<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/NCT01692587</url>
  </required_header>
  <id_info>
    <org_study_id>201011804</org_study_id>
    <nct_id>NCT01692587</nct_id>
  </id_info>
  <brief_title>Does Protein Restriction Inhibit Prostrate Cancer Growth</brief_title>
  <official_title>Does Protein Restriction Inhibit Prostrate Cancer Growth</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Washington University School of Medicine</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Washington University School of Medicine</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The Purpose of the Protein Study is to investigate whether a reduced protein diet can inhibit&#xD;
      the growth of prostate cancer in humans.&#xD;
&#xD;
      The Investigators hypothesis is that a reduced protein diet will inhibit expression of genes&#xD;
      that are involved in the growth of prostate cancer.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The primary objective of this study is to determine whether or not a low protein diet has an&#xD;
      inhibitory effect on prostate cancer cell growth.&#xD;
&#xD;
      The primary outcome measures relative to the investigators primary objectives are:&#xD;
&#xD;
      For Group 1 the expression of genes and proteins of the PI-3K/Akt/mTOR pathway. For Group 2&#xD;
      the PSA values obtained every three months.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 2011</start_date>
  <completion_date type="Actual">March 2015</completion_date>
  <primary_completion_date type="Actual">March 2015</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>
    <primary_purpose>Basic Science</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Group1--Expression of genes and proteins of the PI-3K/Akt/mTOR pathway. Group 2--PSA values obtained every three months</measure>
    <time_frame>group 1- (4-6 weeks), group 2 -(52 weeks)</time_frame>
    <description>The investigators will be looking at the increase or decrease of PSA values between control and protein restricted diet participants obtained for the length of study.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">65</enrollment>
  <condition>Prostate Cancer</condition>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>No changes in dietary group</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Protein restrictive diet</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>reduced protein diet</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Protein restrictive diet</intervention_name>
    <description>To begin a reduced protein diet</description>
    <arm_group_label>Protein restrictive diet</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        group 1&#xD;
&#xD;
          1. Patient must have a diagnosis of prostate cancer confirmed by pathology.&#xD;
&#xD;
          2. Patient must be scheduled to undergo radical prostatectomy no sooner than 6 weeks from&#xD;
             date of enrollment (to allow for a minimum of 4 weeks on the low protein diet).&#xD;
&#xD;
          3. Patient must have adequate baseline protein intake (screening 4-day food record shows&#xD;
             protein &gt; 1.0 g/kg FFM)&#xD;
&#xD;
          4. Patient must be able to understand the English-language instructions.&#xD;
&#xD;
          5. Patient must be able to comply with the low protein diet (as evaluated by the&#xD;
             dietitian and other study team members).&#xD;
&#xD;
          6. Patient must be able to understand and willing to sign an IRB-approved written&#xD;
             informed consent document.&#xD;
&#xD;
        5.2.2 Inclusion Criteria - Group 2&#xD;
&#xD;
          1. Patient must have a diagnosis of prostate cancer.&#xD;
&#xD;
          2. Patient must have previously undergone a radical prostatectomy for treatment of&#xD;
             prostate cancer.&#xD;
&#xD;
          3. Patient must have a detectable PSA (defined as PSA ≥ 0.1) in at least two consecutive&#xD;
             measurements, taken at least one month apart, with no therapy between the PSA&#xD;
             measurements. If the patient has had additional therapy after the radical&#xD;
             prostatectomy, there must be evidence of a rising PSA (i.e., two consecutive&#xD;
             measurements at least one month apart) after the patient has completed the intervening&#xD;
             therapy (meaning that the patient must have failed treatment).&#xD;
&#xD;
          4. Patient must have adequate baseline protein intake (screening 4-day food record shows&#xD;
             protein &gt; 1.0 g/kg FFM).&#xD;
&#xD;
          5. Patient must have adequate baseline caloric intake (screening 4-day food record shows&#xD;
             caloric intake of &gt; 1500 kcal/day).&#xD;
&#xD;
          6. Patient must be able to understand the English-language instructions.&#xD;
&#xD;
          7. Patient must be able to comply with the low protein diet (as evaluated by the&#xD;
             dietitian and other study team members).&#xD;
&#xD;
          8. Patient must be able to understand and willing to sign an IRB-approved written&#xD;
             informed consent document.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Patient must not currently be receiving any therapy for prostate cancer.&#xD;
&#xD;
          2. Patient must not have any serious chronic illness such as unstable angina, any&#xD;
             uncontrolled metabolic disorder, or any immunologic disorder.&#xD;
&#xD;
          3. Patient must not have a history of any previous malignancy (with the exception of&#xD;
             squamous or basal cell carcinoma of the skin) in the 5 years prior to enrollment (for&#xD;
             Group 1) or 12 months prior to enrollment (for Group 2).&#xD;
&#xD;
          4. Patient must not have a previous history of a stroke.&#xD;
&#xD;
          5. Patient must not be taking any medications that might confound the study results&#xD;
             (anabolic agents (such as androgen, androgen precursor, rhGH) in the 6 months prior to&#xD;
             enrollment; corticosteroids (other than nasal) in the 6 months prior to enrollment; or&#xD;
             finasteride or dutasteride).&#xD;
&#xD;
          6. Patient must not have dementia or any other cognitive impairment.&#xD;
&#xD;
          7. Patient must not have a lifestyle or fixed diet pattern that would interfere with&#xD;
             participation in or interpretation of the results of this study&#xD;
&#xD;
             -&#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>Luigi Fontana, MD,PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Washington University School of Medicine</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Valeria Tosti, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Washington University School of Medicine</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Washington University School of Medicine</name>
      <address>
        <city>Saint Louis</city>
        <state>Missouri</state>
        <zip>63110</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>Fontana L, Cummings NE, Arriola Apelo SI, Neuman JC, Kasza I, Schmidt BA, Cava E, Spelta F, Tosti V, Syed FA, Baar EL, Veronese N, Cottrell SE, Fenske RJ, Bertozzi B, Brar HK, Pietka T, Bullock AD, Figenshau RS, Andriole GL, Merrins MJ, Alexander CM, Kimple ME, Lamming DW. Decreased Consumption of Branched-Chain Amino Acids Improves Metabolic Health. Cell Rep. 2016 Jul 12;16(2):520-530. doi: 10.1016/j.celrep.2016.05.092. Epub 2016 Jun 23.</citation>
    <PMID>27346343</PMID>
  </reference>
  <reference>
    <citation>Trevino-Villarreal JH, Reynolds JS, Bartelt A, Langston PK, MacArthur MR, Arduini A, Tosti V, Veronese N, Bertozzi B, Brace LE, Mejia P, Trocha K, Kajitani GS, Longchamp A, Harputlugil E, Gathungu R, Bird SS, Bullock AD, Figenshau RS, Andriole GL, Thompson A, Heeren J, Ozaki CK, Kristal BS, Fontana L, Mitchell JR. Dietary protein restriction reduces circulating VLDL triglyceride levels via CREBH-APOA5-dependent and -independent mechanisms. JCI Insight. 2018 Nov 2;3(21):e99470. doi: 10.1172/jci.insight.99470.</citation>
    <PMID>30385734</PMID>
  </reference>
  <reference>
    <citation>Eitan E, Tosti V, Suire CN, Cava E, Berkowitz S, Bertozzi B, Raefsky SM, Veronese N, Spangler R, Spelta F, Mustapic M, Kapogiannis D, Mattson MP, Fontana L. In a randomized trial in prostate cancer patients, dietary protein restriction modifies markers of leptin and insulin signaling in plasma extracellular vesicles. Aging Cell. 2017 Dec;16(6):1430-1433. doi: 10.1111/acel.12657. Epub 2017 Sep 17.</citation>
    <PMID>28921841</PMID>
  </reference>
  <verification_date>March 2021</verification_date>
  <study_first_submitted>September 7, 2012</study_first_submitted>
  <study_first_submitted_qc>September 20, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 25, 2012</study_first_posted>
  <last_update_submitted>March 24, 2021</last_update_submitted>
  <last_update_submitted_qc>March 24, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">March 26, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>PSA</keyword>
  <keyword>protein</keyword>
  <keyword>prostate</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>
    <ipd_description>Plan to publish</ipd_description>
  </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/NCT01692587
org study id: 201011804
nct id: NCT01692587
lead sponsor: 
has dmc: Yes
The Purpose of the Protein Study is to investigate whether a reduced protein diet can inhibit
      the growth of prostate cancer in humans.

      The Investigators hypothesis is that a reduced protein diet will inhibit expression of genes
      that are involved in the growth of prostate cancer.
The primary objective of this study is to determine whether or not a low protein diet has an
      inhibitory effect on prostate cancer cell growth.

      The primary outcome measures relative to the investigators primary objectives are:

      For Group 1 the expression of genes and proteins of the PI-3K/Akt/mTOR pathway. For Group 2
      the PSA values obtained every three months.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Basic Science
masking: None (Open Label)
measure: Group1--Expression of genes and proteins of the PI-3K/Akt/mTOR pathway. Group 2--PSA values obtained every three months
time frame: group 1- (4-6 weeks), group 2 -(52 weeks)
description: The investigators will be looking at the increase or decrease of PSA values between control and protein restricted diet participants obtained for the length of study.
arm group label: Control
arm group type: No Intervention
description: No changes in dietary group
arm group label: Protein restrictive diet
arm group type: Experimental
description: reduced protein diet
intervention type: Other
intervention name: Protein restrictive diet
description: To begin a reduced protein diet
arm group label: Protein restrictive diet
criteria: 
gender: Male
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: Luigi Fontana, MD,PhD
role: Principal Investigator
affiliation: Washington University School of Medicine
last name: Valeria Tosti, MD
role: Principal Investigator
affiliation: Washington University School of Medicine
facility: 
country: United States
citation: Fontana L, Cummings NE, Arriola Apelo SI, Neuman JC, Kasza I, Schmidt BA, Cava E, Spelta F, Tosti V, Syed FA, Baar EL, Veronese N, Cottrell SE, Fenske RJ, Bertozzi B, Brar HK, Pietka T, Bullock AD, Figenshau RS, Andriole GL, Merrins MJ, Alexander CM, Kimple ME, Lamming DW. Decreased Consumption of Branched-Chain Amino Acids Improves Metabolic Health. Cell Rep. 2016 Jul 12;16(2):520-530. doi: 10.1016/j.celrep.2016.05.092. Epub 2016 Jun 23.
PMID: 27346343
citation: Trevino-Villarreal JH, Reynolds JS, Bartelt A, Langston PK, MacArthur MR, Arduini A, Tosti V, Veronese N, Bertozzi B, Brace LE, Mejia P, Trocha K, Kajitani GS, Longchamp A, Harputlugil E, Gathungu R, Bird SS, Bullock AD, Figenshau RS, Andriole GL, Thompson A, Heeren J, Ozaki CK, Kristal BS, Fontana L, Mitchell JR. Dietary protein restriction reduces circulating VLDL triglyceride levels via CREBH-APOA5-dependent and -independent mechanisms. JCI Insight. 2018 Nov 2;3(21):e99470. doi: 10.1172/jci.insight.99470.
PMID: 30385734
citation: Eitan E, Tosti V, Suire CN, Cava E, Berkowitz S, Bertozzi B, Raefsky SM, Veronese N, Spangler R, Spelta F, Mustapic M, Kapogiannis D, Mattson MP, Fontana L. In a randomized trial in prostate cancer patients, dietary protein restriction modifies markers of leptin and insulin signaling in plasma extracellular vesicles. Aging Cell. 2017 Dec;16(6):1430-1433. doi: 10.1111/acel.12657. Epub 2017 Sep 17.
PMID: 28921841
responsible party type: Sponsor
mesh term: Prostatic Neoplasms
sharing ipd: No
ipd description: Plan to publish