<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/NCT02238366</url>
  </required_header>
  <id_info>
    <org_study_id>A-38-52014-213</org_study_id>
    <nct_id>NCT02238366</nct_id>
  </id_info>
  <brief_title>Study To Assess Renewal Of Treatment In Patients Recently Diagnosed With Prostate Cancer</brief_title>
  <acronym>CHRONOS3</acronym>
  <official_title>A Non-interventional, Multi-centric, Observational, Prospective Study to Collect the Criteria on Which Renewal of GnRH Analogue Treatment With Triptorelin (Diphereline 3.75mg or Diphereline pr 11.25mg) is Made in Patients Recently Diagnosed With Prostate Cancer Requiring Androgen Deprivation Therapy</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 collect some parameters which may help to provide guidance on&#xD;
      how Androgen Deprivation Therapy (ADT) drugs are renewed and physician satisfaction.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>November 2013</start_date>
  <completion_date type="Actual">June 6, 2019</completion_date>
  <primary_completion_date type="Actual">June 6, 2019</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 Gonadotropin-releasing Hormone (GnRH) analogue formulation has been renewed.</measure>
    <time_frame>1 month</time_frame>
    <description>To evaluate the percentage of patients for whom the initial GnRH analogue formulation has been renewed at 1-month +/- 7 days for Diphereline 3.75mg.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Percentage of patients for whom the initial GnRH analogue formulation has been renewed.</measure>
    <time_frame>3 months</time_frame>
    <description>To evaluate the percentage of patients for whom the initial GnRH analogue formulation has been renewed at at 3-months +/- 10 days for Diphereline PR 11.25mg (Visit 2).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Percentage of patients for whom the initial GnRH analogue formulation has been renewed at each follow up visit</measure>
    <time_frame>6 and 12 months</time_frame>
    <description>To evaluate the percentage of patients for whom the initial GnRH formulation (triptorelin-Diphereline®) had been renewed at each follow up visit [Visit 3 (at 6-months +/- 3 weeks), Visit 4 (at 12-months +/- 6 weeks)].</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of patients that switched from a 1-month to a 3-months formulation</measure>
    <time_frame>3, 6, 12 months</time_frame>
    <description>To evaluate the percentage of patients having switched from a 1-month to a 3-months formulation at each visit [Visit 2 (at 1 month or 3 months), Visit 3 (at 6 months +/- 3 weeks), Visit 4 (at 12 months +/- 6 weeks)].</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">368</enrollment>
  <condition>Prostate Cancer</condition>
  <arm_group>
    <arm_group_label>Prostate cancer patients</arm_group_label>
    <description>Patients recently diagnosed with prostate cancer requiring ADT.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>triptorelin</intervention_name>
    <description>This is an observational study. Thus, the treatment selection with triptorelin (Diphereline® or Diphereline PR®) is at investigator's discretion based on the current practice principles and guidelines/protocols, in accordance with the Summary of Product Characteristics (SmPC) approved in Romania by the National Medicines Agency.</description>
    <arm_group_label>Prostate cancer patients</arm_group_label>
    <other_name>Diphereline 3.75mg or Diphereline PR (prolonged release) 11.25mg intramuscular (IM.) Injection</other_name>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Men recently diagnosed with locally advanced or metastatic prostate cancer receiving ADT.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Adult men, ≥18 years old, with recently diagnosed locally advanced or metastatic&#xD;
             prostate cancer scheduled to receive androgen deprivation therapy as monotherapy or as&#xD;
             concomitant and adjuvant therapy in association with radiation therapy, with a 1 or 3&#xD;
             month GnRH analogue triptorelin formulation&#xD;
&#xD;
          -  Expected survival &gt; 12 months.&#xD;
&#xD;
          -  Patients having provided written informed consent.&#xD;
&#xD;
          -  Patients mentally fit for completing a questionnaire.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Treatment with any investigational drug within the last 3 months before study entry or&#xD;
             planning to participate in a study.&#xD;
&#xD;
          -  Patients who already have been treated with a GnRH analogue within the last year.&#xD;
&#xD;
          -  Patients with hypersensitivity to GnRH, GnRH analogue, triptorelin or its excipients.&#xD;
&#xD;
          -  Patients with a contraindication according to SmPC.&#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>
      <address>
        <city>Arad</city>
        <country>Romania</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Bucharest</city>
        <country>Romania</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Cluj-Napoca</city>
        <country>Romania</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Constanta</city>
        <country>Romania</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Craiova</city>
        <country>Romania</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Iasi</city>
        <country>Romania</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Timisoara</city>
        <country>Romania</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Romania</country>
  </location_countries>
  <verification_date>July 2019</verification_date>
  <study_first_submitted>September 2, 2014</study_first_submitted>
  <study_first_submitted_qc>September 10, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 12, 2014</study_first_posted>
  <last_update_submitted>July 24, 2019</last_update_submitted>
  <last_update_submitted_qc>July 24, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">July 25, 2019</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>
  </intervention_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02238366
org study id: A-38-52014-213
nct id: NCT02238366
lead sponsor: 
has dmc: No
The purpose of this study is to collect some parameters which may help to provide guidance on
      how Androgen Deprivation Therapy (ADT) drugs are renewed and physician satisfaction.
observational model: Cohort
time perspective: Prospective
measure: Percentage of patients for whom the initial Gonadotropin-releasing Hormone (GnRH) analogue formulation has been renewed.
time frame: 1 month
description: To evaluate the percentage of patients for whom the initial GnRH analogue formulation has been renewed at 1-month +/- 7 days for Diphereline 3.75mg.
measure: Percentage of patients for whom the initial GnRH analogue formulation has been renewed.
time frame: 3 months
description: To evaluate the percentage of patients for whom the initial GnRH analogue formulation has been renewed at at 3-months +/- 10 days for Diphereline PR 11.25mg (Visit 2).
measure: Percentage of patients for whom the initial GnRH analogue formulation has been renewed at each follow up visit
time frame: 6 and 12 months
description: To evaluate the percentage of patients for whom the initial GnRH formulation (triptorelin-Diphereline®) had been renewed at each follow up visit [Visit 3 (at 6-months +/- 3 weeks), Visit 4 (at 12-months +/- 6 weeks)].
measure: Percentage of patients that switched from a 1-month to a 3-months formulation
time frame: 3, 6, 12 months
description: To evaluate the percentage of patients having switched from a 1-month to a 3-months formulation at each visit [Visit 2 (at 1 month or 3 months), Visit 3 (at 6 months +/- 3 weeks), Visit 4 (at 12 months +/- 6 weeks)].
arm group label: Prostate cancer patients
description: Patients recently diagnosed with prostate cancer requiring ADT.
intervention type: Drug
intervention name: triptorelin
description: This is an observational study. Thus, the treatment selection with triptorelin (Diphereline® or Diphereline PR®) is at investigator's discretion based on the current practice principles and guidelines/protocols, in accordance with the Summary of Product Characteristics (SmPC) approved in Romania by the National Medicines Agency.
arm group label: Prostate cancer patients
other name: Diphereline 3.75mg or Diphereline PR (prolonged release) 11.25mg intramuscular (IM.) Injection
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
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: Romania
responsible party type: Sponsor
mesh term: Prostatic Neoplasms
mesh term: Triptorelin Pamoate