<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/NCT02230059</url>
  </required_header>
  <id_info>
    <org_study_id>CR100943</org_study_id>
    <secondary_id>212082PCR0001</secondary_id>
    <nct_id>NCT02230059</nct_id>
  </id_info>
  <brief_title>Study to Assess the Treatment Patterns in Metastatic Castration-Resistance Prostate Cancer (mCRPC)</brief_title>
  <acronym>REALIST-PRO</acronym>
  <official_title>Treatment Patterns in Metastatic Castration-Resistance Prostate Cancer (mCRPC): Real Life Analysis In Brazilian Oncology Centers (REALIST-PRO)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Janssen Research &amp; Development, LLC</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Janssen Research &amp; Development, LLC</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to assess the treatment patterns in participants with metastatic&#xD;
      castration-resistant prostate cancer (mCRPC). Additionally, participant's demographic and&#xD;
      clinical characteristics, skeletal-related events, criteria used to define CRPC, prostate&#xD;
      specific antigen (PSA) levels and pain related to disease and overall survival will be&#xD;
      observed.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is an observational (study in which participants identified as belonging to study groups&#xD;
      are assessed for biomedical or health outcomes), longitudinal (correlational research study&#xD;
      that involves repeated observations of the same variables over long periods of time) and&#xD;
      retrospective (study looking back over past experience) study to describe the treatment&#xD;
      patterns in mCRPC. Treatment patterns will be assessed by collecting medical charts from&#xD;
      participants diagnosed with mCRPC in or prior 2009. Primarily, percentage of participants who&#xD;
      received therapy as first line treatment will be assessed. All adverse events associated with&#xD;
      the use of Sponsor drugs will be reported.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>July 2013</start_date>
  <completion_date type="Actual">May 2014</completion_date>
  <primary_completion_date type="Actual">May 2014</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>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Percentage of Participants Treated With Chemotherapy in First Line Therapy</measure>
    <time_frame>Day 1</time_frame>
    <description>Participants treated with chemotherapy in first line therapy will be reported.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Percentage of Participants Treated With Other Therapies in First Line Therapy</measure>
    <time_frame>Day 1</time_frame>
    <description>Participants treated with other therapies including secondary hormone therapy, steroids, radiation therapy, radionuclide therapy, bisphosphonates and best supportive care in first line therapy will be reported.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Percentage of Participants Treated With Chemotherapy in Second Line Therapy</measure>
    <time_frame>Day 1</time_frame>
    <description>Participants who were treated with chemotherapy in second line therapy will be reported.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Percentage of Participants Treated With Other Therapies in Second Line Therapy</measure>
    <time_frame>Day 1</time_frame>
    <description>Participants treated with other therapies including secondary hormone therapy, steroids, radiation therapy, radionuclide therapy, bisphosphonates and best supportive care in second line therapy will be reported.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Eastern Cooperative Oncology Group (ECOG) Performance Status</measure>
    <time_frame>Day 1</time_frame>
    <description>ECOG performance status is a scale that measures how cancer affects the daily life of a participant on an ordinal scale from grade 0 (best) to grade 5 (worst).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants with Comorbidities</measure>
    <time_frame>Day 1</time_frame>
    <description>Participants with comorbidities such as hypertension, diabetes, cardiac diseases, congestive cardiac failure, thyroid diseases and stroke will be reported.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Blood Prostate Specific Antigen (PSA) levels</measure>
    <time_frame>Day 1</time_frame>
    <description>Blood PSA levels will be reported.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of participants With Bone or Visceral Metastasis</measure>
    <time_frame>Day 1</time_frame>
    <description>Participants with bone or visceral metastasis will be reported.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Assessment of Pain Related With Disease</measure>
    <time_frame>Day 1</time_frame>
    <description>Pain will be assessed by reviewing the charts having information regarding pain (bone or other sites).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Gleason score</measure>
    <time_frame>Day 1</time_frame>
    <description>Gleason scoring is used to grade tumors. A primary grade is assigned to the most common tumor pattern (how the cancer cells look under a microscope), and a second grade to the next most common pattern. The two grades are added together to get a GS. Gleason grade range= 1-5; 5=worst prognosis. GS range=2-10; 10=worst prognosis. Improvement is defined as a decrease in GS from a Baseline score of 6 (GS&lt;=6; includes no cancer); worsening is defined as an increase in GS from a baseline score of 6 (GS &gt;6).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants With Skeletal Related Events (SREs)</measure>
    <time_frame>Day 1</time_frame>
    <description>SREs include vertebral collapse, bone fractures, spinal cord compression, bone surgery and radiotherapy for bone complications.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants who were used to define mCRPC Criteria</measure>
    <time_frame>Day 1</time_frame>
    <description>Participants with criteria used to define mCRPC as described by European Association of Urology (EAU) International Guidelines will be reported.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants Who Received Therapies After Second Line</measure>
    <time_frame>Day 1</time_frame>
    <description>Participants who received therapies after second line will be reported.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Overall Survival</measure>
    <time_frame>Day 1</time_frame>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">382</enrollment>
  <condition>Prostatic Neoplasms</condition>
  <arm_group>
    <arm_group_label>Metastatic Castration-resistant Prostate Cancer</arm_group_label>
    <description>Medical charts of participants with metastatic castration-resistant prostate cancer will be observed.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>No Intervention</intervention_name>
    <description>Medical charts of participants with metastatic castration-resistant prostate cancer will be observed.</description>
    <arm_group_label>Metastatic Castration-resistant Prostate Cancer</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Male participants with history of prostatic cancer and metastatic castration-resistant&#xD;
        prostate cancer (mCRPC) from Brazil will be assessed.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Histologically or cytologically confirmed adenocarcinoma of the prostate&#xD;
&#xD;
          -  Report of previous surgical or medical castration&#xD;
&#xD;
          -  Castration-resistant prostate cancer (CRPC) diagnosis in or before 2009&#xD;
&#xD;
          -  Metastatic disease documented by positive bone scan or metastatic lesions on computed&#xD;
             tomography or magnetic resonance imaging in or before 2009. If lymph node metastasis&#xD;
             is the only evidence of metastasis, it must be 2 centimeters (cm) in diameter&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Participation in any investigational drug or device study or early access programme&#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>Janssen Research &amp; Development, LLC Clinical Trial</last_name>
    <role>Study Director</role>
    <affiliation>Janssen Research &amp; Development, LLC</affiliation>
  </overall_official>
  <location>
    <facility>
      <address>
        <city>Brasilia</city>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Curitiba</city>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Distrito Federal</city>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Florianopolis</city>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Goiania</city>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Ijuí</city>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Jau</city>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Porto Alegre</city>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Rio De Janeiro</city>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Sao Paulo</city>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Brazil</country>
  </location_countries>
  <verification_date>September 2014</verification_date>
  <study_first_submitted>August 29, 2014</study_first_submitted>
  <study_first_submitted_qc>August 29, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 3, 2014</study_first_posted>
  <last_update_submitted>September 24, 2014</last_update_submitted>
  <last_update_submitted_qc>September 24, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">September 25, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Prostatic Neoplasms</keyword>
  <keyword>observational Study</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/NCT02230059
org study id: CR100943
secondary id: 212082PCR0001
nct id: NCT02230059
lead sponsor: 
has dmc: No
The purpose of this study is to assess the treatment patterns in participants with metastatic
      castration-resistant prostate cancer (mCRPC). Additionally, participant's demographic and
      clinical characteristics, skeletal-related events, criteria used to define CRPC, prostate
      specific antigen (PSA) levels and pain related to disease and overall survival will be
      observed.
This is an observational (study in which participants identified as belonging to study groups
      are assessed for biomedical or health outcomes), longitudinal (correlational research study
      that involves repeated observations of the same variables over long periods of time) and
      retrospective (study looking back over past experience) study to describe the treatment
      patterns in mCRPC. Treatment patterns will be assessed by collecting medical charts from
      participants diagnosed with mCRPC in or prior 2009. Primarily, percentage of participants who
      received therapy as first line treatment will be assessed. All adverse events associated with
      the use of Sponsor drugs will be reported.
observational model: Cohort
time perspective: Retrospective
measure: Percentage of Participants Treated With Chemotherapy in First Line Therapy
time frame: Day 1
description: Participants treated with chemotherapy in first line therapy will be reported.
measure: Percentage of Participants Treated With Other Therapies in First Line Therapy
time frame: Day 1
description: Participants treated with other therapies including secondary hormone therapy, steroids, radiation therapy, radionuclide therapy, bisphosphonates and best supportive care in first line therapy will be reported.
measure: Percentage of Participants Treated With Chemotherapy in Second Line Therapy
time frame: Day 1
description: Participants who were treated with chemotherapy in second line therapy will be reported.
measure: Percentage of Participants Treated With Other Therapies in Second Line Therapy
time frame: Day 1
description: Participants treated with other therapies including secondary hormone therapy, steroids, radiation therapy, radionuclide therapy, bisphosphonates and best supportive care in second line therapy will be reported.
measure: Eastern Cooperative Oncology Group (ECOG) Performance Status
time frame: Day 1
description: ECOG performance status is a scale that measures how cancer affects the daily life of a participant on an ordinal scale from grade 0 (best) to grade 5 (worst).
measure: Number of Participants with Comorbidities
time frame: Day 1
description: Participants with comorbidities such as hypertension, diabetes, cardiac diseases, congestive cardiac failure, thyroid diseases and stroke will be reported.
measure: Blood Prostate Specific Antigen (PSA) levels
time frame: Day 1
description: Blood PSA levels will be reported.
measure: Number of participants With Bone or Visceral Metastasis
time frame: Day 1
description: Participants with bone or visceral metastasis will be reported.
measure: Assessment of Pain Related With Disease
time frame: Day 1
description: Pain will be assessed by reviewing the charts having information regarding pain (bone or other sites).
measure: Number of Participants With Gleason score
time frame: Day 1
description: Gleason scoring is used to grade tumors. A primary grade is assigned to the most common tumor pattern (how the cancer cells look under a microscope), and a second grade to the next most common pattern. The two grades are added together to get a GS. Gleason grade range= 1-5; 5=worst prognosis. GS range=2-10; 10=worst prognosis. Improvement is defined as a decrease in GS from a Baseline score of 6 (GS<=6; includes no cancer); worsening is defined as an increase in GS from a baseline score of 6 (GS >6).
measure: Percentage of Participants With Skeletal Related Events (SREs)
time frame: Day 1
description: SREs include vertebral collapse, bone fractures, spinal cord compression, bone surgery and radiotherapy for bone complications.
measure: Number of Participants who were used to define mCRPC Criteria
time frame: Day 1
description: Participants with criteria used to define mCRPC as described by European Association of Urology (EAU) International Guidelines will be reported.
measure: Percentage of Participants Who Received Therapies After Second Line
time frame: Day 1
description: Participants who received therapies after second line will be reported.
measure: Overall Survival
time frame: Day 1
arm group label: Metastatic Castration-resistant Prostate Cancer
description: Medical charts of participants with metastatic castration-resistant prostate cancer will be observed.
intervention type: Other
intervention name: No Intervention
description: Medical charts of participants with metastatic castration-resistant prostate cancer will be observed.
arm group label: Metastatic Castration-resistant Prostate Cancer
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: Male
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Janssen Research & Development, LLC Clinical Trial
role: Study Director
affiliation: Janssen Research & Development, LLC
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: Brazil
responsible party type: Sponsor
mesh term: Prostatic Neoplasms