<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/NCT02217709</url>
  </required_header>
  <id_info>
    <org_study_id>4P-14-1</org_study_id>
    <secondary_id>NCI-2014-01791</secondary_id>
    <secondary_id>HS-14-00331</secondary_id>
    <secondary_id>4P-14-1</secondary_id>
    <secondary_id>P30CA014089</secondary_id>
    <nct_id>NCT02217709</nct_id>
  </id_info>
  <brief_title>Phenelzine Sulfate in Treating Patients With Non-metastatic Recurrent Prostate Cancer</brief_title>
  <official_title>Phase 2 Trial of Phenelzine in Non-metastatic Recurrent Prostate Cancer</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Southern California</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Cancer Institute (NCI)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Southern California</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 phase II trial studies phenelzine sulfate in treating patients with prostate cancer that&#xD;
      has not spread to other parts of the body and has come back. Phenelzine sulfate is a type of&#xD;
      antidepressant that works by decreasing the amount of a protein called monoamine oxidase&#xD;
      (MAO). MAO drugs may have an anticancer effect in prostate cancer.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      PRIMARY OBJECTIVES:&#xD;
&#xD;
      I. To assess the proportion of patients with biochemical recurrent prostate cancer (BCR-PC)&#xD;
      treated with phenelzine (phenelzine sulfate) who achieve a prostate-specific antigen (PSA)&#xD;
      decline of &gt;= 50% from baseline.&#xD;
&#xD;
      SECONDARY OBJECTIVES:&#xD;
&#xD;
      I. To monitor potential toxicities and/or beneficial effects on quality of life of phenelzine&#xD;
      in prostate cancer patients.&#xD;
&#xD;
      II. To assess time to radiographic disease progression for patients with recurrent prostate&#xD;
      cancer treated with phenelzine.&#xD;
&#xD;
      III. To collect blood and other samples to study the relationship between MAO activity and&#xD;
      prostate cancer.&#xD;
&#xD;
      OUTLINE:&#xD;
&#xD;
      Patients receive phenelzine sulfate 30 mg by mouth (PO) twice daily (BID) (starting dose of&#xD;
      15 mg daily escalated to 30 mg BID over 16 plus or minus 5 days). Patients who have been&#xD;
      treated at 30 mg BID for over 3 cycles with resolution of any and all toxicities to grade &lt;&#xD;
      or = 1 may increase the dose to a maximum of 45 mg BID at the discretion of the treating&#xD;
      investigator. Treatment may continue in the absence of disease progression or unacceptable&#xD;
      toxicity.&#xD;
&#xD;
      After completion of study treatment, patients are followed up every 3 months for up to 3&#xD;
      years.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 8, 2014</start_date>
  <completion_date type="Actual">June 29, 2020</completion_date>
  <primary_completion_date type="Actual">June 29, 2020</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>Occurrence of PSA decline to &gt;= 50% from baseline following at least 12 weeks of treatment with phenelzine sulfate</measure>
    <time_frame>Baseline to up to 12 months</time_frame>
    <description>Assessed independently in two groups of patients defined according to circulating androgen levels as: non-castrate and castrate.</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">26</enrollment>
  <condition>Adenocarcinoma of the Prostate</condition>
  <condition>Recurrent Prostate Cancer</condition>
  <condition>Stage I Prostate Cancer</condition>
  <condition>Stage IIA Prostate Cancer</condition>
  <condition>Stage IIB Prostate Cancer</condition>
  <condition>Stage III Prostate Cancer</condition>
  <arm_group>
    <arm_group_label>Treatment (phenelzine sulfate)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients receive phenelzine sulfate 30 mg by mouth (PO) twice daily (BID) (starting dose of 15 mg daily escalated to 30 mg BID over 16 plus or minus 5 days). Patients who have been treated at 30 mg BID for over 3 cycles with resolution of any and all toxicities to grade &lt; or = 1 may increase the dose to a maximum of 45 mg BID at the discretion of the treating investigator. Treatment may continue in the absence of disease progression or unacceptable toxicity.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>phenelzine sulfate</intervention_name>
    <description>Given by mouth</description>
    <arm_group_label>Treatment (phenelzine sulfate)</arm_group_label>
    <other_name>Nardil</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>laboratory biomarker analysis</intervention_name>
    <description>Correlative studies</description>
    <arm_group_label>Treatment (phenelzine sulfate)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>questionnaire administration</intervention_name>
    <description>Ancillary studies</description>
    <arm_group_label>Treatment (phenelzine sulfate)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Histologically confirmed adenocarcinoma of the prostate&#xD;
&#xD;
          -  Recurrent prostate cancer following primary therapy as defined by:&#xD;
&#xD;
               -  Post-radical prostatectomy: Any PSA &gt;= 0.4 ng/ml&#xD;
&#xD;
               -  Post-primary radiotherapy: PSA &gt;= 2 ng/ml above a post-radiotherapy nadir&#xD;
&#xD;
               -  Post-primary androgen-deprivation therapy: A confirmed rise of PSA &gt;= 2 ng/ml&#xD;
                  above a post-therapy nadir&#xD;
&#xD;
          -  For patients with non-castrate levels of circulating androgen levels (testosterone &gt;=&#xD;
             50 g/dl)&#xD;
&#xD;
               -  PSA levels should be increasing on at least two occasions &gt;= 1 week apart&#xD;
&#xD;
               -  Patients should not be considered candidates for radiation therapy&#xD;
&#xD;
          -  For patients with castrate levels of circulating androgen levels (testosterone &lt; 50&#xD;
             ng/dl):&#xD;
&#xD;
               -  PSA levels must be &gt;= 0.4 ng/ml (if history of radical prostatectomy) or &gt;= 2&#xD;
                  ng/ml (if history of non-surgical primary treatment) and found to be increasing&#xD;
                  on at least two occasions &gt;= 1 week apart&#xD;
&#xD;
          -  At least 4 weeks must have elapsed since any changes to hormonal therapy, including at&#xD;
             least 4 weeks since flutamide and at least 6 weeks since bicalutamide, nilutamide, or&#xD;
             enzalutamide&#xD;
&#xD;
          -  No evidence of metastatic cancer on imaging including a bone scan and computed&#xD;
             tomography (CT) scan of chest/abdomen/pelvis&#xD;
&#xD;
          -  Able to understand and adhere to dietary and medication restrictions as recommended&#xD;
             for the safe use of phenelzine&#xD;
&#xD;
          -  Men with child bearing potential are required to use an effective means of&#xD;
             contraception&#xD;
&#xD;
          -  Leukocytes &gt;= 3,000/mcL&#xD;
&#xD;
          -  Absolute neutrophil count &gt;= 1,500/mcL&#xD;
&#xD;
          -  Platelets &gt;= 100,000/mcL&#xD;
&#xD;
          -  Total bilirubin =&lt; 1.5 x upper limit of normal (ULN) except in cases of benign&#xD;
             isolated hyperbilirubinemia such as Gilbert's syndrome.&#xD;
&#xD;
          -  Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase&#xD;
             [SGOT])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SPGT])&#xD;
             =&lt; 2.5 x ULN&#xD;
&#xD;
          -  Creatinine =&lt; 1.5 x ULN&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Uncontrolled hypertension despite appropriate medical therapy (blood pressure [BP]&#xD;
             greater than 160 mmHg systolic and 90 mmHg diastolic at 2 separate measurements no&#xD;
             more than 60 minutes apart during the screening visit); Note: patients may be&#xD;
             rescreened after adjustment of antihypertensive medications&#xD;
&#xD;
          -  Known prior history of mania or major psychiatric illness (schizophrenia, bipolar&#xD;
             disorder, severe major depression requiring hospitalization, etc.)&#xD;
&#xD;
          -  Concurrent use of medications contra-indicated due to potential interactions with&#xD;
             phenelzine&#xD;
&#xD;
          -  Inability to comply with dietary restrictions for foods, supplements, and medications&#xD;
             with potential for adverse interactions with phenelzine or to otherwise cooperate&#xD;
             fully with the investigator and study personnel&#xD;
&#xD;
          -  History of allergic reactions attributed to compounds of similar chemical or biologic&#xD;
             composition to phenelzine or other monoamine oxidase inhibitors&#xD;
&#xD;
          -  Patients may not be receiving any other investigational agents&#xD;
&#xD;
          -  Uncontrolled intercurrent illness including, but not limited to, ongoing or active&#xD;
             infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac&#xD;
             arrhythmia, or psychiatric illness/social situations that would limit compliance with&#xD;
             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>Mitchell Gross, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Southern California</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Jean C. Shih, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Southern California</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>USC Norris Westside Cancer Center</name>
      <address>
        <city>Beverly Hills</city>
        <state>California</state>
        <zip>90211</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Los Angeles County-USC Medical Center</name>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <zip>90033</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>USC Norris Comprehensive Cancer Center</name>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <zip>90033</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Keck Medical Center of USC Pasadena</name>
      <address>
        <city>Pasadena</city>
        <state>California</state>
        <zip>91105</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>December 2022</verification_date>
  <study_first_submitted>August 13, 2014</study_first_submitted>
  <study_first_submitted_qc>August 14, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 15, 2014</study_first_posted>
  <last_update_submitted>December 8, 2022</last_update_submitted>
  <last_update_submitted_qc>December 8, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">December 12, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Prostatic Neoplasms</mesh_term>
    <mesh_term>Recurrence</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Phenelzine</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/NCT02217709
org study id: 4P-14-1
secondary id: NCI-2014-01791
secondary id: HS-14-00331
secondary id: 4P-14-1
secondary id: P30CA014089
nct id: NCT02217709
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
This phase II trial studies phenelzine sulfate in treating patients with prostate cancer that
      has not spread to other parts of the body and has come back. Phenelzine sulfate is a type of
      antidepressant that works by decreasing the amount of a protein called monoamine oxidase
      (MAO). MAO drugs may have an anticancer effect in prostate cancer.
PRIMARY OBJECTIVES:

      I. To assess the proportion of patients with biochemical recurrent prostate cancer (BCR-PC)
      treated with phenelzine (phenelzine sulfate) who achieve a prostate-specific antigen (PSA)
      decline of >= 50% from baseline.

      SECONDARY OBJECTIVES:

      I. To monitor potential toxicities and/or beneficial effects on quality of life of phenelzine
      in prostate cancer patients.

      II. To assess time to radiographic disease progression for patients with recurrent prostate
      cancer treated with phenelzine.

      III. To collect blood and other samples to study the relationship between MAO activity and
      prostate cancer.

      OUTLINE:

      Patients receive phenelzine sulfate 30 mg by mouth (PO) twice daily (BID) (starting dose of
      15 mg daily escalated to 30 mg BID over 16 plus or minus 5 days). Patients who have been
      treated at 30 mg BID for over 3 cycles with resolution of any and all toxicities to grade <
      or = 1 may increase the dose to a maximum of 45 mg BID at the discretion of the treating
      investigator. Treatment may continue in the absence of disease progression or unacceptable
      toxicity.

      After completion of study treatment, patients are followed up every 3 months for up to 3
      years.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Occurrence of PSA decline to >= 50% from baseline following at least 12 weeks of treatment with phenelzine sulfate
time frame: Baseline to up to 12 months
description: Assessed independently in two groups of patients defined according to circulating androgen levels as: non-castrate and castrate.
arm group label: Treatment (phenelzine sulfate)
arm group type: Experimental
description: Patients receive phenelzine sulfate 30 mg by mouth (PO) twice daily (BID) (starting dose of 15 mg daily escalated to 30 mg BID over 16 plus or minus 5 days). Patients who have been treated at 30 mg BID for over 3 cycles with resolution of any and all toxicities to grade < or = 1 may increase the dose to a maximum of 45 mg BID at the discretion of the treating investigator. Treatment may continue in the absence of disease progression or unacceptable toxicity.
intervention type: Drug
intervention name: phenelzine sulfate
description: Given by mouth
arm group label: Treatment (phenelzine sulfate)
other name: Nardil
intervention type: Other
intervention name: laboratory biomarker analysis
description: Correlative studies
arm group label: Treatment (phenelzine sulfate)
intervention type: Other
intervention name: questionnaire administration
description: Ancillary studies
arm group label: Treatment (phenelzine sulfate)
criteria: 
gender: Male
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Mitchell Gross, MD
role: Principal Investigator
affiliation: University of Southern California
last name: Jean C. Shih, PhD
role: Principal Investigator
affiliation: University of Southern California
facility: 
facility: 
facility: 
facility: 
country: United States
responsible party type: Sponsor
mesh term: Prostatic Neoplasms
mesh term: Recurrence
mesh term: Phenelzine