<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/NCT03285815</url>
  </required_header>
  <id_info>
    <org_study_id>NCC 2016-0120</org_study_id>
    <nct_id>NCT03285815</nct_id>
  </id_info>
  <brief_title>Prostate Cancer - Localized Adenocarcinoma Proton Therapy</brief_title>
  <official_title>A Phase II Randomized Trial of Hypofractionated Proton Therapy in Patients With a Localized Prostate Adenocarcinoma</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>National Cancer Center, Korea</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>National Cancer Center, Korea</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      A Phase II Randomized Trial of Hypofractionated Proton Therapy in Patients With A Localized&#xD;
      Prostate Adenocarcinoma&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      For Proton therapy with prostate adenocarcinoma patients.&#xD;
&#xD;
      Arm 1: Proton therapy 3CGE x 20days = Total 60 CGE for 4 weeks.&#xD;
&#xD;
      Arm 2: Proton therapy 4.7CGE x 10days = Total 47 CGE for 2 weeks.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date>May 2016</start_date>
  <completion_date type="Anticipated">December 2025</completion_date>
  <primary_completion_date type="Anticipated">May 2024</primary_completion_date>
  <phase>N/A</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>BCFFS</measure>
    <time_frame>up to 5 years from a initial follow-up</time_frame>
    <description>To evaluate biochemical failure-free survival (BCFFS)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Acute/late toxicity (CTCAE v4.0)</measure>
    <time_frame>up to 5 years from a initial follow-up</time_frame>
    <description>Common Terminology Criteria for Adverse Events (CTCAE) V 4.0</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Disease specific survival</measure>
    <time_frame>up to 5 years from a initial follow-up</time_frame>
    <description>follow-up</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>EPIC (Extended Prostate Cancer Index Composite)</measure>
    <time_frame>up to 5 years from a initial follow-up</time_frame>
    <description>questionnaire</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">156</enrollment>
  <condition>Prostate Adenocarcinoma</condition>
  <arm_group>
    <arm_group_label>Proton Therapy 60 CGE</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>60 CGE (3CGE X 20) for 4wks</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Proton Therapy 47 CGE</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>47 CGE (4.7CGE X 10) for 2wks</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Proton Therapy</intervention_name>
    <arm_group_label>Proton Therapy 47 CGE</arm_group_label>
    <arm_group_label>Proton Therapy 60 CGE</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Biopsy proven prostate adenocarcinoma Stage: T1-T2cN0M0&#xD;
&#xD;
          -  ECOG performance status:0-1&#xD;
&#xD;
          -  Signed study specific informed consent prior to study entry.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Postoperative residual or recurrent tumor&#xD;
&#xD;
          -  Evidence of distant metastasis previous irradiation for the tumor in the same location&#xD;
&#xD;
          -  Adjuvant anti-androgenic hormonal therapy High risk group (NCCN guide line)&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Kwanho Cho</last_name>
    <role>Principal Investigator</role>
    <affiliation>National Cancer Center, Korea</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Kwanho Cho</last_name>
    <phone>82-31-920-1720</phone>
    <email>kwancho@ncc.re.kr</email>
  </overall_contact>
  <location>
    <facility>
      <name>Kwanho Cho</name>
      <address>
        <city>Ilsan</city>
        <state>Gyenggi-do</state>
        <country>Korea, Republic of</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Kwanho Cho</last_name>
      <phone>82-31-920-1720</phone>
      <email>kwancho@ncc.re.kr</email>
    </contact>
    <investigator>
      <last_name>Taehyun Kim</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Yeonjoo Kim</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Kanghyun Lee</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Youngkyung Lim</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Jaeyoung Jung</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Byungho Nam</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <verification_date>September 2017</verification_date>
  <study_first_submitted>September 12, 2017</study_first_submitted>
  <study_first_submitted_qc>September 15, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 18, 2017</study_first_posted>
  <last_update_submitted>September 15, 2017</last_update_submitted>
  <last_update_submitted_qc>September 15, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">September 18, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>National Cancer Center, Korea</investigator_affiliation>
    <investigator_full_name>Kwan Ho Cho</investigator_full_name>
    <investigator_title>Principal Investigator</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>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/NCT03285815
org study id: NCC 2016-0120
nct id: NCT03285815
lead sponsor: 
has dmc: No
A Phase II Randomized Trial of Hypofractionated Proton Therapy in Patients With A Localized
      Prostate Adenocarcinoma
For Proton therapy with prostate adenocarcinoma patients.

      Arm 1: Proton therapy 3CGE x 20days = Total 60 CGE for 4 weeks.

      Arm 2: Proton therapy 4.7CGE x 10days = Total 47 CGE for 2 weeks.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: BCFFS
time frame: up to 5 years from a initial follow-up
description: To evaluate biochemical failure-free survival (BCFFS)
measure: Acute/late toxicity (CTCAE v4.0)
time frame: up to 5 years from a initial follow-up
description: Common Terminology Criteria for Adverse Events (CTCAE) V 4.0
measure: Disease specific survival
time frame: up to 5 years from a initial follow-up
description: follow-up
measure: EPIC (Extended Prostate Cancer Index Composite)
time frame: up to 5 years from a initial follow-up
description: questionnaire
arm group label: Proton Therapy 60 CGE
arm group type: Experimental
description: 60 CGE (3CGE X 20) for 4wks
arm group label: Proton Therapy 47 CGE
arm group type: Experimental
description: 47 CGE (4.7CGE X 10) for 2wks
intervention type: Device
intervention name: Proton Therapy
arm group label: Proton Therapy 47 CGE
arm group label: Proton Therapy 60 CGE
criteria: 
gender: Male
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: Kwanho Cho
role: Principal Investigator
affiliation: National Cancer Center, Korea
last name: Kwanho Cho
phone: 82-31-920-1720
email: kwancho@ncc.re.kr
facility: 
status: Recruiting
contact: 
investigator: 
investigator: 
investigator: 
investigator: 
investigator: 
investigator: 
country: Korea, Republic of
responsible party type: Principal Investigator
investigator affiliation: National Cancer Center, Korea
investigator full name: Kwan Ho Cho
investigator title: Principal Investigator
mesh term: Adenocarcinoma
mesh term: Prostatic Neoplasms
sharing ipd: No