<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/NCT01674270</url>
  </required_header>
  <id_info>
    <org_study_id>DEG_PRE-OP_001</org_study_id>
    <secondary_id>Degarelix Pre-Op</secondary_id>
    <nct_id>NCT01674270</nct_id>
  </id_info>
  <brief_title>Degarelix Neo-Adjuvant Radical Prostatectomy Trial</brief_title>
  <official_title>Phase II Randomized Open Label Study of Neo-Adjuvant Degarelix vs. LHRH Agonist in Prostate Cancer Patients Prior to Radical Prostatectomy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Health Network, Toronto</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University Health Network, Toronto</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      To assess the effect of neo-adjuvant GnRH antagonist, degarelix, versus LHRH agonist on&#xD;
      intratumoral levels of androgens.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>August 2012</start_date>
  <completion_date type="Actual">November 2015</completion_date>
  <primary_completion_date type="Actual">December 2014</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Intratumoral androgen levels</measure>
    <time_frame>Week 12</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Prostate tumour morphology related to androgen withdrawal after neo-adjuvant therapy</measure>
    <time_frame>Week 12</time_frame>
  </secondary_outcome>
  <other_outcome>
    <measure>Serum levels of Androgen Receptor after neo-adjuvant therapy</measure>
    <time_frame>Baseline, Week 12</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Serum level of Follicle Stimulating Hormone (FSH) after neo-adjuvant therapy</measure>
    <time_frame>Baseline, Week 12</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Serum Level of Inhibin-b and GnRH after neo-adjuvant therapy</measure>
    <time_frame>Baseline, Week 12</time_frame>
  </other_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">35</enrollment>
  <condition>Prostate Cancer</condition>
  <arm_group>
    <arm_group_label>Degarelix</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Degarelix Alone</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Degarelix + Casodex</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Degarelix and Casodex</description>
  </arm_group>
  <arm_group>
    <arm_group_label>LHRH Agonist + Casodex</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>LHRH Agonist and Casodex</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Degarelix</intervention_name>
    <arm_group_label>Degarelix</arm_group_label>
    <arm_group_label>Degarelix + Casodex</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Casodex</intervention_name>
    <arm_group_label>Degarelix + Casodex</arm_group_label>
    <arm_group_label>LHRH Agonist + Casodex</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>LHRH Agonist</intervention_name>
    <arm_group_label>LHRH Agonist + Casodex</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Men &gt;18 and =&lt; 75 years of age&#xD;
&#xD;
          -  Willing and able to provide informed consent, either alone or with the aid of a&#xD;
             translator&#xD;
&#xD;
          -  Histologically confirmed prostate cancer as determined by transrectal ultrasound&#xD;
             (TRUS) guided prostate biopsy performed within 6 months of study enrolment&#xD;
&#xD;
          -  Gleason Score &gt;= 7and/or prostate cancer that is clinical stage T2 disease.&#xD;
&#xD;
          -  Candidates for open radical prostatectomy considered surgically resectable by urologic&#xD;
             evaluation&#xD;
&#xD;
          -  Normal organ and marrow function as defined by the following criteria:&#xD;
&#xD;
          -  Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Previous or current use of hormonal management of prostate cancer (surgical castration&#xD;
             or other hormonal manipulation, including GnRH receptor agonists, GnRH receptor&#xD;
             antagonists, anti-androgens, estrogens, megestrol acetate, and ketoconazole)&#xD;
&#xD;
          -  History of receiving radiation to the pelvic area.&#xD;
&#xD;
          -  Previously received therapy with 5-alpha reductase inhibitors finasteride and/or&#xD;
             dutasteride 4 weeks prior to randomization.&#xD;
&#xD;
          -  History of bilateral orchiectomy, adrenalectomy, or hypophysectomy.&#xD;
&#xD;
          -  History of severe untreated asthma, anaphylactic reactions, or severe urticaria and/or&#xD;
             angioedema.&#xD;
&#xD;
          -  Known hypersensitivity towards any component of the investigational medicinal product&#xD;
             or Casodex (bicalutamide) or their excipients.&#xD;
&#xD;
          -  Marked baseline prolongation of QT/QTcF interval (e.g. repeated demonstration of a&#xD;
             QTcF interval &gt;450 ms).&#xD;
&#xD;
          -  History of risk factors for Torsade de Pointes ventricular arrhythmias (e.g. heart&#xD;
             failure, hypokalemia, or family history of Long QT Syndrome).&#xD;
&#xD;
          -  Previous history or presence of another malignancy, other than prostate cancer or&#xD;
             treated squamous / basal cell carcinoma of the skin, within the last five years.&#xD;
&#xD;
          -  Clinically significant laboratory abnormalities (e.g. severe renal or hepatic&#xD;
             impairment) which in the judgment of the Investigator would affect the patient's&#xD;
             health or the outcome of the trial.&#xD;
&#xD;
          -  Clinically significant disorder (other than prostate cancer) including, but not&#xD;
             limited to, renal, haematological, gastrointestinal, endocrine, cardiac, neurological,&#xD;
             or psychiatric disease, and alcohol or drug abuse or any other condition, which may&#xD;
             affect the patient's health or the outcome of the trial as judged by the Investigator.&#xD;
&#xD;
          -  Use of natural medicines thought to have endocrine effects on prostate cancer (e.g.&#xD;
             saw palmetto and St. John's Wort) 4 weeks prior to randomization.&#xD;
&#xD;
          -  Mental incapacity or language barrier precluding adequate understanding or co&#xD;
             operation.&#xD;
&#xD;
          -  Use of an investigational drug within the last 28 days preceding the Screening Visit&#xD;
             or longer if considered to possibly influence the outcome of the current trial.&#xD;
&#xD;
          -  Previously participated in any degarelix trial.&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Vancouver General Hospital</name>
      <address>
        <city>Vancouver</city>
        <state>British Columbia</state>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University Health Network</name>
      <address>
        <city>Toronto</city>
        <state>Ontario</state>
        <zip>M5G 2M9</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <verification_date>December 2015</verification_date>
  <study_first_submitted>August 23, 2012</study_first_submitted>
  <study_first_submitted_qc>August 23, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 28, 2012</study_first_posted>
  <last_update_submitted>December 21, 2015</last_update_submitted>
  <last_update_submitted_qc>December 21, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">December 22, 2015</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>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Bicalutamide</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/NCT01674270
org study id: DEG_PRE-OP_001
secondary id: Degarelix Pre-Op
nct id: NCT01674270
lead sponsor: 
has dmc: Yes
To assess the effect of neo-adjuvant GnRH antagonist, degarelix, versus LHRH agonist on
      intratumoral levels of androgens.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Intratumoral androgen levels
time frame: Week 12
measure: Prostate tumour morphology related to androgen withdrawal after neo-adjuvant therapy
time frame: Week 12
measure: Serum levels of Androgen Receptor after neo-adjuvant therapy
time frame: Baseline, Week 12
measure: Serum level of Follicle Stimulating Hormone (FSH) after neo-adjuvant therapy
time frame: Baseline, Week 12
measure: Serum Level of Inhibin-b and GnRH after neo-adjuvant therapy
time frame: Baseline, Week 12
arm group label: Degarelix
arm group type: Experimental
description: Degarelix Alone
arm group label: Degarelix + Casodex
arm group type: Experimental
description: Degarelix and Casodex
arm group label: LHRH Agonist + Casodex
arm group type: Active Comparator
description: LHRH Agonist and Casodex
intervention type: Drug
intervention name: Degarelix
arm group label: Degarelix
arm group label: Degarelix + Casodex
intervention type: Drug
intervention name: Casodex
arm group label: Degarelix + Casodex
arm group label: LHRH Agonist + Casodex
intervention type: Drug
intervention name: LHRH Agonist
arm group label: LHRH Agonist + Casodex
criteria: 
gender: Male
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: No
facility: 
facility: 
country: Canada
responsible party type: Sponsor
mesh term: Prostatic Neoplasms
mesh term: Bicalutamide