<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/NCT03290508</url>
  </required_header>
  <id_info>
    <org_study_id>URO-008</org_study_id>
    <nct_id>NCT03290508</nct_id>
  </id_info>
  <brief_title>Long-term Study to Evaluate and Clinical Outcomes in Patients With Favorable Intermediate Risk Localized Prostate Cancer</brief_title>
  <official_title>Long-Term Prospective Registry to Evaluate Treatment Decisions and Clinical Outcomes in Patients With Favorable Intermediate-Risk Localized Prostate Cancer Following Cell Cycle Progression (CCP) Testing (Prolaris® Test)</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 is a long-term prospective registry study to determine whether Prolaris testing in&#xD;
      patients with favorable intermediate risk prostate cancer influences physician management&#xD;
      decisions toward conservative treatment in patients with Prolaris low-risk scores without&#xD;
      negatively impacting patient oncologic outcomes, thereby sparing low-risk patients from&#xD;
      unnecessary treatments and associated side-effects.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a long-term prospective registry to evaluate the impact of Prolaris testing on&#xD;
      therapeutic decisions in patients with newly diagnosed favorable intermediate-risk localized&#xD;
      prostate cancer and to summarize clinical oncologic outcomes. The design of the study is&#xD;
      non-interventional, and therefore the protocol will not require a specific treatment plan for&#xD;
      study participants. However, in the absence of a universally accepted timeframe for repeat&#xD;
      biopsies within existing active surveillance recommendations, study sites will be encouraged&#xD;
      to monitor patients for disease progression as per the standard of care (e.g., current&#xD;
      National Comprehensive Cancer Network [NCCN] guidelines) with the expectation of a repeat&#xD;
      biopsy within 18 months of the initial biopsy.&#xD;
&#xD;
      Patients who undergo Prolaris testing will be included in the registry as well as patients&#xD;
      who do not undergo Prolaris testing. Data collection for the first primary objective extends&#xD;
      over a 3-year period. During this time, data is collected on the treatment initiated, any&#xD;
      follow-up prostate biopsy performed in patients initially treated with active surveillance,&#xD;
      definitive treatments performed (with pathology data if surgical therapy is performed), and&#xD;
      the reasons definitive treatment was pursued, as well as data related to disease progression&#xD;
      such as biochemical recurrence, development of prostate cancer metastases, or disease&#xD;
      specific death.&#xD;
&#xD;
      Data collection for the second primary objective extends out to 8 years. During this time&#xD;
      data is collected on any follow-up prostate biopsy in patients still treated with active&#xD;
      surveillance, definitive treatments performed (with pathology data if surgical therapy is&#xD;
      performed), and the reasons definitive treatment was pursued, as well as data related to&#xD;
      disease progression such as biochemical recurrence, development of prostate cancer&#xD;
      metastases, or disease specific death.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    There is sufficient follow-up data to meet the endpoints of the study.&#xD;
  </why_stopped>
  <start_date type="Actual">September 14, 2017</start_date>
  <completion_date type="Actual">January 14, 2022</completion_date>
  <primary_completion_date type="Actual">January 14, 2022</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>8 Years</target_duration>
  <primary_outcome>
    <measure>Low Prolaris Score, on Active Surveillance</measure>
    <time_frame>3 years</time_frame>
    <description>Proportion of patients with low Prolaris scores who are initially treated with active surveillance</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Low Prolaris Score, Definitive Treatment Following Active Surveillance</measure>
    <time_frame>3 years</time_frame>
    <description>Proportion of patients with low Prolaris scores and initially treated with active surveillance who proceed to definitive treatment at 3 year follow-up</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Low Prolaris Score, Disease Progression Following Delayed Definitive Treatment</measure>
    <time_frame>8 years</time_frame>
    <description>Proportion of patients with low Prolaris scores and initially treated with active surveillance and later proceed to definitive treatment who develop disease progression at 5 years subsequent to the start of definitive treatment.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Low Prolaris Score, Time to Definitive Treatment following Active Surveillance</measure>
    <time_frame>8 years</time_frame>
    <description>Time to definitive treatment in patients with low Prolaris scores who are initially treated with active surveillance.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>No Prolaris Score, on Active Surveillance</measure>
    <time_frame>3 years</time_frame>
    <description>Proportion of patients without Prolaris testing who are initially treated with active surveillance.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>No Prolaris Score, Definitive Treatment Following Active Surveillance</measure>
    <time_frame>3 years</time_frame>
    <description>Proportion of patients without Prolaris testing initially treated with active surveillance who proceed to definitive treatment at 3 year follow-up.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>No Prolaris Score, Time to Definitive Treatment Following Active Surveillance</measure>
    <time_frame>8 years</time_frame>
    <description>Time to definitive treatment in patients without Prolaris testing who are initially treated with Active Surveillance.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>No Prolaris Score, Disease Progression Following Delayed Definitive Treatment</measure>
    <time_frame>8 years</time_frame>
    <description>Proportion of patients without Prolaris testing and initially treated with active surveillance who proceed with definitive treatment that develop disease progression at 5 years subsequent to the start of definitive treatment.</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">524</enrollment>
  <condition>Prostate Cancer</condition>
  <arm_group>
    <arm_group_label>Prolaris Testing</arm_group_label>
    <description>Recently diagnosed treatment-naïve patients with early stage localized prostate cancer who undergo Prolaris testing</description>
  </arm_group>
  <arm_group>
    <arm_group_label>No Prolaris Testing</arm_group_label>
    <description>Patients with newly diagnosed favorable intermediate-risk localized prostate cancer who DO NOT undergo Prolaris testing</description>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Prolaris Testing</intervention_name>
    <description>Recently diagnosed treatment-naïve patients with early stage localized prostate cancer who undergo Prolaris testing</description>
    <arm_group_label>Prolaris Testing</arm_group_label>
    <other_name>RNA expression signature of cell cycle progression genes</other_name>
  </intervention>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Formalin-fixed paraffin-embedded (FFPE) tissue from blocks or slides of prostatic&#xD;
      adenocarcinoma biopsies&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Newly diagnosed (≤ 6 months), treatment-naïve patients with favorable intermediate-risk&#xD;
        localized prostate cancer whose initial treatment has not been decided and who are being&#xD;
        seen at Medicare Certification and Training Registry (CTR) practices in the United States.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients who have undergone CCP testing and patients who have not undergone CCP&#xD;
             testing will be considered for enrollment in the study.&#xD;
&#xD;
               1. Willing to provide written informed consent.&#xD;
&#xD;
               2. Males ≥65 years old.&#xD;
&#xD;
               3. Newly diagnosed (≤6 months), treatment-naïve patient with histologically proven&#xD;
                  localized adenocarcinoma of prostate whose initial treatment has not been&#xD;
                  decided.&#xD;
&#xD;
               4. Candidate for and considering AS and yet would be eligible for definitive&#xD;
                  therapy.&#xD;
&#xD;
               5. Favorable intermediate-risk disease, defined by the NCCN as follows:&#xD;
&#xD;
                    -  predominant Gleason grade 3; AND&#xD;
&#xD;
                    -  percentage of positive cores &lt;50%; AND&#xD;
&#xD;
                    -  no more than 1 of the following NCCN intermediate-risk factors:&#xD;
&#xD;
                         -  Gleason grade 7&#xD;
&#xD;
                         -  T2b-T2c&#xD;
&#xD;
                         -  PSA 10-20 ng/mL&#xD;
&#xD;
               6. Estimated life expectancy ≥10 years.&#xD;
&#xD;
               7. Can be monitored for disease progression according to standard of care (e.g.,&#xD;
                  current NCCN guidelines).&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  1. Clinical evidence of metastasis or lymph node involvement.&#xD;
&#xD;
          -  2. Received pelvic radiation prior to biopsy.&#xD;
&#xD;
          -  3. Received androgen deprivation therapy (ADT) prior to biopsy; however, 5&#xD;
             alpha-reductase inhibitors (5-ARIs) are permitted.&#xD;
&#xD;
          -  4. Participation in interventional clinical trials.&#xD;
&#xD;
          -  5. Patient is considering watchful waiting.&#xD;
&#xD;
          -  6. Has a known history of hypogonadism.&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>65 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Urology Centers of Alabama</name>
      <address>
        <city>Homewood</city>
        <state>Alabama</state>
        <zip>35209</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>East Valley Urology Center</name>
      <address>
        <city>Mesa</city>
        <state>Arizona</state>
        <zip>85206</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Arkansas for Medical Sciences</name>
      <address>
        <city>Little Rock</city>
        <state>Arkansas</state>
        <zip>72205</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Arkansas Urology</name>
      <address>
        <city>Little Rock</city>
        <state>Arkansas</state>
        <zip>72211</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Pacific Urology</name>
      <address>
        <city>Concord</city>
        <state>California</state>
        <zip>94520</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>VA Long Beach Healthcare</name>
      <address>
        <city>Long Beach</city>
        <state>California</state>
        <zip>90822</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>UCI Medical Center</name>
      <address>
        <city>Orange</city>
        <state>California</state>
        <zip>92866</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ssg Md Apc</name>
      <address>
        <city>San Jose</city>
        <state>California</state>
        <zip>95124</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Advanced Urology Institute</name>
      <address>
        <city>Daytona Beach</city>
        <state>Florida</state>
        <zip>32114</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Urology Group of Florida</name>
      <address>
        <city>Delray Beach</city>
        <state>Florida</state>
        <zip>33484</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Pinellas Urology</name>
      <address>
        <city>Saint Petersburg</city>
        <state>Florida</state>
        <zip>33710</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>21st Century Oncology</name>
      <address>
        <city>Sunrise</city>
        <state>Florida</state>
        <zip>33351</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Meridian Clinical Research</name>
      <address>
        <city>Savannah</city>
        <state>Georgia</state>
        <zip>31405</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>North Idaho Urology</name>
      <address>
        <city>Coeur d'Alene</city>
        <state>Idaho</state>
        <zip>83814</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>URO Partners</name>
      <address>
        <city>Westchester</city>
        <state>Illinois</state>
        <zip>60154</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Wichita Urology</name>
      <address>
        <city>Wichita</city>
        <state>Kansas</state>
        <zip>67226</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Regional Urology</name>
      <address>
        <city>Shreveport</city>
        <state>Louisiana</state>
        <zip>71106</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Tufts Medical Center</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02111</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Michigan, Department of Urologic Oncology</name>
      <address>
        <city>Ann Arbor</city>
        <state>Michigan</state>
        <zip>48109</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Comprehensive Urology</name>
      <address>
        <city>Royal Oak</city>
        <state>Michigan</state>
        <zip>48073</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Michigan Institute of Urology</name>
      <address>
        <city>Troy</city>
        <state>Michigan</state>
        <zip>48084</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>UroLogic</name>
      <address>
        <city>Tupelo</city>
        <state>Mississippi</state>
        <zip>38801</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Premier Urology Group, LLC</name>
      <address>
        <city>Cranford</city>
        <state>New Jersey</state>
        <zip>07016</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Premier Urology</name>
      <address>
        <city>Cranford</city>
        <state>New Jersey</state>
        <zip>07016</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Urologic Research and Consulting LLC</name>
      <address>
        <city>Englewood</city>
        <state>New Jersey</state>
        <zip>07631</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Stony Brook University</name>
      <address>
        <city>Stony Brook</city>
        <state>New York</state>
        <zip>11794</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>A.M.P. Radiation Oncology</name>
      <address>
        <city>Syracuse</city>
        <state>New York</state>
        <zip>13210</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Associated Urologists of North Carolina</name>
      <address>
        <city>Raleigh</city>
        <state>North Carolina</state>
        <zip>27612</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Lehigh Valley Health Network</name>
      <address>
        <city>Allentown</city>
        <state>Pennsylvania</state>
        <zip>18103</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Medical University of South Carolina</name>
      <address>
        <city>Charleston</city>
        <state>South Carolina</state>
        <zip>29425</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Carolina Urology Partners</name>
      <address>
        <city>West Columbia</city>
        <state>South Carolina</state>
        <zip>29163</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Urology Associates</name>
      <address>
        <city>Nashville</city>
        <state>Tennessee</state>
        <zip>37209</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Rio Grande Urology</name>
      <address>
        <city>El Paso</city>
        <state>Texas</state>
        <zip>79912</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Seattle Urology Research Center</name>
      <address>
        <city>Burien</city>
        <state>Washington</state>
        <zip>98166</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>June 2022</verification_date>
  <study_first_submitted>September 19, 2017</study_first_submitted>
  <study_first_submitted_qc>September 19, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 25, 2017</study_first_posted>
  <last_update_submitted>June 17, 2022</last_update_submitted>
  <last_update_submitted_qc>June 17, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">June 23, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Prolaris</keyword>
  <keyword>Prostate Cancer</keyword>
  <keyword>Cell Cycle Progression Test</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>Yes</sharing_ipd>
    <ipd_description>Results of Prolaris testing to be shared with patient and patient's provider. Individual participant data will be shared with investigators. Aggregate clinical date will be presented in manuscript form.</ipd_description>
    <ipd_time_frame>Within 1 year of last study out.</ipd_time_frame>
  </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/NCT03290508
org study id: URO-008
nct id: NCT03290508
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This is a long-term prospective registry study to determine whether Prolaris testing in
      patients with favorable intermediate risk prostate cancer influences physician management
      decisions toward conservative treatment in patients with Prolaris low-risk scores without
      negatively impacting patient oncologic outcomes, thereby sparing low-risk patients from
      unnecessary treatments and associated side-effects.
This is a long-term prospective registry to evaluate the impact of Prolaris testing on
      therapeutic decisions in patients with newly diagnosed favorable intermediate-risk localized
      prostate cancer and to summarize clinical oncologic outcomes. The design of the study is
      non-interventional, and therefore the protocol will not require a specific treatment plan for
      study participants. However, in the absence of a universally accepted timeframe for repeat
      biopsies within existing active surveillance recommendations, study sites will be encouraged
      to monitor patients for disease progression as per the standard of care (e.g., current
      National Comprehensive Cancer Network [NCCN] guidelines) with the expectation of a repeat
      biopsy within 18 months of the initial biopsy.

      Patients who undergo Prolaris testing will be included in the registry as well as patients
      who do not undergo Prolaris testing. Data collection for the first primary objective extends
      over a 3-year period. During this time, data is collected on the treatment initiated, any
      follow-up prostate biopsy performed in patients initially treated with active surveillance,
      definitive treatments performed (with pathology data if surgical therapy is performed), and
      the reasons definitive treatment was pursued, as well as data related to disease progression
      such as biochemical recurrence, development of prostate cancer metastases, or disease
      specific death.

      Data collection for the second primary objective extends out to 8 years. During this time
      data is collected on any follow-up prostate biopsy in patients still treated with active
      surveillance, definitive treatments performed (with pathology data if surgical therapy is
      performed), and the reasons definitive treatment was pursued, as well as data related to
      disease progression such as biochemical recurrence, development of prostate cancer
      metastases, or disease specific death.
observational model: Cohort
time perspective: Prospective
measure: Low Prolaris Score, on Active Surveillance
time frame: 3 years
description: Proportion of patients with low Prolaris scores who are initially treated with active surveillance
measure: Low Prolaris Score, Definitive Treatment Following Active Surveillance
time frame: 3 years
description: Proportion of patients with low Prolaris scores and initially treated with active surveillance who proceed to definitive treatment at 3 year follow-up
measure: Low Prolaris Score, Disease Progression Following Delayed Definitive Treatment
time frame: 8 years
description: Proportion of patients with low Prolaris scores and initially treated with active surveillance and later proceed to definitive treatment who develop disease progression at 5 years subsequent to the start of definitive treatment.
measure: Low Prolaris Score, Time to Definitive Treatment following Active Surveillance
time frame: 8 years
description: Time to definitive treatment in patients with low Prolaris scores who are initially treated with active surveillance.
measure: No Prolaris Score, on Active Surveillance
time frame: 3 years
description: Proportion of patients without Prolaris testing who are initially treated with active surveillance.
measure: No Prolaris Score, Definitive Treatment Following Active Surveillance
time frame: 3 years
description: Proportion of patients without Prolaris testing initially treated with active surveillance who proceed to definitive treatment at 3 year follow-up.
measure: No Prolaris Score, Time to Definitive Treatment Following Active Surveillance
time frame: 8 years
description: Time to definitive treatment in patients without Prolaris testing who are initially treated with Active Surveillance.
measure: No Prolaris Score, Disease Progression Following Delayed Definitive Treatment
time frame: 8 years
description: Proportion of patients without Prolaris testing and initially treated with active surveillance who proceed with definitive treatment that develop disease progression at 5 years subsequent to the start of definitive treatment.
arm group label: Prolaris Testing
description: Recently diagnosed treatment-naïve patients with early stage localized prostate cancer who undergo Prolaris testing
arm group label: No Prolaris Testing
description: Patients with newly diagnosed favorable intermediate-risk localized prostate cancer who DO NOT undergo Prolaris testing
intervention type: Diagnostic Test
intervention name: Prolaris Testing
description: Recently diagnosed treatment-naïve patients with early stage localized prostate cancer who undergo Prolaris testing
arm group label: Prolaris Testing
other name: RNA expression signature of cell cycle progression genes
Formalin-fixed paraffin-embedded (FFPE) tissue from blocks or slides of prostatic
      adenocarcinoma biopsies
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: Male
minimum age: 65 Years
maximum age: N/A
healthy volunteers: No
facility: 
facility: 
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country: United States
responsible party type: Sponsor
mesh term: Prostatic Neoplasms
sharing ipd: Yes
ipd description: Results of Prolaris testing to be shared with patient and patient's provider. Individual participant data will be shared with investigators. Aggregate clinical date will be presented in manuscript form.
ipd time frame: Within 1 year of last study out.