<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/NCT01710098</url>
  </required_header>
  <id_info>
    <org_study_id>UCM12-01</org_study_id>
    <nct_id>NCT01710098</nct_id>
  </id_info>
  <brief_title>Treatment of Prostate Cancer With Firmagon®</brief_title>
  <official_title>Effectiveness and Safety as Well as Adherence of the &quot;S3 Guidelines for the Treatment of Prostate Cancer&quot; in the Treatment of Patients of Patients With Firmagon®</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>United Clinic Management GmbH</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>United Clinic Management GmbH</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      How are testosterone levels of patients with prostate cancer under treatment with Firmagon®&#xD;
      changing.&#xD;
&#xD;
      Former studies showed a quick fall of testosterone levels after start of therapy with&#xD;
      Firmagon® and a quick recovery when therapy is stopped. The investigators want to prove this&#xD;
      in a normal outpatient urologist setting. Furthermore data is collected to prove the&#xD;
      adherence to the German S3-Guideline for the treatment of prostate cancer.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>June 2012</start_date>
  <completion_date type="Actual">September 24, 2015</completion_date>
  <primary_completion_date type="Actual">June 2014</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Control</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>PSA-/Testosterone Level</measure>
    <time_frame>12 months</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>S3 Guideline</measure>
    <time_frame>12 months</time_frame>
    <description>Percentage of patients who have been treated in accordance with the grade A recommendations of the S3 guideline for treatment of prostate cancer</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Anxiety</measure>
    <time_frame>12 Months</time_frame>
    <description>Anxiety score</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">100</enrollment>
  <condition>Prostate Cancer</condition>
  <arm_group>
    <arm_group_label>Degarelix</arm_group_label>
    <description>adult male patients with advanced hormone dependent prostate cancer who receive 240 mg as a start dose and then monthly 80mg Firmagon® for one year</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Degarelix</intervention_name>
    <description>subcutaneous injection</description>
    <arm_group_label>Degarelix</arm_group_label>
    <other_name>Firmagon®</other_name>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        adult male patients of outpatient urological medical practice&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  advanced hormone-dependent prostate cancer with no other previous hormone therapy for&#xD;
             whom - irrespectively of this NIS -the use of Firmagon® is intended&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  contraindication for Degarelix&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>95 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Leopold Durner, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>UCM GmbH</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>UCM GmbH</name>
      <address>
        <city>Planegg</city>
        <state>Bavaria</state>
        <zip>82152</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Germany</country>
  </location_countries>
  <reference>
    <citation>Thompson IM, Zeidman EJ, Rodriguez FR. Sudden death due to disease flare with luteinizing hormone-releasing hormone agonist therapy for carcinoma of the prostate. J Urol. 1990 Dec;144(6):1479-80. doi: 10.1016/s0022-5347(17)39774-4.</citation>
    <PMID>2122011</PMID>
  </reference>
  <reference>
    <citation>Klotz L, Boccon-Gibod L, Shore ND, Andreou C, Persson BE, Cantor P, Jensen JK, Olesen TK, Schroder FH. The efficacy and safety of degarelix: a 12-month, comparative, randomized, open-label, parallel-group phase III study in patients with prostate cancer. BJU Int. 2008 Dec;102(11):1531-8. doi: 10.1111/j.1464-410X.2008.08183.x.</citation>
    <PMID>19035858</PMID>
  </reference>
  <reference>
    <citation>Morote J, Orsola A, Planas J, Trilla E, Raventos CX, Cecchini L, Catalan R. Redefining clinically significant castration levels in patients with prostate cancer receiving continuous androgen deprivation therapy. J Urol. 2007 Oct;178(4 Pt 1):1290-5. doi: 10.1016/j.juro.2007.05.129. Epub 2007 Aug 14.</citation>
    <PMID>17698136</PMID>
  </reference>
  <reference>
    <citation>Perachino M, Cavalli V, Bravi F. Testosterone levels in patients with metastatic prostate cancer treated with luteinizing hormone-releasing hormone therapy: prognostic significance? BJU Int. 2010 Mar;105(5):648-51. doi: 10.1111/j.1464-410X.2009.08814.x. Epub 2009 Aug 28.</citation>
    <PMID>19747358</PMID>
  </reference>
  <reference>
    <citation>Mariani S, Salvatori L, Basciani S, Arizzi M, Franco G, Petrangeli E, Spera G, Gnessi L. Expression and cellular localization of follicle-stimulating hormone receptor in normal human prostate, benign prostatic hyperplasia and prostate cancer. J Urol. 2006 Jun;175(6):2072-7; discussion 2077. doi: 10.1016/S0022-5347(06)00273-4.</citation>
    <PMID>16697805</PMID>
  </reference>
  <reference>
    <citation>Radu A, Pichon C, Camparo P, Antoine M, Allory Y, Couvelard A, Fromont G, Hai MT, Ghinea N. Expression of follicle-stimulating hormone receptor in tumor blood vessels. N Engl J Med. 2010 Oct 21;363(17):1621-30. doi: 10.1056/NEJMoa1001283.</citation>
    <PMID>20961245</PMID>
  </reference>
  <reference>
    <citation>Heidenreich A., Epplen R., Thüer D., Van Erps T., D.P., EURO Prostate Center. EAU guideline on advanced prostate cancer: Compliance among urologists conderning androgen deprivation therapy</citation>
  </reference>
  <verification_date>April 2020</verification_date>
  <study_first_submitted>October 10, 2012</study_first_submitted>
  <study_first_submitted_qc>October 16, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 18, 2012</study_first_posted>
  <last_update_submitted>April 9, 2020</last_update_submitted>
  <last_update_submitted_qc>April 9, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">April 13, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>United Clinic Management GmbH</investigator_affiliation>
    <investigator_full_name>Karin Buchsteiner</investigator_full_name>
    <investigator_title>Head of Study Group</investigator_title>
  </responsible_party>
  <keyword>testosterone</keyword>
  <keyword>S3-Adherence</keyword>
  <keyword>Quality of Life</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Prostatic Neoplasms</mesh_term>
  </condition_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/NCT01710098
org study id: UCM12-01
nct id: NCT01710098
lead sponsor: 
has dmc: No
How are testosterone levels of patients with prostate cancer under treatment with Firmagon®
      changing.

      Former studies showed a quick fall of testosterone levels after start of therapy with
      Firmagon® and a quick recovery when therapy is stopped. The investigators want to prove this
      in a normal outpatient urologist setting. Furthermore data is collected to prove the
      adherence to the German S3-Guideline for the treatment of prostate cancer.
observational model: Case-Control
time perspective: Prospective
measure: PSA-/Testosterone Level
time frame: 12 months
measure: S3 Guideline
time frame: 12 months
description: Percentage of patients who have been treated in accordance with the grade A recommendations of the S3 guideline for treatment of prostate cancer
measure: Anxiety
time frame: 12 Months
description: Anxiety score
arm group label: Degarelix
description: adult male patients with advanced hormone dependent prostate cancer who receive 240 mg as a start dose and then monthly 80mg Firmagon® for one year
intervention type: Drug
intervention name: Degarelix
description: subcutaneous injection
arm group label: Degarelix
other name: Firmagon®
study pop: 
sampling method: Probability Sample
criteria: 
gender: Male
minimum age: 18 Years
maximum age: 95 Years
healthy volunteers: No
last name: Leopold Durner, MD
role: Principal Investigator
affiliation: UCM GmbH
facility: 
country: Germany
citation: Thompson IM, Zeidman EJ, Rodriguez FR. Sudden death due to disease flare with luteinizing hormone-releasing hormone agonist therapy for carcinoma of the prostate. J Urol. 1990 Dec;144(6):1479-80. doi: 10.1016/s0022-5347(17)39774-4.
PMID: 2122011
citation: Klotz L, Boccon-Gibod L, Shore ND, Andreou C, Persson BE, Cantor P, Jensen JK, Olesen TK, Schroder FH. The efficacy and safety of degarelix: a 12-month, comparative, randomized, open-label, parallel-group phase III study in patients with prostate cancer. BJU Int. 2008 Dec;102(11):1531-8. doi: 10.1111/j.1464-410X.2008.08183.x.
PMID: 19035858
citation: Morote J, Orsola A, Planas J, Trilla E, Raventos CX, Cecchini L, Catalan R. Redefining clinically significant castration levels in patients with prostate cancer receiving continuous androgen deprivation therapy. J Urol. 2007 Oct;178(4 Pt 1):1290-5. doi: 10.1016/j.juro.2007.05.129. Epub 2007 Aug 14.
PMID: 17698136
citation: Perachino M, Cavalli V, Bravi F. Testosterone levels in patients with metastatic prostate cancer treated with luteinizing hormone-releasing hormone therapy: prognostic significance? BJU Int. 2010 Mar;105(5):648-51. doi: 10.1111/j.1464-410X.2009.08814.x. Epub 2009 Aug 28.
PMID: 19747358
citation: Mariani S, Salvatori L, Basciani S, Arizzi M, Franco G, Petrangeli E, Spera G, Gnessi L. Expression and cellular localization of follicle-stimulating hormone receptor in normal human prostate, benign prostatic hyperplasia and prostate cancer. J Urol. 2006 Jun;175(6):2072-7; discussion 2077. doi: 10.1016/S0022-5347(06)00273-4.
PMID: 16697805
citation: Radu A, Pichon C, Camparo P, Antoine M, Allory Y, Couvelard A, Fromont G, Hai MT, Ghinea N. Expression of follicle-stimulating hormone receptor in tumor blood vessels. N Engl J Med. 2010 Oct 21;363(17):1621-30. doi: 10.1056/NEJMoa1001283.
PMID: 20961245
citation: Heidenreich A., Epplen R., Thüer D., Van Erps T., D.P., EURO Prostate Center. EAU guideline on advanced prostate cancer: Compliance among urologists conderning androgen deprivation therapy
responsible party type: Principal Investigator
investigator affiliation: United Clinic Management GmbH
investigator full name: Karin Buchsteiner
investigator title: Head of Study Group
mesh term: Prostatic Neoplasms