<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/NCT04472338</url>
  </required_header>
  <id_info>
    <org_study_id>RG1004195</org_study_id>
    <secondary_id>NCI-2020-04602</secondary_id>
    <secondary_id>8760</secondary_id>
    <secondary_id>RG1004195</secondary_id>
    <secondary_id>P50CA097186</secondary_id>
    <nct_id>NCT04472338</nct_id>
  </id_info>
  <brief_title>Prostate Cancer Screening for People at Genetic Risk for Aggressive Disease, PATROL Study</brief_title>
  <official_title>PATROL: Prostate Cancer Screening for People AT Genetic Risk FOr Aggressive Disease</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Washington</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Cancer Institute (NCI)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
    <collaborator>
      <agency>Canary Foundation</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>CureBRCA</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Washington</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>
      This study investigates ways to detect prostate cancer earlier in people at genetic risk for&#xD;
      disease that forms, grows, or spreads quickly (aggressive). Studying samples of blood, urine,&#xD;
      and/or tissue in the laboratory may help doctors further understand the genetics of prostate&#xD;
      cancer and help identify ways to detect cancer earlier, thereby improving treatment and&#xD;
      methods of early detection in the future.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      OUTLINE:&#xD;
&#xD;
      Participants undergo collection of blood, urine, and/or tissue samples every 6-12 months,&#xD;
      when any biopsy occurs, and if relevant, at time of curative therapy and 3-9 months after&#xD;
      completion of curative therapy for up to 3 years.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">May 21, 2020</start_date>
  <completion_date type="Anticipated">August 31, 2030</completion_date>
  <primary_completion_date type="Anticipated">August 31, 2030</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>Positive predictive values (PPVs) of age-based prostate specific antigen (PSA) thresholds</measure>
    <time_frame>Up to 10 years</time_frame>
    <description>To estimate PPVs of age-based PSA thresholds for biopsy referral in this patient population, will first fit a logistic regression model to estimate the odds that biopsy leads to a prostate cancer diagnosis. The regression will have a binary indicator of prostate cancer diagnosis as the response variable, patient age at biopsy (categorized as &lt; 50, 50-59, or &gt;= 60 years to correspond to the age-based PSA thresholds) as a fixed effect, and a unique patient identifier as a random effect to account for possibly repeated biopsies. Will then convert the estimated odds that biopsy leads to a prostate cancer diagnosis within each age category into corresponding probabilities of this outcome-i.e., PPV point estimates and associated 95% confidence intervals-using the inverse logit function.</description>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">450</enrollment>
  <condition>Prostate Carcinoma</condition>
  <arm_group>
    <arm_group_label>Screening (biospecimen collection)</arm_group_label>
    <description>Participants undergo collection of blood, urine, and/or tissue samples every 12 months, when any biopsy occurs, and if relevant, at time of curative therapy and 12 months after completion of curative therapy.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Biospecimen Collection</intervention_name>
    <description>Undergo collection of blood, urine, and/or tissue samples</description>
    <arm_group_label>Screening (biospecimen collection)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Laboratory Biomarker Analysis</intervention_name>
    <description>Correlative studies</description>
    <arm_group_label>Screening (biospecimen collection)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Quality-of-Life Assessment</intervention_name>
    <description>Ancillary studies</description>
    <arm_group_label>Screening (biospecimen collection)</arm_group_label>
    <other_name>Quality of Life Assessment</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Questionnaire Administration</intervention_name>
    <description>Ancillary studies</description>
    <arm_group_label>Screening (biospecimen collection)</arm_group_label>
  </intervention>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Blood, urine, tissue&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Germline carriers of pathogenic or likely pathogenic mutations in genes associated with&#xD;
        increased risk of prostate cancer&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  People with prostates ≥40 years of age&#xD;
&#xD;
          -  Documented germline pathogenic variant in known or suspected genes associated with&#xD;
             prostate cancer risk.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Prior diagnosis of prostate cancer&#xD;
&#xD;
          -  Medical contraindication to any of the study procedures (e.g., prostate biopsy)&#xD;
&#xD;
          -  For all cancer types except non-melanoma skin cancer, any cancer treatment with&#xD;
             curative intent within the past 12 months (e.g., surgery, radiation, chemotherapy,&#xD;
             immunotherapy)&#xD;
&#xD;
          -  Unable to provide written informed consent&#xD;
&#xD;
          -  Unable or unwilling to complete clinical care and study procedures as indicated by the&#xD;
             study protocol.&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <gender_based>Yes</gender_based>
    <gender_description>People with prostates</gender_description>
    <minimum_age>40 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Heather H. Cheng</last_name>
    <role>Principal Investigator</role>
    <affiliation>Fred Hutch/University of Washington Cancer Consortium</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Study Team Coordinator</last_name>
    <phone>206-598-0850</phone>
    <email>patrolstudy@uw.edu</email>
  </overall_contact>
  <location>
    <facility>
      <name>OHSU Knight Cancer Institute</name>
      <address>
        <city>Portland</city>
        <state>Oregon</state>
        <zip>97239</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Alexandra Sokolova</last_name>
      <phone>503-494-7999</phone>
    </contact>
    <investigator>
      <last_name>Alexandra Sokolova</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>University of Pennsylvania/Abramson Cancer Center</name>
      <address>
        <city>Philadelphia</city>
        <state>Pennsylvania</state>
        <zip>19104</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Kara Maxwell</last_name>
      <phone>215-316-5151</phone>
    </contact>
    <investigator>
      <last_name>Kara Maxwell</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <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>Not yet recruiting</status>
    <contact>
      <last_name>Michael Liss</last_name>
      <phone>210-567-1100</phone>
      <email>liss@uthscsa.edu</email>
    </contact>
    <investigator>
      <last_name>Michael Liss</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Fred Hutch/University of Washington Cancer Consortium</name>
      <address>
        <city>Seattle</city>
        <state>Washington</state>
        <zip>98109</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Study Team Coordinator</last_name>
      <phone>206-598-0850</phone>
      <email>patrolstudy@uw.edu</email>
    </contact>
    <investigator>
      <last_name>Heather H. Cheng</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>September 2023</verification_date>
  <study_first_submitted>July 10, 2020</study_first_submitted>
  <study_first_submitted_qc>July 10, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 15, 2020</study_first_posted>
  <last_update_submitted>September 8, 2023</last_update_submitted>
  <last_update_submitted_qc>September 8, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">September 13, 2023</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>
  <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/NCT04472338
org study id: RG1004195
secondary id: NCI-2020-04602
secondary id: 8760
secondary id: RG1004195
secondary id: P50CA097186
nct id: NCT04472338
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This study investigates ways to detect prostate cancer earlier in people at genetic risk for
      disease that forms, grows, or spreads quickly (aggressive). Studying samples of blood, urine,
      and/or tissue in the laboratory may help doctors further understand the genetics of prostate
      cancer and help identify ways to detect cancer earlier, thereby improving treatment and
      methods of early detection in the future.
OUTLINE:

      Participants undergo collection of blood, urine, and/or tissue samples every 6-12 months,
      when any biopsy occurs, and if relevant, at time of curative therapy and 3-9 months after
      completion of curative therapy for up to 3 years.
observational model: Cohort
time perspective: Prospective
measure: Positive predictive values (PPVs) of age-based prostate specific antigen (PSA) thresholds
time frame: Up to 10 years
description: To estimate PPVs of age-based PSA thresholds for biopsy referral in this patient population, will first fit a logistic regression model to estimate the odds that biopsy leads to a prostate cancer diagnosis. The regression will have a binary indicator of prostate cancer diagnosis as the response variable, patient age at biopsy (categorized as < 50, 50-59, or >= 60 years to correspond to the age-based PSA thresholds) as a fixed effect, and a unique patient identifier as a random effect to account for possibly repeated biopsies. Will then convert the estimated odds that biopsy leads to a prostate cancer diagnosis within each age category into corresponding probabilities of this outcome-i.e., PPV point estimates and associated 95% confidence intervals-using the inverse logit function.
arm group label: Screening (biospecimen collection)
description: Participants undergo collection of blood, urine, and/or tissue samples every 12 months, when any biopsy occurs, and if relevant, at time of curative therapy and 12 months after completion of curative therapy.
intervention type: Procedure
intervention name: Biospecimen Collection
description: Undergo collection of blood, urine, and/or tissue samples
arm group label: Screening (biospecimen collection)
intervention type: Other
intervention name: Laboratory Biomarker Analysis
description: Correlative studies
arm group label: Screening (biospecimen collection)
intervention type: Other
intervention name: Quality-of-Life Assessment
description: Ancillary studies
arm group label: Screening (biospecimen collection)
other name: Quality of Life Assessment
intervention type: Other
intervention name: Questionnaire Administration
description: Ancillary studies
arm group label: Screening (biospecimen collection)
Blood, urine, tissue
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: Male
gender based: Yes
gender description: People with prostates
minimum age: 40 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Heather H. Cheng
role: Principal Investigator
affiliation: Fred Hutch/University of Washington Cancer Consortium
last name: Study Team Coordinator
phone: 206-598-0850
email: patrolstudy@uw.edu
facility: 
status: Not yet recruiting
contact: 
investigator: 
facility: 
status: Not yet recruiting
contact: 
investigator: 
facility: 
status: Not yet recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
country: United States
responsible party type: Sponsor
mesh term: Prostatic Neoplasms
sharing ipd: No