<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/NCT01731912</url>
  </required_header>
  <id_info>
    <org_study_id>7846</org_study_id>
    <secondary_id>NCI-2012-02136</secondary_id>
    <secondary_id>RAD2</secondary_id>
    <secondary_id>7846</secondary_id>
    <secondary_id>P30CA015704</secondary_id>
    <nct_id>NCT01731912</nct_id>
  </id_info>
  <brief_title>Degarelix Acetate Before and During Radiation Therapy in Treating Patients With Prostate Cancer</brief_title>
  <official_title>Degarelix Acetate Prior to Radiation Therapy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Washington</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 Washington</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This pilot clinical trial studies how well degarelix acetate before and during radiation&#xD;
      therapy works in treating patients with prostate cancer. Androgens can cause the growth of&#xD;
      prostate cancer cells. Drugs, such as degarelix acetate, may lessen the amount of androgens&#xD;
      made by the body. Radiation therapy uses high energy x-rays to kill tumor cells and shrink&#xD;
      tumors. Giving degarelix acetate together with radiation therapy may work better in treating&#xD;
      prostate cancer.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      PRIMARY OBJECTIVES:&#xD;
&#xD;
      I. To evaluate the effect of neoadjuvant degarelix (degarelix acetate) on prostate&#xD;
      dihydrotestosterone (DHT) and testosterone levels.&#xD;
&#xD;
      SECONDARY OBJECTIVES:&#xD;
&#xD;
      I. To determine the effect of degarelix acetate on androgen-regulated gene expression and&#xD;
      apoptosis as assessed by immunohistochemistry, complementary deoxyribonucleic acid (cDNA)&#xD;
      microarray analysis and reverse transcriptase (RT)-polymerase chain reaction (PCR).&#xD;
&#xD;
      II. To determine the effect of degarelix acetate on follicle stimulating hormone (FSH) and&#xD;
      FSH receptor expression in prostate cancer and surrounding microenvironment.&#xD;
&#xD;
      OUTLINE:&#xD;
&#xD;
      Patients receive degarelix acetate subcutaneously (SC) on day 1. Treatment repeats every 4&#xD;
      weeks for up to 6 courses. Beginning at week 15, patients also undergo standard external beam&#xD;
      radiation therapy (EBRT) for 8.5 weeks.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>May 2013</start_date>
  <completion_date type="Actual">September 2016</completion_date>
  <primary_completion_date type="Actual">September 2016</primary_completion_date>
  <phase>N/A</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>Tissue Levels of DHT in Prostate Tissue as Measured by Mass Spectometry</measure>
    <time_frame>At week 24</time_frame>
    <description>Differences in tissue androgen levels between this group and historical comparisons will be evaluated by performing a one-way analysis of variance (ANOVA), followed by pair-wise two-sample t-tests to determine which groups are statistically different.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Tissue Levels of Testosterone in Prostate Tissue as Measured by Mass Spectometry</measure>
    <time_frame>At week 24</time_frame>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">16</enrollment>
  <condition>Prostate Adenocarcinoma</condition>
  <condition>Stage IIA Prostate Cancer</condition>
  <condition>Stage IIB Prostate Cancer</condition>
  <condition>Stage III Prostate Cancer</condition>
  <condition>Stage IV Prostate Cancer</condition>
  <arm_group>
    <arm_group_label>Treatment (degarelix acetate, EBRT)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients receive degarelix acetate SC on day 1. Treatment repeats every 4 weeks for up to 6 courses. Beginning at week 15, patients also undergo standard EBRT for 8.5 weeks.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Degarelix</intervention_name>
    <description>Given SC</description>
    <arm_group_label>Treatment (degarelix acetate, EBRT)</arm_group_label>
    <other_name>FE200486</other_name>
    <other_name>Firmagon</other_name>
  </intervention>
  <intervention>
    <intervention_type>Radiation</intervention_type>
    <intervention_name>External Beam Radiation Therapy</intervention_name>
    <description>Undergo standard EBRT</description>
    <arm_group_label>Treatment (degarelix acetate, EBRT)</arm_group_label>
    <other_name>Definitive Radiation Therapy</other_name>
    <other_name>EBRT</other_name>
    <other_name>External Beam Radiotherapy</other_name>
    <other_name>External Beam RT</other_name>
    <other_name>external radiation</other_name>
    <other_name>External Radiation Therapy</other_name>
    <other_name>external-beam radiation</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Laboratory Biomarker Analysis</intervention_name>
    <description>Correlative studies</description>
    <arm_group_label>Treatment (degarelix acetate, EBRT)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Willing and able to provide written informed consent&#xD;
&#xD;
          -  Written authorization for use and release of health and research study information has&#xD;
             been obtained&#xD;
&#xD;
          -  Histologically proven adenocarcinoma of the prostate&#xD;
&#xD;
          -  Patients must be candidates for short or long term androgen deprivation in combination&#xD;
             with external beam radiation therapy (RT) based on the following criteria:&#xD;
&#xD;
               -  Intermediate risk disease: T2b/c, or Gleason 7, or prostate-specific antigen&#xD;
                  (PSA) 10-20&#xD;
&#xD;
               -  High risk disease: Gleason 8-10, or PSA &gt; 20, or T3/4&#xD;
&#xD;
          -  Patients may not have received any prior pharmacologic therapy or RT for prostate&#xD;
             cancer&#xD;
&#xD;
          -  Eastern Cooperative Oncology Group (ECOG) performance status =&lt; 2 (Karnofsky &gt;= 60%)&#xD;
&#xD;
          -  Eligibility of patients receiving any medications or substances known to affect or&#xD;
             with the potential to affect the androgen axis will be determined following review of&#xD;
             their case by the principal investigator&#xD;
&#xD;
          -  Patients must allow biopsy at the time of fiducial placement&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients may not be receiving any investigational agents&#xD;
&#xD;
          -  Patients who are currently receiving active therapy for other neoplastic disorders&#xD;
             will not be eligible&#xD;
&#xD;
          -  Patients with histologic evidence of small cell carcinoma of the prostate will not be&#xD;
             eligible&#xD;
&#xD;
          -  Patients with hypogonadism or severe androgen deficiency as defined by serum&#xD;
             testosterone less than 100 ng/dL will not be eligible&#xD;
&#xD;
          -  History of pituitary dysfunction&#xD;
&#xD;
          -  Patients who are receiving any androgens, estrogens or progestational agents, or who&#xD;
             received any of these agents within the 6 months prior to evaluation will not be&#xD;
             eligible&#xD;
&#xD;
          -  Patients who are taking drugs which affect androgen metabolism (e.g. spironolactone,&#xD;
             ketoconazole, finasteride, dutasteride) will not be eligible; patients who received&#xD;
             any of these agents within the 6 months prior to evaluation will be reviewed for&#xD;
             eligibility by the principal investigator on a case by case basis&#xD;
&#xD;
          -  Patients with inflammatory bowel disease or other autoimmune conditions which might&#xD;
             affect the radiated colon or rectum&#xD;
&#xD;
          -  Patients with uncontrolled intercurrent illness including, but not limited to, ongoing&#xD;
             or active infection, unstable angina pectoris, cardiac arrhythmia which is symptomatic&#xD;
             or requires active therapy, recent deep venous thrombosis, pulmonary emboli,&#xD;
             cerebrovascular accident or ischemia will not be eligible&#xD;
&#xD;
          -  Patients with dementia/psychiatric illness/social situations that would limit&#xD;
             compliance with study requirements or would prohibit the understanding and/or giving&#xD;
             of informed consent will not be eligible&#xD;
&#xD;
          -  Patients with medical conditions, which, in the opinion of the investigators, would&#xD;
             jeopardize either the patient or the integrity of the data obtained will not be&#xD;
             eligible&#xD;
&#xD;
          -  Other active malignancy, except non-melanoma skin cancer and superficial bladder&#xD;
             cancer&#xD;
&#xD;
          -  Patients unwilling to use contraceptives while on study&#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>Robert Montgomery</last_name>
    <role>Principal Investigator</role>
    <affiliation>Fred Hutch/University of Washington Cancer Consortium</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Fred Hutch/University of Washington Cancer Consortium</name>
      <address>
        <city>Seattle</city>
        <state>Washington</state>
        <zip>98109</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>December 2018</verification_date>
  <study_first_submitted>November 19, 2012</study_first_submitted>
  <study_first_submitted_qc>November 19, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 22, 2012</study_first_posted>
  <results_first_submitted>January 11, 2018</results_first_submitted>
  <results_first_submitted_qc>December 21, 2018</results_first_submitted_qc>
  <results_first_posted type="Actual">January 18, 2019</results_first_posted>
  <disposition_first_submitted>August 30, 2017</disposition_first_submitted>
  <disposition_first_submitted_qc>August 30, 2017</disposition_first_submitted_qc>
  <disposition_first_posted type="Actual">September 6, 2017</disposition_first_posted>
  <last_update_submitted>December 21, 2018</last_update_submitted>
  <last_update_submitted_qc>December 21, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">January 18, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Washington</investigator_affiliation>
    <investigator_full_name>Bruce Montgomery</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Prostatic Neoplasms</mesh_term>
  </condition_browse>

  <clinical_results>

    <participant_flow>
      <pre_assignment_details>16 started therapy. 14 completed therapy</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Degarelix</title>
          <description>Patients receive 3 months of degarelix prior to radiation and then for 3 months during radiation. Subsequent therapy is determined by the treating physician</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="16"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="14"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>noncompliance</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Degarelix</title>
          <description>Patients receive 3 months of degarelix prior to radiation and then for 3 months during radiation. Subsequent therapy is determined by the treating physician</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="16"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Median</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="65" spread="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_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="16"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Tissue Levels of DHT in Prostate Tissue as Measured by Mass Spectometry</title>
        <description>Differences in tissue androgen levels between this group and historical comparisons will be evaluated by performing a one-way analysis of variance (ANOVA), followed by pair-wise two-sample t-tests to determine which groups are statistically different.</description>
        <time_frame>At week 24</time_frame>
        <population>Tissue DHT at 24 weeks</population>
        <group_list>
          <group group_id="O1">
            <title>Degarelix</title>
            <description>Patients receive 3 months of degarelix prior to radiation and then for 3 months during radiation. Subsequent therapy is determined by the treating physician</description>
          </group>
        </group_list>
        <measure>
          <title>Tissue Levels of DHT in Prostate Tissue as Measured by Mass Spectometry</title>
          <description>Differences in tissue androgen levels between this group and historical comparisons will be evaluated by performing a one-way analysis of variance (ANOVA), followed by pair-wise two-sample t-tests to determine which groups are statistically different.</description>
          <population>Tissue DHT at 24 weeks</population>
          <units>pg/mg</units>
          <param>Median</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="14"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.6" spread="0.34"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Tissue Levels of Testosterone in Prostate Tissue as Measured by Mass Spectometry</title>
        <time_frame>At week 24</time_frame>
        <population>Tissue testosterone levels at 24 weeks</population>
        <group_list>
          <group group_id="O1">
            <title>Degarelix</title>
            <description>Patients receive 3 months of degarelix prior to radiation and then for 3 months during radiation. Subsequent therapy is determined by the treating physician</description>
          </group>
        </group_list>
        <measure>
          <title>Tissue Levels of Testosterone in Prostate Tissue as Measured by Mass Spectometry</title>
          <population>Tissue testosterone levels at 24 weeks</population>
          <units>pg/mg</units>
          <param>Median</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="14"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.17" spread="0.13"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <desc>Degarelix is FDA approved for hormonal treatment of prostate cancer and concurrent administration with radiotherapy in this study and is not considered outside of the standard of care; reporting adverse events was not required. Per the protocol AE reporting was not planned, therefore no AE data was collected.</desc>
      <group_list>
        <group group_id="E1">
          <title>Degarelix</title>
          <description>Patients receive 3 months of degarelix prior to radiation and then for 3 months during radiation. Subsequent therapy is determined by the treating physician</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="0"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <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="0"/>
              </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. Bruce Montgomery</name_or_title>
      <organization>University of Washington</organization>
      <phone>206-598-0860</phone>
      <email>rbmontgo@uw.edu</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/NCT01731912
org study id: 7846
secondary id: NCI-2012-02136
secondary id: RAD2
secondary id: 7846
secondary id: P30CA015704
nct id: NCT01731912
lead sponsor: 
collaborator: 
has dmc: No
This pilot clinical trial studies how well degarelix acetate before and during radiation
      therapy works in treating patients with prostate cancer. Androgens can cause the growth of
      prostate cancer cells. Drugs, such as degarelix acetate, may lessen the amount of androgens
      made by the body. Radiation therapy uses high energy x-rays to kill tumor cells and shrink
      tumors. Giving degarelix acetate together with radiation therapy may work better in treating
      prostate cancer.
PRIMARY OBJECTIVES:

      I. To evaluate the effect of neoadjuvant degarelix (degarelix acetate) on prostate
      dihydrotestosterone (DHT) and testosterone levels.

      SECONDARY OBJECTIVES:

      I. To determine the effect of degarelix acetate on androgen-regulated gene expression and
      apoptosis as assessed by immunohistochemistry, complementary deoxyribonucleic acid (cDNA)
      microarray analysis and reverse transcriptase (RT)-polymerase chain reaction (PCR).

      II. To determine the effect of degarelix acetate on follicle stimulating hormone (FSH) and
      FSH receptor expression in prostate cancer and surrounding microenvironment.

      OUTLINE:

      Patients receive degarelix acetate subcutaneously (SC) on day 1. Treatment repeats every 4
      weeks for up to 6 courses. Beginning at week 15, patients also undergo standard external beam
      radiation therapy (EBRT) for 8.5 weeks.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Tissue Levels of DHT in Prostate Tissue as Measured by Mass Spectometry
time frame: At week 24
description: Differences in tissue androgen levels between this group and historical comparisons will be evaluated by performing a one-way analysis of variance (ANOVA), followed by pair-wise two-sample t-tests to determine which groups are statistically different.
measure: Tissue Levels of Testosterone in Prostate Tissue as Measured by Mass Spectometry
time frame: At week 24
arm group label: Treatment (degarelix acetate, EBRT)
arm group type: Experimental
description: Patients receive degarelix acetate SC on day 1. Treatment repeats every 4 weeks for up to 6 courses. Beginning at week 15, patients also undergo standard EBRT for 8.5 weeks.
intervention type: Drug
intervention name: Degarelix
description: Given SC
arm group label: Treatment (degarelix acetate, EBRT)
other name: FE200486
other name: Firmagon
intervention type: Radiation
intervention name: External Beam Radiation Therapy
description: Undergo standard EBRT
arm group label: Treatment (degarelix acetate, EBRT)
other name: Definitive Radiation Therapy
other name: EBRT
other name: External Beam Radiotherapy
other name: External Beam RT
other name: external radiation
other name: External Radiation Therapy
other name: external-beam radiation
intervention type: Other
intervention name: Laboratory Biomarker Analysis
description: Correlative studies
arm group label: Treatment (degarelix acetate, EBRT)
criteria: 
gender: Male
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Robert Montgomery
role: Principal Investigator
affiliation: Fred Hutch/University of Washington Cancer Consortium
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: University of Washington
investigator full name: Bruce Montgomery
investigator title: Principal Investigator
mesh term: Prostatic Neoplasms
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 