<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/NCT03290417</url>
  </required_header>
  <id_info>
    <org_study_id>CASE3816</org_study_id>
    <nct_id>NCT03290417</nct_id>
  </id_info>
  <brief_title>Correlative Analysis of the Genomics of Vitamin D and Omega-3 Fatty Acid Intake in Prostate Cancer</brief_title>
  <official_title>Correlative Analysis of the Genomics of Vitamin D and Omega-3 Fatty Acid Intake in Men Managed With Active Surveillance for Prostate Cancer</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Case Comprehensive Cancer Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Case Comprehensive Cancer Center</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>
      The purpose of this study is to see if eating vitamin D, omega 3 and turmeric (curcumin)&#xD;
      slows the growth of prostate cancer in men on active surveillance.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The primary objective is to investigate the influence of vitamin D, omega-3 fatty acids, and&#xD;
      turmeric curcumin intake on the genomic landscape of NCCN very low and low risk patients&#xD;
      managed with Active Surveillance. This will be measured by using genomic signatures in&#xD;
      Decipher GRID and using the mixed effect linear model that tests for the interaction of&#xD;
      treatment arm and time (base-line, 6 month and 12 month time points) with gene expression as&#xD;
      the response variable.&#xD;
&#xD;
      The secondary objective is to evaluate prostate cancer aggressiveness pre and post&#xD;
      intervention by looking at genes and gene signatures associated with vitamin D and omega-3&#xD;
      fatty acids pathways. Prognostic performance of GRID gene signatures will be evaluated using&#xD;
      Active Surveillance 'Failure' (deferred treatment) as an additional endpoint.&#xD;
&#xD;
      The exploratory objective is to be able to use predictive genes and/or genomic signatures to&#xD;
      assess benefit from vitamin D, omega-3 fatty acid and turmeric curcumin intake. This will&#xD;
      only be possible once sufficient patient follow up is available.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 7, 2017</start_date>
  <completion_date type="Actual">December 20, 2019</completion_date>
  <primary_completion_date type="Actual">June 20, 2019</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <intervention_model_description>Parallel groups, one with a control diet, the other with a modified diet</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>gene expression of very low and low risk prostate cancer patients on Active Surveillance</measure>
    <time_frame>Up to 6 months</time_frame>
    <description>The primary objective is to investigate the influence of vitamin D, omega-3 fatty acids, and turmeric curcumin intake on the genomic landscape of NCCN very low and low risk patients managed with Active Surveillance. This will be measured by using genomic signatures in Decipher GRID and using the mixed effect linear model that tests for the interaction of treatment arm and time</description>
  </primary_outcome>
  <primary_outcome>
    <measure>gene expression of very low and low risk prostate cancer patients on Active Surveillance</measure>
    <time_frame>Up to 12 months</time_frame>
    <description>The primary objective is to investigate the influence of vitamin D, omega-3 fatty acids, and turmeric curcumin intake on the genomic landscape of NCCN very low and low risk patients managed with Active Surveillance. This will be measured by using genomic signatures in Decipher GRID and using the mixed effect linear model that tests for the interaction of treatment arm and time</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Active Surveillance Failure</measure>
    <time_frame>Up to 12 months</time_frame>
    <description>Cox proportional hazards model will be used to study if genes are significantly predictive of this outcome. P-values will be corrected for multiple testing using the Benjamini-Hochberg procedure. Genes will be considered significant if the corresponding p-value is below 0.05 using a two-sided test.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to Active Surveillance Failure</measure>
    <time_frame>Up to 12 months</time_frame>
    <description>Time to event will be defined as time from enrollment into the study. P-values will be corrected for multiple testing using the Benjamini-Hochberg procedure.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">37</enrollment>
  <condition>Prostate Cancer</condition>
  <arm_group>
    <arm_group_label>Unmodified Diet</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Patients are under active surveillance with no modification to their diet, as is standard of care for low risk prostate cancer</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Diet modification</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients receive Vitamin D, Omega-3 and turmeric curcumin as dietary supplements</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Vitamin D</intervention_name>
    <description>5000 IU/cap; One cap by mouth daily</description>
    <arm_group_label>Diet modification</arm_group_label>
    <other_name>Vitamin D3</other_name>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Omega-3</intervention_name>
    <description>720 mg/cap; one capsule by mouth 3 times per day</description>
    <arm_group_label>Diet modification</arm_group_label>
    <other_name>Omegagenics</other_name>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Turmeric</intervention_name>
    <description>250mg/cap; two capsules by mouth 4 times per day</description>
    <arm_group_label>Diet modification</arm_group_label>
    <other_name>Turmeric curcumin</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Subjects must have the diagnosis of prostate cancer and be on active surveillance. For&#xD;
             the purpose of this study, Active surveillance implies prostate-specific antigen&#xD;
             (PSA)&lt;10 ng/mL, biopsy Gleason sum &lt;/=6 with no pattern 4 or 5, cancer involvement of&#xD;
             &lt;33% of biopsy cores, and clinical stage T1/T2a tumor.&#xD;
&#xD;
          -  Subjects must be followed at the Cleveland Clinic for active surveillance.&#xD;
&#xD;
          -  Subjects must be willing to adhere to the dietary modification outlined in the&#xD;
             protocol.&#xD;
&#xD;
          -  Subjects must be willing to have prostate biopsies at the baseline, and six months&#xD;
             after enrollment into the protocol&#xD;
&#xD;
          -  Subjects must have the ability to understand and the willingness to sign a written&#xD;
             informed consent document.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Subjects receiving any treatment other than AS for prostate cancer.&#xD;
&#xD;
          -  Subjects not followed by the Cleveland Clinic.&#xD;
&#xD;
          -  Subjects unable to adhere to the dietary modification outlined in the protocol.&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>David Levy, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Cleveland Clinic, Case Comprehensive Cancer Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Cleveland Clinic, Case Comprehensive Cancer Center</name>
      <address>
        <city>Cleveland</city>
        <state>Ohio</state>
        <zip>44195</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>February 2020</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 21, 2017</study_first_posted>
  <last_update_submitted>February 17, 2020</last_update_submitted>
  <last_update_submitted_qc>February 17, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">February 18, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Active Surveillance</keyword>
  <keyword>Vitamin D</keyword>
  <keyword>Omega-3 Fatty Acid</keyword>
  <keyword>tumeric curcumin</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Prostatic Neoplasms</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Vitamin D</mesh_term>
    <mesh_term>Ergocalciferols</mesh_term>
    <mesh_term>Cholecalciferol</mesh_term>
    <mesh_term>Vitamins</mesh_term>
    <mesh_term>Curcumin</mesh_term>
    <mesh_term>Turmeric extract</mesh_term>
  </intervention_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/NCT03290417
org study id: CASE3816
nct id: NCT03290417
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The purpose of this study is to see if eating vitamin D, omega 3 and turmeric (curcumin)
      slows the growth of prostate cancer in men on active surveillance.
The primary objective is to investigate the influence of vitamin D, omega-3 fatty acids, and
      turmeric curcumin intake on the genomic landscape of NCCN very low and low risk patients
      managed with Active Surveillance. This will be measured by using genomic signatures in
      Decipher GRID and using the mixed effect linear model that tests for the interaction of
      treatment arm and time (base-line, 6 month and 12 month time points) with gene expression as
      the response variable.

      The secondary objective is to evaluate prostate cancer aggressiveness pre and post
      intervention by looking at genes and gene signatures associated with vitamin D and omega-3
      fatty acids pathways. Prognostic performance of GRID gene signatures will be evaluated using
      Active Surveillance 'Failure' (deferred treatment) as an additional endpoint.

      The exploratory objective is to be able to use predictive genes and/or genomic signatures to
      assess benefit from vitamin D, omega-3 fatty acid and turmeric curcumin intake. This will
      only be possible once sufficient patient follow up is available.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Parallel groups, one with a control diet, the other with a modified diet
primary purpose: Treatment
masking: None (Open Label)
measure: gene expression of very low and low risk prostate cancer patients on Active Surveillance
time frame: Up to 6 months
description: The primary objective is to investigate the influence of vitamin D, omega-3 fatty acids, and turmeric curcumin intake on the genomic landscape of NCCN very low and low risk patients managed with Active Surveillance. This will be measured by using genomic signatures in Decipher GRID and using the mixed effect linear model that tests for the interaction of treatment arm and time
measure: gene expression of very low and low risk prostate cancer patients on Active Surveillance
time frame: Up to 12 months
description: The primary objective is to investigate the influence of vitamin D, omega-3 fatty acids, and turmeric curcumin intake on the genomic landscape of NCCN very low and low risk patients managed with Active Surveillance. This will be measured by using genomic signatures in Decipher GRID and using the mixed effect linear model that tests for the interaction of treatment arm and time
measure: Active Surveillance Failure
time frame: Up to 12 months
description: Cox proportional hazards model will be used to study if genes are significantly predictive of this outcome. P-values will be corrected for multiple testing using the Benjamini-Hochberg procedure. Genes will be considered significant if the corresponding p-value is below 0.05 using a two-sided test.
measure: Time to Active Surveillance Failure
time frame: Up to 12 months
description: Time to event will be defined as time from enrollment into the study. P-values will be corrected for multiple testing using the Benjamini-Hochberg procedure.
arm group label: Unmodified Diet
arm group type: No Intervention
description: Patients are under active surveillance with no modification to their diet, as is standard of care for low risk prostate cancer
arm group label: Diet modification
arm group type: Experimental
description: Patients receive Vitamin D, Omega-3 and turmeric curcumin as dietary supplements
intervention type: Dietary Supplement
intervention name: Vitamin D
description: 5000 IU/cap; One cap by mouth daily
arm group label: Diet modification
other name: Vitamin D3
intervention type: Dietary Supplement
intervention name: Omega-3
description: 720 mg/cap; one capsule by mouth 3 times per day
arm group label: Diet modification
other name: Omegagenics
intervention type: Dietary Supplement
intervention name: Turmeric
description: 250mg/cap; two capsules by mouth 4 times per day
arm group label: Diet modification
other name: Turmeric curcumin
criteria: 
gender: Male
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: David Levy, MD
role: Principal Investigator
affiliation: Cleveland Clinic, Case Comprehensive Cancer Center
facility: 
country: United States
responsible party type: Sponsor
mesh term: Prostatic Neoplasms
mesh term: Vitamin D
mesh term: Ergocalciferols
mesh term: Cholecalciferol
mesh term: Vitamins
mesh term: Curcumin
mesh term: Turmeric extract