm group label: Hormonal therapy with radiotherapy
arm group type: Active Comparator
description: total androgen ablation or antiandrogen therapy for 2-3 years combined with radiotherapy on whole pelvis
intervention type: Radiation
intervention name: Intensity modulated radiotherapy
arm group label: Hormonal therapy with radiotherapy
criteria: 
gender: Male
minimum age: 20 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Won Park, M.D.,Ph.D
role: Principal Investigator
affiliation: Korean Radiation Oncology Group
facility: 
country: Korea, Republic of
responsible party type: Sponsor
mesh term: Prostatic Neoplasms
sharing ipd: No