<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/NCT03256630</url>
  </required_header>
  <id_info>
    <org_study_id>09-048</org_study_id>
    <nct_id>NCT03256630</nct_id>
  </id_info>
  <brief_title>Evaluation of a Blood Biomarker to Try and Distinguish Between the Presence or Absence of Aggressive Prostate Cancer</brief_title>
  <official_title>A Laboratory Study To Evaluate A Blood Biomarker That Can Distinguish Between the Presence Or Absence of Aggressive Prostate Cancer</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Genomic Health®, Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>AdventHealth</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Genomic Health®, Inc.</source>
  <oversight_info>
    <has_dmc>No</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>
      A Laboratory Study to Evaluate Urine and Blood Biomarkers That Can Distinguish Between the&#xD;
      Presence or Absence of Aggressive Prostate Cancer&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The over-arching goal of this study is to evaluate if biomarkers within the blood or urine of&#xD;
      men with localized prostate cancer can distinguish between those with indolent cancer,&#xD;
      defined as Gleason Grade Groups 1 and 2 and those with more aggressive disease (Gleason Grade&#xD;
      Groups 3, 4, and 5).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Business decision to discontinue development of the IsoPSA assay.&#xD;
  </why_stopped>
  <start_date type="Actual">January 10, 2018</start_date>
  <completion_date type="Actual">February 28, 2019</completion_date>
  <primary_completion_date type="Actual">December 20, 2018</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Characterize the distribution of clinical/pathological factors of the samples by the Gleason Grade Group and to characterize the distribution of the signal of each biomarker by the Gleason Grade Group or combination of groups.</measure>
    <time_frame>1 year</time_frame>
  </primary_outcome>
  <enrollment type="Actual">128</enrollment>
  <condition>Prostate Cancer</condition>
  <biospec_descr>
    <textblock>
      Blood, Urine&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Prostate cancer patients who are planning to have a Radical Prostatectomy at the Global&#xD;
        Robotics Institute and are informed and willing to participate in study.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Patient has been diagnosed with Prostate Cancer and is planning on having a Radical&#xD;
             Prostatectomy performed at the Global Robotics Institute.&#xD;
&#xD;
          2. Diagnostic PSA ≤ 20 ng/mL.&#xD;
&#xD;
          3. Pathology report from most recent positive biopsy, prior to Radical Prostatectomy, is&#xD;
             available.&#xD;
&#xD;
          4. Ability to read and understand the informed consent form.&#xD;
&#xD;
          5. Patient must have signed informed consent form&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Any of the following active therapies received: radiation, chemotherapy, biologic&#xD;
             agents, surgery, local therapies including cryotherapy or HIFU.&#xD;
&#xD;
          2. Diagnostic PSA &gt; 20 ng/mL or missing PSA.&#xD;
&#xD;
          3. Patients who are unable or unwilling to provide informed consent.&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Florida Hospital Global Robotics Institute</name>
      <address>
        <city>Celebration</city>
        <state>Florida</state>
        <zip>34747</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>February 2020</verification_date>
  <study_first_submitted>August 16, 2017</study_first_submitted>
  <study_first_submitted_qc>August 17, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 22, 2017</study_first_posted>
  <last_update_submitted>February 3, 2020</last_update_submitted>
  <last_update_submitted_qc>February 3, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">February 5, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Active Surveillance</keyword>
  <keyword>Radical Prostatectomy</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/NCT03256630
org study id: 09-048
nct id: NCT03256630
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
A Laboratory Study to Evaluate Urine and Blood Biomarkers That Can Distinguish Between the
      Presence or Absence of Aggressive Prostate Cancer
The over-arching goal of this study is to evaluate if biomarkers within the blood or urine of
      men with localized prostate cancer can distinguish between those with indolent cancer,
      defined as Gleason Grade Groups 1 and 2 and those with more aggressive disease (Gleason Grade
      Groups 3, 4, and 5).
observational model: Case-Only
time perspective: Prospective
measure: Characterize the distribution of clinical/pathological factors of the samples by the Gleason Grade Group and to characterize the distribution of the signal of each biomarker by the Gleason Grade Group or combination of groups.
time frame: 1 year
Blood, Urine
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: Male
minimum age: N/A
maximum age: N/A
healthy volunteers: No
facility: 
country: United States
responsible party type: Sponsor
mesh term: Prostatic Neoplasms