<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/NCT02236637</url>
  </required_header>
  <id_info>
    <org_study_id>CR100857</org_study_id>
    <secondary_id>212082PCR4001</secondary_id>
    <nct_id>NCT02236637</nct_id>
  </id_info>
  <brief_title>A Registry to Observe the Treatment of Prostate Cancer Under Routine Medical Care</brief_title>
  <official_title>A Prospective Registry of Patients With a Confirmed Diagnosis of Adenocarcinoma of the Prostate Presenting With Metastatic Castrate-Resistant Prostate Cancer</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Janssen Pharmaceutica N.V., Belgium</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Janssen Pharmaceutica N.V., Belgium</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this registry is to document the characteristics and management of patients&#xD;
      with metastatic castrate resistant prostate cancer (mCRPC) in routine clinical practice,&#xD;
      independent of treatment used. Given the rapidly evolving landscape in mCRPC treatments,&#xD;
      there is a need for a current and improved understanding of how these treatments fit into the&#xD;
      current treatment paradigm for mCRPC, how they are combined and sequenced, and how their&#xD;
      relative effectiveness profiles emerge outside of a clinical trial setting. This will be&#xD;
      based on documentation and description of sequencing of treatment initiation, termination,&#xD;
      and duration; relative effectiveness of treatments; defined medical resource utilization&#xD;
      (MRU) and quality-of-life parameters and follow-up for survival.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a non-interventional, multicenter, prospective registry of patients with a confirmed&#xD;
      diagnosis of adenocarcinoma of the prostate presenting with mCRPC, based on documented&#xD;
      metastatic prostate cancer and documented castration resistance. Castrate-resistant prostate&#xD;
      cancer is defined by disease progression despite testosterone &lt;50 ng/dL, and/or androgen&#xD;
      deprivation therapy, and/or a history of orchiectomy, and may present as a continuous rise in&#xD;
      prostate-specific antigen (PSA), and/or worsening of existing disease/symptoms, and/or the&#xD;
      appearance of new metastases. Observational methodology will be used to capture data. The&#xD;
      decision of patients to take part in the registry will not influence their medical care.&#xD;
      Treatment decisions will be made at the discretion of the treating physician, per routine&#xD;
      clinical practice. Only data available from routine clinical practice will be collected. It&#xD;
      is expected that approximately 3,000 patients will participate in this registry. To ensure a&#xD;
      patient population representative of clinical practice and to reduce selection bias, all&#xD;
      patients meeting the eligibility criteria at a participating site should be consecutively&#xD;
      enrolled in the registry, irrespective of their treatment. The planned total duration of the&#xD;
      registry will be 5.5 years from the date that the first patient is enrolled, irrespective of&#xD;
      the country or registry site. The anticipated duration of patient enrollment is 2.5 years.&#xD;
      The maximum duration of follow-up for individual patients in the observational period of the&#xD;
      registry will be 3 years, regardless of when they are enrolled. The 3-year period of the&#xD;
      observational period will document the sequencing of systemic mCRPC treatments during routine&#xD;
      clinical practice, considering the life expectancy of patients with mCRPC in the registry.&#xD;
      Unless specified otherwise per local regulations, all patients must give their informed&#xD;
      consent to participate in this registry before data collection (ie, data entry into the case&#xD;
      report form [CRF]) is performed. Patients will be enrolled at the time of initiation of a new&#xD;
      systemic mCRPC treatment or during a period when a patient is considered to be in&#xD;
      surveillance according to clinical practice. Baseline data collection will include details of&#xD;
      the patient's prostate cancer history and prior prostate cancer treatment. This will be&#xD;
      followed by a prospective observational period during which patients may cycle through&#xD;
      multiple systemic mCRPC treatment periods and periods of surveillance. During the&#xD;
      observational period, data will be collected at the following time points of a patient's&#xD;
      course of treatment in routine clinical practice: initiation of a new systemic mCRPC&#xD;
      treatment; termination of a systemic mCRPC treatment; when the duration of a systemic mCRPC&#xD;
      treatment or surveillance period is &gt;3 months, data collection will be performed at a minimum&#xD;
      frequency of 3-monthly intervals during that period. Survival data will be collected for all&#xD;
      patients 3 years after their enrollment or at the close of the registry, whichever occurs&#xD;
      first, except for those patients who withdraw their consent prior to completing the&#xD;
      observation period.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 14, 2013</start_date>
  <completion_date type="Actual">November 21, 2018</completion_date>
  <primary_completion_date type="Actual">November 21, 2018</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>Sequencing of treatment initiation, termination, and duration</measure>
    <time_frame>At baseline, at treatment initiation/termination and at least every 3 months during maximum 3 years</time_frame>
    <description>During the registry all systemic mCRPC therapies, corticoids for systemic use in the context of prostate cancer treatment and local mCRPC therapies, including but not limited to urologic surgery, orthopaedic surgery, and local radiotherapy, will be documented.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Clinical Benefit</measure>
    <time_frame>At baseline, at treatment initiation/termination and at least every 3 months during maximum 3 years</time_frame>
    <description>Clinical benefit will be based on the Eastern Cooperative Oncology Group (ECOG) performance status, which measure the patient status on a scale from 0 (fully active) to 5 (dead).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Medical Resource Utilization</measure>
    <time_frame>At baseline, at treatment initiation/termination and at least every 3 months during maximum 3 years</time_frame>
    <description>Total number of days of hospitalization due to prostate cancer, or treatment of the disease, total number of visits to an emergency room due to prostate cancer, or treatment of the disease, and total number of outpatient visits due to prostate cancer, or treatment of the disease</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>European Quality of Life-5 Dimensions, 5 Levels Questionnaire (EQ-5D-(5L))</measure>
    <time_frame>At baseline, at treatment initiation/termination and at least every 3 months during maximum 3 years</time_frame>
    <description>The EQ-5D-5L is an instrument for measuring health status. It consists of the descriptive system and the EQ visual Analogue scale (EQ VAS). The descriptive system comprises the same 5 dimensions (mobility, self care, usual activities, pain/discomfort, and anxiety/depression). There are 5 levels for each dimension: no problems, slight problems, moderate problems, severe problems, and extreme problems. The EQ VAS records the respondent's self-rated health on a 20 cm vertical, visual analogue scale with endpoints labeled 'the best health you can imagine' and 'the worst health you can imagine'.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Functional Assessment of Cancer Therapy - Prostate Cancer (FACT-P)</measure>
    <time_frame>At baseline, at treatment initiation/termination and at least every 3 months during maximum 3 years</time_frame>
    <description>The FACT-P consists of the FACT-General (FACT-G) and a prostate cancer subscale. The FACT-G (Version 4) contains a 27-item questionnaire and is composed of 4 subscales of health-related quality-of-life: physical well-being, social/family well-being, emotional well being, and functional well-being. The prostate cancer subscale is composed of 12 items, related to prostate-specific questions, which include sexuality, bowel/bladder function, and pain. The score for each of the 39 questions ranges from 0 to 4. The total FACT-P score thus ranges from 0 to 156; a higher score indicates better QOL</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Overall Survival</measure>
    <time_frame>At treatment initiation/termination or every 3 months from baseline to 3 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Radiologic Assessment</measure>
    <time_frame>At baseline, at treatment initiation/termination and at least every 3 months during maximum 3 years</time_frame>
    <description>Radiologic assessment methodology and radiologic response will be documented. Prostate Cancer Working Group 2 (PCWG2) and Response Evaluation Criteria In Solid Tumor (RECIST) are recommended guidelines for assessment.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Prior prostate cancer treatment</measure>
    <time_frame>At baseline</time_frame>
    <description>Prior prostate cancer treatment (local and systemic therapy) from the time of diagnosis of prostate cancer to entry in the registry will be recorded.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Reason for start and rationale for choice of treatment</measure>
    <time_frame>At treatment initiation during maximum 3 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Reason for treatment discontinuation</measure>
    <time_frame>At treatment discontinuation during maximum 3 years</time_frame>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">3050</enrollment>
  <condition>Prostate Cancer</condition>
  <arm_group>
    <arm_group_label>mCRPC patients</arm_group_label>
    <description>Patients with metastatic castration-resistant prostate cancer treated according to routine clinical practice</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        Approximately 3,000 patients will be enrolled in this registry. Patients eligible for&#xD;
        enrollment will be men aged at least 18 years, with a confirmed diagnosis of adenocarcinoma&#xD;
        of the prostate, with documented metastatic prostate cancer and documented castration&#xD;
        resistance. Patients will be enrolled at the time of initiating a new systemic anticancer&#xD;
        mCRPC treatment or during surveillance; for the purpose of the registry, at enrollment,&#xD;
        initiation of a new systemic mCRPC treatment is considered as ±30 days from a patient's&#xD;
        baseline data collection.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Patients with a histologically or cytologically confirmed diagnosis of adenocarcinoma of&#xD;
        the prostate Patients with documented metastatic prostate cancer Patients with documented&#xD;
        castration resistance Patients either: Initiating a new systemic mCRPC treatment; or&#xD;
        considered to be in surveillance according to clinical practice Sign (or their&#xD;
        legally-acceptable representatives must sign) a participation agreement or informed consent&#xD;
        form (ICF), per local regulations.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Any patient who is withdrawn from the registry for any reason may not re-enter the registry&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <address>
        <city>Salzburg</city>
        <country>Austria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Vienna</city>
        <country>Austria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Aalst</city>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Antwerpen</city>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Bonheiden</city>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Brasschaat</city>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Brugge</city>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Edegem</city>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Gent</city>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Kortrijk</city>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Liège</city>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Oostende</city>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Ottignies</city>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Roeselare</city>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Turnhout</city>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Angers</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Avignon Cedex 9</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Brest</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Béziers</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>GAP</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Hyeres</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>La Tronche</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Marseille</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Metz</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Montpellier</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Nancy</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Paris</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Perigueux</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Pierre Benite Cedex</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Pringy</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Reims Cedex</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Rennes cedex 09</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Saint Mande</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>St Gregoire Cedex</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>St Quentin Cedex</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Toulouse</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Tours Cedex</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Augsburg</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Bad Saarow</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Bautzen</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Berlin</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Braunschweig</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Chemnitz</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Duisburg</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Erkrath</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Frankfurt</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Hamburg</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Holzminden</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Jena</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Kiel</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Kirchheim</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Nürtingen</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Remscheid</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Reutlingen</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Rostock</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Schwerin</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Sindelfingen</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Tübingen</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Ulm</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Weiden</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Wilhelmshaven</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Würselen</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Beer Sheva</city>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Beer Yaakov</city>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Haifa</city>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Holon</city>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Tel-Aviv</city>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Luxembourg</city>
        <country>Luxembourg</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Niederkorn</city>
        <country>Luxembourg</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Bydgoszcz</city>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Gdynia</city>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Krakow</city>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Lodz</city>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Opole</city>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Poznañ</city>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Warsaw</city>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Warszawa</city>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Braga</city>
        <country>Portugal</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Coimbra</city>
        <country>Portugal</country>
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    <facility>
      <address>
        <city>Evora</city>
        <country>Portugal</country>
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    <facility>
      <address>
        <city>Lisboa</city>
        <country>Portugal</country>
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    <facility>
      <address>
        <city>Porto</city>
        <country>Portugal</country>
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        <city>Setubal</city>
        <country>Portugal</country>
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      <address>
        <city>Ekaterinbourg</city>
        <country>Russian Federation</country>
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    <facility>
      <address>
        <city>Moscow N/a</city>
        <country>Russian Federation</country>
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    <facility>
      <address>
        <city>Obninsk</city>
        <country>Russian Federation</country>
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    <facility>
      <address>
        <city>Omsk</city>
        <country>Russian Federation</country>
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    <facility>
      <address>
        <city>Rostov-on-Don</city>
        <country>Russian Federation</country>
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    <facility>
      <address>
        <city>St.-Petersburg</city>
        <country>Russian Federation</country>
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    <facility>
      <address>
        <city>Ufa</city>
        <country>Russian Federation</country>
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        <city>Celje</city>
        <country>Slovenia</country>
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      <address>
        <city>Ljubljana</city>
        <country>Slovenia</country>
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    <facility>
      <address>
        <city>Slovenj Gradec</city>
        <country>Slovenia</country>
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    <facility>
      <address>
        <city>Asturias</city>
        <country>Spain</country>
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    <facility>
      <address>
        <city>Barakaldo Vizcaya</city>
        <country>Spain</country>
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    </facility>
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    <facility>
      <address>
        <city>Barcelona</city>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Bilbao Vizcaya</city>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Girona</city>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>La Coruña</city>
        <country>Spain</country>
      </address>
    </facility>
  </location>
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    <facility>
      <address>
        <city>Langreo</city>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Palma De Mallorca</city>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Pontevedra</city>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Sabadell</city>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Salamanca</city>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Santiago de Compostela</city>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Valladolid</city>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Zaragoza</city>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Borås</city>
        <country>Sweden</country>
      </address>
    </facility>
  </location>
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    <facility>
      <address>
        <city>Göteborg</city>
        <country>Sweden</country>
      </address>
    </facility>
  </location>
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    <facility>
      <address>
        <city>Malmö</city>
        <country>Sweden</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Stockholm</city>
        <country>Sweden</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Umeå</city>
        <country>Sweden</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Västerås</city>
        <country>Sweden</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Växjö</city>
        <country>Sweden</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Örebro</city>
        <country>Sweden</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Östersund</city>
        <country>Sweden</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Aarau</city>
        <country>Switzerland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Winterthur</city>
        <country>Switzerland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Ankara</city>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Edirne</city>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Istanbul</city>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Izmir</city>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Kayseri</city>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Kocaeli</city>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Turkey</city>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Ashton Under Lyne</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Barnstaple</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Blackburn</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Bournemouth</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Bradford</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Brighton Sussex</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Burton</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Crewe</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Huddersfield</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Lancaster</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Leeds Yorks</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>London</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>N/a N/a</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Plymouth</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Scunthorpe</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Steeton</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Stoke On Trent</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Taunton</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Torquay</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Wakefield</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Wigan</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>York</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Austria</country>
    <country>Belgium</country>
    <country>France</country>
    <country>Germany</country>
    <country>Israel</country>
    <country>Luxembourg</country>
    <country>Poland</country>
    <country>Portugal</country>
    <country>Russian Federation</country>
    <country>Slovenia</country>
    <country>Spain</country>
    <country>Sweden</country>
    <country>Switzerland</country>
    <country>Turkey</country>
    <country>United Kingdom</country>
  </location_countries>
  <removed_countries>
    <country>Italy</country>
  </removed_countries>
  <verification_date>November 2019</verification_date>
  <study_first_submitted>September 8, 2014</study_first_submitted>
  <study_first_submitted_qc>September 9, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 10, 2014</study_first_posted>
  <last_update_submitted>November 7, 2019</last_update_submitted>
  <last_update_submitted_qc>November 7, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">November 12, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Adenocarcinoma of the Prostate</keyword>
  <keyword>Registry</keyword>
  <keyword>metastatic castration-resistant prostate cancer</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Prostatic Neoplasms</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02236637
org study id: CR100857
secondary id: 212082PCR4001
nct id: NCT02236637
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The purpose of this registry is to document the characteristics and management of patients
      with metastatic castrate resistant prostate cancer (mCRPC) in routine clinical practice,
      independent of treatment used. Given the rapidly evolving landscape in mCRPC treatments,
      there is a need for a current and improved understanding of how these treatments fit into the
      current treatment paradigm for mCRPC, how they are combined and sequenced, and how their
      relative effectiveness profiles emerge outside of a clinical trial setting. This will be
      based on documentation and description of sequencing of treatment initiation, termination,
      and duration; relative effectiveness of treatments; defined medical resource utilization
      (MRU) and quality-of-life parameters and follow-up for survival.
This is a non-interventional, multicenter, prospective registry of patients with a confirmed
      diagnosis of adenocarcinoma of the prostate presenting with mCRPC, based on documented
      metastatic prostate cancer and documented castration resistance. Castrate-resistant prostate
      cancer is defined by disease progression despite testosterone <50 ng/dL, and/or androgen
      deprivation therapy, and/or a history of orchiectomy, and may present as a continuous rise in
      prostate-specific antigen (PSA), and/or worsening of existing disease/symptoms, and/or the
      appearance of new metastases. Observational methodology will be used to capture data. The
      decision of patients to take part in the registry will not influence their medical care.
      Treatment decisions will be made at the discretion of the treating physician, per routine
      clinical practice. Only data available from routine clinical practice will be collected. It
      is expected that approximately 3,000 patients will participate in this registry. To ensure a
      patient population representative of clinical practice and to reduce selection bias, all
      patients meeting the eligibility criteria at a participating site should be consecutively
      enrolled in the registry, irrespective of their treatment. The planned total duration of the
      registry will be 5.5 years from the date that the first patient is enrolled, irrespective of
      the country or registry site. The anticipated duration of patient enrollment is 2.5 years.
      The maximum duration of follow-up for individual patients in the observational period of the
      registry will be 3 years, regardless of when they are enrolled. The 3-year period of the
      observational period will document the sequencing of systemic mCRPC treatments during routine
      clinical practice, considering the life expectancy of patients with mCRPC in the registry.
      Unless specified otherwise per local regulations, all patients must give their informed
      consent to participate in this registry before data collection (ie, data entry into the case
      report form [CRF]) is performed. Patients will be enrolled at the time of initiation of a new
      systemic mCRPC treatment or during a period when a patient is considered to be in
      surveillance according to clinical practice. Baseline data collection will include details of
      the patient's prostate cancer history and prior prostate cancer treatment. This will be
      followed by a prospective observational period during which patients may cycle through
      multiple systemic mCRPC treatment periods and periods of surveillance. During the
      observational period, data will be collected at the following time points of a patient's
      course of treatment in routine clinical practice: initiation of a new systemic mCRPC
      treatment; termination of a systemic mCRPC treatment; when the duration of a systemic mCRPC
      treatment or surveillance period is >3 months, data collection will be performed at a minimum
      frequency of 3-monthly intervals during that period. Survival data will be collected for all
      patients 3 years after their enrollment or at the close of the registry, whichever occurs
      first, except for those patients who withdraw their consent prior to completing the
      observation period.
observational model: Cohort
time perspective: Prospective
measure: Sequencing of treatment initiation, termination, and duration
time frame: At baseline, at treatment initiation/termination and at least every 3 months during maximum 3 years
description: During the registry all systemic mCRPC therapies, corticoids for systemic use in the context of prostate cancer treatment and local mCRPC therapies, including but not limited to urologic surgery, orthopaedic surgery, and local radiotherapy, will be documented.
measure: Clinical Benefit
time frame: At baseline, at treatment initiation/termination and at least every 3 months during maximum 3 years
description: Clinical benefit will be based on the Eastern Cooperative Oncology Group (ECOG) performance status, which measure the patient status on a scale from 0 (fully active) to 5 (dead).
measure: Medical Resource Utilization
time frame: At baseline, at treatment initiation/termination and at least every 3 months during maximum 3 years
description: Total number of days of hospitalization due to prostate cancer, or treatment of the disease, total number of visits to an emergency room due to prostate cancer, or treatment of the disease, and total number of outpatient visits due to prostate cancer, or treatment of the disease
measure: European Quality of Life-5 Dimensions, 5 Levels Questionnaire (EQ-5D-(5L))
time frame: At baseline, at treatment initiation/termination and at least every 3 months during maximum 3 years
description: The EQ-5D-5L is an instrument for measuring health status. It consists of the descriptive system and the EQ visual Analogue scale (EQ VAS). The descriptive system comprises the same 5 dimensions (mobility, self care, usual activities, pain/discomfort, and anxiety/depression). There are 5 levels for each dimension: no problems, slight problems, moderate problems, severe problems, and extreme problems. The EQ VAS records the respondent's self-rated health on a 20 cm vertical, visual analogue scale with endpoints labeled 'the best health you can imagine' and 'the worst health you can imagine'.
measure: Functional Assessment of Cancer Therapy - Prostate Cancer (FACT-P)
time frame: At baseline, at treatment initiation/termination and at least every 3 months during maximum 3 years
description: The FACT-P consists of the FACT-General (FACT-G) and a prostate cancer subscale. The FACT-G (Version 4) contains a 27-item questionnaire and is composed of 4 subscales of health-related quality-of-life: physical well-being, social/family well-being, emotional well being, and functional well-being. The prostate cancer subscale is composed of 12 items, related to prostate-specific questions, which include sexuality, bowel/bladder function, and pain. The score for each of the 39 questions ranges from 0 to 4. The total FACT-P score thus ranges from 0 to 156; a higher score indicates better QOL
measure: Overall Survival
time frame: At treatment initiation/termination or every 3 months from baseline to 3 years
measure: Radiologic Assessment
time frame: At baseline, at treatment initiation/termination and at least every 3 months during maximum 3 years
description: Radiologic assessment methodology and radiologic response will be documented. Prostate Cancer Working Group 2 (PCWG2) and Response Evaluation Criteria In Solid Tumor (RECIST) are recommended guidelines for assessment.
measure: Prior prostate cancer treatment
time frame: At baseline
description: Prior prostate cancer treatment (local and systemic therapy) from the time of diagnosis of prostate cancer to entry in the registry will be recorded.
measure: Reason for start and rationale for choice of treatment
time frame: At treatment initiation during maximum 3 years
measure: Reason for treatment discontinuation
time frame: At treatment discontinuation during maximum 3 years
arm group label: mCRPC patients
description: Patients with metastatic castration-resistant prostate cancer treated according to routine clinical practice
study pop: 
sampling method: Probability Sample
criteria: 
gender: Male
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
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country: Austria
country: Belgium
country: France
country: Germany
country: Israel
country: Luxembourg
country: Poland
country: Portugal
country: Russian Federation
country: Slovenia
country: Spain
country: Sweden
country: Switzerland
country: Turkey
country: United Kingdom
country: Italy
responsible party type: Sponsor
mesh term: Prostatic Neoplasms