<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/NCT01682941</url>
  </required_header>
  <id_info>
    <org_study_id>OSU-08027</org_study_id>
    <secondary_id>NCI-2010-02387</secondary_id>
    <secondary_id>R21CA125909</secondary_id>
    <nct_id>NCT01682941</nct_id>
  </id_info>
  <brief_title>Soy Isoflavones in Treating Patients With Recurrent Prostate Cancer or Rising Prostate-Specific Antigen</brief_title>
  <official_title>Bioavailability of Isoflavones Delivered by Soy Almond Bread in Men With Recurring Prostate Cancer and Rising Prostate Specific Antigen</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Ohio State University Comprehensive Cancer Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Cancer Institute (NCI)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>Ohio State University Comprehensive Cancer Center</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      RATIONALE: Eating a diet high in soy foods may lower the risk of some types of cancer.&#xD;
      Isoflavones are compounds found in soy food that may prevent cancer.&#xD;
&#xD;
      PURPOSE: This randomized phase II trial is studying how well soy isoflavones work in treating&#xD;
      patients with recurrent prostate cancer or rising prostate-specific antigen&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      OBJECTIVES:&#xD;
&#xD;
      I. To precisely quantify the absorption, serum concentrations over time, and excretion&#xD;
      patterns of soy isoflavones and metabolites in men consuming the two bread products to define&#xD;
      relationships between dietary intake, isoflavone metabolism and the biological outcomes.&#xD;
&#xD;
      II. To describe the safety as well as incidence and severity of toxicity in men consuming the&#xD;
      control soy bread or beta-glucosidase-enriched soy bread.&#xD;
&#xD;
      III. To see if consumption of beta-glucosidase-enriched soy bread compared to control soy&#xD;
      bread has a greater effect on blood hormonal patterns and biomarkers that favor anti-prostate&#xD;
      cancer activity.&#xD;
&#xD;
      IV. To see if beta-glucosidase-enriched soy bread compared to control soy bread improves&#xD;
      hormonal patterns (lower insulin like growth factor-I, increased insulin like growth factor&#xD;
      binding protein 3, lower androgens), reduce prostate specific antigen velocity, and lower&#xD;
      circulating vascular endothelial growth factor concentrations.&#xD;
&#xD;
      OUTLINE: Patients are randomized to 1 of 2 treatment arms (closed to accrual as of&#xD;
      02/14/2011).&#xD;
&#xD;
      ARM I: Patients consume 2 slices of soy bread daily for 8 weeks.&#xD;
&#xD;
      ARM II: Patients consume 2 slices of soy almond bread daily for 8 weeks.&#xD;
&#xD;
      After a 2 week washout period, patients crossover to the alternate treatment arm.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Active, not recruiting</overall_status>
  <start_date>October 2009</start_date>
  <completion_date type="Anticipated">December 2023</completion_date>
  <primary_completion_date type="Actual">June 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>Crossover Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Peak plasma concentrations (Cmax) of soy isoflavones and their metabolites</measure>
    <time_frame>0, 2, 3, 4, 5, 6, 8, 10, 12, 24 hours post dose</time_frame>
    <description>Quantification of absorption, serum concentrations over time, and excretion patterns of soy isoflavones and metabolites to define relationships between dietary intake, isoflavone metabolism and the biological outcomes</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in hormonal patterns after soy bread and soy-almond bread interventions</measure>
    <time_frame>Day 0, 56, 70, and126</time_frame>
    <description>Comparison of hormonal patterns (lower insulin like growth factor-I, increased insulin like growth factor binding protein-3, lower androgens), prostate specific antigen velocity, and circulating vascular endothelial growth factor concentrations</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in hormonal patterns that favor anti-prostate cancer activity</measure>
    <time_frame>Days 0, 28, 56, 70, 98, and 126</time_frame>
    <description>Comparison of isoflavone metabolites on blood hormonal patterns and biomarkers that favor anti-prostate cancer activity.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Severity of toxicity in participants after consumption of the control soy bread or beta-glucosidase-enriched soy almond bread</measure>
    <time_frame>Day 0 and Day 126</time_frame>
    <description>Safety (NIH criteria) and toxicity will be measured at day 0 (start of first intervention), day 56 (end of first intervention), day 70 (start of second intervention), and day 126 (end of second intervention)</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">32</enrollment>
  <condition>Recurrent Prostate Cancer</condition>
  <condition>Stage IV Prostate Cancer</condition>
  <arm_group>
    <arm_group_label>Soy Bread Intervention</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Arm I Soy Bread</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Soy -Almond Bread Intervention</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Arm II Soy-Almond Bread</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Arm I Soy Bread</intervention_name>
    <description>On day 0 or day 70 pharmacokinetic study of isoflavones over 24 hours will follow after consumption of 2 slices of soy bread. Afterwards 2 slices of soy bread/day will be consumed for 56 days and isoflavone metabolites will be assessed in urine at days 0, 28, 56, 70, 98, and 126.</description>
    <arm_group_label>Soy Bread Intervention</arm_group_label>
    <other_name>soy isoflavones</other_name>
    <other_name>soy phytoestrogens</other_name>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Arm II Soy-Almond Bread</intervention_name>
    <description>On day 0 or day 70 pharmacokinetic study of isoflavones over 24 hours will follow after consumption of 2 slices of soy-almond bread. Afterwards 2 slices of soy-almond bread/day will be consumed for 56 days and isoflavone metabolites will be assessed in urine at days 0, 28, 56, 70, 98, and 126.</description>
    <arm_group_label>Soy -Almond Bread Intervention</arm_group_label>
    <other_name>soy isoflavones</other_name>
    <other_name>soy phytoestrogens</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Have histologically confirmed prostate cancer.&#xD;
&#xD;
          -  Have completed primary therapy (radical prostatectomy, external beam radiation,&#xD;
             brachytherapy) for prostate cancer. &quot;Watchful waiting&quot; patients will also be eligible.&#xD;
&#xD;
          -  Have either two consecutive rises in prostate specific antigen (PSA) or a series of at&#xD;
             least four PSA's over two years where the PSA doubling time is at least 3 months&#xD;
             following a nadir response to localized therapy. The minimum PSA for this study is 0.2&#xD;
             ng/dL.&#xD;
&#xD;
          -  Not be receiving ongoing chemotherapy, radiation therapy or biological therapy for&#xD;
             internal malignancy including prostate cancer.&#xD;
&#xD;
          -  At time of entry, the clinical team expects that no additional interventions for&#xD;
             prostate cancer therapy (hormonal, chemotherapy, radiotherapy, etc.) will be necessary&#xD;
             over the next 5 months.&#xD;
&#xD;
          -  Not be currently using Finasteride, androgens, or other PSA modifying hormonal agents.&#xD;
             Utilizing prescription medications for urinary outlet obstructive symptoms will not be&#xD;
             permitted. The use of non-prescription substances to improve urinary tract symptoms&#xD;
             will not be permitted (i.e. Saw Palmetto, other herbal, alternative products).&#xD;
&#xD;
          -  Have kidney and liver enzymes within normal limits. Men with kidney and liver enzymes&#xD;
             that are slightly elevated (&lt; 1.5 times the upper normal limit), but have been stable&#xD;
             for several months particularly those that are related to a known disorder (such as&#xD;
             Gilberts syndrome, past history of alcohol, hepatitis, or a history of non-alcoholic&#xD;
             steatohepatitis) will be permitted to participate after clinical evaluation by the&#xD;
             study physician.&quot;&#xD;
&#xD;
          -  Have no history of malabsorptive disorders or other metabolic disorders requiring&#xD;
             special diet recommendations. Diabetics will be permitted to participate.&#xD;
&#xD;
          -  Voluntarily agree to participate and a sign an informed consent document.&#xD;
&#xD;
          -  Agree to consume a standardized vitamin and mineral supplement and avoid other&#xD;
             nutrition, dietary, or alternative medications/supplements for the duration of the&#xD;
             study.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Have an active malignancy other than prostate cancer that requires therapy.&#xD;
&#xD;
          -  Have a history of pituitary hormone diseases that currently require supplemental&#xD;
             hormonal administration (thyroid hormones, adrenocorticotropic hormone, growth&#xD;
             hormone) or other endocrine disorders requiring hormone administration with the&#xD;
             exception of diabetes, osteoporosis and men who have been stable (&gt; 6 months of&#xD;
             thyroid stimulating hormone within normal limits) on thyroid replacement therapy.&#xD;
&#xD;
          -  Have a known allergy to tree nuts, soy or wheat protein.&#xD;
&#xD;
          -  Have a recent history of iron deficient anemia (possible accentuation by soy).&#xD;
&#xD;
          -  Antibiotic use in the last 6 months.&#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>Yael Vodovotz</last_name>
    <role>Principal Investigator</role>
    <affiliation>Ohio State University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>The Ohio State University Medical Center</name>
      <address>
        <city>Columbus</city>
        <state>Ohio</state>
        <zip>43210</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>http://cancer.osu.edu</url>
    <description>Jamesline</description>
  </link>
  <verification_date>March 2023</verification_date>
  <study_first_submitted>September 6, 2012</study_first_submitted>
  <study_first_submitted_qc>September 7, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 11, 2012</study_first_posted>
  <last_update_submitted>March 23, 2023</last_update_submitted>
  <last_update_submitted_qc>March 23, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">March 24, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Ohio State University Comprehensive Cancer Center</investigator_affiliation>
    <investigator_full_name>Yael Vodovotz</investigator_full_name>
    <investigator_title>Associate Professor</investigator_title>
  </responsible_party>
  <keyword>soy, isoflavones, functional food, prostate cancer</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>Phytoestrogens</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/NCT01682941
org study id: OSU-08027
secondary id: NCI-2010-02387
secondary id: R21CA125909
nct id: NCT01682941
lead sponsor: 
collaborator: 
has dmc: Yes
RATIONALE: Eating a diet high in soy foods may lower the risk of some types of cancer.
      Isoflavones are compounds found in soy food that may prevent cancer.

      PURPOSE: This randomized phase II trial is studying how well soy isoflavones work in treating
      patients with recurrent prostate cancer or rising prostate-specific antigen
OBJECTIVES:

      I. To precisely quantify the absorption, serum concentrations over time, and excretion
      patterns of soy isoflavones and metabolites in men consuming the two bread products to define
      relationships between dietary intake, isoflavone metabolism and the biological outcomes.

      II. To describe the safety as well as incidence and severity of toxicity in men consuming the
      control soy bread or beta-glucosidase-enriched soy bread.

      III. To see if consumption of beta-glucosidase-enriched soy bread compared to control soy
      bread has a greater effect on blood hormonal patterns and biomarkers that favor anti-prostate
      cancer activity.

      IV. To see if beta-glucosidase-enriched soy bread compared to control soy bread improves
      hormonal patterns (lower insulin like growth factor-I, increased insulin like growth factor
      binding protein 3, lower androgens), reduce prostate specific antigen velocity, and lower
      circulating vascular endothelial growth factor concentrations.

      OUTLINE: Patients are randomized to 1 of 2 treatment arms (closed to accrual as of
      02/14/2011).

      ARM I: Patients consume 2 slices of soy bread daily for 8 weeks.

      ARM II: Patients consume 2 slices of soy almond bread daily for 8 weeks.

      After a 2 week washout period, patients crossover to the alternate treatment arm.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Treatment
masking: Double (Participant, Investigator)
measure: Peak plasma concentrations (Cmax) of soy isoflavones and their metabolites
time frame: 0, 2, 3, 4, 5, 6, 8, 10, 12, 24 hours post dose
description: Quantification of absorption, serum concentrations over time, and excretion patterns of soy isoflavones and metabolites to define relationships between dietary intake, isoflavone metabolism and the biological outcomes
measure: Change in hormonal patterns after soy bread and soy-almond bread interventions
time frame: Day 0, 56, 70, and126
description: Comparison of hormonal patterns (lower insulin like growth factor-I, increased insulin like growth factor binding protein-3, lower androgens), prostate specific antigen velocity, and circulating vascular endothelial growth factor concentrations
measure: Changes in hormonal patterns that favor anti-prostate cancer activity
time frame: Days 0, 28, 56, 70, 98, and 126
description: Comparison of isoflavone metabolites on blood hormonal patterns and biomarkers that favor anti-prostate cancer activity.
measure: Severity of toxicity in participants after consumption of the control soy bread or beta-glucosidase-enriched soy almond bread
time frame: Day 0 and Day 126
description: Safety (NIH criteria) and toxicity will be measured at day 0 (start of first intervention), day 56 (end of first intervention), day 70 (start of second intervention), and day 126 (end of second intervention)
arm group label: Soy Bread Intervention
arm group type: Active Comparator
description: Arm I Soy Bread
arm group label: Soy -Almond Bread Intervention
arm group type: Experimental
description: Arm II Soy-Almond Bread
intervention type: Dietary Supplement
intervention name: Arm I Soy Bread
description: On day 0 or day 70 pharmacokinetic study of isoflavones over 24 hours will follow after consumption of 2 slices of soy bread. Afterwards 2 slices of soy bread/day will be consumed for 56 days and isoflavone metabolites will be assessed in urine at days 0, 28, 56, 70, 98, and 126.
arm group label: Soy Bread Intervention
other name: soy isoflavones
other name: soy phytoestrogens
intervention type: Dietary Supplement
intervention name: Arm II Soy-Almond Bread
description: On day 0 or day 70 pharmacokinetic study of isoflavones over 24 hours will follow after consumption of 2 slices of soy-almond bread. Afterwards 2 slices of soy-almond bread/day will be consumed for 56 days and isoflavone metabolites will be assessed in urine at days 0, 28, 56, 70, 98, and 126.
arm group label: Soy -Almond Bread Intervention
other name: soy isoflavones
other name: soy phytoestrogens
criteria: 
gender: Male
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: Yael Vodovotz
role: Principal Investigator
affiliation: Ohio State University
facility: 
country: United States
url: http://cancer.osu.edu
description: Jamesline
responsible party type: Principal Investigator
investigator affiliation: Ohio State University Comprehensive Cancer Center
investigator full name: Yael Vodovotz
investigator title: Associate Professor
mesh term: Prostatic Neoplasms
mesh term: Phytoestrogens