<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/NCT02198859</url>
  </required_header>
  <id_info>
    <org_study_id>13582</org_study_id>
    <nct_id>NCT02198859</nct_id>
  </id_info>
  <brief_title>Evaluation of Lithium and It's Effect on Clinically Localized Prostate Cancer</brief_title>
  <official_title>Phase 1 Study of Evaluation of Lithium and it's Effect on Clinically Localized Prostate Cancer.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Kansas Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Kansas Medical Center</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Laboratory testing has suggested that lithium may decrease the incidence of certain types of&#xD;
      cancer, including prostate cancer. Additional research has suggested that lithium decreases&#xD;
      prostate cancer tumor size over time. This study will investigate the effect of lithium on&#xD;
      men with prostate cancer.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      As lithium has been shown in an in vitro model to suppress cellular proliferation, and&#xD;
      suppress tumor growth in an in vivo xenograft model, we propose to determine its effect on&#xD;
      prostate cancer cells in human patients undergoing radical prostatectomy. In this pilot study&#xD;
      we plan to assess the toxicity of lithium administration in patients prior to radical&#xD;
      prostatectomy. This will include any clinical toxicity as well as any increase in intra-,&#xD;
      peri- or postoperative complications.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>April 2014</start_date>
  <completion_date type="Actual">August 2016</completion_date>
  <primary_completion_date type="Actual">August 2016</primary_completion_date>
  <phase>Phase 1</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>Observe any change to Performance Status and Adverse Events related to Lithium</measure>
    <time_frame>Weekly for 4 weeks prior to radical prostatectomy and continuing for 1 - 2 weeks after surgery</time_frame>
    <description>To determine the safety and tolerability of lithium in subjects with clinically localized prostate cancer.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Serum lithium levels</measure>
    <time_frame>Weekly for up to 4 weeks prior to radical prostatectomy</time_frame>
    <description>To document observed levels of lithium in the serum</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Tumor response by lithium concentration</measure>
    <time_frame>Sample collected during surgery and up to 4 weeks after baseline</time_frame>
    <description>To evaluate tumor response by lithium concentration in the surgically removed prostate and serum PSA levels.</description>
  </other_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">11</enrollment>
  <condition>Prostate Cancer</condition>
  <arm_group>
    <arm_group_label>Lithium</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Oral lithium carbonate dose escalation: Level 1 of 600 mg/day, then escalating to Level 2 of 900 mg/day, then the final Level 3 of 1200 mg/day.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Lithium Carbonate</intervention_name>
    <arm_group_label>Lithium</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Ability to understand and the willingness to sign a written informed consent form.&#xD;
&#xD;
          -  Subjects with histologically confirmed local adenocarcinoma of the prostate who have&#xD;
             elected to proceed with radical prostatectomy as primary curative therapy.&#xD;
&#xD;
          -  Subjects having no prior administration of lithium or lithium containing medications&#xD;
             within 90 days of study enrollment.&#xD;
&#xD;
          -  Subjects &gt;/= 18 years of age.&#xD;
&#xD;
          -  ECOG (Eastern Cooperative Oncology Group) performance status of &lt;/= 1.&#xD;
&#xD;
          -  Adequate renal function defined as GFR (Glomerular Filtration Rate) &gt;/= 50 mL/min.&#xD;
&#xD;
          -  Use of adequate contraception&#xD;
&#xD;
          -  ECG (Electrocardiogram) within normal limits.&#xD;
&#xD;
          -  Subjects must agree not to take any new vitamin supplements or herbal remedy during&#xD;
             the study period.&#xD;
&#xD;
          -  Subjects must be able to safety take lithium carbonate for at least 4 weeks before&#xD;
             scheduled prostatectomy.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Subjects who have received any investigational medication within 30 days of first&#xD;
             lithium dose.&#xD;
&#xD;
          -  Subjects currently receiving, or who have had previous hormonal, chemotherapy or&#xD;
             radiotherapy for prostate cancer.&#xD;
&#xD;
          -  Subjects with known brain metastases.&#xD;
&#xD;
          -  History of allergic reactions attributed to compounds of similar chemical or biologic&#xD;
             composition to lithium carbonate.&#xD;
&#xD;
          -  Uncontrolled intercurrent illness such as ongoing or active infection, symptomatic&#xD;
             congestive heart failure, unstable angina pectoris, cardiac arrhythmia or psychiatric&#xD;
             illness/social situations that would 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>Moben Mirza, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Kansas Medical Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Kansas Medical Center</name>
      <address>
        <city>Kansas City</city>
        <state>Kansas</state>
        <zip>66160</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>January 2017</verification_date>
  <study_first_submitted>July 7, 2014</study_first_submitted>
  <study_first_submitted_qc>July 22, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 24, 2014</study_first_posted>
  <last_update_submitted>January 6, 2017</last_update_submitted>
  <last_update_submitted_qc>January 6, 2017</last_update_submitted_qc>
  <last_update_posted type="Estimate">January 9, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Prostate Cancer</keyword>
  <keyword>Lithium</keyword>
  <keyword>Androgen</keyword>
  <keyword>PSA</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>Lithium Carbonate</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/NCT02198859
org study id: 13582
nct id: NCT02198859
lead sponsor: 
has dmc: Yes
Laboratory testing has suggested that lithium may decrease the incidence of certain types of
      cancer, including prostate cancer. Additional research has suggested that lithium decreases
      prostate cancer tumor size over time. This study will investigate the effect of lithium on
      men with prostate cancer.
As lithium has been shown in an in vitro model to suppress cellular proliferation, and
      suppress tumor growth in an in vivo xenograft model, we propose to determine its effect on
      prostate cancer cells in human patients undergoing radical prostatectomy. In this pilot study
      we plan to assess the toxicity of lithium administration in patients prior to radical
      prostatectomy. This will include any clinical toxicity as well as any increase in intra-,
      peri- or postoperative complications.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Observe any change to Performance Status and Adverse Events related to Lithium
time frame: Weekly for 4 weeks prior to radical prostatectomy and continuing for 1 - 2 weeks after surgery
description: To determine the safety and tolerability of lithium in subjects with clinically localized prostate cancer.
measure: Serum lithium levels
time frame: Weekly for up to 4 weeks prior to radical prostatectomy
description: To document observed levels of lithium in the serum
measure: Tumor response by lithium concentration
time frame: Sample collected during surgery and up to 4 weeks after baseline
description: To evaluate tumor response by lithium concentration in the surgically removed prostate and serum PSA levels.
arm group label: Lithium
arm group type: Experimental
description: Oral lithium carbonate dose escalation: Level 1 of 600 mg/day, then escalating to Level 2 of 900 mg/day, then the final Level 3 of 1200 mg/day.
intervention type: Drug
intervention name: Lithium Carbonate
arm group label: Lithium
criteria: 
gender: Male
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Moben Mirza, MD
role: Principal Investigator
affiliation: University of Kansas Medical Center
facility: 
country: United States
responsible party type: Sponsor
mesh term: Prostatic Neoplasms
mesh term: Lithium Carbonate