<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/NCT03830164</url>
  </required_header>
  <id_info>
    <org_study_id>2018-0785</org_study_id>
    <secondary_id>NCI-2019-00235</secondary_id>
    <secondary_id>2018-0785</secondary_id>
    <nct_id>NCT03830164</nct_id>
  </id_info>
  <brief_title>Pentoxifylline, Atorvastatin, and Vitamin E in Treating Patients With Erectile Dysfunction After Radiation Therapy for Prostate Cancer</brief_title>
  <official_title>Pentoxifylline, Atorvastatin, and Vitamin E (PAVE) as Treatment for Radiation-Induced Erectile Dysfunction</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>M.D. Anderson 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>M.D. Anderson Cancer Center</source>
  <oversight_info>
    <has_dmc>No</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 how well pentoxifylline, atorvastatin, and vitamin E (PAVE) work&#xD;
      in treating patients with erectile dysfunction after radiation therapy for prostate cancer.&#xD;
      Atorvastatin may reduce high cholesterol. Pentoxifylline and vitamin E may enhance blood&#xD;
      flow. Giving PAVE may work better in treating prostate cancer patients with post-radiation&#xD;
      therapy erectile dysfunction.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      PRIMARY OBJECTIVE:&#xD;
&#xD;
      I. To estimate the proportion of patients who achieve a clinically significant improvement in&#xD;
      erectile dysfunction (ED) when treated with a combination of atorvastatin or patient's&#xD;
      currently prescribed statin, vitamin E, and pentoxifylline (PAVE).&#xD;
&#xD;
      SECONDARY OBJECTIVES:&#xD;
&#xD;
      I. To report the safety profile of PAVE. II. To report the rate of choosing other ED&#xD;
      treatments after PAVE.&#xD;
&#xD;
      OUTLINE:&#xD;
&#xD;
      Patients receive atorvastatin orally (PO) once daily (QD) for up to 6 weeks in the absence of&#xD;
      disease progression or unacceptable toxicity. Beginning week 7, patients receive atorvastatin&#xD;
      PO QD, vitamin E PO QD, and pentoxifylline PO thrice daily (TID) for up to 12 months in the&#xD;
      absence of disease progression or unacceptable toxicity.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 20, 2019</start_date>
  <completion_date type="Actual">November 2, 2022</completion_date>
  <primary_completion_date type="Actual">November 2, 2022</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <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>Change in International Index of Erectile Function (IIEF) Scores</measure>
    <time_frame>12 months</time_frame>
    <description>To estimate the proportion of participants who achieve a clinically significant improvement in erectile dysfunction (ED) when treated with a combination of Atorvastatin or participant's currently prescribed statin, Vitamin E, and Pentoxifylline (PAVE)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Incidence of Adverse Events (AEs)</measure>
    <time_frame>Up to 12 months</time_frame>
    <description>The safety profile of the pentoxifylline, atorvastatin and vitamin E (PAVE) combination will be reported for each cohort, with adverse events summarized by grade and time to onset to first grade 3 adverse event.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Choosing Other Erectile Dysfunction (ED) Treatments After Pentoxifylline, Atorvastatin and Vitamin E (PAVE)</measure>
    <time_frame>Up to 12 months</time_frame>
    <description>To report the rate of choosing other ED treatments after PAVE.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">14</enrollment>
  <condition>Male Erectile Disorder</condition>
  <condition>Prostate Adenocarcinoma</condition>
  <condition>Erectile Dysfunction, CTCAE</condition>
  <condition>Impotence</condition>
  <arm_group>
    <arm_group_label>Treatment (atorvastatin, vitamin E, pentoxifylline)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients receive atorvastatin PO QD for up to 6 weeks in the absence of disease progression or unacceptable toxicity. Beginning week 7, patients receive atorvastatin PO QD, vitamin E PO QD, and pentoxifylline PO TID for up to 12 months in the absence of disease progression or unacceptable toxicity.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Atorvastatin</intervention_name>
    <description>Given PO</description>
    <arm_group_label>Treatment (atorvastatin, vitamin E, pentoxifylline)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Pentoxifylline</intervention_name>
    <description>Given PO</description>
    <arm_group_label>Treatment (atorvastatin, vitamin E, pentoxifylline)</arm_group_label>
    <other_name>Oxpentifylline</other_name>
    <other_name>Pentoxyphylline</other_name>
    <other_name>PTX</other_name>
    <other_name>Trental</other_name>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Vitamin E Compound</intervention_name>
    <description>Given PO</description>
    <arm_group_label>Treatment (atorvastatin, vitamin E, pentoxifylline)</arm_group_label>
    <other_name>2,5,7,8-tetramethyl-2-(4,8,12-trimethyltridecyl)chroman-6-ol</other_name>
    <other_name>E Vitamin</other_name>
    <other_name>Vitamin E</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Histologically or cytologically confirmed diagnosis of adenocarcinoma of the prostate&#xD;
&#xD;
          -  Previous radiation therapy (any form) with curative intent for prostate cancer&#xD;
&#xD;
          -  Erectile dysfunction, as determined by an International Index of Erectile Function&#xD;
             (IIEF)-5 score of &lt; 22&#xD;
&#xD;
          -  Normal testosterone (including men on testosterone replacement), defined as&#xD;
             testosterone &gt; 150 ng/dl at the time of screening&#xD;
&#xD;
          -  Karnofsky Performance Status (KPS) &gt;= 70, or Eastern Cooperative Oncology Group (ECOG)&#xD;
             0-2&#xD;
&#xD;
          -  Patients may be taking an HMG-coA-reductase inhibitor&#xD;
&#xD;
          -  Serum alanine aminotransferase (ALT) and aspartate aminotransferase (AST) =&lt; 3 X upper&#xD;
             limits of normal (ULN)&#xD;
&#xD;
          -  Creatinine kinase &lt; 5 times ULN&#xD;
&#xD;
          -  Normal renal function is defined as creatinine clearance &gt;= 30 ml/min via the&#xD;
             Cockcroft Gault formula&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  No androgen deprivation therapy within the past 12 months&#xD;
&#xD;
          -  No contraindication to an HMG-coA-reductase inhibitor, vitamin E or pentoxifylline&#xD;
&#xD;
          -  Not currently taking cyclosporine, the human immunodeficiency virus (HIV) protease&#xD;
             inhibitors, hepatitis C protease inhibitors, gemfibrozil, other fibrates,&#xD;
             clarithromycin, itraconazole or strong inhibitors of CYP3A4&#xD;
&#xD;
          -  No recent cerebral or retinal hemorrhage that in the opinion of the treating physician&#xD;
             would make PAVE unsafe (within 6 months)&#xD;
&#xD;
          -  No current chemotherapy during study participation&#xD;
&#xD;
          -  No active liver or muscle disease that in the opinion of the treating physician would&#xD;
             make PAVE unsafe&#xD;
&#xD;
          -  No prior radical prostatectomy, cystoprostatectomy, abdominoperineal resection or&#xD;
             retroperitoneal lymph node dissection&#xD;
&#xD;
          -  Not currently taking a 5PDE inhibitor nor have used one within 30 days of enrolling in&#xD;
             the study&#xD;
&#xD;
          -  No recent deep venous thrombosis, myocardial infarction or pulmonary embolism (within&#xD;
             6 months) requiring continued anticoagulation other than aspirin (acetylsalicylic acid&#xD;
             [ASA])&#xD;
&#xD;
          -  No cardiac arrhythmias or artificial heart valves requiring anticoagulation other than&#xD;
             ASA&#xD;
&#xD;
          -  No concurrent drugs with anti-platelet therapy properties (e.g., P2Y12 inhibitors,&#xD;
             non-steroidal anti-inflammatory agents, selective serotonin reuptake inhibitors) other&#xD;
             than low dose ASA (81 mg/d)&#xD;
&#xD;
          -  Not currently taking high dose statin therapy, defined as rosuvastatin &gt; 10 mg/d or&#xD;
             atorvastatin &gt; 40 mg/d&#xD;
&#xD;
          -  Not currently taking theophylline&#xD;
&#xD;
          -  No history of active peptic ulcer disease in the past 6 months&#xD;
&#xD;
          -  No history of intolerance to pentoxifylline or methylxanthines such as caffeine,&#xD;
             theophylline and theobromine that in the opinion of the treating physician would make&#xD;
             PAVE unsafe&#xD;
&#xD;
          -  No concurrent use of CYP1A2 inhibitors (e.g., ciprofloxacin), ketorolac, or vitamin K&#xD;
             antagonists (e.g. warfarin)&#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>Chad Tang</last_name>
    <role>Principal Investigator</role>
    <affiliation>M.D. Anderson Cancer Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>M D Anderson Cancer Center</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77030</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>February 2023</verification_date>
  <study_first_submitted>February 1, 2019</study_first_submitted>
  <study_first_submitted_qc>February 1, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 5, 2019</study_first_posted>
  <results_first_submitted>January 5, 2023</results_first_submitted>
  <results_first_submitted_qc>March 7, 2023</results_first_submitted_qc>
  <results_first_posted type="Actual">April 3, 2023</results_first_posted>
  <last_update_submitted>March 7, 2023</last_update_submitted>
  <last_update_submitted_qc>March 7, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">April 3, 2023</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>Erectile Dysfunction</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Vitamins</mesh_term>
    <mesh_term>Vitamin E</mesh_term>
    <mesh_term>Tocopherols</mesh_term>
    <mesh_term>Tocotrienols</mesh_term>
    <mesh_term>alpha-Tocopherol</mesh_term>
    <mesh_term>Pentoxifylline</mesh_term>
    <mesh_term>Atorvastatin</mesh_term>
  </intervention_browse>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>March 10, 2021</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/64/NCT03830164/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <recruitment_details>Recruitment Details: November 2019 to April of 2021. The recruitment of the participants occurred at the clinic and remotely via telephone calls.</recruitment_details>
      <group_list>
        <group group_id="P1">
          <title>Cohort 1</title>
          <description>Participants not on any statin and were started on Atorvastatin 10 mg 1 tab daily with addition of receiving Pentoxyfilline 400 mg 1 tab 3 times daily and Vitamin E 1000units 1 tab daily.</description>
        </group>
        <group group_id="P2">
          <title>Cohort 2</title>
          <description>Participants were on some amount of Atorvastatin and the dosage ramined the same With addition of receiving Pentoxyfilline 400 mg 1 tab 3 times daily and Vitamin E 1000units 1 tab daily.</description>
        </group>
        <group group_id="P3">
          <title>Cohort 3</title>
          <description>Participants on some other statin beside atorvastatin and the dosage remained the same with addition of receiving Pentoxyfilline 400 mg 1 tab 3 times daily and Vitamin E 1000units 1 tab daily.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="5"/>
                <participants group_id="P2" count="8"/>
                <participants group_id="P3" count="1"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="3"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="1"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="8"/>
                <participants group_id="P3" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Adverse Event</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="2"/>
                <participants group_id="P3" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lack of Efficacy</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="5"/>
                <participants group_id="P3" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="1"/>
                <participants group_id="P3" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Cohort 1</title>
          <description>Participants not on any statin and were started on Atorvastatin 10 mg 1 tab daily with addition of receiving Pentoxyfilline 400 mg 1 tab 3 times daily and Vitamin E 1000units 1 tab daily.</description>
        </group>
        <group group_id="B2">
          <title>Cohort 2</title>
          <description>Participants were on some amount of Atorvastatin and the dosage ramined the same With addition of receiving Pentoxyfilline 400 mg 1 tab 3 times daily and Vitamin E 1000units 1 tab daily.</description>
        </group>
        <group group_id="B3">
          <title>Cohort 3</title>
          <description>Participants on some other statin beside atorvastatin and the dosage remained the same with addition of receiving Pentoxyfilline 400 mg 1 tab 3 times daily and Vitamin E 1000units 1 tab daily.</description>
        </group>
        <group group_id="B4">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="5"/>
            <count group_id="B2" value="8"/>
            <count group_id="B3" value="1"/>
            <count group_id="B4" value="14"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>&lt;=18 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                    <measurement group_id="B2" value="4"/>
                    <measurement group_id="B3" value="1"/>
                    <measurement group_id="B4" value="9"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="4"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="5"/>
                    <measurement group_id="B2" value="8"/>
                    <measurement group_id="B3" value="1"/>
                    <measurement group_id="B4" value="14"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Ethnicity (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="1"/>
                    <measurement group_id="B4" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="5"/>
                    <measurement group_id="B2" value="8"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="13"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                    <measurement group_id="B2" value="6"/>
                    <measurement group_id="B3" value="1"/>
                    <measurement group_id="B4" value="11"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="5"/>
                    <measurement group_id="B2" value="8"/>
                    <measurement group_id="B3" value="1"/>
                    <measurement group_id="B4" value="14"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Change in International Index of Erectile Function (IIEF) Scores</title>
        <description>To estimate the proportion of participants who achieve a clinically significant improvement in erectile dysfunction (ED) when treated with a combination of Atorvastatin or participant's currently prescribed statin, Vitamin E, and Pentoxifylline (PAVE)</description>
        <time_frame>12 months</time_frame>
        <population>The data shows that 0 participants achieved any clinically significant improvement.</population>
        <group_list>
          <group group_id="O1">
            <title>Cohort 1</title>
            <description>Participants not on any statin and were started on Atorvastatin 10 mg 1 tab daily with addition of receiving Pentoxyfilline 400 mg 1 tab 3 times daily and Vitamin E 1000units 1 tab daily.</description>
          </group>
          <group group_id="O2">
            <title>Cohort 2</title>
            <description>Participants were on some amount of Atorvastatin and the dosage ramined the same With addition of receiving Pentoxyfilline 400 mg 1 tab 3 times daily and Vitamin E 1000units 1 tab daily.</description>
          </group>
          <group group_id="O3">
            <title>Cohort 3</title>
            <description>Participants on some other statin beside atorvastatin and the dosage remained the same with addition of receiving Pentoxyfilline 400 mg 1 tab 3 times daily and Vitamin E 1000units 1 tab daily.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in International Index of Erectile Function (IIEF) Scores</title>
          <description>To estimate the proportion of participants who achieve a clinically significant improvement in erectile dysfunction (ED) when treated with a combination of Atorvastatin or participant's currently prescribed statin, Vitamin E, and Pentoxifylline (PAVE)</description>
          <population>The data shows that 0 participants achieved any clinically significant improvement.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="3"/>
                <count group_id="O2" value="0"/>
                <count group_id="O3" value="1"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Incidence of Adverse Events (AEs)</title>
        <description>The safety profile of the pentoxifylline, atorvastatin and vitamin E (PAVE) combination will be reported for each cohort, with adverse events summarized by grade and time to onset to first grade 3 adverse event.</description>
        <time_frame>Up to 12 months</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Cohort 1</title>
            <description>Participants not on any statin and were started on Atorvastatin 10 mg 1 tab daily with addition of receiving Pentoxyfilline 400 mg 1 tab 3 times daily and Vitamin E 1000units 1 tab daily.</description>
          </group>
          <group group_id="O2">
            <title>Cohort 2</title>
            <description>Participants were on some amount of Atorvastatin and the dosage ramined the same With addition of receiving Pentoxyfilline 400 mg 1 tab 3 times daily and Vitamin E 1000units 1 tab daily.</description>
          </group>
          <group group_id="O3">
            <title>Cohort 3</title>
            <description>Participants on some other statin beside atorvastatin and the dosage remained the same with addition of receiving Pentoxyfilline 400 mg 1 tab 3 times daily and Vitamin E 1000units 1 tab daily.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Incidence of Adverse Events (AEs)</title>
          <description>The safety profile of the pentoxifylline, atorvastatin and vitamin E (PAVE) combination will be reported for each cohort, with adverse events summarized by grade and time to onset to first grade 3 adverse event.</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="5"/>
                <count group_id="O2" value="8"/>
                <count group_id="O3" value="1"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Serious Adverse Event</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Adverse Event</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="2"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Choosing Other Erectile Dysfunction (ED) Treatments After Pentoxifylline, Atorvastatin and Vitamin E (PAVE)</title>
        <description>To report the rate of choosing other ED treatments after PAVE.</description>
        <time_frame>Up to 12 months</time_frame>
        <population>No participants on cohort 2.</population>
        <group_list>
          <group group_id="O1">
            <title>Cohort 1</title>
            <description>Participants not on any statin and were started on Atorvastatin 10 mg 1 tab daily with addition of receiving Pentoxyfilline 400 mg 1 tab 3 times daily and Vitamin E 1000units 1 tab daily.</description>
          </group>
          <group group_id="O2">
            <title>Cohort 2</title>
            <description>Participants were on some amount of Atorvastatin and the dosage ramined the same With addition of receiving Pentoxyfilline 400 mg 1 tab 3 times daily and Vitamin E 1000units 1 tab daily.</description>
          </group>
          <group group_id="O3">
            <title>Cohort 3</title>
            <description>Participants on some other statin beside atorvastatin and the dosage remained the same with addition of receiving Pentoxyfilline 400 mg 1 tab 3 times daily and Vitamin E 1000units 1 tab daily.</description>
          </group>
        </group_list>
        <measure>
          <title>Choosing Other Erectile Dysfunction (ED) Treatments After Pentoxifylline, Atorvastatin and Vitamin E (PAVE)</title>
          <description>To report the rate of choosing other ED treatments after PAVE.</description>
          <population>No participants on cohort 2.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="3"/>
                <count group_id="O2" value="0"/>
                <count group_id="O3" value="1"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>at baseline and throughout the trial and at 30 days after stopping the active treatment portion of this trial and the serious adverse events were captured from the time of the first protocol-specific intervention, until 30 days after the last dose of drug, unless the participant withdraws consent, up to 12 months</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Cohort 1</title>
          <description>Participants not on any statin and were started on Atorvastatin 10 mg 1 tab daily with addition of receiving Pentoxyfilline 400 mg 1 tab 3 times daily and Vitamin E 1000units 1 tab daily.</description>
        </group>
        <group group_id="E2">
          <title>Cohort 2</title>
          <description>Participants were on some amount of Atorvastatin and the dosage ramined the same With addition of receiving Pentoxyfilline 400 mg 1 tab 3 times daily and Vitamin E 1000units 1 tab daily.</description>
        </group>
        <group group_id="E3">
          <title>Cohort 3</title>
          <description>Participants on some other statin beside atorvastatin and the dosage remained the same with addition of receiving Pentoxyfilline 400 mg 1 tab 3 times daily and Vitamin E 1000units 1 tab daily.</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="1"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <default_vocab>CTCAE (4.3)</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="8"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="1"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Stomach Pain</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Dyspepsia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Diarrhea</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="1"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Blurry vision</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="1"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>All Principal Investigators ARE employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Dr. Chad Tang, Associate Professor, Radiation Oncology Department</name_or_title>
      <organization>UT MD Anderson Cancer Center</organization>
      <phone>(713) 745-7179</phone>
      <email>ctang1@mdanderson.org</email>
    </point_of_contact>
  </clinical_results>
</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/NCT03830164
org study id: 2018-0785
secondary id: NCI-2019-00235
secondary id: 2018-0785
nct id: NCT03830164
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
This phase II trial studies how well pentoxifylline, atorvastatin, and vitamin E (PAVE) work
      in treating patients with erectile dysfunction after radiation therapy for prostate cancer.
      Atorvastatin may reduce high cholesterol. Pentoxifylline and vitamin E may enhance blood
      flow. Giving PAVE may work better in treating prostate cancer patients with post-radiation
      therapy erectile dysfunction.
PRIMARY OBJECTIVE:

      I. To estimate the proportion of patients who achieve a clinically significant improvement in
      erectile dysfunction (ED) when treated with a combination of atorvastatin or patient's
      currently prescribed statin, vitamin E, and pentoxifylline (PAVE).

      SECONDARY OBJECTIVES:

      I. To report the safety profile of PAVE. II. To report the rate of choosing other ED
      treatments after PAVE.

      OUTLINE:

      Patients receive atorvastatin orally (PO) once daily (QD) for up to 6 weeks in the absence of
      disease progression or unacceptable toxicity. Beginning week 7, patients receive atorvastatin
      PO QD, vitamin E PO QD, and pentoxifylline PO thrice daily (TID) for up to 12 months in the
      absence of disease progression or unacceptable toxicity.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Change in International Index of Erectile Function (IIEF) Scores
time frame: 12 months
description: To estimate the proportion of participants who achieve a clinically significant improvement in erectile dysfunction (ED) when treated with a combination of Atorvastatin or participant's currently prescribed statin, Vitamin E, and Pentoxifylline (PAVE)
measure: Number of Participants With Incidence of Adverse Events (AEs)
time frame: Up to 12 months
description: The safety profile of the pentoxifylline, atorvastatin and vitamin E (PAVE) combination will be reported for each cohort, with adverse events summarized by grade and time to onset to first grade 3 adverse event.
measure: Choosing Other Erectile Dysfunction (ED) Treatments After Pentoxifylline, Atorvastatin and Vitamin E (PAVE)
time frame: Up to 12 months
description: To report the rate of choosing other ED treatments after PAVE.
arm group label: Treatment (atorvastatin, vitamin E, pentoxifylline)
arm group type: Experimental
description: Patients receive atorvastatin PO QD for up to 6 weeks in the absence of disease progression or unacceptable toxicity. Beginning week 7, patients receive atorvastatin PO QD, vitamin E PO QD, and pentoxifylline PO TID for up to 12 months in the absence of disease progression or unacceptable toxicity.
intervention type: Drug
intervention name: Atorvastatin
description: Given PO
arm group label: Treatment (atorvastatin, vitamin E, pentoxifylline)
intervention type: Drug
intervention name: Pentoxifylline
description: Given PO
arm group label: Treatment (atorvastatin, vitamin E, pentoxifylline)
other name: Oxpentifylline
other name: Pentoxyphylline
other name: PTX
other name: Trental
intervention type: Dietary Supplement
intervention name: Vitamin E Compound
description: Given PO
arm group label: Treatment (atorvastatin, vitamin E, pentoxifylline)
other name: 2,5,7,8-tetramethyl-2-(4,8,12-trimethyltridecyl)chroman-6-ol
other name: E Vitamin
other name: Vitamin E
criteria: 
gender: Male
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Chad Tang
role: Principal Investigator
affiliation: M.D. Anderson Cancer Center
facility: 
country: United States
responsible party type: Sponsor
mesh term: Erectile Dysfunction
mesh term: Vitamins
mesh term: Vitamin E
mesh term: Tocopherols
mesh term: Tocotrienols
mesh term: alpha-Tocopherol
mesh term: Pentoxifylline
mesh term: Atorvastatin
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 