<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/NCT02209584</url>
  </required_header>
  <id_info>
    <org_study_id>PROCEDE-2000</org_study_id>
    <nct_id>NCT02209584</nct_id>
  </id_info>
  <brief_title>Open Registry Measuring Impact of Genomic Testing on Treatment Decision After Biopsy in Newly Diagnosed Prostate Cancer Patients</brief_title>
  <acronym>PROCEDE-2000</acronym>
  <official_title>An Open Registry to Measure the Impact of Adding Genomic Testing (Prolaris®) on the Treatment Decision Following Biopsy in Newly Diagnosed Prostate Cancer Patients by Specialists</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Myriad Genetic Laboratories, Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Myriad Genetic Laboratories, Inc.</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This registry is intended to measure the impact of Prolaris® testing on therapeutic decisions&#xD;
      when added to standard clinical-pathological parameters in men with newly diagnosed prostate&#xD;
      cancer.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>May 2014</start_date>
  <completion_date type="Actual">December 8, 2015</completion_date>
  <primary_completion_date type="Actual">April 15, 2015</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>Percentage change from the recorded PRE-Prolaris® test treatment option versus the ACTUAL treatment option of genomic risk assessment testing (Prolaris®).</measure>
    <time_frame>1 months</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Percentage change from the recorded PRE-Prolaris® test treatment option versus the POST-Prolaris® test treatment plan (prior to patient consultation).</measure>
    <time_frame>1 month</time_frame>
  </secondary_outcome>
  <other_outcome>
    <measure>Percentage change from the recorded PRE-Prolaris® test treatment option versus the POST-Prolaris® test treatment plan following consultation with the patient.</measure>
    <time_frame>1 month</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>The mean change in the physician's likelihood of recommending non-interventional therapy (watchful waiting or active surveillance) post-genomic testing compared to pre-genomic testing.</measure>
    <time_frame>1 month</time_frame>
  </other_outcome>
  <enrollment type="Actual">274</enrollment>
  <condition>Prostate Cancer</condition>
  <eligibility>
    <study_pop>
      <textblock>
        Recently diagnosed treatment-naïve patients with early stage localized prostate cancer.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Newly diagnosed (≤6 months), untreated patients with histologically proven&#xD;
             adenocarcinoma of the prostate that have the following characteristics.&#xD;
&#xD;
          -  Clinically localized (no evidence on clinical or imaging studies of advanced disease.&#xD;
&#xD;
          -  No hormonal therapy including LHRH agonist or antagonist, anti-androgen, 5-alpha&#xD;
             reductase inhibitor, estrogens or exogenous androgens, when applicable.&#xD;
&#xD;
          -  Sufficient amount of tissue remains from biopsy to perform genomic testing.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients with known history of hypogonadism will be excluded from the registry&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Richard Wenstrup, MD</last_name>
    <role>Study Director</role>
    <affiliation>Myriad Genetic Laboratories, Inc.</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Washington</name>
      <address>
        <city>Seattle</city>
        <state>Washington</state>
        <zip>98195</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>May 2015</verification_date>
  <study_first_submitted>April 29, 2014</study_first_submitted>
  <study_first_submitted_qc>August 5, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 6, 2014</study_first_posted>
  <last_update_submitted>August 31, 2017</last_update_submitted>
  <last_update_submitted_qc>August 31, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">September 5, 2017</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>
  <!-- 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/NCT02209584
org study id: PROCEDE-2000
nct id: NCT02209584
lead sponsor: 
has dmc: No
This registry is intended to measure the impact of Prolaris® testing on therapeutic decisions
      when added to standard clinical-pathological parameters in men with newly diagnosed prostate
      cancer.
observational model: Cohort
time perspective: Prospective
measure: Percentage change from the recorded PRE-Prolaris® test treatment option versus the ACTUAL treatment option of genomic risk assessment testing (Prolaris®).
time frame: 1 months
measure: Percentage change from the recorded PRE-Prolaris® test treatment option versus the POST-Prolaris® test treatment plan (prior to patient consultation).
time frame: 1 month
measure: Percentage change from the recorded PRE-Prolaris® test treatment option versus the POST-Prolaris® test treatment plan following consultation with the patient.
time frame: 1 month
measure: The mean change in the physician's likelihood of recommending non-interventional therapy (watchful waiting or active surveillance) post-genomic testing compared to pre-genomic testing.
time frame: 1 month
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: Male
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Richard Wenstrup, MD
role: Study Director
affiliation: Myriad Genetic Laboratories, Inc.
facility: 
country: United States
responsible party type: Sponsor
mesh term: Prostatic Neoplasms