<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/NCT03035500</url>
  </required_header>
  <id_info>
    <org_study_id>07101</org_study_id>
    <secondary_id>NCI-2017-00090</secondary_id>
    <secondary_id>07101</secondary_id>
    <nct_id>NCT03035500</nct_id>
  </id_info>
  <brief_title>Long-Term Follow-Up in Patients With Prostate Cancer After Surgery</brief_title>
  <official_title>Long-term Follow-up After Prostate Cancer</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>City of Hope Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Cancer Institute (NCI)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>City of Hope Medical Center</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This clinical trial studies how well a long-term follow-up works in patients with prostate&#xD;
      cancer after surgery. Long-term follow-up data may serve as a resource to help ask clinical&#xD;
      questions, describe health-related quality of life and long-term complications related, and&#xD;
      facilitate future studies focusing on interventions to improve health status and&#xD;
      health-related quality of life in prostate cancer survivors.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      PRIMARY OBJECTIVES:&#xD;
&#xD;
      I. To provide comprehensive long-term follow-up care to prostate cancer survivors at the City&#xD;
      of Hope who underwent definitive surgical therapy.&#xD;
&#xD;
      II. To use the information obtained from follow-up of prostate cancer survivors who underwent&#xD;
      definitive surgical therapy to serve as a resource that will help answer clinical questions,&#xD;
      generate and test hypotheses, describe the incidence of long-term complications, and&#xD;
      facilitate future studies focusing on interventions for long-term complications of prostate&#xD;
      cancer and its therapy.&#xD;
&#xD;
      III. To use the information gained from follow-up of prostate cancer survivors who underwent&#xD;
      definitive surgical therapy to describe health-related quality of life (HRQL) concerns and to&#xD;
      serve as a resource to facilitate future studies focusing on interventions to improve health&#xD;
      status and HRQL in prostate cancer survivors.&#xD;
&#xD;
      OUTLINE:&#xD;
&#xD;
      Patients undergo long-term follow-up and receive a written survivorship care plan including&#xD;
      comprehensive health evaluation and health education beginning 1 year post surgery.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">July 23, 2008</start_date>
  <completion_date type="Anticipated">December 30, 2023</completion_date>
  <primary_completion_date type="Anticipated">December 30, 2023</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>HRQL assessed using Expanded Prostate Cancer Index Composite</measure>
    <time_frame>Up to 10 years</time_frame>
    <description>Linear mixed effects models can be used to estimate long-term trends and examine the effects of baseline and concomitant factors on these trends.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>HRQL assessed using Sexual Health Inventory for Men</measure>
    <time_frame>Up to 10 years</time_frame>
    <description>Linear mixed effects models can be used to estimate long-term trends and examine the effects of baseline and concomitant factors on these trends.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Incidence rates of the study end-points</measure>
    <time_frame>Up to 10 years</time_frame>
    <description>Incidence rates of the study end-points that may be associated with original diagnosis or treatment received, and delineation of temporal changes in serial measurements and their relationship to time-invariant characteristics such as original diagnosis, race, and education and time-varying characteristics such as age and body mass index will be estimated. Incidence rates may be compared with national standards adjusted for key demographic variables and between patient subgroups.</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">2500</enrollment>
  <condition>Cancer Survivor</condition>
  <condition>Prostate Carcinoma</condition>
  <arm_group>
    <arm_group_label>Supportive Care (long-term follow-up)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients undergo long-term follow-up and receive a written survivorship care plan including comprehensive health evaluation and health education beginning 1 year post surgery.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Educational Intervention</intervention_name>
    <description>Receive health education</description>
    <arm_group_label>Supportive Care (long-term follow-up)</arm_group_label>
    <other_name>Education for Intervention</other_name>
    <other_name>Intervention by Education</other_name>
    <other_name>Intervention through Education</other_name>
    <other_name>Intervention, Educational</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Laboratory Biomarker Analysis</intervention_name>
    <description>Correlative studies</description>
    <arm_group_label>Supportive Care (long-term follow-up)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Long-term Follow-up</intervention_name>
    <description>Undergo long-term follow-up using survivorship care plan</description>
    <arm_group_label>Supportive Care (long-term follow-up)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Quality-of-Life Assessment</intervention_name>
    <description>Ancillary studies</description>
    <arm_group_label>Supportive Care (long-term follow-up)</arm_group_label>
    <other_name>Quality of Life Assessment</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Questionnaire Administration</intervention_name>
    <description>Ancillary studies</description>
    <arm_group_label>Supportive Care (long-term follow-up)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Diagnosis of prostate cancer&#xD;
&#xD;
          -  Treated with a definitive surgical procedure at City of Hope&#xD;
&#xD;
          -  At least one year post surgical treatment for prostate cancer&#xD;
&#xD;
          -  No history of recurrent, progressive, or metastatic disease&#xD;
&#xD;
          -  Currently stable disease or no evidence of disease&#xD;
&#xD;
          -  No prior treatment of prostate cancer with radiation or chemotherapy&#xD;
&#xD;
          -  No history of other urologic cancer (e.g., bladder cancer, renal cell carcinoma) in&#xD;
             addition to prostate cancer&#xD;
&#xD;
               -  Note: Patients who develop recurrence while participating in the Prostate Cancer&#xD;
                  Survivorship Clinic will be referred back to their urologist and may resume&#xD;
                  participation in the Survivorship Clinic when deemed appropriate by their&#xD;
                  treating physician&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Current treatment with testosterone replacement or androgen deprivation therapy&#xD;
&#xD;
          -  Treatment for another noncutaneous cancer within the past 2 years&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Saro Armenian, DO</last_name>
    <role>Principal Investigator</role>
    <affiliation>City of Hope Medical Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>City of Hope Medical Center</name>
      <address>
        <city>Duarte</city>
        <state>California</state>
        <zip>91010</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>August 2023</verification_date>
  <study_first_submitted>January 25, 2017</study_first_submitted>
  <study_first_submitted_qc>January 26, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 30, 2017</study_first_posted>
  <last_update_submitted>August 3, 2023</last_update_submitted>
  <last_update_submitted_qc>August 3, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">August 4, 2023</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/NCT03035500
org study id: 07101
secondary id: NCI-2017-00090
secondary id: 07101
nct id: NCT03035500
lead sponsor: 
collaborator: 
has dmc: Yes
This clinical trial studies how well a long-term follow-up works in patients with prostate
      cancer after surgery. Long-term follow-up data may serve as a resource to help ask clinical
      questions, describe health-related quality of life and long-term complications related, and
      facilitate future studies focusing on interventions to improve health status and
      health-related quality of life in prostate cancer survivors.
PRIMARY OBJECTIVES:

      I. To provide comprehensive long-term follow-up care to prostate cancer survivors at the City
      of Hope who underwent definitive surgical therapy.

      II. To use the information obtained from follow-up of prostate cancer survivors who underwent
      definitive surgical therapy to serve as a resource that will help answer clinical questions,
      generate and test hypotheses, describe the incidence of long-term complications, and
      facilitate future studies focusing on interventions for long-term complications of prostate
      cancer and its therapy.

      III. To use the information gained from follow-up of prostate cancer survivors who underwent
      definitive surgical therapy to describe health-related quality of life (HRQL) concerns and to
      serve as a resource to facilitate future studies focusing on interventions to improve health
      status and HRQL in prostate cancer survivors.

      OUTLINE:

      Patients undergo long-term follow-up and receive a written survivorship care plan including
      comprehensive health evaluation and health education beginning 1 year post surgery.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Supportive Care
masking: None (Open Label)
measure: HRQL assessed using Expanded Prostate Cancer Index Composite
time frame: Up to 10 years
description: Linear mixed effects models can be used to estimate long-term trends and examine the effects of baseline and concomitant factors on these trends.
measure: HRQL assessed using Sexual Health Inventory for Men
time frame: Up to 10 years
description: Linear mixed effects models can be used to estimate long-term trends and examine the effects of baseline and concomitant factors on these trends.
measure: Incidence rates of the study end-points
time frame: Up to 10 years
description: Incidence rates of the study end-points that may be associated with original diagnosis or treatment received, and delineation of temporal changes in serial measurements and their relationship to time-invariant characteristics such as original diagnosis, race, and education and time-varying characteristics such as age and body mass index will be estimated. Incidence rates may be compared with national standards adjusted for key demographic variables and between patient subgroups.
arm group label: Supportive Care (long-term follow-up)
arm group type: Experimental
description: Patients undergo long-term follow-up and receive a written survivorship care plan including comprehensive health evaluation and health education beginning 1 year post surgery.
intervention type: Other
intervention name: Educational Intervention
description: Receive health education
arm group label: Supportive Care (long-term follow-up)
other name: Education for Intervention
other name: Intervention by Education
other name: Intervention through Education
other name: Intervention, Educational
intervention type: Other
intervention name: Laboratory Biomarker Analysis
description: Correlative studies
arm group label: Supportive Care (long-term follow-up)
intervention type: Other
intervention name: Long-term Follow-up
description: Undergo long-term follow-up using survivorship care plan
arm group label: Supportive Care (long-term follow-up)
intervention type: Other
intervention name: Quality-of-Life Assessment
description: Ancillary studies
arm group label: Supportive Care (long-term follow-up)
other name: Quality of Life Assessment
intervention type: Other
intervention name: Questionnaire Administration
description: Ancillary studies
arm group label: Supportive Care (long-term follow-up)
criteria: 
gender: Male
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: Saro Armenian, DO
role: Principal Investigator
affiliation: City of Hope Medical Center
facility: 
country: United States
responsible party type: Sponsor
mesh term: Prostatic Neoplasms