<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/NCT04404894</url>
  </required_header>
  <id_info>
    <org_study_id>URO-013</org_study_id>
    <nct_id>NCT04404894</nct_id>
  </id_info>
  <brief_title>Long-Term Prospective Registry in Prostate Cancer Patients From Diverse Urology Practice Settings Following Prolaris® Testing</brief_title>
  <official_title>Long-Term Prospective Registry to Evaluate Treatment Decisions and Clinical Outcomes in Prostate Cancer Patients From Diverse Urology Practice Settings Following Prolaris® Testing</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>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This registry will evaluate treatment selection for patients with newly diagnosed, localized&#xD;
      prostate cancer following Prolaris testing. It will measure the proportion of men who&#xD;
      initially select treatment with active surveillance, the time frame between active&#xD;
      surveillance selection and any change in treatment, and clinical outcomes.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      To evaluate use of the Prolaris score in treatment management decisions in an ethnically and&#xD;
      racially diverse population of men who have been newly diagnosed with prostate cancer and who&#xD;
      are potential candidates for active surveillance. This registry will evaluate oncologic and&#xD;
      co-morbidity outcomes in patients who receive Prolaris testing. Additionally, the registry&#xD;
      will measure the prevalence and distribution of pathogenic mutations in hereditary cancer&#xD;
      risk-associated genes among men with prostate cancer who meet National Cancer Center Network&#xD;
      (NCCN) criteria for hereditary cancer genetic testing.&#xD;
&#xD;
      The primary objective of this registry is to evaluate initial selection of active&#xD;
      surveillance (Active Surveillance selection) versus definitive therapy (DT) among men with&#xD;
      newly diagnosed prostate cancer who make treatment decisions with Prolaris testing, and among&#xD;
      patient subsets defined by race/ethnicity.&#xD;
&#xD;
      The secondary objectives of the registry are to evaluate progression of from Active&#xD;
      Surveillance to definitive therapy over time and prostate cancer-associated morbidities that&#xD;
      affect quality of life among men with newly diagnosed prostate cancer and who undergo&#xD;
      Prolaris testing, and among patient subsets defined by racial/ethnic background and ancestry.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">April 30, 2020</start_date>
  <completion_date type="Anticipated">November 2029</completion_date>
  <primary_completion_date type="Anticipated">November 2029</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>10 Years</target_duration>
  <primary_outcome>
    <measure>Active Surveillance (AS) selection versus Definitive Therapy (DT</measure>
    <time_frame>1 Year</time_frame>
    <description>The primary endpoint of the registry is Active Surveillance selection, defined as the proportion of all men who select Active Surveillance in lieu of definitive therapy following confirmatory diagnosis of localized Prostate Cancer and Prolaris testing. Active Surveillance selection is&#xD;
documented by the treating provider and reflects the patient-provider decision at the time to pursue Active Surveillance with no curative intent.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Active Surveillance Durability; Comorbidities</measure>
    <time_frame>Active Surveillance durability, date of diagnostic biopsy will be recorded as the Active Surveillance initiation date. Definitive treatments collected at baseline and annually up to 10 years Comorbidities collected annually up to 10 years.</time_frame>
    <description>Active Surveillance durability, measured as the length of time between the Active Surveillance initiation date and the first definitive therapy date. Comorbidities, including voiding problems, erectile dysfunction, bowel dysfunction, stress or urgency incontinence, depression, and anxiety, as measured by validated, standard of care quality-of-life assessments: the Expanded Prostate Cancer Index Composite Instrument (EPIC-26) and the Generalized Anxiety Disorder scale (GAD-7).</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Disease Progression</measure>
    <time_frame>Baseline to year 10</time_frame>
    <description>• Disease progression, measured as the proportion of men who:&#xD;
Initiate and remain on Active Surveillance and subsequently experience distant metastasis or disease-specific mortality.&#xD;
Initiate Active Surveillance and proceed to definitive therapy, or initially select definitive therapy, and subsequently experience biochemical recurrence (BCR), distant metastasis or disease-specific mortality. For radical prostatectomy (RP) patients, BCR is defined as PSA &gt;0.2 ng/mL on at least two occasions more than two weeks apart or initiation of any salvage therapy greater than or equal to 6 months after surgery. For patients treated by external beam radiation therapy (EBRT), BCR is defined by reaching a post-EBRT PSA of nadir + 2 ng/mL (Phoenix criteria) or initiation of any salvage therapy 6 months after radiation.</description>
  </other_outcome>
  <other_outcome>
    <measure>Disease reclassification</measure>
    <time_frame>Baseline to year 10</time_frame>
    <description>Disease reclassification, defined as a patient initially treated with Active Surveillance for whom follow-up biopsy results in reclassification of the disease into a different NCCN risk category.</description>
  </other_outcome>
  <other_outcome>
    <measure>Baseline Clinicopathologic measures</measure>
    <time_frame>Baseline to year 10</time_frame>
    <description>Baseline clinicopathologic measures, including pre-biopsy PSA, date of biopsy, prostate volume, biopsy findings, total number of biopsy cores, number of positive cores, clinical stage, Gleason score, NCCN risk category, and Prostate Magnetic Resonance Imaging (MRI) assessment results with Prostate Imaging Reporting and Data System (PI-RADS) score(s) when available.</description>
  </other_outcome>
  <other_outcome>
    <measure>The Proportion of Men with PrCa who:</measure>
    <time_frame>Baseline to year 10</time_frame>
    <description>(1) Meet NCCN hereditary high-risk criteria, (2) undergo and complete hereditary cancer genetic testing; and (3) are found to carry pathogenic variants in tested cancer-predisposition genes.</description>
  </other_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">500</enrollment>
  <condition>Prostate Cancer</condition>
  <arm_group>
    <arm_group_label>Prolaris tested patients with Prostate Cancer</arm_group_label>
    <description>Recently diagnosed patients with histologically proven, localized adenocarcinoma of prostate determined via transrectal ultrasonography and biopsy of at least 10 prostate sites who have undergone Prolaris testing.</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        Urology Practices&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age 18 years or older on date of enrollment.&#xD;
&#xD;
          -  Diagnosed within the past six months with histologically proven, localized&#xD;
             adenocarcinoma of prostate determined via transrectal ultrasonography and biopsy of at&#xD;
             least 10 prostate sites.&#xD;
&#xD;
          -  Received Prolaris testing and a resulting CCR score from the diagnostic biopsy sample&#xD;
             as standard of care.&#xD;
&#xD;
          -  Can be monitored for disease progression according to standard of care (e.g., current&#xD;
             NCCN guidelines).&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Estimated life expectancy &lt; 10 years.&#xD;
&#xD;
          -  Clinical evidence of metastasis or lymph node involvement.&#xD;
&#xD;
          -  Received pelvic radiation prior to biopsy.&#xD;
&#xD;
          -  Received androgen deprivation therapy (ADT) prior to biopsy; however, 5 alpha-&#xD;
             reductase inhibitor (5-ARI) use is permitted.&#xD;
&#xD;
          -  Plan to use PrCa-specific prognostic testing other than PSA for treatment decision&#xD;
             making during Active Surveillance.&#xD;
&#xD;
          -  Currently participating in an interventional clinical trial.&#xD;
&#xD;
          -  Unable to provide routine clinical informed consent.&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <gender_based>Yes</gender_based>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Walter Rayford, M.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>The Urology Group</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Erica Akins</last_name>
    <phone>513-477-7732</phone>
    <email>Erica.Akins@myriad.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Thaylon Davis</last_name>
    <phone>801-505-5109</phone>
    <email>Tdavis@myriad.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>VA Long Beach Healthcare System</name>
      <address>
        <city>Long Beach</city>
        <state>California</state>
        <zip>90822</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Mina Behdad</last_name>
      <phone>562-826-8000</phone>
      <phone_ext>5062</phone_ext>
      <email>mina.behdad@va.gov</email>
    </contact>
    <investigator>
      <last_name>Greg Gin, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Manatee Medical Research Institute</name>
      <address>
        <city>Bradenton</city>
        <state>Florida</state>
        <zip>34205</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Amy Boucher</last_name>
      <phone>941-792-0340</phone>
      <phone_ext>1328</phone_ext>
      <email>aboucher@mmrinstitute.com</email>
    </contact>
    <investigator>
      <last_name>Alan Miller, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>University of Florida - Jacksonville</name>
      <address>
        <city>Jacksonville</city>
        <state>Florida</state>
        <zip>32209</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Withdrawn</status>
  </location>
  <location>
    <facility>
      <name>Georgia Urology</name>
      <address>
        <city>Decatur</city>
        <state>Georgia</state>
        <zip>30033</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Withdrawn</status>
  </location>
  <location>
    <facility>
      <name>UroPartners, LLC</name>
      <address>
        <city>Westchester</city>
        <state>Illinois</state>
        <zip>60440</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Celeste Ruiz</last_name>
      <phone>708-273-3735</phone>
      <email>CRuiz@uropartners.com</email>
    </contact>
    <investigator>
      <last_name>Paul Yonover, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Johns Hopkins University</name>
      <address>
        <city>Baltimore</city>
        <state>Maryland</state>
        <zip>21218</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Brandy Yeater</last_name>
      <email>dyeater1@jhmi.edu</email>
    </contact>
    <investigator>
      <last_name>Arthur Burnett, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>The Urology Group</name>
      <address>
        <city>Memphis</city>
        <state>Tennessee</state>
        <zip>38018</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Tracy Stewart</last_name>
      <phone>901-832-9909</phone>
      <email>tstewart@memphisurology.com</email>
    </contact>
    <investigator>
      <last_name>Walter Rayford, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Vanderbilt University Medical Center</name>
      <address>
        <city>Nashville</city>
        <state>Tennessee</state>
        <zip>37232</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Pamela Steele, BSN</last_name>
      <phone>635-343-2120</phone>
      <email>pamela.steele@vumc.org</email>
    </contact>
    <investigator>
      <last_name>Kelvin Moses, M.D., PhD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>July 2023</verification_date>
  <study_first_submitted>May 22, 2020</study_first_submitted>
  <study_first_submitted_qc>May 22, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">May 28, 2020</study_first_posted>
  <last_update_submitted>July 18, 2023</last_update_submitted>
  <last_update_submitted_qc>July 18, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">July 19, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Prostate Cancer</keyword>
  <keyword>Active Surveillance</keyword>
  <keyword>Active Surveillance Durability</keyword>
  <keyword>Prostate Cancer Treatment Selection</keyword>
  <keyword>Prostate Cancer Risk Stratification</keyword>
  <keyword>Prostate Cancer Oncological Outcomes</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>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/NCT04404894
org study id: URO-013
nct id: NCT04404894
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This registry will evaluate treatment selection for patients with newly diagnosed, localized
      prostate cancer following Prolaris testing. It will measure the proportion of men who
      initially select treatment with active surveillance, the time frame between active
      surveillance selection and any change in treatment, and clinical outcomes.
To evaluate use of the Prolaris score in treatment management decisions in an ethnically and
      racially diverse population of men who have been newly diagnosed with prostate cancer and who
      are potential candidates for active surveillance. This registry will evaluate oncologic and
      co-morbidity outcomes in patients who receive Prolaris testing. Additionally, the registry
      will measure the prevalence and distribution of pathogenic mutations in hereditary cancer
      risk-associated genes among men with prostate cancer who meet National Cancer Center Network
      (NCCN) criteria for hereditary cancer genetic testing.

      The primary objective of this registry is to evaluate initial selection of active
      surveillance (Active Surveillance selection) versus definitive therapy (DT) among men with
      newly diagnosed prostate cancer who make treatment decisions with Prolaris testing, and among
      patient subsets defined by race/ethnicity.

      The secondary objectives of the registry are to evaluate progression of from Active
      Surveillance to definitive therapy over time and prostate cancer-associated morbidities that
      affect quality of life among men with newly diagnosed prostate cancer and who undergo
      Prolaris testing, and among patient subsets defined by racial/ethnic background and ancestry.
observational model: Cohort
time perspective: Prospective
measure: Active Surveillance (AS) selection versus Definitive Therapy (DT
time frame: 1 Year
description: The primary endpoint of the registry is Active Surveillance selection, defined as the proportion of all men who select Active Surveillance in lieu of definitive therapy following confirmatory diagnosis of localized Prostate Cancer and Prolaris testing. Active Surveillance selection is
documented by the treating provider and reflects the patient-provider decision at the time to pursue Active Surveillance with no curative intent.
measure: Active Surveillance Durability; Comorbidities
time frame: Active Surveillance durability, date of diagnostic biopsy will be recorded as the Active Surveillance initiation date. Definitive treatments collected at baseline and annually up to 10 years Comorbidities collected annually up to 10 years.
description: Active Surveillance durability, measured as the length of time between the Active Surveillance initiation date and the first definitive therapy date. Comorbidities, including voiding problems, erectile dysfunction, bowel dysfunction, stress or urgency incontinence, depression, and anxiety, as measured by validated, standard of care quality-of-life assessments: the Expanded Prostate Cancer Index Composite Instrument (EPIC-26) and the Generalized Anxiety Disorder scale (GAD-7).
measure: Disease Progression
time frame: Baseline to year 10
description: • Disease progression, measured as the proportion of men who:
Initiate and remain on Active Surveillance and subsequently experience distant metastasis or disease-specific mortality.
Initiate Active Surveillance and proceed to definitive therapy, or initially select definitive therapy, and subsequently experience biochemical recurrence (BCR), distant metastasis or disease-specific mortality. For radical prostatectomy (RP) patients, BCR is defined as PSA >0.2 ng/mL on at least two occasions more than two weeks apart or initiation of any salvage therapy greater than or equal to 6 months after surgery. For patients treated by external beam radiation therapy (EBRT), BCR is defined by reaching a post-EBRT PSA of nadir + 2 ng/mL (Phoenix criteria) or initiation of any salvage therapy 6 months after radiation.
measure: Disease reclassification
time frame: Baseline to year 10
description: Disease reclassification, defined as a patient initially treated with Active Surveillance for whom follow-up biopsy results in reclassification of the disease into a different NCCN risk category.
measure: Baseline Clinicopathologic measures
time frame: Baseline to year 10
description: Baseline clinicopathologic measures, including pre-biopsy PSA, date of biopsy, prostate volume, biopsy findings, total number of biopsy cores, number of positive cores, clinical stage, Gleason score, NCCN risk category, and Prostate Magnetic Resonance Imaging (MRI) assessment results with Prostate Imaging Reporting and Data System (PI-RADS) score(s) when available.
measure: The Proportion of Men with PrCa who:
time frame: Baseline to year 10
description: (1) Meet NCCN hereditary high-risk criteria, (2) undergo and complete hereditary cancer genetic testing; and (3) are found to carry pathogenic variants in tested cancer-predisposition genes.
arm group label: Prolaris tested patients with Prostate Cancer
description: Recently diagnosed patients with histologically proven, localized adenocarcinoma of prostate determined via transrectal ultrasonography and biopsy of at least 10 prostate sites who have undergone Prolaris testing.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: Male
gender based: Yes
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Walter Rayford, M.D.
role: Principal Investigator
affiliation: The Urology Group
last name: Erica Akins
phone: 513-477-7732
email: Erica.Akins@myriad.com
last name: Thaylon Davis
phone: 801-505-5109
email: Tdavis@myriad.com
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Withdrawn
facility: 
status: Withdrawn
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
country: United States
responsible party type: Sponsor
mesh term: Prostatic Neoplasms
sharing ipd: No