<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/NCT02189486</url>
  </required_header>
  <id_info>
    <org_study_id>HSC20140367H</org_study_id>
    <secondary_id>5P30CA054174</secondary_id>
    <nct_id>NCT02189486</nct_id>
  </id_info>
  <brief_title>Prostate Cancer Upgrading Reference Set</brief_title>
  <official_title>Biomarkers and Clinical Parameters Associated With Gleason Score Upgrading</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>The University of Texas Health Science Center at San Antonio</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Emory University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Stanford University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>University of California, Irvine</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>University of Michigan</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>The Cleveland Clinic</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>University of Washington</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Fred Hutchinson Cancer Center</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>University of Miami</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Johns Hopkins University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>M.D. Anderson Cancer Center</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Weill Medical College of Cornell University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Icahn School of Medicine at Mount Sinai</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Eastern Virginia Medical School</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>National Cancer Institute (NCI)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>The University of Texas Health Science Center at San Antonio</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Research repository designed to establish prostate cancer upgrading reference set and&#xD;
      development of a risk prediction tool. Repository will include clinical information and&#xD;
      biologics on a cohort of 240 men, to predict presence of high grade cancer at time of&#xD;
      prostatectomy (removal of prostate) among patients with a low grade cancer diagnosis at time&#xD;
      of biopsy.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The primary endpoint of this study is the presence of tumor upgrading at the time of radical&#xD;
      prostatectomy. Upgrading is defined as: Gleason 3+4 or higher grade A secondary study&#xD;
      endpoint is presence of prostate cancer beyond the prostate (pathologic T3 disease) at&#xD;
      radical prostatectomy. (This finding may be considered as a rationale for treatment.)&#xD;
      Evidence of pathologic stage T3 or higher disease will be assessed by the presence of: (1)&#xD;
      seminal vesicle invasion or (2) positive surgical margins or (3) established extracapsular&#xD;
      extension or (4) lymph node involvement by tumor. It should be noted that pathologic stage T3&#xD;
      disease, while generally portending a greater risk of disease recurrence, may not be an&#xD;
      intrinsic feature of disease prognosis but can be an artifact of surgical technique.&#xD;
      Nonetheless, a secondary risk assessment tool will include both a Gleason 7-10 endpoint plus&#xD;
      any patients with pT3+ disease to a composite endpoint that could indicate disease best&#xD;
      managed with treatment in lieu of active surveillance.Prostate cancer, confirmed on prostate&#xD;
      biopsy, within two years of scheduled radical prostatectomy.&#xD;
&#xD;
      2. Prostate cancer must be graded as Gleason 3+3 on the biopsy immediately prior to radical&#xD;
      prostatectomy. (Secondary eligibility will be established on central review of pathology&#xD;
      slides, and blocks if available, at Cornell Central Pathology Laboratory to confirm&#xD;
      eligibility.) 3. Prostate cancer may have been detected on prior biopsy as well but must not&#xD;
      be greater than Gleason 3+3. (Also requires Central Pathology Laboratory review.) 4. Slides&#xD;
      must be available for Central Pathology Laboratory review on any biopsy showing prostate&#xD;
      cancer. FFPE (formalin fixed paraffin embedded) blocks may also be requested if available.&#xD;
&#xD;
      5. Patient must have selected radical prostatectomy as treatment for prostate cancer.&#xD;
&#xD;
      6. Signed informed consent. 7. Blocks and/or slides from prostate biopsy and from radical&#xD;
      prostatectomy must be available for analysis by Central Pathology laboratory.&#xD;
&#xD;
      8. Willingness to provide long-term follow-up information regarding additional treatments and&#xD;
      cancer status.&#xD;
&#xD;
      9. Willingness to provide blood and urine specimens prior to radical prostatectomy for&#xD;
      placement in the Early Detection Research Network (EDRN) Upgrading Reference Set repository.&#xD;
&#xD;
      10. Willingness to provide demographic and clinical information related to prostate cancer&#xD;
      and prostate cancer risk (e.g., race/ethnicity, family history of prostate cancer).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date>August 2014</start_date>
  <completion_date type="Anticipated">December 2025</completion_date>
  <primary_completion_date type="Anticipated">December 2024</primary_completion_date>
  <study_type>Observational</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>
  <primary_outcome>
    <measure>Prostate cancer tumor upgrading at time of radical prostatectomy (Gleason 3+4 or higher grade)</measure>
    <time_frame>4 years</time_frame>
    <description>The primary endpoint of this study is the presence of tumor upgrading at the time of radical prostatectomy. Upgrading is defined as: Gleason 3+4 or higher grade</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Presence of prostate cancer beyond the prostate at radical prostatectomy (pathologic T3 disease)</measure>
    <time_frame>10 years</time_frame>
    <description>A secondary study endpoint is presence of prostate cancer beyond the prostate (pathologic T3 disease) at radical prostatectomy. (This finding may be considered as a rationale for treatment.) Evidence of pathologic stage T3 or higher disease will be assessed by the presence of: (1) seminal vesicle invasion or (2) positive surgical margins or (3) established extracapsular extension or (4) lymph node involvement by tumor. It should be noted that pathologic stage T3 disease, while generally portending a greater risk of disease recurrence, may not be an intrinsic feature of disease prognosis but can be an artifact of surgical technique. Nonetheless, a secondary risk assessment tool will include both a Gleason 7-10 endpoint plus any patients with pT3+ disease to a composite endpoint that could indicate disease best managed with treatment in lieu of active surveillance.</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">600</enrollment>
  <condition>Prostate Cancer</condition>
  <arm_group>
    <arm_group_label>Prostate Cancer Cohort</arm_group_label>
    <description>Men with prostate cancer who have elected radical prostatectomy for their treatment of their prostate cancer within two years after prostate biopsy.</description>
  </arm_group>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Blood, voided urine and prostate tissue slides and blocks&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        We will recruit a cohort of 600 men with prostate cancer who have elected radical&#xD;
        prostatectomy for treatment of their prostate cancer within two years after prostate&#xD;
        biopsy. This biopsy must show no greater grade than Gleason 3+3 disease as determined on&#xD;
        central pathology review. The patient may have had previous biopsies that showed cancer but&#xD;
        may never have had a tumor grade greater than Gleason 3+3.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Prostate cancer, confirmed on prostate biopsy, within two years of scheduled radical&#xD;
             prostatectomy.&#xD;
&#xD;
          2. Prostate cancer must be graded as Gleason 3+3 on the biopsy immediately prior to&#xD;
             radical prostatectomy. (Secondary eligibility will be established on central review of&#xD;
             pathology slides, and blocks if available, at Cornell Central Pathology Laboratory to&#xD;
             confirm eligibility.)&#xD;
&#xD;
          3. Prostate cancer may have been detected on prior biopsy as well but must not be greater&#xD;
             than Gleason 3+3. (Also requires Central Pathology Laboratory review.)&#xD;
&#xD;
          4. Slides must be available for Central Pathology Laboratory review on any biopsy showing&#xD;
             prostate cancer. FFPE Blocks may also be requested if available.&#xD;
&#xD;
          5. Patient must have selected radical prostatectomy as treatment for prostate cancer.&#xD;
&#xD;
          6. Signed informed consent.&#xD;
&#xD;
          7. Blocks and/or slides from prostate biopsy and from radical prostatectomy must be&#xD;
             available for analysis by Central Pathology laboratory.&#xD;
&#xD;
          8. Willingness to provide long-term follow-up information regarding additional treatments&#xD;
             and cancer status.&#xD;
&#xD;
          9. Willingness to provide blood and urine specimens prior to radical prostatectomy for&#xD;
             placement in the EDRN Upgrading Reference Set repository.&#xD;
&#xD;
         10. Willingness to provide demographic and clinical information related to prostate cancer&#xD;
             and prostate cancer risk (e.g., race/ethnicity, family history of prostate cancer).&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Gleason score greater than 3+3 on any prior prostate biopsy.&#xD;
&#xD;
          2. Any treatment other than radical prostatectomy planned for prostate cancer.&#xD;
&#xD;
          3. Prior treatment of the prostate with androgen deprivation, radiation, or other&#xD;
             cytotoxic chemotherapy.&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>35 Years</minimum_age>
    <maximum_age>99 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Ian M Thompson Jr, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Texas</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Texas Health Science Center at San Antonio</name>
      <address>
        <city>San Antonio</city>
        <state>Texas</state>
        <zip>78229</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Robert Hudson, BS</last_name>
      <phone>210-450-8688</phone>
      <email>hudsonr1@uthscsa.edu</email>
    </contact>
    <investigator>
      <last_name>Ian M Thompson Jr., MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>February 2023</verification_date>
  <study_first_submitted>July 8, 2014</study_first_submitted>
  <study_first_submitted_qc>July 10, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 14, 2014</study_first_posted>
  <last_update_submitted>February 27, 2023</last_update_submitted>
  <last_update_submitted_qc>February 27, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">March 1, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Prostate Cancer</keyword>
  <keyword>Radical Prostatectomy</keyword>
  <keyword>Prostate biopsy</keyword>
  <keyword>Upgrading</keyword>
  <keyword>Upgrading Reference set</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Prostatic Neoplasms</mesh_term>
  </condition_browse>
  <!-- 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/NCT02189486
org study id: HSC20140367H
secondary id: 5P30CA054174
nct id: NCT02189486
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
has dmc: Yes
Research repository designed to establish prostate cancer upgrading reference set and
      development of a risk prediction tool. Repository will include clinical information and
      biologics on a cohort of 240 men, to predict presence of high grade cancer at time of
      prostatectomy (removal of prostate) among patients with a low grade cancer diagnosis at time
      of biopsy.
The primary endpoint of this study is the presence of tumor upgrading at the time of radical
      prostatectomy. Upgrading is defined as: Gleason 3+4 or higher grade A secondary study
      endpoint is presence of prostate cancer beyond the prostate (pathologic T3 disease) at
      radical prostatectomy. (This finding may be considered as a rationale for treatment.)
      Evidence of pathologic stage T3 or higher disease will be assessed by the presence of: (1)
      seminal vesicle invasion or (2) positive surgical margins or (3) established extracapsular
      extension or (4) lymph node involvement by tumor. It should be noted that pathologic stage T3
      disease, while generally portending a greater risk of disease recurrence, may not be an
      intrinsic feature of disease prognosis but can be an artifact of surgical technique.
      Nonetheless, a secondary risk assessment tool will include both a Gleason 7-10 endpoint plus
      any patients with pT3+ disease to a composite endpoint that could indicate disease best
      managed with treatment in lieu of active surveillance.Prostate cancer, confirmed on prostate
      biopsy, within two years of scheduled radical prostatectomy.

      2. Prostate cancer must be graded as Gleason 3+3 on the biopsy immediately prior to radical
      prostatectomy. (Secondary eligibility will be established on central review of pathology
      slides, and blocks if available, at Cornell Central Pathology Laboratory to confirm
      eligibility.) 3. Prostate cancer may have been detected on prior biopsy as well but must not
      be greater than Gleason 3+3. (Also requires Central Pathology Laboratory review.) 4. Slides
      must be available for Central Pathology Laboratory review on any biopsy showing prostate
      cancer. FFPE (formalin fixed paraffin embedded) blocks may also be requested if available.

      5. Patient must have selected radical prostatectomy as treatment for prostate cancer.

      6. Signed informed consent. 7. Blocks and/or slides from prostate biopsy and from radical
      prostatectomy must be available for analysis by Central Pathology laboratory.

      8. Willingness to provide long-term follow-up information regarding additional treatments and
      cancer status.

      9. Willingness to provide blood and urine specimens prior to radical prostatectomy for
      placement in the Early Detection Research Network (EDRN) Upgrading Reference Set repository.

      10. Willingness to provide demographic and clinical information related to prostate cancer
      and prostate cancer risk (e.g., race/ethnicity, family history of prostate cancer).
observational model: Cohort
time perspective: Prospective
measure: Prostate cancer tumor upgrading at time of radical prostatectomy (Gleason 3+4 or higher grade)
time frame: 4 years
description: The primary endpoint of this study is the presence of tumor upgrading at the time of radical prostatectomy. Upgrading is defined as: Gleason 3+4 or higher grade
measure: Presence of prostate cancer beyond the prostate at radical prostatectomy (pathologic T3 disease)
time frame: 10 years
description: A secondary study endpoint is presence of prostate cancer beyond the prostate (pathologic T3 disease) at radical prostatectomy. (This finding may be considered as a rationale for treatment.) Evidence of pathologic stage T3 or higher disease will be assessed by the presence of: (1) seminal vesicle invasion or (2) positive surgical margins or (3) established extracapsular extension or (4) lymph node involvement by tumor. It should be noted that pathologic stage T3 disease, while generally portending a greater risk of disease recurrence, may not be an intrinsic feature of disease prognosis but can be an artifact of surgical technique. Nonetheless, a secondary risk assessment tool will include both a Gleason 7-10 endpoint plus any patients with pT3+ disease to a composite endpoint that could indicate disease best managed with treatment in lieu of active surveillance.
arm group label: Prostate Cancer Cohort
description: Men with prostate cancer who have elected radical prostatectomy for their treatment of their prostate cancer within two years after prostate biopsy.
Blood, voided urine and prostate tissue slides and blocks
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: Male
minimum age: 35 Years
maximum age: 99 Years
healthy volunteers: No
last name: Ian M Thompson Jr, MD
role: Principal Investigator
affiliation: University of Texas
facility: 
status: Recruiting
contact: 
investigator: 
country: United States
responsible party type: Sponsor
mesh term: Prostatic Neoplasms