<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/NCT02971085</url>
  </required_header>
  <id_info>
    <org_study_id>2016-2957</org_study_id>
    <nct_id>NCT02971085</nct_id>
  </id_info>
  <brief_title>Seoul National University Prospectively Enrolled Registry for Prostate Cancer With Active Surveillance</brief_title>
  <acronym>SUPER-PC-AS</acronym>
  <official_title>Seoul National University Prospectively Enrolled Registry for Prostate Cancer With Active Surveillance</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Seoul National University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Seoul National University Hospital</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      In this study, the investigators aim to establish the prostate cancer active surveillance&#xD;
      prospective cohort in our institution, and finally investigate the 5 year rates of&#xD;
      reclassification during active surveillance as the primary endpoint of the current study.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Prostate cancer (PCa) remains one of the most commonly diagnosed malignancies in men&#xD;
      worldwide. Early diagnosis and definitive therapy seem to improve oncological outcomes in men&#xD;
      with high-risk disease, but significant concerns exist in terms of the overdiagnosis and&#xD;
      overtreatment of patients with lower-risk tumors. In this context, active surveillance (AS)&#xD;
      has recently emerged as a alternative treatment strategy in PCa patients with low risk&#xD;
      cancers. However, published data are based on Western population with different protocol, and&#xD;
      therefore; well-controlled data with well-organized and prospective cohort are urgently&#xD;
      needed in Korean patients with low-risk PCa because Korean patients have significantly&#xD;
      different tumor characteristics compared to Western patients. Here, the investigators have a&#xD;
      plan to establish the Seoul National University Enrolled Registry for Prostate Cancer with&#xD;
      Active Surveillance, and finally provide the concrete evidence for the clinical outcomes of&#xD;
      active surveillance program as the primary therapeutic strategy for low-risk PCa in Korean&#xD;
      men.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">December 2016</start_date>
  <completion_date type="Anticipated">January 2027</completion_date>
  <primary_completion_date type="Anticipated">January 2022</primary_completion_date>
  <study_type>Observational [Patient Registry]</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <target_duration>3 Months</target_duration>
  <primary_outcome>
    <measure>Pathological reclassification</measure>
    <time_frame>5 year</time_frame>
    <description>5-year rate of pathological reclassification during active surveillance</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>active treatment-free survival</measure>
    <time_frame>1, 3, 5, 7, 10 years</time_frame>
    <description>active treatment-free survival rate</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>metastasis-free survival</measure>
    <time_frame>3, 5, 10 years</time_frame>
    <description>metastasis-free survival rate</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>overall survival</measure>
    <time_frame>3, 5, 10 years</time_frame>
    <description>overall survival rate</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>rates of active surveillance maintenance</measure>
    <time_frame>1, 3, 5, 7, 10 years</time_frame>
    <description>rates of active surveillance maintenance</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>HRQoL scores (measured by EPIC-CP)</measure>
    <time_frame>1, 3, 5, 7, 10 years</time_frame>
    <description>HRQoL scores (measured by EPIC-CP)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Utility value (measured by EQ-5D-5L)</measure>
    <time_frame>1, 3, 5, 7, 10 years</time_frame>
    <description>Utility value (measured by EQ-5D-5L)</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">410</enrollment>
  <condition>Prostate Cancer</condition>
  <arm_group>
    <arm_group_label>Active surveillance</arm_group_label>
    <description>This is the prospective cohort study with single group of active surveillance. We define our cohort group as the patients with following criteria: Men &lt; 80 years, pathologically proven adenocarcinoma of the prostate by transrectal prostate biopsy ≥ 10 cores, pre-biopsy PSA ≤ 10ng/ml, PSA density &lt; 0.15 ng/ml/ml, clinical stage T1-2a, biopsy Gleason score ≤ 6, number of positive cores ≤ 2, maximum cancer involvement in any one core ≤ 20%, and no PIRADS 5 lesion on multiparametric prostate MRI (1.5T or 3T).</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Active surveillance</intervention_name>
    <description>Active surveillance cohorts are routinely performed the systematic biopsy ≥ 12 cores by TRUS-guided or MR-TRUS fusion according to the protocol based by time path as 1, 2, 4, 7, 10 years and subsequently every 5 years following initial TRUS biopsy.</description>
    <arm_group_label>Active surveillance</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Korean men with pathologically proven adenocarcinoma of prostate cancer with low-risk who&#xD;
        will be treated by active surveillance protocol in Seoul National University Hospital.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Men &lt; 80 years&#xD;
&#xD;
          2. Pathologically proven adenocarcinoma of the prostate by transrectal prostate biopsy ≥&#xD;
             10 cores&#xD;
&#xD;
          3. Pre-Bx PSA ≤ 10ng/ml&#xD;
&#xD;
          4. PSA density &lt; 0.15ng/ml/ml&#xD;
&#xD;
          5. Clinical stage T1-2a&#xD;
&#xD;
          6. Biopsy Gleason score ≤ 6&#xD;
&#xD;
          7. No. of positive cores ≤ 2&#xD;
&#xD;
          8. Maximum cancer involvement in any one core ≤ 20%.&#xD;
&#xD;
          9. No PIRADS 5 lesion on multiparametric prostate MRI (1.5T or 3T)&#xD;
&#xD;
         10. Participants must be willing to attend the follow-up visits - T1a-b disease should be&#xD;
             confirmed by systematic TRUS-Bx ≥ 10 cores&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        1. A former therapy for prostate cancer.&#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>Chang Wook Jeong, M.D, Ph.D</last_name>
    <role>Principal Investigator</role>
    <affiliation>Seoul National University Hospital</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Min Ji Seo, Bachelor</last_name>
    <phone>+82-2-2072-3899</phone>
    <email>seomj0722@gmail.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Chang Wook Jeong, M.D, Ph.D</last_name>
    <phone>+82-2-2072-3899</phone>
    <email>drboss@gmail.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Seoul National University Hospital</name>
      <address>
        <city>Seoul</city>
        <zip>110-744</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Chang Wook Jeong, M.D., Ph.D.</last_name>
      <phone>+82-2-2072-3899</phone>
      <email>drboss@snuh.org</email>
    </contact>
    <investigator>
      <last_name>Chang Wook Jeong, M.D., Ph.D.</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Hyeon Hoe Kim, M.D., Ph.D.</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Cheol Kwak, M.D., Ph.D.</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Ja Hyeon Ku, M.D., Ph.D.</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <verification_date>February 2019</verification_date>
  <study_first_submitted>November 13, 2016</study_first_submitted>
  <study_first_submitted_qc>November 18, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 22, 2016</study_first_posted>
  <last_update_submitted>February 10, 2019</last_update_submitted>
  <last_update_submitted_qc>February 10, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">February 12, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Seoul National University Hospital</investigator_affiliation>
    <investigator_full_name>Chang Wook Jeong</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <keyword>low-risk prostate cancer</keyword>
  <keyword>active surveillance</keyword>
  <keyword>pathologic reclassification</keyword>
  <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>Undecided</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/NCT02971085
org study id: 2016-2957
nct id: NCT02971085
lead sponsor: 
has dmc: Yes
In this study, the investigators aim to establish the prostate cancer active surveillance
      prospective cohort in our institution, and finally investigate the 5 year rates of
      reclassification during active surveillance as the primary endpoint of the current study.
Prostate cancer (PCa) remains one of the most commonly diagnosed malignancies in men
      worldwide. Early diagnosis and definitive therapy seem to improve oncological outcomes in men
      with high-risk disease, but significant concerns exist in terms of the overdiagnosis and
      overtreatment of patients with lower-risk tumors. In this context, active surveillance (AS)
      has recently emerged as a alternative treatment strategy in PCa patients with low risk
      cancers. However, published data are based on Western population with different protocol, and
      therefore; well-controlled data with well-organized and prospective cohort are urgently
      needed in Korean patients with low-risk PCa because Korean patients have significantly
      different tumor characteristics compared to Western patients. Here, the investigators have a
      plan to establish the Seoul National University Enrolled Registry for Prostate Cancer with
      Active Surveillance, and finally provide the concrete evidence for the clinical outcomes of
      active surveillance program as the primary therapeutic strategy for low-risk PCa in Korean
      men.
observational model: Cohort
time perspective: Prospective
measure: Pathological reclassification
time frame: 5 year
description: 5-year rate of pathological reclassification during active surveillance
measure: active treatment-free survival
time frame: 1, 3, 5, 7, 10 years
description: active treatment-free survival rate
measure: metastasis-free survival
time frame: 3, 5, 10 years
description: metastasis-free survival rate
measure: overall survival
time frame: 3, 5, 10 years
description: overall survival rate
measure: rates of active surveillance maintenance
time frame: 1, 3, 5, 7, 10 years
description: rates of active surveillance maintenance
measure: HRQoL scores (measured by EPIC-CP)
time frame: 1, 3, 5, 7, 10 years
description: HRQoL scores (measured by EPIC-CP)
measure: Utility value (measured by EQ-5D-5L)
time frame: 1, 3, 5, 7, 10 years
description: Utility value (measured by EQ-5D-5L)
arm group label: Active surveillance
description: This is the prospective cohort study with single group of active surveillance. We define our cohort group as the patients with following criteria: Men < 80 years, pathologically proven adenocarcinoma of the prostate by transrectal prostate biopsy ≥ 10 cores, pre-biopsy PSA ≤ 10ng/ml, PSA density < 0.15 ng/ml/ml, clinical stage T1-2a, biopsy Gleason score ≤ 6, number of positive cores ≤ 2, maximum cancer involvement in any one core ≤ 20%, and no PIRADS 5 lesion on multiparametric prostate MRI (1.5T or 3T).
intervention type: Procedure
intervention name: Active surveillance
description: Active surveillance cohorts are routinely performed the systematic biopsy ≥ 12 cores by TRUS-guided or MR-TRUS fusion according to the protocol based by time path as 1, 2, 4, 7, 10 years and subsequently every 5 years following initial TRUS biopsy.
arm group label: Active surveillance
study pop: 
sampling method: Probability Sample
criteria: 
gender: Male
minimum age: 40 Years
maximum age: 80 Years
healthy volunteers: No
last name: Chang Wook Jeong, M.D, Ph.D
role: Principal Investigator
affiliation: Seoul National University Hospital
last name: Min Ji Seo, Bachelor
phone: +82-2-2072-3899
email: seomj0722@gmail.com
last name: Chang Wook Jeong, M.D, Ph.D
phone: +82-2-2072-3899
email: drboss@gmail.com
facility: 
status: Recruiting
contact: 
investigator: 
investigator: 
investigator: 
investigator: 
country: Korea, Republic of
responsible party type: Principal Investigator
investigator affiliation: Seoul National University Hospital
investigator full name: Chang Wook Jeong
investigator title: Professor
mesh term: Prostatic Neoplasms
sharing ipd: Undecided