<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/NCT01673984</url>
  </required_header>
  <id_info>
    <org_study_id>A-97-52014-181</org_study_id>
    <secondary_id>2011-004213-16</secondary_id>
    <nct_id>NCT01673984</nct_id>
  </id_info>
  <brief_title>GP Extended Action Triptorelin</brief_title>
  <acronym>GREAT</acronym>
  <official_title>A Phase IV, Randomised, Open-label, Multi-centre Study to Assess the Impact on Disease Control, Safety, Patient and Clinician Experience of Changing Patients With Advanced Prostate Cancer From a 3-monthly LHRH Agonist to 6-monthly Injections of Decapeptyl® SR 22.5 MG</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Ipsen</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Ipsen</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to demonstrate that treatment with a 6-monthly injection of&#xD;
      hormone therapy is as good and as well tolerated as the standard 3-monthly hormone therapy&#xD;
      injections available for treating prostate cancer. The study will also aim to answer whether&#xD;
      both doctors and patients would prefer treatment with a 6-monthly injection rather than&#xD;
      injections every 3 months.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    The study was discontinued prematurely by the sponsor due to non-medical reasons&#xD;
  </why_stopped>
  <start_date>August 2012</start_date>
  <completion_date type="Actual">February 2014</completion_date>
  <primary_completion_date type="Actual">February 2014</primary_completion_date>
  <phase>Phase 4</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>Percentage of Participants Maintaining Biochemical Castration</measure>
    <time_frame>6 months</time_frame>
    <description>Patients with serum total testosterone (STT) level lower than 0.5 ng/mL after 6 months of treatment.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants Maintaining Biochemical Castration After 12 Months of Treatment.</measure>
    <time_frame>12 months</time_frame>
    <description>Patients with serum total testosterone (STT) level lower than 0.5 ng/mL, 12 months after randomisation..</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants Demonstrating Stable Prostate-specific Antigen (PSA) Levels</measure>
    <time_frame>6 and 12 months</time_frame>
    <description>Stable PSA level was noted as value either lower or less than 25% higher than the baseline value, or PSA value ≤0.5 ng/mL higher than the baseline value, if value ≥25% higher than the baseline value.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Quality of Life Using EuroQol 5 Dimensions 5 Levels [EQ-5D-5L] Questionnaire.</measure>
    <time_frame>Baseline and Month 12</time_frame>
    <description>The EQ-5D-5L questionnaire consisted of a description of raw data which comprised of five dimensions (mobility, self-care, usual activities, pain/discomfort and anxiety/depression). Each dimension had five levels: no problems, slight problems, moderate problems, severe problems, and extreme problems. The visual analogical scale of the EQ-5D-5L questionnaire was numbered from 0 to 100 (0 meaning the worst health the patient can imagine and 100 the best health the patient can imagine).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Patient Satisfaction With Medication Using Treatment Satisfaction Questionnaire for Medication (TSQM Version II)</measure>
    <time_frame>6 and 12 month</time_frame>
    <description>TSQM comprised of four dimensions: effectiveness, side effects, convenience and overall global satisfaction. Each score ranged from 0 to 100. For effectiveness, convenience and overall global satisfaction scores, 0 indicated an extreme dissatisfaction and 100 indicated an extreme satisfaction. For side effects score, 0 indicated an extreme dissatisfaction and 100 indicated no dissatisfaction at all.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient Satisfaction With Treatment.</measure>
    <time_frame>Month 12</time_frame>
    <description>Using a non-validated study-specific descriptive Likert-type scale (with no units) comprising a simple six-question patient questionnaire.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants Who Changed Injection Frequency After Completion of the Study</measure>
    <time_frame>Month 12</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">27</enrollment>
  <condition>Prostate Cancer</condition>
  <arm_group>
    <arm_group_label>Decapeptyl® SR 22.5mg (Triptorelin)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Current 3-monthly LHRH agonist</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>One of the following: Decapeptyl® SR 11.25mg (Triptorelin), Prostap® 3 DCS 11.25mg, Zoladex® LA 10.8mg</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Decapeptyl® SR 22.5mg</intervention_name>
    <description>22.5mg, intramuscular injection, given on day 1 / month 0 &amp; month 6 (+/- 7 days).</description>
    <arm_group_label>Decapeptyl® SR 22.5mg (Triptorelin)</arm_group_label>
    <other_name>Triptorelin</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Decapeptyl® SR 11.25mg; Prostap® 3 DCS 11.25mg; Zoladex® LA 10.8mg</intervention_name>
    <description>For Decapeptyl® SR 11.25mg: 11.25 mg, intramuscular injection For Prostap® 3 DCS 11.25mg: 11.25mg, depot injected subcutaneously For Zoladex® LA 10.8mg: 10.8mg, depot injected subcutaneously into anterior abdominal wall</description>
    <arm_group_label>Current 3-monthly LHRH agonist</arm_group_label>
    <other_name>Triptorelin</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients must give written (personally signed and dated) informed consent before&#xD;
             completing any study related procedure.&#xD;
&#xD;
          -  Patients must be 18 years old or over.&#xD;
&#xD;
          -  Patients must have a documented diagnosis of locally advanced or metastatic prostate&#xD;
             cancer suitable for hormonal treatment&#xD;
&#xD;
          -  Patients must be medically castrated with serum testosterone ≤ 0.5ng/mL&#xD;
&#xD;
          -  Patients must have received at least two injections of a 3- monthly LHRH agonist by&#xD;
             the time of the screening tests&#xD;
&#xD;
          -  Patients must be stable on a 3-monthly LHRH agonist injection with stable PSA levels&#xD;
             between screening and baseline (i.e. the baseline value must either be lower or less&#xD;
             than 25% higher than the Screening value or if ≥25% higher, ≤0.5ng/mL higher than the&#xD;
             screening value).&#xD;
&#xD;
        In addition:&#xD;
&#xD;
          -  For patients with locally advanced prostate cancer (M0), LHRH agonist injection (any&#xD;
             formulation) must have been initiated within the last 3 years from Baseline,&#xD;
&#xD;
          -  For patients with metastatic prostate cancer (M+) and a Gleason score&#xD;
&#xD;
             ≤ 7, LHRH agonist injection (any formulation) must have been initiated within the last&#xD;
             2 years from Baseline,&#xD;
&#xD;
          -  For patients with metastatic prostate cancer (M+) and a Gleason score &gt; 7, LHRH&#xD;
             agonist injection (any formulation) must have been initiated within the last 12 months&#xD;
             from Baseline.&#xD;
&#xD;
          -  Patients must have an estimated life expectancy of at least twelve months according to&#xD;
             the investigator's assessment.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients have had previous surgical castration or present any concomitant condition&#xD;
             which could compromise the objectives of the study and/or preclude the&#xD;
             protocol-defined procedures (e.g. severe medical conditions, brain metastases,&#xD;
             psychiatric disorders, active or uncontrolled infection, known pituitary disease).&#xD;
&#xD;
          -  Patients are, in the opinion of the investigator, unable to comply fully with the&#xD;
             protocol and the study instructions.&#xD;
&#xD;
          -  Patients have received investigational drug(s) or treatment(s) within 30 days prior to&#xD;
             study entry or will require a concurrent treatment with any other experimental drugs&#xD;
             or treatments or present any concomitant condition which could compromise the&#xD;
             objectives of the study and/or preclude the protocol-defined procedures (e.g. severe&#xD;
             medical conditions, brain metastases, psychiatric disorders, active or uncontrolled&#xD;
             infection, known pituitary disease).&#xD;
&#xD;
          -  Patients have had a diagnosis of any other cancer without a history of&#xD;
             stability/remission within five years of screening, with the exception of&#xD;
             non-metastatic basal cell carcinoma.&#xD;
&#xD;
          -  Patients currently taking additional anti-androgen therapy as part of an active&#xD;
             hormonal control therapy.&#xD;
&#xD;
          -  Patients scheduled to receive palliative radiotherapy during the course of the study.&#xD;
&#xD;
          -  Patients receiving an LHRH agonist as neo-adjuvant to radiotherapy or adjuvant to&#xD;
             radiotherapy.&#xD;
&#xD;
          -  Patients receiving LHRH agonist as adjuvant to surgery.&#xD;
&#xD;
          -  Patients scheduled to undergo radical prostatectomy during the course of the study.&#xD;
&#xD;
          -  Patients with known hypersensitivity to LHRH agonists, their analogues or any or any&#xD;
             other component of the products to be administered.&#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>Ipsen Medical Director</last_name>
    <role>Study Director</role>
    <affiliation>Ipsen</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>The Crouch Oak Family Practice</name>
      <address>
        <city>Addlestone</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Dr Carter &amp; Partners</name>
      <address>
        <city>Ashford</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Westongrove Research Centre, Aston Clinton Surgery</name>
      <address>
        <city>Aylesbury</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinical Research Unit, Oldfield Surgery</name>
      <address>
        <city>Bath</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinical Research Unit, The Pulteney Practice</name>
      <address>
        <city>Bath</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>St James' Surgery</name>
      <address>
        <city>Bath</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Waterloo Medical Centre</name>
      <address>
        <city>Blackpool</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Woolpit Health Centre</name>
      <address>
        <city>Bury St. Edmunds</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cossington House Surgery</name>
      <address>
        <city>Canterbury</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Office, Avondale Surgery</name>
      <address>
        <city>Chesterfield</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinical Research Dept., Rowden Surgery</name>
      <address>
        <city>Chippenham</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinical Research Unit, Hathaway Medical Centre</name>
      <address>
        <city>Chippenham</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Porch Surgery</name>
      <address>
        <city>Corsham</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Pound Hill Surgery</name>
      <address>
        <city>Crawley</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Medical Centre</name>
      <address>
        <city>East Horsley</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Burbage Surgery</name>
      <address>
        <city>Hinckley</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Portmill Surgery</name>
      <address>
        <city>Hitchin</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Townhead Surgery</name>
      <address>
        <city>Irvine</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sherbourne Medical Centre</name>
      <address>
        <city>Leamington Spa</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mortimer Surgery</name>
      <address>
        <city>Mortimer Common</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kiltearn Medical Centre</name>
      <address>
        <city>Nantwich</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Danes Camp Surgery</name>
      <address>
        <city>Northampton</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kingsthorpe Medical Centre</name>
      <address>
        <city>Northampton</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cape Cornwall Surgery</name>
      <address>
        <city>Penzance</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Alverton Practice</name>
      <address>
        <city>Penzance</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Wansford &amp; Kings Cliffe Practice, Wansford Surgery</name>
      <address>
        <city>Peterborough</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Knowle House Surgery</name>
      <address>
        <city>Plymouth</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Rame Group Practice</name>
      <address>
        <city>Plymouth</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ashfields Primary Care Centre</name>
      <address>
        <city>Sandbach</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Brannel Surgery</name>
      <address>
        <city>St Austell</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sunbury Health Centre Group Practice</name>
      <address>
        <city>Sunbury-on-Thames</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Adcroft Surgery</name>
      <address>
        <city>Trowbridge</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sheepcot Medical Centre</name>
      <address>
        <city>Watford</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Albany House Medical Centre</name>
      <address>
        <city>Wellingborough</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Woosehill Medical Centre</name>
      <address>
        <city>Wokingham</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <verification_date>November 2020</verification_date>
  <study_first_submitted>August 23, 2012</study_first_submitted>
  <study_first_submitted_qc>August 27, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 28, 2012</study_first_posted>
  <results_first_submitted>July 10, 2015</results_first_submitted>
  <results_first_submitted_qc>August 28, 2015</results_first_submitted_qc>
  <results_first_posted type="Estimate">September 29, 2015</results_first_posted>
  <last_update_submitted>November 4, 2020</last_update_submitted>
  <last_update_submitted_qc>November 4, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">November 5, 2020</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>Triptorelin Pamoate</mesh_term>
    <mesh_term>Goserelin</mesh_term>
  </intervention_browse>

  <clinical_results>

    <participant_flow>
      <recruitment_details>35 subjects screened and 27 subjects were enrolled. Following enrollment, 21 patients were randomised before the study was prematurely discontinued.</recruitment_details>
      <group_list>
        <group group_id="P1">
          <title>Decapeptyl® SR 22.5mg</title>
          <description>Decapeptyl® SR 22.5mg: 22.5mg, intramuscular injection, given on day 1 / month 0 &amp; month 6 (+/- 7 days).</description>
        </group>
        <group group_id="P2">
          <title>Current 3-monthly LHRH Agonist</title>
          <description>One of the following: Decapeptyl® SR 11.25mg, Prostap® 3 DCS 11.25mg, Zoladex® LA 10.8mg&#xD;
Decapeptyl® SR 11.25mg; Prostap® 3 DCS 11.25mg; Zoladex® LA 10.8mg: For Decapeptyl® SR 11.25mg: 11.25 mg, intramuscular injection For Prostap® 3 DCS 11.25mg: 11.25mg, depot injected subcutaneously For Zoladex® LA 10.8mg: 10.8mg, depot injected subcutaneously into anterior abdominal wall</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="14"/>
                <participants group_id="P2" count="7"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="4"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="10"/>
                <participants group_id="P2" count="6"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Adverse Event</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Study termination</title>
              <participants_list>
                <participants group_id="P1" count="9"/>
                <participants group_id="P2" count="6"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Decapeptyl® SR 22.5mg</title>
          <description>Decapeptyl® SR 22.5mg: 22.5mg, intramuscular injection, given on day 1 / month 0 &amp; month 6 (+/- 7 days).</description>
        </group>
        <group group_id="B2">
          <title>Current 3-monthly LHRH Agonist</title>
          <description>One of the following: Decapeptyl® SR 11.25mg, Prostap® 3 DCS 11.25mg, Zoladex® LA 10.8mg&#xD;
Decapeptyl® SR 11.25mg; Prostap® 3 DCS 11.25mg; Zoladex® LA 10.8mg: For Decapeptyl® SR 11.25mg: 11.25 mg, intramuscular injection For Prostap® 3 DCS 11.25mg: 11.25mg, depot injected subcutaneously For Zoladex® LA 10.8mg: 10.8mg, depot injected subcutaneously into anterior abdominal wall</description>
        </group>
        <group group_id="B3">
          <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="14"/>
            <count group_id="B2" value="7"/>
            <count group_id="B3" value="21"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="77.2" spread="5.4"/>
                    <measurement group_id="B2" value="78.7" spread="9.3"/>
                    <measurement group_id="B3" value="77.7" spread="6.7"/>
                  </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_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="14"/>
                    <measurement group_id="B2" value="7"/>
                    <measurement group_id="B3" value="21"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Employment status/Occupation</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>Employed</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Retired</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="12"/>
                    <measurement group_id="B2" value="6"/>
                    <measurement group_id="B3" value="18"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Percentage of Participants Maintaining Biochemical Castration</title>
        <description>Patients with serum total testosterone (STT) level lower than 0.5 ng/mL after 6 months of treatment.</description>
        <time_frame>6 months</time_frame>
        <population>Analysis based on intent-to-treat (ITT) population comprised of 21 patients.</population>
        <group_list>
          <group group_id="O1">
            <title>Decapeptyl® SR 22.5mg</title>
            <description>Decapeptyl® SR 22.5mg: 22.5mg, intramuscular injection, given on day 1 / month 0 &amp; month 6 (+/- 7 days).</description>
          </group>
          <group group_id="O2">
            <title>Current 3-monthly LHRH Agonist</title>
            <description>One of the following: Decapeptyl® SR 11.25mg, Prostap® 3 DCS 11.25mg, Zoladex® LA 10.8mg&#xD;
Decapeptyl® SR 11.25mg; Prostap® 3 DCS 11.25mg; Zoladex® LA 10.8mg: For Decapeptyl® SR 11.25mg: 11.25 mg, intramuscular injection For Prostap® 3 DCS 11.25mg: 11.25mg, depot injected subcutaneously For Zoladex® LA 10.8mg: 10.8mg, depot injected subcutaneously into anterior abdominal wall</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants Maintaining Biochemical Castration</title>
          <description>Patients with serum total testosterone (STT) level lower than 0.5 ng/mL after 6 months of treatment.</description>
          <population>Analysis based on intent-to-treat (ITT) population comprised of 21 patients.</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="14"/>
                <count group_id="O2" value="7"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="92.9"/>
                    <measurement group_id="O2" value="100"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants Maintaining Biochemical Castration After 12 Months of Treatment.</title>
        <description>Patients with serum total testosterone (STT) level lower than 0.5 ng/mL, 12 months after randomisation..</description>
        <time_frame>12 months</time_frame>
        <population>Analysis based on the number of subjects with a valid value in the ITT population comprised of 21 patients.</population>
        <group_list>
          <group group_id="O1">
            <title>Decapeptyl® SR 22.5mg</title>
            <description>Decapeptyl® SR 22.5mg: 22.5mg, intramuscular injection, given on day 1 / month 0 &amp; month 6 (+/- 7 days).</description>
          </group>
          <group group_id="O2">
            <title>Current 3-monthly LHRH Agonist</title>
            <description>One of the following: Decapeptyl® SR 11.25mg, Prostap® 3 DCS 11.25mg, Zoladex® LA 10.8mg&#xD;
Decapeptyl® SR 11.25mg; Prostap® 3 DCS 11.25mg; Zoladex® LA 10.8mg: For Decapeptyl® SR 11.25mg: 11.25 mg, intramuscular injection For Prostap® 3 DCS 11.25mg: 11.25mg, depot injected subcutaneously For Zoladex® LA 10.8mg: 10.8mg, depot injected subcutaneously into anterior abdominal wall</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants Maintaining Biochemical Castration After 12 Months of Treatment.</title>
          <description>Patients with serum total testosterone (STT) level lower than 0.5 ng/mL, 12 months after randomisation..</description>
          <population>Analysis based on the number of subjects with a valid value in the ITT population comprised of 21 patients.</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="9"/>
                <count group_id="O2" value="4"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="22.2"/>
                    <measurement group_id="O2" value="25.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants Demonstrating Stable Prostate-specific Antigen (PSA) Levels</title>
        <description>Stable PSA level was noted as value either lower or less than 25% higher than the baseline value, or PSA value ≤0.5 ng/mL higher than the baseline value, if value ≥25% higher than the baseline value.</description>
        <time_frame>6 and 12 months</time_frame>
        <population>Analysis based on number (n) of patients with a valid value in the intent-to-treat (ITT) population which comprised of 21 patients.</population>
        <group_list>
          <group group_id="O1">
            <title>Decapeptyl® SR 22.5mg</title>
            <description>Decapeptyl® SR 22.5mg: 22.5mg, intramuscular injection, given on day 1 / month 0 &amp; month 6 (+/- 7 days).</description>
          </group>
          <group group_id="O2">
            <title>Current 3-monthly LHRH Agonist</title>
            <description>One of the following: Decapeptyl® SR 11.25mg, Prostap® 3 DCS 11.25mg, Zoladex® LA 10.8mg&#xD;
Decapeptyl® SR 11.25mg; Prostap® 3 DCS 11.25mg; Zoladex® LA 10.8mg: For Decapeptyl® SR 11.25mg: 11.25 mg, intramuscular injection For Prostap® 3 DCS 11.25mg: 11.25mg, depot injected subcutaneously For Zoladex® LA 10.8mg: 10.8mg, depot injected subcutaneously into anterior abdominal wall</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants Demonstrating Stable Prostate-specific Antigen (PSA) Levels</title>
          <description>Stable PSA level was noted as value either lower or less than 25% higher than the baseline value, or PSA value ≤0.5 ng/mL higher than the baseline value, if value ≥25% higher than the baseline value.</description>
          <population>Analysis based on number (n) of patients with a valid value in the intent-to-treat (ITT) population which comprised of 21 patients.</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="13"/>
                <count group_id="O2" value="7"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>6 months (n = 13, 7)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="84.6"/>
                    <measurement group_id="O2" value="100"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>12 months (n = 2, 1)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="50"/>
                    <measurement group_id="O2" value="100"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Quality of Life Using EuroQol 5 Dimensions 5 Levels [EQ-5D-5L] Questionnaire.</title>
        <description>The EQ-5D-5L questionnaire consisted of a description of raw data which comprised of five dimensions (mobility, self-care, usual activities, pain/discomfort and anxiety/depression). Each dimension had five levels: no problems, slight problems, moderate problems, severe problems, and extreme problems. The visual analogical scale of the EQ-5D-5L questionnaire was numbered from 0 to 100 (0 meaning the worst health the patient can imagine and 100 the best health the patient can imagine).</description>
        <time_frame>Baseline and Month 12</time_frame>
        <population>Analysis based on the number of subjects with a valid value in the ITT population which comprised of 21 patients.</population>
        <group_list>
          <group group_id="O1">
            <title>Decapeptyl® SR 22.5mg</title>
            <description>Decapeptyl® SR 22.5mg: 22.5mg, intramuscular injection, given on day 1 / month 0 &amp; month 6 (+/- 7 days).</description>
          </group>
          <group group_id="O2">
            <title>Current 3-monthly LHRH Agonist</title>
            <description>One of the following: Decapeptyl® SR 11.25mg, Prostap® 3 DCS 11.25mg, Zoladex® LA 10.8mg&#xD;
Decapeptyl® SR 11.25mg; Prostap® 3 DCS 11.25mg; Zoladex® LA 10.8mg: For Decapeptyl® SR 11.25mg: 11.25 mg, intramuscular injection For Prostap® 3 DCS 11.25mg: 11.25mg, depot injected subcutaneously For Zoladex® LA 10.8mg: 10.8mg, depot injected subcutaneously into anterior abdominal wall</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Quality of Life Using EuroQol 5 Dimensions 5 Levels [EQ-5D-5L] Questionnaire.</title>
          <description>The EQ-5D-5L questionnaire consisted of a description of raw data which comprised of five dimensions (mobility, self-care, usual activities, pain/discomfort and anxiety/depression). Each dimension had five levels: no problems, slight problems, moderate problems, severe problems, and extreme problems. The visual analogical scale of the EQ-5D-5L questionnaire was numbered from 0 to 100 (0 meaning the worst health the patient can imagine and 100 the best health the patient can imagine).</description>
          <population>Analysis based on the number of subjects with a valid value in the ITT population which comprised of 21 patients.</population>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="3"/>
                <count group_id="O2" value="2"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="71.7" lower_limit="40.4" upper_limit="102.9"/>
                    <measurement group_id="O2" value="70.0" lower_limit="-57.1" upper_limit="197.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Patient Satisfaction With Medication Using Treatment Satisfaction Questionnaire for Medication (TSQM Version II)</title>
        <description>TSQM comprised of four dimensions: effectiveness, side effects, convenience and overall global satisfaction. Each score ranged from 0 to 100. For effectiveness, convenience and overall global satisfaction scores, 0 indicated an extreme dissatisfaction and 100 indicated an extreme satisfaction. For side effects score, 0 indicated an extreme dissatisfaction and 100 indicated no dissatisfaction at all.</description>
        <time_frame>6 and 12 month</time_frame>
        <population>Analysis based on the number (n) of subjects with a valid value in each arm of the ITT population which comprised of 21 patients.</population>
        <group_list>
          <group group_id="O1">
            <title>Decapeptyl® SR 22.5mg</title>
            <description>Decapeptyl® SR 22.5mg: 22.5mg, intramuscular injection, given on day 1 / month 0 &amp; month 6 (+/- 7 days).</description>
          </group>
          <group group_id="O2">
            <title>Current 3-monthly LHRH Agonist</title>
            <description>One of the following: Decapeptyl® SR 11.25mg, Prostap® 3 DCS 11.25mg, Zoladex® LA 10.8mg&#xD;
Decapeptyl® SR 11.25mg; Prostap® 3 DCS 11.25mg; Zoladex® LA 10.8mg: For Decapeptyl® SR 11.25mg: 11.25 mg, intramuscular injection For Prostap® 3 DCS 11.25mg: 11.25mg, depot injected subcutaneously For Zoladex® LA 10.8mg: 10.8mg, depot injected subcutaneously into anterior abdominal wall</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Patient Satisfaction With Medication Using Treatment Satisfaction Questionnaire for Medication (TSQM Version II)</title>
          <description>TSQM comprised of four dimensions: effectiveness, side effects, convenience and overall global satisfaction. Each score ranged from 0 to 100. For effectiveness, convenience and overall global satisfaction scores, 0 indicated an extreme dissatisfaction and 100 indicated an extreme satisfaction. For side effects score, 0 indicated an extreme dissatisfaction and 100 indicated no dissatisfaction at all.</description>
          <population>Analysis based on the number (n) of subjects with a valid value in each arm of the ITT population which comprised of 21 patients.</population>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="14"/>
                <count group_id="O2" value="7"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline to 6 months - Effectiveness (n= 13, 7)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.2" lower_limit="-12.5" upper_limit="18.9"/>
                    <measurement group_id="O2" value="13.1" lower_limit="-10.8" upper_limit="37.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Baseline to 12 months - Effectiveness (n= 3, 2)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-33.3" lower_limit="-74.7" upper_limit="8.1"/>
                    <measurement group_id="O2" value="-12.5" lower_limit="-383.1" upper_limit="358.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Baseline to 6 months - Side Effects (n= 13, 7)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-2.6" lower_limit="-12.9" upper_limit="7.8"/>
                    <measurement group_id="O2" value="4.8" lower_limit="-6.0" upper_limit="15.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Baseline to 12 months - Side Effects (n= 3, 2)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-25.0" lower_limit="-115.2" upper_limit="65.2"/>
                    <measurement group_id="O2" value="12.5" lower_limit="-146.3" upper_limit="171.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Baseline to 6 months - Convenience (n= 13, 7)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.7" lower_limit="-6.3" upper_limit="15.7"/>
                    <measurement group_id="O2" value="2.0" lower_limit="-9.8" upper_limit="13.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Baseline to 12 months - Convenience (n= 3, 2)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.9" lower_limit="-36.6" upper_limit="32.9"/>
                    <measurement group_id="O2" value="2.8" lower_limit="-103.1" upper_limit="108.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Baseline to 6months -Global Satisfaction(n= 12, 6)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.7" lower_limit="-15.9" upper_limit="14.5"/>
                    <measurement group_id="O2" value="-4.2" lower_limit="-11.5" upper_limit="3.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Baseline to 12months -Global Satisfaction(n= 2, 2)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-12.5" lower_limit="-171.3" upper_limit="146.3"/>
                    <measurement group_id="O2" value="4.2" lower_limit="-48.8" upper_limit="57.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Patient Satisfaction With Treatment.</title>
        <description>Using a non-validated study-specific descriptive Likert-type scale (with no units) comprising a simple six-question patient questionnaire.</description>
        <time_frame>Month 12</time_frame>
        <population>No participant analysis as no data was collected due to low number of participants recruited in the study.</population>
        <group_list>
          <group group_id="O1">
            <title>Decapeptyl® SR 22.5mg</title>
            <description>Decapeptyl® SR 22.5mg: 22.5mg, intramuscular injection, given on day 1 / month 0 &amp; month 6 (+/- 7 days).</description>
          </group>
          <group group_id="O2">
            <title>Current 3-monthly LHRH Agonist</title>
            <description>One of the following: Decapeptyl® SR 11.25mg, Prostap® 3 DCS 11.25mg, Zoladex® LA 10.8mg&#xD;
Decapeptyl® SR 11.25mg; Prostap® 3 DCS 11.25mg; Zoladex® LA 10.8mg: For Decapeptyl® SR 11.25mg: 11.25 mg, intramuscular injection For Prostap® 3 DCS 11.25mg: 11.25mg, depot injected subcutaneously For Zoladex® LA 10.8mg: 10.8mg, depot injected subcutaneously into anterior abdominal wall</description>
          </group>
        </group_list>
        <measure>
          <title>Patient Satisfaction With Treatment.</title>
          <description>Using a non-validated study-specific descriptive Likert-type scale (with no units) comprising a simple six-question patient questionnaire.</description>
          <population>No participant analysis as no data was collected due to low number of participants recruited in the study.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants Who Changed Injection Frequency After Completion of the Study</title>
        <time_frame>Month 12</time_frame>
        <population>Analysis based on the number of subjects with a valid value in the ITT population which comprised of 21 patients.</population>
        <group_list>
          <group group_id="O1">
            <title>Decapeptyl® SR 22.5mg</title>
            <description>Decapeptyl® SR 22.5mg: 22.5mg, intramuscular injection, given on day 1 / month 0 &amp; month 6 (+/- 7 days).</description>
          </group>
          <group group_id="O2">
            <title>Current 3-monthly LHRH Agonist</title>
            <description>One of the following: Decapeptyl® SR 11.25mg, Prostap® 3 DCS 11.25mg, Zoladex® LA 10.8mg&#xD;
Decapeptyl® SR 11.25mg; Prostap® 3 DCS 11.25mg; Zoladex® LA 10.8mg: For Decapeptyl® SR 11.25mg: 11.25 mg, intramuscular injection For Prostap® 3 DCS 11.25mg: 11.25mg, depot injected subcutaneously For Zoladex® LA 10.8mg: 10.8mg, depot injected subcutaneously into anterior abdominal wall</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants Who Changed Injection Frequency After Completion of the Study</title>
          <population>Analysis based on the number of subjects with a valid value in the ITT population which comprised of 21 patients.</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="5"/>
                <count group_id="O2" value="3"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="80"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Up to 12 months</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Decapeptyl® SR 22.5mg</title>
          <description>Decapeptyl® SR 22.5mg: 22.5mg, intramuscular injection, given on day 1 / month 0 &amp; month 6 (+/- 7 days).</description>
        </group>
        <group group_id="E2">
          <title>Current 3-monthly LHRH Agonist</title>
          <description>One of the following: Decapeptyl® SR 11.25mg, Prostap® 3 DCS 11.25mg, Zoladex® LA 10.8mg&#xD;
Decapeptyl® SR 11.25mg; Prostap® 3 DCS 11.25mg; Zoladex® LA 10.8mg: For Decapeptyl® SR 11.25mg: 11.25 mg, intramuscular injection For Prostap® 3 DCS 11.25mg: 11.25mg, depot injected subcutaneously For Zoladex® LA 10.8mg: 10.8mg, depot injected subcutaneously into anterior abdominal wall</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>MedDRA Version 15.1</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="14"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="7"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Disease progression</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="14"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="7"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Pneumonia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="14"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="7"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Subdural haematoma</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="14"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="7"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <default_vocab>MedDRA Version 15.1</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="12" subjects_at_risk="14"/>
                <counts group_id="E2" subjects_affected="7" subjects_at_risk="7"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Blood and lymphatic system disorders</title>
            <event_list>
              <event>
                <sub_title>Anaemia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="14"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="7"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Bundle branch block right</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="14"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="7"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Ear and labyrinth disorders</title>
            <event_list>
              <event>
                <sub_title>Deafness</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="14"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>Cerumen impaction</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>Tinnitus</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="7"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Eye disorders</title>
            <event_list>
              <event>
                <sub_title>Cataract</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="14"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>Conjunctival haemorrhage</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="7"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Colitis microscopic</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="14"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>Constipation</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="14"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>Dysphagia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="14"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>Glossodynia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="14"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>Hiatus hernia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="14"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>Oesophagitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="14"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>Eructation</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="7"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Fatigue</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="14"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>Gait disturbance</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="14"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>Oedema peripheral</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="14"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>Pain</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="14"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>Suprapubic pain</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="14"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="7"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Bronchitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="14"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>Ear infection</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="14"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>Eye infection bacterial</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="14"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>Lower respiratory tract infection</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="14"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>Upper respiratory tract infection</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="14"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>Urinary tract infection</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="14"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>Viral infection</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="14"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>Bronchitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>Lower respiratory tract infection</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="7"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Humerus fracture</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="14"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>Joint injury</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="14"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>Laceration</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="14"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>Post procedural haemorrhage</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="7"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Haemoglobin decreased</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="14"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>Serum ferritin increased</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="14"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="7"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Decreased appetite</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="14"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>Gout</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>Hypercholesterolaemia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="7"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Back pain</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="14"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>Muscle atrophy</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="14"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>Musculoskeletal chest pain</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="14"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>Pain in extremity</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="14"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>Arthralgia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="7"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Dizziness</sub_title>
                <counts group_id="E1" events="5" subjects_affected="5" subjects_at_risk="14"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="14"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>Hemiparesis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="14"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>Sciatica</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="14"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>Carpal tunnel syndrome</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>Poor quality sleep</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>Transient ischaemic attack</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="7"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Depression</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="14"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="7"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>Dysuria</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="14"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>Haematuria</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="14"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>Micturition urgency</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="14"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>Pollakiuria</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="14"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="7"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Reproductive system and breast disorders</title>
            <event_list>
              <event>
                <sub_title>Penile pain</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="14"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>Prostatitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="14"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="7"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Asthma</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="14"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>Chronic obstructive pulmonary disease</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="14"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>Cough</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="14"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>Dyspnoea</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="14"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>Productive cough</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="7"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Actinic keratosis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="14"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>Eczema</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="14"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>Hyperhidrosis</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="14"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>Rash</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="14"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>Skin ulcer</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="14"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>Skin lesion</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="7"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Hot flush</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="14"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>Peripheral vascular disorder</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="14"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>Aortic stenosis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="7"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT 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>Medical Director, Uro-Oncology</name_or_title>
      <organization>Ipsen</organization>
      <phone>clinical.trials@ipsen.com</phone>
      <email>clinical.trials@ipsen.com</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/NCT01673984
org study id: A-97-52014-181
secondary id: 2011-004213-16
nct id: NCT01673984
lead sponsor: 
has dmc: No
The purpose of this study is to demonstrate that treatment with a 6-monthly injection of
      hormone therapy is as good and as well tolerated as the standard 3-monthly hormone therapy
      injections available for treating prostate cancer. The study will also aim to answer whether
      both doctors and patients would prefer treatment with a 6-monthly injection rather than
      injections every 3 months.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Percentage of Participants Maintaining Biochemical Castration
time frame: 6 months
description: Patients with serum total testosterone (STT) level lower than 0.5 ng/mL after 6 months of treatment.
measure: Percentage of Participants Maintaining Biochemical Castration After 12 Months of Treatment.
time frame: 12 months
description: Patients with serum total testosterone (STT) level lower than 0.5 ng/mL, 12 months after randomisation..
measure: Percentage of Participants Demonstrating Stable Prostate-specific Antigen (PSA) Levels
time frame: 6 and 12 months
description: Stable PSA level was noted as value either lower or less than 25% higher than the baseline value, or PSA value ≤0.5 ng/mL higher than the baseline value, if value ≥25% higher than the baseline value.
measure: Change From Baseline in Quality of Life Using EuroQol 5 Dimensions 5 Levels [EQ-5D-5L] Questionnaire.
time frame: Baseline and Month 12
description: The EQ-5D-5L questionnaire consisted of a description of raw data which comprised of five dimensions (mobility, self-care, usual activities, pain/discomfort and anxiety/depression). Each dimension had five levels: no problems, slight problems, moderate problems, severe problems, and extreme problems. The visual analogical scale of the EQ-5D-5L questionnaire was numbered from 0 to 100 (0 meaning the worst health the patient can imagine and 100 the best health the patient can imagine).
measure: Change From Baseline in Patient Satisfaction With Medication Using Treatment Satisfaction Questionnaire for Medication (TSQM Version II)
time frame: 6 and 12 month
description: TSQM comprised of four dimensions: effectiveness, side effects, convenience and overall global satisfaction. Each score ranged from 0 to 100. For effectiveness, convenience and overall global satisfaction scores, 0 indicated an extreme dissatisfaction and 100 indicated an extreme satisfaction. For side effects score, 0 indicated an extreme dissatisfaction and 100 indicated no dissatisfaction at all.
measure: Patient Satisfaction With Treatment.
time frame: Month 12
description: Using a non-validated study-specific descriptive Likert-type scale (with no units) comprising a simple six-question patient questionnaire.
measure: Percentage of Participants Who Changed Injection Frequency After Completion of the Study
time frame: Month 12
arm group label: Decapeptyl® SR 22.5mg (Triptorelin)
arm group type: Experimental
arm group label: Current 3-monthly LHRH agonist
arm group type: Active Comparator
description: One of the following: Decapeptyl® SR 11.25mg (Triptorelin), Prostap® 3 DCS 11.25mg, Zoladex® LA 10.8mg
intervention type: Drug
intervention name: Decapeptyl® SR 22.5mg
description: 22.5mg, intramuscular injection, given on day 1 / month 0 & month 6 (+/- 7 days).
arm group label: Decapeptyl® SR 22.5mg (Triptorelin)
other name: Triptorelin
intervention type: Drug
intervention name: Decapeptyl® SR 11.25mg; Prostap® 3 DCS 11.25mg; Zoladex® LA 10.8mg
description: For Decapeptyl® SR 11.25mg: 11.25 mg, intramuscular injection For Prostap® 3 DCS 11.25mg: 11.25mg, depot injected subcutaneously For Zoladex® LA 10.8mg: 10.8mg, depot injected subcutaneously into anterior abdominal wall
arm group label: Current 3-monthly LHRH agonist
other name: Triptorelin
criteria: 
gender: Male
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Ipsen Medical Director
role: Study Director
affiliation: Ipsen
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country: United Kingdom
responsible party type: Sponsor
mesh term: Prostatic Neoplasms
mesh term: Triptorelin Pamoate
mesh term: Goserelin
participant flow: 
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reported events: 
certain agreements: 
point of contact: 