<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/NCT03769766</url>
  </required_header>
  <id_info>
    <org_study_id>STU 012018-071</org_study_id>
    <nct_id>NCT03769766</nct_id>
  </id_info>
  <brief_title>Trial of Curcumin to Prevent Progression of Low-risk Prostate Cancer Under Active Surveillance</brief_title>
  <official_title>A Randomized, Double-Blind, Placebo-Controlled Trial of Curcumin to Prevent Progression of Biopsy Proven, Low-risk Localized Prostate Cancer Patients Undergoing Active Surveillance</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Texas Southwestern Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Texas Southwestern Medical Center</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>
      This is a prospective study to determine if the use of curcumin randomized against placebo&#xD;
      will reduce cancer progression in patients with prostate cancer undergoing active&#xD;
      surveillance.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Prostate cancer is the most common cancer in men with an estimated 180,890 new cases and&#xD;
      26,120 deaths from prostate cancer expected in 2016 in the United States. Although the&#xD;
      lifetime risk of developing prostate cancer, the risk of death is only about 3%. A major&#xD;
      concern regarding the utility of prostate cancer screening is the risk of over diagnosis and&#xD;
      subsequent overtreatment. Many patients with small low grade cancers might not benefit from&#xD;
      treatment and treatment can result in lower quality of life. A major concern for patients and&#xD;
      physicians using active surveillance (AS) is the risk for progression of disease. Several&#xD;
      reviews of active surveillance suggest that stage or grade progression occur in approximately&#xD;
      30% of patients with some patients choosing treatment due to anxiety. Overall survival in AS&#xD;
      series is uniformly high but the need for close monitoring and anxiety associated with risk&#xD;
      of progression has inhibited use among patients.&#xD;
&#xD;
      There are no currently accepted medications to reduce risk of progression in patients with&#xD;
      active surveillance. With the rising use of AS, there is a role for therapies to reduce risk&#xD;
      for progression in this population. One promising source of therapies involves use of&#xD;
      nutraceuticals for the prevention and treatment of human diseases. Curcumin is a widely&#xD;
      studied nutraceutical that was first discovered about two centuries ago from the rhizomes of&#xD;
      Curcuma longa (turmeric). Curcumin is a safe supplement and in this study we will evaluate if&#xD;
      it reduces risk of cancer progression compared to placebo.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">March 11, 2019</start_date>
  <completion_date type="Anticipated">November 2026</completion_date>
  <primary_completion_date type="Anticipated">November 2023</primary_completion_date>
  <phase>Phase 3</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>placebo/active Curcumin</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>The primary end point is rate of disease progression.</measure>
    <time_frame>2 years</time_frame>
    <description>The primary endpoint is the number of patients who have progressed at 2 years of follow up defined as one of the following events: receipt of primary therapy for prostate cancer (eg, prostatectomy, radiation, hormonal therapy) or pathologic progression (&gt; 4 cores involved, ≥ 50% of any core involved, or any Gleason score ≥ 7)</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">291</enrollment>
  <condition>Prostate Cancer</condition>
  <arm_group>
    <arm_group_label>Curcumin</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Other names for the supplement: BCM-95 CG (Biocurcumax),Tumeric&#xD;
Manufacture- DolCas Biotech, LLC.&#xD;
Classification - type of agent: Supplement&#xD;
Protocol dose: 500 mg twice</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Drug: placebo&#xD;
placebo orally twice a day Other Names: •sugar pill</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Curcumin</intervention_name>
    <description>Take medication one 500 mg pill of BCM-95 taken twice daily</description>
    <arm_group_label>Curcumin</arm_group_label>
    <other_name>biocurcumax (BCM-95)</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Take medication one 500mg pill twice daily</description>
    <arm_group_label>Placebo</arm_group_label>
    <other_name>sugar pill</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age between 40-89 years&#xD;
&#xD;
          -  Biopsy proven, low-risk, localized prostate cancer (minimum of 8 cores)&#xD;
&#xD;
          -  May have had biopsy within last 12 months ≤4 cores involved with cancer&#xD;
&#xD;
          -  Gleason score ≤6 with no Gleason pattern 4&#xD;
&#xD;
          -  Clinical stage T1c-T2a/b&#xD;
&#xD;
          -  Serum PSA ≤15 ng/ml&#xD;
&#xD;
          -  Life expectancy &gt; 5 years&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Any previous prostate cancer treatment (radiotherapy, chemotherapy, hormonal therapy,&#xD;
             oral glucocorticoids, GnRH analogues, prostatectomy)&#xD;
&#xD;
          -  Concurrent or previous use within 6 months of screening of any 5α-reductase inhibitor&#xD;
&#xD;
          -  Use of anabolic steroids or drugs with antiandrogenic properties&#xD;
&#xD;
          -  Prostate volume &gt;150 grams&#xD;
&#xD;
          -  Patients who are taking antiplatelet, anticoagulant agents or have a history of a&#xD;
             bleeding disorder. Patients taking 81 mg of Aspirin will be allowed to enroll with&#xD;
             close observation&#xD;
&#xD;
          -  History of gastric or duodenal ulcers or untreated hyperacidity syndromes. Patients on&#xD;
             stable doses (2 months of therapy) of GERD medication allowed.&#xD;
&#xD;
          -  Patients who are currently taking Curcumin and are unwilling to stop or plan to take&#xD;
             Curcumin during the study&#xD;
&#xD;
          -  Patients with a history of gallbladder problems or gallstones or biliary&#xD;
             obstruction,unless patient had cholecystectomy&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <gender_based>Yes</gender_based>
    <gender_description>Patients have to have prostate cancer</gender_description>
    <minimum_age>40 Years</minimum_age>
    <maximum_age>89 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Yair Lotan, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>UT Southwestern Medical Center</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Jessica Williams</last_name>
    <phone>214-648-9195</phone>
    <email>Jessica.Williams2@utsouthwestern.edu</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Maricruz Ibarra</last_name>
    <phone>214-645-8788</phone>
    <email>maricruz.ibarra@utsouthwestern.edu</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>UT Southwestern Medical Center</name>
      <address>
        <city>Dallas</city>
        <state>Texas</state>
        <zip>75390</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Yair Lotan, MD</last_name>
      <phone>214-645-8787</phone>
      <email>Yair.Lotan@utsouthwestern.edu</email>
    </contact>
    <contact_backup>
      <last_name>Jessica Williams</last_name>
      <phone>214-648-9195</phone>
      <email>Jessica.Williams2@utsouthwestern.edu</email>
    </contact_backup>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>December 2022</verification_date>
  <study_first_submitted>December 5, 2018</study_first_submitted>
  <study_first_submitted_qc>December 6, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 10, 2018</study_first_posted>
  <last_update_submitted>December 20, 2022</last_update_submitted>
  <last_update_submitted_qc>December 20, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">December 21, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Texas Southwestern Medical Center</investigator_affiliation>
    <investigator_full_name>yair lotan</investigator_full_name>
    <investigator_title>MD, Professor and Chief of Urologic Oncology</investigator_title>
  </responsible_party>
  <keyword>prostate cancer</keyword>
  <keyword>active surveillance</keyword>
  <keyword>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>Curcumin</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/NCT03769766
org study id: STU 012018-071
nct id: NCT03769766
lead sponsor: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
This is a prospective study to determine if the use of curcumin randomized against placebo
      will reduce cancer progression in patients with prostate cancer undergoing active
      surveillance.
Prostate cancer is the most common cancer in men with an estimated 180,890 new cases and
      26,120 deaths from prostate cancer expected in 2016 in the United States. Although the
      lifetime risk of developing prostate cancer, the risk of death is only about 3%. A major
      concern regarding the utility of prostate cancer screening is the risk of over diagnosis and
      subsequent overtreatment. Many patients with small low grade cancers might not benefit from
      treatment and treatment can result in lower quality of life. A major concern for patients and
      physicians using active surveillance (AS) is the risk for progression of disease. Several
      reviews of active surveillance suggest that stage or grade progression occur in approximately
      30% of patients with some patients choosing treatment due to anxiety. Overall survival in AS
      series is uniformly high but the need for close monitoring and anxiety associated with risk
      of progression has inhibited use among patients.

      There are no currently accepted medications to reduce risk of progression in patients with
      active surveillance. With the rising use of AS, there is a role for therapies to reduce risk
      for progression in this population. One promising source of therapies involves use of
      nutraceuticals for the prevention and treatment of human diseases. Curcumin is a widely
      studied nutraceutical that was first discovered about two centuries ago from the rhizomes of
      Curcuma longa (turmeric). Curcumin is a safe supplement and in this study we will evaluate if
      it reduces risk of cancer progression compared to placebo.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: placebo/active Curcumin
primary purpose: Treatment
masking: Double (Participant, Investigator)
measure: The primary end point is rate of disease progression.
time frame: 2 years
description: The primary endpoint is the number of patients who have progressed at 2 years of follow up defined as one of the following events: receipt of primary therapy for prostate cancer (eg, prostatectomy, radiation, hormonal therapy) or pathologic progression (> 4 cores involved, ≥ 50% of any core involved, or any Gleason score ≥ 7)
arm group label: Curcumin
arm group type: Active Comparator
description: Other names for the supplement: BCM-95 CG (Biocurcumax),Tumeric
Manufacture- DolCas Biotech, LLC.
Classification - type of agent: Supplement
Protocol dose: 500 mg twice
arm group label: Placebo
arm group type: Placebo Comparator
description: Drug: placebo
placebo orally twice a day Other Names: •sugar pill
intervention type: Drug
intervention name: Curcumin
description: Take medication one 500 mg pill of BCM-95 taken twice daily
arm group label: Curcumin
other name: biocurcumax (BCM-95)
intervention type: Drug
intervention name: Placebo
description: Take medication one 500mg pill twice daily
arm group label: Placebo
other name: sugar pill
criteria: 
gender: Male
gender based: Yes
gender description: Patients have to have prostate cancer
minimum age: 40 Years
maximum age: 89 Years
healthy volunteers: No
last name: Yair Lotan, MD
role: Principal Investigator
affiliation: UT Southwestern Medical Center
last name: Jessica Williams
phone: 214-648-9195
email: Jessica.Williams2@utsouthwestern.edu
last name: Maricruz Ibarra
phone: 214-645-8788
email: maricruz.ibarra@utsouthwestern.edu
facility: 
status: Recruiting
contact: 
contact backup: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: University of Texas Southwestern Medical Center
investigator full name: yair lotan
investigator title: MD, Professor and Chief of Urologic Oncology
mesh term: Prostatic Neoplasms
mesh term: Curcumin