<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/NCT03770351</url>
  </required_header>
  <id_info>
    <org_study_id>CIAPM [HS# 2017-3634]</org_study_id>
    <nct_id>NCT03770351</nct_id>
  </id_info>
  <brief_title>Early Prostate Cancer: Predicting Treatment Response</brief_title>
  <official_title>Precision Medicine for Early Prostate Cancer: Integrating Biological and Patient Complexity Variables to Predict Treatment Response</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of California, Irvine</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>University of California, Los Angeles</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Cedars-Sinai Medical Center</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>VA Medical Center-West Los Angeles</agency>
      <agency_class>U.S. Fed</agency_class>
    </collaborator>
    <collaborator>
      <agency>VA Long Beach Healthcare System</agency>
      <agency_class>U.S. Fed</agency_class>
    </collaborator>
  </sponsors>
  <source>University of California, Irvine</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 will replicate/validate the risk prediction model developed for the Comparative&#xD;
      Effectiveness Analysis of Surgery and Radiation (CEASAR) study in a more diverse patient&#xD;
      population to assess generalizability of the model as well as evaluate the relative&#xD;
      contribution of the Decipher Prostate Cancer Test and ProstateNext Test from Ambry Genetics,&#xD;
      to the risk prediction model for estimating treatment outcomes, and thereby improve&#xD;
      personalization of treatment options.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The study will contribute a replicable model for improving risk prediction from patient&#xD;
      characteristics, clinical severity indicators, and genomic tests to aid in personalizing&#xD;
      treatment. The proposed registry would also allow future comparisons of the gene expression&#xD;
      used in other competing commercial test. The addition of the suggested genomic classifier and&#xD;
      its associations with other patient and clinical characteristics will enhance the ability of&#xD;
      future studies, analogous to CEASAR, to accurately predict the risk of tumor aggressiveness&#xD;
      in prostate cancer.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">January 2017</start_date>
  <completion_date type="Anticipated">July 2021</completion_date>
  <primary_completion_date type="Anticipated">July 2021</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>1 Year</target_duration>
  <primary_outcome>
    <measure>Prostate-Cancer-specific change in quality of life</measure>
    <time_frame>Day of enrollment, 6-months, and 12-months after enrollment</time_frame>
    <description>Quality of life is measured by the Expanded Prostate Cancer Index Composite (EPIC). The Expanded Prostate Cancer Index Composite [EPIC] is a validated instrument for measuring disease-specific function/ The domain scores range from 0 to 100, with higher scores representing better function. Patients will be asked to complete the questionnaires during a consultation visit or remotely. EPIC scores will be collected at baseline, 6 month follow up, and at 12 month follow up via the questionnaire. EPIC scores from each time point will then be compared to look at the change in quality of life over the duration of the study.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Recurrence of cancer</measure>
    <time_frame>EMR data abstraction around the 6-month time point after enrollment</time_frame>
    <description>Recurrence will be recorded from data abstraction from the electronic medical records (EMR).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Complications of treatment</measure>
    <time_frame>EMR data abstraction around the 6-month time point after enrollment</time_frame>
    <description>Complications of treatment will be measured using general scales for identifying complications and severity (the Clavien system) as well as assessment of a priori identified complications that are known to occur with prostate cancer care. This information will be collected from electronic medical records.</description>
  </secondary_outcome>
  <enrollment type="Anticipated">693</enrollment>
  <condition>Prostate Cancer</condition>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      De-identified specimens stored.&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Our study population will be selected from clinics at 5 major southern California hospitals&#xD;
        including: University of California, Irvine, University of California, Los Angeles,&#xD;
        Cedars-Sinai Medical Center, Veterans Affair Healthcare Center Long Beach, and Veterans&#xD;
        Affair Healthcare Center West Los Angeles.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  18 - 90 years of age&#xD;
&#xD;
          -  Prostate-Specific Antigen (PSA) values &lt;50ng/ml&#xD;
&#xD;
          -  Clinical stage of T1 or T2&#xD;
&#xD;
          -  No evidence of metastasis or nodal involvement&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Age 91 or greater&#xD;
&#xD;
          -  Clinically locally advanced or metastatic disease&#xD;
&#xD;
          -  PSA equal to or greater than 50ng/ml&#xD;
&#xD;
          -  Diagnosis of malignancy (excluding squamous or basal cell carcinoma of the skin)&#xD;
             within 3 years of diagnosis of prostate cancer&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <gender_based>Yes</gender_based>
    <gender_description>Since this study is working with prostate cancer, our cohort will only be males.</gender_description>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>90 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Sheldon Greenfield</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of California, Irvine</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Sheldon Greenfield, M.D.</last_name>
    <phone>949-824-7286</phone>
    <email>sgreenfi@uci.edu</email>
  </overall_contact>
  <location>
    <facility>
      <name>University of California, Irvine</name>
      <address>
        <city>Irvine</city>
        <state>California</state>
        <zip>92697</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Veterans Affair 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>
  </location>
  <location>
    <facility>
      <name>Cedars-Sinai Medical Center</name>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <zip>90048</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>University of California, Los Angeles</name>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <zip>90095</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Veterans Affair West Los Angeles Healthcare System</name>
      <address>
        <city>West Los Angeles</city>
        <state>California</state>
        <zip>90073</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>April 2021</verification_date>
  <study_first_submitted>December 3, 2018</study_first_submitted>
  <study_first_submitted_qc>December 6, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 10, 2018</study_first_posted>
  <last_update_submitted>April 7, 2021</last_update_submitted>
  <last_update_submitted_qc>April 7, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">April 9, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>genomics</keyword>
  <keyword>racial disparities</keyword>
  <keyword>patient reported 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>Yes</sharing_ipd>
    <ipd_description>De-identified individual patient data for all primary and secondary outcome measures will be consolidated into one database and be made available to all participating research sites.</ipd_description>
    <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
    <ipd_info_type>Clinical Study Report (CSR)</ipd_info_type>
    <ipd_info_type>Analytic Code</ipd_info_type>
    <ipd_time_frame>Data will be available within 6 months of study completion</ipd_time_frame>
    <ipd_access_criteria>Data access will only be allowed for the principal investigators from each research site.</ipd_access_criteria>
  </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/NCT03770351
org study id: CIAPM [HS# 2017-3634]
nct id: NCT03770351
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This study will replicate/validate the risk prediction model developed for the Comparative
      Effectiveness Analysis of Surgery and Radiation (CEASAR) study in a more diverse patient
      population to assess generalizability of the model as well as evaluate the relative
      contribution of the Decipher Prostate Cancer Test and ProstateNext Test from Ambry Genetics,
      to the risk prediction model for estimating treatment outcomes, and thereby improve
      personalization of treatment options.
The study will contribute a replicable model for improving risk prediction from patient
      characteristics, clinical severity indicators, and genomic tests to aid in personalizing
      treatment. The proposed registry would also allow future comparisons of the gene expression
      used in other competing commercial test. The addition of the suggested genomic classifier and
      its associations with other patient and clinical characteristics will enhance the ability of
      future studies, analogous to CEASAR, to accurately predict the risk of tumor aggressiveness
      in prostate cancer.
observational model: Cohort
time perspective: Prospective
measure: Prostate-Cancer-specific change in quality of life
time frame: Day of enrollment, 6-months, and 12-months after enrollment
description: Quality of life is measured by the Expanded Prostate Cancer Index Composite (EPIC). The Expanded Prostate Cancer Index Composite [EPIC] is a validated instrument for measuring disease-specific function/ The domain scores range from 0 to 100, with higher scores representing better function. Patients will be asked to complete the questionnaires during a consultation visit or remotely. EPIC scores will be collected at baseline, 6 month follow up, and at 12 month follow up via the questionnaire. EPIC scores from each time point will then be compared to look at the change in quality of life over the duration of the study.
measure: Recurrence of cancer
time frame: EMR data abstraction around the 6-month time point after enrollment
description: Recurrence will be recorded from data abstraction from the electronic medical records (EMR).
measure: Complications of treatment
time frame: EMR data abstraction around the 6-month time point after enrollment
description: Complications of treatment will be measured using general scales for identifying complications and severity (the Clavien system) as well as assessment of a priori identified complications that are known to occur with prostate cancer care. This information will be collected from electronic medical records.
De-identified specimens stored.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: Male
gender based: Yes
gender description: Since this study is working with prostate cancer, our cohort will only be males.
minimum age: 18 Years
maximum age: 90 Years
healthy volunteers: No
last name: Sheldon Greenfield
role: Principal Investigator
affiliation: University of California, Irvine
last name: Sheldon Greenfield, M.D.
phone: 949-824-7286
email: sgreenfi@uci.edu
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
country: United States
responsible party type: Sponsor
mesh term: Prostatic Neoplasms
sharing ipd: Yes
ipd description: De-identified individual patient data for all primary and secondary outcome measures will be consolidated into one database and be made available to all participating research sites.
ipd info type: Statistical Analysis Plan (SAP)
ipd info type: Clinical Study Report (CSR)
ipd info type: Analytic Code
ipd time frame: Data will be available within 6 months of study completion
ipd access criteria: Data access will only be allowed for the principal investigators from each research site.