xml: <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/NCT06022822</url>
    </required_header>
    <id_info>
      <org_study_id>NCI-2023-03835</org_study_id>
      <secondary_id>NCI-2023-03835</secondary_id>
      <secondary_id>NCI22-12-01</secondary_id>
      <secondary_id>NWU22-12-01</secondary_id>
      <secondary_id>P30CA060553</secondary_id>
      <secondary_id>UG1CA189828</secondary_id>
      <nct_id>NCT06022822</nct_id>
    </id_info>
    <brief_title>Placebo-Controlled Trial of Urolithin A Supplementation in Men With Prostate Cancer Undergoing Radical Prostatectomy, URO-PRO Trial</brief_title>
    <official_title>A Phase 2 Placebo-Controlled Trial of Urolithin A Supplementation in Men With Prostate Cancer Undergoing Radical Prostatectomy</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>National Cancer Institute (NCI)</agency>
        <agency_class>NIH</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>National Cancer Institute (NCI)</source>
    <oversight_info>
      <has_dmc>Yes</has_dmc>
      <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        Apalutamide is an anti-androgen that blocks the effect of testosterone on prostate cancer&#xD;
        growth. This phase IIa trial is designed to determine whether very low doses of apalutamide,&#xD;
        given for 3 to 4 weeks before prostate surgery to men with prostate cancer confined to the&#xD;
        prostate gland, reduces plasma levels of PSA (a biomarker of apalutamide's ability to block&#xD;
        testosterone). If low dose apalutamide lowers PSA levels in this setting, further study of&#xD;
        this agent in men with localized prostate cancer who wish to delay definitive therapy with&#xD;
        surgery or radiation may be warranted.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        PRIMARY OBJECTIVE:&#xD;
  &#xD;
        I. To determine the effect of a 3-to-6-week intervention of urolithin A (Uro-A) supplements&#xD;
        versus placebo on 8-OHdG percent positive change in prostate cancer tumor tissue obtained by&#xD;
        core needle biopsy in participants who undergo radical prostatectomy after 3 to 6 weeks of&#xD;
        therapy.&#xD;
  &#xD;
        SECONDARY OBJECTIVES:&#xD;
  &#xD;
        I. To determine prostate tissue and serum concentrations of Uro-A, urolithin sulfate and&#xD;
        urolithin A glucuronide, as measured by change from baseline to end-of-study, in comparison&#xD;
        to changes from baseline to end-of-study in a control group receiving a placebo (except&#xD;
        tissue levels, which will be compared between arms using end-of-study tissue only).&#xD;
  &#xD;
        II. To compare the change in expression of cell cycle genes in prostate cancer tumor tissue&#xD;
        from pre-study biopsy to radical prostatectomy in men receiving Uro-A supplements for 3 to 6&#xD;
        weeks and a control group of men receiving a placebo.&#xD;
  &#xD;
        III. To determine the effect of Uro-A supplements on change in 8-OHdG expression in benign&#xD;
        and tumor-adjacent prostatic tissue from pre-study biopsy to radical prostatectomy (RP)&#xD;
        following 3-6 weeks of therapy in comparison to a control group of men receiving a placebo.&#xD;
  &#xD;
        EXPLORATORY OBJECTIVES:&#xD;
  &#xD;
        I. To determine the effect of Uro-A supplements on circulating levels of high sensitivity&#xD;
        C-reactive protein (hsCRP), TNF-alpha, and IL-6, as measured by change from baseline to&#xD;
        end-of-study compared with the men receiving a placebo.&#xD;
  &#xD;
        II. To compare change in tumor gene expression patterns of Hallmark androgen signaling&#xD;
        between study arms.&#xD;
  &#xD;
        III. To determine the effect of a 3-to-6-week intervention of urolithin A (Uro-A) supplements&#xD;
        versus placebo on 8-OHdG H-index (percent staining positive at each score in a 0-3 scale)&#xD;
        change in prostate cancer tumor tissue obtained by core needle biopsy at baseline and at&#xD;
        radical prostatectomy after 3 to 6 weeks of therapy.&#xD;
  &#xD;
        IV. To collect stool samples for future analyses to determine the effect of Uro-A supplements&#xD;
        on change in stool microbiome 16s ribosomal ribonucleic acid (rRNA) gene sequencing.&#xD;
  &#xD;
        OUTLINE: Patients are randomized to 1 of 2 arms.&#xD;
  &#xD;
        ARM I: Patients receive urolithin A orally (PO) on study. Patients also undergo biopsy at&#xD;
        time of surgery and collection of blood samples during screening and on study. Patients may&#xD;
        also undergo collection of stool samples during screening and on study.&#xD;
  &#xD;
        ARM II: Patients receive placebo PO on study. Patients also undergo biopsy at time of surgery&#xD;
        and collection of blood samples during screening and on study. Patients may also undergo&#xD;
        collection of stool samples during screening and on study.&#xD;
  &#xD;
        Patients are followed up at 2 weeks after surgery.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">February 17, 2024</start_date>
    <completion_date type="Anticipated">January 1, 2026</completion_date>
    <primary_completion_date type="Anticipated">January 1, 2026</primary_completion_date>
    <phase>Phase 2</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>
      <primary_purpose>Prevention</primary_purpose>
      <masking>Double (Participant, Investigator)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Percent positive change in 8-OHdG</measure>
      <time_frame>Baseline up to radical prostatectomy (RP) after 3 to 6 weeks of therapy</time_frame>
      <description>The primary endpoint will be analyzed using a linear regression model. Standard descriptive statistics, including mean, standard deviation, median and interquartile range for continuous variables, and frequency and percent for categorical variables, will be used to summarize baseline variables by treatment arm. Changes will be summarized similarly. Graphical techniques, including boxplots and histograms, will be used to examine the distribution and to assess assumptions made for the primary analysis.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Changes in prostate tissue and serum concentrations of urolithin A (Uro-A), urolithin sulfate and urolithin A glucuronide</measure>
      <time_frame>Baseline up to 2 years</time_frame>
      <description>Measured by change from baseline to end-of-study, in comparison to changes from baseline to end-of-study in a control group receiving a placebo (except tissue levels, which will be compared between arms using end-of-tissue only). Wll be analyzed using the same approach as the analysis of the primary endpoint. Changes in serum concentrations of Uro-A, urolithin sulfate and urolithin A glucuronide, from baseline to radical prostatectomy will be estimated and summarized using standard descriptive statistics.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Changes in expression of cell cycle genes</measure>
      <time_frame>Baseline up to RP after 3 to 6 weeks of therapy</time_frame>
      <description>The ribonucleic sequencing will be used to compute a single z-score (i.e. one data point per patient) which will represent the composite expression of 31 cell-cycle genes.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Changes in 8-OHdG expression</measure>
      <time_frame>Baseline up to RP after 3 to 6 weeks of therapy</time_frame>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">90</enrollment>
    <condition>Prostate Adenocarcinoma</condition>
    <arm_group>
      <arm_group_label>Arm I (urolithin A)</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Patients receive urolithin A PO on study. Patients also undergo biopsy at time of surgery and collection of blood samples during screening and on study. Patients may also undergo collection of stool samples during screening and on study.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Arm II (placebo)</arm_group_label>
      <arm_group_type>Placebo Comparator</arm_group_type>
      <description>Patients receive placebo PO on study. Patients also undergo biopsy at time of surgery and collection of blood samples during screening and on study. Patients may also undergo collection of stool samples during screening and on study.</description>
    </arm_group>
    <intervention>
      <intervention_type>Procedure</intervention_type>
      <intervention_name>Biopsy</intervention_name>
      <description>Undergo biopsy</description>
      <arm_group_label>Arm I (urolithin A)</arm_group_label>
      <arm_group_label>Arm II (placebo)</arm_group_label>
      <other_name>BIOPSY_TYPE</other_name>
      <other_name>Bx</other_name>
    </intervention>
    <intervention>
      <intervention_type>Procedure</intervention_type>
      <intervention_name>Biospecimen Collection</intervention_name>
      <description>Undergo collection of blood and stool samples</description>
      <arm_group_label>Arm I (urolithin A)</arm_group_label>
      <arm_group_label>Arm II (placebo)</arm_group_label>
      <other_name>Biological Sample Collection</other_name>
      <other_name>Biospecimen Collected</other_name>
      <other_name>Specimen Collection</other_name>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Placebo Administration</intervention_name>
      <description>Given PO</description>
      <arm_group_label>Arm II (placebo)</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Dietary Supplement</intervention_type>
      <intervention_name>Urolithin A Supplement</intervention_name>
      <description>Given PO</description>
      <arm_group_label>Arm I (urolithin A)</arm_group_label>
      <other_name>Mitopure</other_name>
      <other_name>Uro-A Supplement</other_name>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Participants must have pathologically confirmed adenocarcinoma of the prostate with&#xD;
               formalin-fixed paraffin embedded (FFPE) biopsy tissue available for analysis.&#xD;
               Diagnosis can be any time in the six months prior to registration/randomization&#xD;
  &#xD;
            -  Participants &gt;= 18 years will be enrolled. Because no dosing or adverse event (AE)&#xD;
               data are currently available on the use of urolithin A in participants &lt; 18 years of&#xD;
               age, children and adolescents are excluded from this study&#xD;
  &#xD;
            -  Eastern Cooperative Oncology Group (ECOG) performance status =&lt; 2 (Karnofsky &gt;= 60%)&#xD;
  &#xD;
            -  Absolute neutrophil count &gt;= 1,000/microliter&#xD;
  &#xD;
            -  Platelets &gt;= 100,000/microliter&#xD;
  &#xD;
            -  Total bilirubin =&lt; 1.5 x institutional upper limit of normal (ULN) Note: Higher total&#xD;
               bilirubin levels (=&lt; 3 mg/dL) can be allowed if due to known benign liver condition,&#xD;
               i.e. Gilbert's&#xD;
  &#xD;
            -  Aspartate aminotransferase (AST) (serum glutamic-oxaloacetic transaminase&#xD;
               [SGOT])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT])&#xD;
               =&lt; 3.0 x institutional upper limit of normal&#xD;
  &#xD;
            -  Creatinine =&lt; 1.5 x institutional upper limit of normal&#xD;
  &#xD;
            -  Human immunodeficiency virus (HIV)-infected participants on effective anti-retroviral&#xD;
               therapy with undetectable viral load within 6 months are eligible for this trial&#xD;
  &#xD;
            -  For participants with evidence of chronic hepatitis B virus (HBV) infection, the HBV&#xD;
               viral load must be undetectable on suppressive therapy, if indicated&#xD;
  &#xD;
            -  Participants with a history of hepatitis C virus (HCV) infection must have been&#xD;
               treated and cured. For patients with HCV infection who are currently on treatment,&#xD;
               they are eligible if they have an undetectable HCV viral load&#xD;
  &#xD;
            -  Participants on chronic suppressive antiviral therapy for herpes simplex virus (HSV)&#xD;
               are eligible&#xD;
  &#xD;
            -  Scheduled to undergo RP in the next 3-6 weeks&#xD;
  &#xD;
            -  Ability to understand and the willingness to sign a written informed consent document&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Participants with prior primary treatment or hormonal therapy for prostate cancer (PC)&#xD;
  &#xD;
            -  Participants already receiving urolithin A (Mitopure, commercially available in the&#xD;
               United States), or pomegranate supplements. Note: Other supplements are allowed but&#xD;
               must be documented&#xD;
  &#xD;
            -  Participants receiving any other investigational agents&#xD;
  &#xD;
            -  History of allergic reactions attributed to compounds of similar chemical or biologic&#xD;
               composition to urolithin A&#xD;
  &#xD;
            -  Uncontrolled intercurrent illness, or psychiatric illness/social situations that would&#xD;
               limit compliance with study requirements&#xD;
        </textblock>
      </criteria>
      <gender>Male</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Stephen J Freedland</last_name>
      <role>Principal Investigator</role>
      <affiliation>Cedars-Sinai Medical Center</affiliation>
    </overall_official>
    <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>
      <contact>
        <last_name>Stephen J. Freedland</last_name>
        <phone>310-423-3974</phone>
        <email>Stephen.Freedland@cshs.org</email>
      </contact>
      <investigator>
        <last_name>Stephen J. Freedland</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>Northwestern University</name>
        <address>
          <city>Chicago</city>
          <state>Illinois</state>
          <zip>60611</zip>
          <country>United States</country>
        </address>
      </facility>
      <contact>
        <last_name>Ashley E. Ross</last_name>
        <phone>312-694-1117</phone>
        <email>ashley.ross1@northwestern.edu</email>
      </contact>
      <investigator>
        <last_name>Ashley E. Ross</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>University of Chicago Comprehensive Cancer Center</name>
        <address>
          <city>Chicago</city>
          <state>Illinois</state>
          <zip>60637</zip>
          <country>United States</country>
        </address>
      </facility>
      <contact>
        <last_name>Scott E. Eggener</last_name>
        <phone>773-702-5195</phone>
        <email>seggener@surgery.bsd.uchicago.edu</email>
      </contact>
      <investigator>
        <last_name>Scott E. Eggener</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>Duke University Medical Center</name>
        <address>
          <city>Durham</city>
          <state>North Carolina</state>
          <zip>27710</zip>
          <country>United States</country>
        </address>
      </facility>
      <contact>
        <last_name>Judd W. Moul</last_name>
        <phone>919-668-8108</phone>
        <email>judd.moul@duke.edu</email>
      </contact>
      <investigator>
        <last_name>Judd W. Moul</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>University of Wisconsin Carbone Cancer Center</name>
        <address>
          <city>Madison</city>
          <state>Wisconsin</state>
          <zip>53792</zip>
          <country>United States</country>
        </address>
      </facility>
      <contact>
        <last_name>David F. Jarrard</last_name>
        <phone>608-262-0759</phone>
        <email>jarrard@urology.wisc.edu</email>
      </contact>
      <investigator>
        <last_name>David F. Jarrard</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>September 1, 2023</study_first_submitted>
    <study_first_submitted_qc>September 1, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 5, 2023</study_first_posted>
    <last_update_submitted>September 7, 2023</last_update_submitted>
    <last_update_submitted_qc>September 7, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 8, 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>Adenocarcinoma</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>Yes</sharing_ipd>
      <ipd_description>NCI is committed to sharing data in accordance with NIH policy. For more details on how clinical trial data is shared, access the link to the NIH data sharing policy page.</ipd_description>
      <ipd_url>https://grants.nih.gov/policy/sharing.htm</ipd_url>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06022822
  org study id: NCI-2023-03835
  secondary id: NCI-2023-03835
  secondary id: NCI22-12-01
  secondary id: NWU22-12-01
  secondary id: P30CA060553
  secondary id: UG1CA189828
  nct id: NCT06022822
  lead sponsor: 
  has dmc: Yes
  is fda regulated drug: Yes
  is fda regulated device: No
  Apalutamide is an anti-androgen that blocks the effect of testosterone on prostate cancer
        growth. This phase IIa trial is designed to determine whether very low doses of apalutamide,
        given for 3 to 4 weeks before prostate surgery to men with prostate cancer confined to the
        prostate gland, reduces plasma levels of PSA (a biomarker of apalutamide's ability to block
        testosterone). If low dose apalutamide lowers PSA levels in this setting, further study of
        this agent in men with localized prostate cancer who wish to delay definitive therapy with
        surgery or radiation may be warranted.
  PRIMARY OBJECTIVE:
  
        I. To determine the effect of a 3-to-6-week intervention of urolithin A (Uro-A) supplements
        versus placebo on 8-OHdG percent positive change in prostate cancer tumor tissue obtained by
        core needle biopsy in participants who undergo radical prostatectomy after 3 to 6 weeks of
        therapy.
  
        SECONDARY OBJECTIVES:
  
        I. To determine prostate tissue and serum concentrations of Uro-A, urolithin sulfate and
        urolithin A glucuronide, as measured by change from baseline to end-of-study, in comparison
        to changes from baseline to end-of-study in a control group receiving a placebo (except
        tissue levels, which will be compared between arms using end-of-study tissue only).
  
        II. To compare the change in expression of cell cycle genes in prostate cancer tumor tissue
        from pre-study biopsy to radical prostatectomy in men receiving Uro-A supplements for 3 to 6
        weeks and a control group of men receiving a placebo.
  
        III. To determine the effect of Uro-A supplements on change in 8-OHdG expression in benign
        and tumor-adjacent prostatic tissue from pre-study biopsy to radical prostatectomy (RP)
        following 3-6 weeks of therapy in comparison to a control group of men receiving a placebo.
  
        EXPLORATORY OBJECTIVES:
  
        I. To determine the effect of Uro-A supplements on circulating levels of high sensitivity
        C-reactive protein (hsCRP), TNF-alpha, and IL-6, as measured by change from baseline to
        end-of-study compared with the men receiving a placebo.
  
        II. To compare change in tumor gene expression patterns of Hallmark androgen signaling
        between study arms.
  
        III. To determine the effect of a 3-to-6-week intervention of urolithin A (Uro-A) supplements
        versus placebo on 8-OHdG H-index (percent staining positive at each score in a 0-3 scale)
        change in prostate cancer tumor tissue obtained by core needle biopsy at baseline and at
        radical prostatectomy after 3 to 6 weeks of therapy.
  
        IV. To collect stool samples for future analyses to determine the effect of Uro-A supplements
        on change in stool microbiome 16s ribosomal ribonucleic acid (rRNA) gene sequencing.
  
        OUTLINE: Patients are randomized to 1 of 2 arms.
  
        ARM I: Patients receive urolithin A orally (PO) on study. Patients also undergo biopsy at
        time of surgery and collection of blood samples during screening and on study. Patients may
        also undergo collection of stool samples during screening and on study.
  
        ARM II: Patients receive placebo PO on study. Patients also undergo biopsy at time of surgery
        and collection of blood samples during screening and on study. Patients may also undergo
        collection of stool samples during screening and on study.
  
        Patients are followed up at 2 weeks after surgery.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Prevention
  masking: Double (Participant, Investigator)
  measure: Percent positive change in 8-OHdG
  time frame: Baseline up to radical prostatectomy (RP) after 3 to 6 weeks of therapy
  description: The primary endpoint will be analyzed using a linear regression model. Standard descriptive statistics, including mean, standard deviation, median and interquartile range for continuous variables, and frequency and percent for categorical variables, will be used to summarize baseline variables by treatment arm. Changes will be summarized similarly. Graphical techniques, including boxplots and histograms, will be used to examine the distribution and to assess assumptions made for the primary analysis.
  measure: Changes in prostate tissue and serum concentrations of urolithin A (Uro-A), urolithin sulfate and urolithin A glucuronide
  time frame: Baseline up to 2 years
  description: Measured by change from baseline to end-of-study, in comparison to changes from baseline to end-of-study in a control group receiving a placebo (except tissue levels, which will be compared between arms using end-of-tissue only). Wll be analyzed using the same approach as the analysis of the primary endpoint. Changes in serum concentrations of Uro-A, urolithin sulfate and urolithin A glucuronide, from baseline to radical prostatectomy will be estimated and summarized using standard descriptive statistics.
  measure: Changes in expression of cell cycle genes
  time frame: Baseline up to RP after 3 to 6 weeks of therapy
  description: The ribonucleic sequencing will be used to compute a single z-score (i.e. one data point per patient) which will represent the composite expression of 31 cell-cycle genes.
  measure: Changes in 8-OHdG expression
  time frame: Baseline up to RP after 3 to 6 weeks of therapy
  arm group label: Arm I (urolithin A)
  arm group type: Experimental
  description: Patients receive urolithin A PO on study. Patients also undergo biopsy at time of surgery and collection of blood samples during screening and on study. Patients may also undergo collection of stool samples during screening and on study.
  arm group label: Arm II (placebo)
  arm group type: Placebo Comparator
  description: Patients receive placebo PO on study. Patients also undergo biopsy at time of surgery and collection of blood samples during screening and on study. Patients may also undergo collection of stool samples during screening and on study.
  intervention type: Procedure
  intervention name: Biopsy
  description: Undergo biopsy
  arm group label: Arm I (urolithin A)
  arm group label: Arm II (placebo)
  other name: BIOPSY_TYPE
  other name: Bx
  intervention type: Procedure
  intervention name: Biospecimen Collection
  description: Undergo collection of blood and stool samples
  arm group label: Arm I (urolithin A)
  arm group label: Arm II (placebo)
  other name: Biological Sample Collection
  other name: Biospecimen Collected
  other name: Specimen Collection
  intervention type: Drug
  intervention name: Placebo Administration
  description: Given PO
  arm group label: Arm II (placebo)
  intervention type: Dietary Supplement
  intervention name: Urolithin A Supplement
  description: Given PO
  arm group label: Arm I (urolithin A)
  other name: Mitopure
  other name: Uro-A Supplement
  criteria: 
  gender: Male
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Stephen J Freedland
  role: Principal Investigator
  affiliation: Cedars-Sinai Medical Center
  facility: 
  contact: 
  investigator: 
  facility: 
  contact: 
  investigator: 
  facility: 
  contact: 
  investigator: 
  facility: 
  contact: 
  investigator: 
  facility: 
  contact: 
  investigator: 
  country: United States
  responsible party type: Sponsor
  mesh term: Adenocarcinoma
  sharing ipd: Yes
  ipd description: NCI is committed to sharing data in accordance with NIH policy. For more details on how clinical trial data is shared, access the link to the NIH data sharing policy page.
  ipd url: https://grants.nih.gov/policy/sharing.htm