<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/NCT03017313</url>
  </required_header>
  <id_info>
    <org_study_id>A-ES-52014-224</org_study_id>
    <nct_id>NCT03017313</nct_id>
  </id_info>
  <brief_title>To Evaluate the Criteria for Renewal of Luteinizing Hormone-Releasing Hormone (LHRH) Analogue Treatment in Prostate Cancer Patients</brief_title>
  <acronym>ANAREN</acronym>
  <official_title>A Prospective Post Marketing Non Interventional Study to Evaluate the Criteria on Which Renewal of LHRH Analogue Treatment is Made in Patients With Prostate Cancer Locally Advanced or Metastatic.</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 the study, is to determine the percentage of patients for whom the initial&#xD;
      LHRH prescription has been renewed&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 13, 2017</start_date>
  <completion_date type="Actual">June 14, 2021</completion_date>
  <primary_completion_date type="Actual">June 14, 2021</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Percentage of patients for whom the initial LHRH prescription (the prescription at the baseline visit) has been renewed at first follow-up visit (same type, same formulation).</measure>
    <time_frame>First follow-up visit (occurs 3 to 6 months from baseline)</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Percentage of patients for whom the initial LHRH prescription has been renewed at each visit.</measure>
    <time_frame>Baseline, between 3 to 6 months, 12 months, 18 months and 24 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of patients having switched from a 3 months to a 6 months and also 6 months to 3 months formulation at each visit.</measure>
    <time_frame>Baseline, between 3 to 6 months, 12 months, 18 months and 24 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of patients starting a 6-month formulation at baseline.</measure>
    <time_frame>Baseline</time_frame>
    <description>The decision to prescribe a LHRH analogue as a 3- or 6-months formulation will be made prior to and independently from the decision to enroll the subject. This decision should be made in accordance with the usual medical practice of the concerned investigator.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Reasons leading to a switch from a 3 months to a 6 months formulation (patient) presented as proportion of patients</measure>
    <time_frame>Baseline, between 3 to 6 months, 12 months, 18 months and 24 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Reasons leading to a switch from a 3 months to a 6 months formulation (physician) presented as proportion of physicians</measure>
    <time_frame>Baseline, between 3 to 6 months, 12 months, 18 months and 24 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Criteria for choice of formulation at start of hormonal treatment taking into consideration the patient characteristics and his disease status.</measure>
    <time_frame>Baseline</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change of the Quality of Life Questionnaire QLQ-PR25 score compared to baseline and each visit.</measure>
    <time_frame>Baseline, between 3 to 6 months, 12 months, 18 months and 24 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Correlation between physician and patient satisfaction and the evolution of the biological parameters (Prostate-specific antigen)</measure>
    <time_frame>Baseline, between 3 to 6 months, 12 months, 18 months and 24 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of patients for which the initial prescription (the prescription at the baseline visit) of a LHRH analogue (3 or 6 months) has been stopped and later on renewed (intermittent treatment)</measure>
    <time_frame>Baseline, between 3 to 6 months, 12 months, 18 months and 24 months</time_frame>
  </secondary_outcome>
  <enrollment type="Actual">510</enrollment>
  <condition>Prostate Cancer</condition>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>LHRH analogues</intervention_name>
    <description>3-or 6-month formulations</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients with Prostate cancer locally advanced or metastatic&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Adult men diagnosed of locally advanced or metastatic prostate cancer scheduled to&#xD;
             receive androgen deprivation therapy with a 3 or 6 month LHRH analogue including those&#xD;
             requiring neo-adjuvant or adjuvant androgen deprivation therapy in association with&#xD;
             radiotherapy&#xD;
&#xD;
          -  Patients having provided written informed consent&#xD;
&#xD;
          -  Patients mentally fit for completing a self-administrated questionnaire&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients participating in another clinical study at the time of inclusion&#xD;
&#xD;
          -  Patients with another severe malignant disease&#xD;
&#xD;
          -  Life expectancy of less than 12 months&#xD;
&#xD;
          -  Patients already treated with a LHRH analogue within the last year&#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>Hospital A Coruña</name>
      <address>
        <city>A Coruña</city>
        <zip>15006</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital del Sureste</name>
      <address>
        <city>Arganda</city>
        <zip>28500</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital San Agustín</name>
      <address>
        <city>Avilés</city>
        <zip>33401</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital de Txagorritxu</name>
      <address>
        <city>Barakaldo</city>
        <zip>48902</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital de Basurto</name>
      <address>
        <city>Bilbao</city>
        <zip>48902</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Gral. Univ. Santa Lucía</name>
      <address>
        <city>Cartagena</city>
        <zip>30202</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Arquitecto Marcide</name>
      <address>
        <city>Ferrol</city>
        <zip>15405</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Univ. de Getafe</name>
      <address>
        <city>Getafe</city>
        <zip>28905</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital de Cabueñes</name>
      <address>
        <city>Gijón</city>
        <zip>33394</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario Dr Negrín</name>
      <address>
        <city>Las Palmas De Gran Canaria</city>
        <zip>35010</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital de León</name>
      <address>
        <city>León</city>
        <zip>37007</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital de la Princesa</name>
      <address>
        <city>Madrid</city>
        <zip>28006</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Univ. La Paz</name>
      <address>
        <city>Madrid</city>
        <zip>28046</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Univ. Infanta Sofía</name>
      <address>
        <city>Madrid</city>
        <zip>28703</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital de Torrejón</name>
      <address>
        <city>Madrid</city>
        <zip>28850</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Rey Juan Carlos</name>
      <address>
        <city>Madrid</city>
        <zip>28933</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Comarcal Santiago Apóstol</name>
      <address>
        <city>Miranda de Ebro</city>
        <zip>34004</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Uni. Virgen de la Arrixaca</name>
      <address>
        <city>Murcia</city>
        <zip>30120</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Ntra. Señora del Cristal</name>
      <address>
        <city>Ourense</city>
        <zip>36312</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Son Llàtzer</name>
      <address>
        <city>Palma</city>
        <zip>08003</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Virgen del Camino</name>
      <address>
        <city>Pamplona</city>
        <zip>31008</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital de Montecelo</name>
      <address>
        <city>Pontevedra</city>
        <zip>36312</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Univ. de Salamanca</name>
      <address>
        <city>Salamanca</city>
        <zip>37007</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Clínico de Santiago</name>
      <address>
        <city>Santiago de Compostela</city>
        <zip>15706</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario de Canarias</name>
      <address>
        <city>Tenerife</city>
        <zip>38320</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Clínico de Valladolid</name>
      <address>
        <city>Valladolid</city>
        <zip>47005</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Álvaro Cunqueiro</name>
      <address>
        <city>Vigo</city>
        <zip>36312</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Spain</country>
  </location_countries>
  <verification_date>June 2021</verification_date>
  <study_first_submitted>December 30, 2016</study_first_submitted>
  <study_first_submitted_qc>January 9, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 11, 2017</study_first_posted>
  <last_update_submitted>June 23, 2021</last_update_submitted>
  <last_update_submitted_qc>June 23, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">June 24, 2021</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>
  <!-- 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/NCT03017313
org study id: A-ES-52014-224
nct id: NCT03017313
lead sponsor: 
has dmc: No
The purpose of the study, is to determine the percentage of patients for whom the initial
      LHRH prescription has been renewed
observational model: Cohort
time perspective: Prospective
measure: Percentage of patients for whom the initial LHRH prescription (the prescription at the baseline visit) has been renewed at first follow-up visit (same type, same formulation).
time frame: First follow-up visit (occurs 3 to 6 months from baseline)
measure: Percentage of patients for whom the initial LHRH prescription has been renewed at each visit.
time frame: Baseline, between 3 to 6 months, 12 months, 18 months and 24 months
measure: Percentage of patients having switched from a 3 months to a 6 months and also 6 months to 3 months formulation at each visit.
time frame: Baseline, between 3 to 6 months, 12 months, 18 months and 24 months
measure: Percentage of patients starting a 6-month formulation at baseline.
time frame: Baseline
description: The decision to prescribe a LHRH analogue as a 3- or 6-months formulation will be made prior to and independently from the decision to enroll the subject. This decision should be made in accordance with the usual medical practice of the concerned investigator.
measure: Reasons leading to a switch from a 3 months to a 6 months formulation (patient) presented as proportion of patients
time frame: Baseline, between 3 to 6 months, 12 months, 18 months and 24 months
measure: Reasons leading to a switch from a 3 months to a 6 months formulation (physician) presented as proportion of physicians
time frame: Baseline, between 3 to 6 months, 12 months, 18 months and 24 months
measure: Criteria for choice of formulation at start of hormonal treatment taking into consideration the patient characteristics and his disease status.
time frame: Baseline
measure: Change of the Quality of Life Questionnaire QLQ-PR25 score compared to baseline and each visit.
time frame: Baseline, between 3 to 6 months, 12 months, 18 months and 24 months
measure: Correlation between physician and patient satisfaction and the evolution of the biological parameters (Prostate-specific antigen)
time frame: Baseline, between 3 to 6 months, 12 months, 18 months and 24 months
measure: Percentage of patients for which the initial prescription (the prescription at the baseline visit) of a LHRH analogue (3 or 6 months) has been stopped and later on renewed (intermittent treatment)
time frame: Baseline, between 3 to 6 months, 12 months, 18 months and 24 months
intervention type: Drug
intervention name: LHRH analogues
description: 3-or 6-month formulations
study pop: 
sampling method: Non-Probability Sample
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: Spain
responsible party type: Sponsor
mesh term: Prostatic Neoplasms