<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/NCT01687049</url>
  </required_header>
  <id_info>
    <org_study_id>REALITY</org_study_id>
    <secondary_id>SHSC</secondary_id>
    <nct_id>NCT01687049</nct_id>
  </id_info>
  <brief_title>Red Yeast Rice in Subjects With Clinically Localized Prostate Cancer Undergoing Active Surveillance</brief_title>
  <official_title>A Prospective Study of Red Yeast Rice in Subjects With Clinically Localized Prostate Cancer Undergoing Active Surveillance</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Dr. Laurence Klotz</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Sunnybrook Health Sciences Centre</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Agents that inhibit cholesterol synthesis are being investigated in cancers dependent upon&#xD;
      cholesterogenesis. Red yeast rice (RYR), is a reddish-purple fermented rice, containing&#xD;
      statins which are known to inhibit cholesterol synthesis. Laboratory studies have also shown&#xD;
      that RYR has direct effects on androgen dependent and androgen independent prostate cancer&#xD;
      cells, inhibiting their growth. It is thought that RYR may have clinical benefit in those&#xD;
      subjects with localized prostate cancer who have chosen to be managed by active surveillance.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Red yeast rice has been promoted as a safe and effective alternative to statin therapy in the&#xD;
      treatment of hypercholesterolemia. Red yeast rice has the potential to slow prostate cancer&#xD;
      growth by inhibiting cholesterol and androgen biosynthesis. There is a strong rationale for&#xD;
      the use of RYR in patients being managed with active surveillance for localized, low risk,&#xD;
      prostate cancer. To date, no human studies utilizing RYR in this setting have been reported.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date>January 2013</start_date>
  <completion_date type="Anticipated">December 2017</completion_date>
  <primary_completion_date type="Anticipated">December 2017</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Expression of Ki-67 and p27 biomarkers</measure>
    <time_frame>6 months</time_frame>
    <description>Determine effect of red yeast rice therapy on expression of ki67 and p27 biomarkers in a post-treatment biopsy</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>PSA kinetics</measure>
    <time_frame>6 months</time_frame>
    <description>Determine effect of red yeast rice daily therapy on PSA kinetics in men on active surveillance for localized prostate cancer</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Presence of prostatic interepithelial neoplasia</measure>
    <time_frame>6 months</time_frame>
    <description>To evaluate the effect of red yeast rice daily therapy on grade and the presence of prostatic intraepithelial neoplasia (PIN) in post treatment biopsy</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Expression of hs-CRP and cardiac CRP</measure>
    <time_frame>6 months</time_frame>
    <description>To assess the effect of red yeast rice therapy on the expression of high sensitivity C-reactive protein (hs-CRP) and cardiac C-reactive protein (CRP) in serum</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">60</enrollment>
  <condition>Prostate Cancer</condition>
  <arm_group>
    <arm_group_label>red yeast rice (RYR)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Two RYR capsules three times daily for a minimum of 6 months</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Red yeast rice</intervention_name>
    <arm_group_label>red yeast rice (RYR)</arm_group_label>
    <other_name>Aliperol</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  histologically diagnosis of prostate adenocarcinoma&#xD;
&#xD;
          -  being monitored by active surveillance for favourable risk prostate cancer&#xD;
&#xD;
          -  tumour material from most recent prostate biopsy available with sample&#xD;
&#xD;
          -  scheduled to have an active surveillance mandated transrectal ultrasound (TRUS) guided&#xD;
             biopsy within 6 - 12 months of Day 1 of the study&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  previous malignancy in the past 5 years&#xD;
&#xD;
          -  no previous or concurrent treatment for prostate cancer&#xD;
&#xD;
          -  inability to undergo TRUS biopsy&#xD;
&#xD;
          -  ECOG &gt; 2&#xD;
&#xD;
          -  known or previous history of liver disease&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>19 Years</minimum_age>
    <maximum_age>90 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Laurence Klotz, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Sunnybrook Health Sciences Centre</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Marlene Kebabdjian, BA</last_name>
    <phone>416-480-6100</phone>
    <phone_ext>7939</phone_ext>
    <email>marlene.kebabdjian@sunnybrook.ca</email>
  </overall_contact>
  <location>
    <facility>
      <name>Sunnybrook Health Sciences Centre</name>
      <address>
        <city>Toronto</city>
        <state>Ontario</state>
        <zip>M4N 3M5</zip>
        <country>Canada</country>
      </address>
    </facility>
    <investigator>
      <last_name>Laurence Klotz, Md</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <verification_date>November 2012</verification_date>
  <study_first_submitted>September 13, 2012</study_first_submitted>
  <study_first_submitted_qc>September 13, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 18, 2012</study_first_posted>
  <last_update_submitted>November 6, 2012</last_update_submitted>
  <last_update_submitted_qc>November 6, 2012</last_update_submitted_qc>
  <last_update_posted type="Estimate">November 7, 2012</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Sunnybrook Health Sciences Centre</investigator_affiliation>
    <investigator_full_name>Dr. Laurence Klotz</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>nonmetastatic</keyword>
  <keyword>localized</keyword>
  <keyword>prostate</keyword>
  <keyword>active surveillance</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>Red yeast rice</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/NCT01687049
org study id: REALITY
secondary id: SHSC
nct id: NCT01687049
lead sponsor: 
has dmc: No
Agents that inhibit cholesterol synthesis are being investigated in cancers dependent upon
      cholesterogenesis. Red yeast rice (RYR), is a reddish-purple fermented rice, containing
      statins which are known to inhibit cholesterol synthesis. Laboratory studies have also shown
      that RYR has direct effects on androgen dependent and androgen independent prostate cancer
      cells, inhibiting their growth. It is thought that RYR may have clinical benefit in those
      subjects with localized prostate cancer who have chosen to be managed by active surveillance.
Red yeast rice has been promoted as a safe and effective alternative to statin therapy in the
      treatment of hypercholesterolemia. Red yeast rice has the potential to slow prostate cancer
      growth by inhibiting cholesterol and androgen biosynthesis. There is a strong rationale for
      the use of RYR in patients being managed with active surveillance for localized, low risk,
      prostate cancer. To date, no human studies utilizing RYR in this setting have been reported.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Expression of Ki-67 and p27 biomarkers
time frame: 6 months
description: Determine effect of red yeast rice therapy on expression of ki67 and p27 biomarkers in a post-treatment biopsy
measure: PSA kinetics
time frame: 6 months
description: Determine effect of red yeast rice daily therapy on PSA kinetics in men on active surveillance for localized prostate cancer
measure: Presence of prostatic interepithelial neoplasia
time frame: 6 months
description: To evaluate the effect of red yeast rice daily therapy on grade and the presence of prostatic intraepithelial neoplasia (PIN) in post treatment biopsy
measure: Expression of hs-CRP and cardiac CRP
time frame: 6 months
description: To assess the effect of red yeast rice therapy on the expression of high sensitivity C-reactive protein (hs-CRP) and cardiac C-reactive protein (CRP) in serum
arm group label: red yeast rice (RYR)
arm group type: Experimental
description: Two RYR capsules three times daily for a minimum of 6 months
intervention type: Drug
intervention name: Red yeast rice
arm group label: red yeast rice (RYR)
other name: Aliperol
criteria: 
gender: Male
minimum age: 19 Years
maximum age: 90 Years
healthy volunteers: No
last name: Laurence Klotz, MD
role: Principal Investigator
affiliation: Sunnybrook Health Sciences Centre
last name: Marlene Kebabdjian, BA
phone: 416-480-6100
phone ext: 7939
email: marlene.kebabdjian@sunnybrook.ca
facility: 
investigator: 
country: Canada
responsible party type: Sponsor-Investigator
investigator affiliation: Sunnybrook Health Sciences Centre
investigator full name: Dr. Laurence Klotz
investigator title: Principal Investigator
mesh term: Prostatic Neoplasms
mesh term: Red yeast rice