<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/NCT03275181</url>
  </required_header>
  <id_info>
    <org_study_id>Pro8861</org_study_id>
    <nct_id>NCT03275181</nct_id>
  </id_info>
  <brief_title>Effect of Androgen Deprivation Therapy on Cardiovascular Function in Prostate Cancer</brief_title>
  <official_title>Effect of Androgen Deprivation Therapy on Left Ventricular Function in Prostate Cancer Patients and Survivors</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Kansas State University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Kansas State University</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 aim of this project is to determine whether androgen deprivation therapy (ADT) decreases&#xD;
      left ventricular function in prostate cancer patients. If found successful, this may lead to&#xD;
      improved cardiovascular health via treatment and/or lifestyle interventions in prostate&#xD;
      cancer populations.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Prostate Cancer is the second most common cancer among American men. Approximately 1 in 7 men&#xD;
      will be diagnosed with prostate cancer during his lifetime. In prostate cancer patients&#xD;
      alone, hypotestosteronemia, caused by prostate cancer treatment is associated with visceral&#xD;
      adiposity, insulin resistance, metabolic syndrome, decreased high-density lipoprotein,&#xD;
      increased low-density lipoprotein, increased triglycerides, loss of muscle mass, erectile&#xD;
      disfunction, and a loss of microvascular endothelial function. Recently, several&#xD;
      population-based studies have reported an association between androgen deprivation therapy&#xD;
      and an increased risk of cardiovascular events, that include myocardial infarction and&#xD;
      cardiovascular mortality. Given this link and the growing evidence that androgen-deprivation&#xD;
      therapy adversely affects traditional risk factors, it is essential to better understand the&#xD;
      role this type of treatment has on cardiac structure and function. As such, the manifestation&#xD;
      of cardiovascular toxicities with prostate cancer treatment will initially be subclinical&#xD;
      (left ventricular function changes in asymptomatic individuals) compared to clinical&#xD;
      (including coronary symptoms or heart failure) and may develop subacutely (during treatment)&#xD;
      or chronically.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">August 1, 2017</start_date>
  <completion_date type="Anticipated">December 31, 2018</completion_date>
  <primary_completion_date type="Anticipated">July 31, 2018</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Control</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Left ventricular ejection fraction</measure>
    <time_frame>1 day</time_frame>
    <description>measure of left ventricular systolic function</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Left ventricular strain rate</measure>
    <time_frame>1 day</time_frame>
    <description>measure of left ventricular systolic and diastolic function</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Cardiac output</measure>
    <time_frame>1 day</time_frame>
    <description>measure of cardiac function at rest and during submaximal exercise</description>
  </secondary_outcome>
  <number_of_groups>3</number_of_groups>
  <enrollment type="Anticipated">60</enrollment>
  <condition>Prostate Cancer</condition>
  <arm_group>
    <arm_group_label>Prostate cancer patient/survivor with ADT history</arm_group_label>
    <description>Prostate cancer patients or survivors who have a treatment history that includes androgen deprivation therapy. This includes 1) orchiectomy (surgical castration), 2) luteinizing hormone-releasing hormone (LHRH) agonists (also called LHRH analogs or Gonadotrophin-releasing hormone (GnRH) agonists), 3) LHRH antagonist, 4) CYP17 inhibitor, or 5) anti-androgen.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Prostate cancer patient/survivor without ADT history</arm_group_label>
    <description>Prostate cancer patients or survivors who have never been treated with androgen deprivation therapy.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <description>Individuals with no history of prostate caner androgen deprivation therapy. Free of known clinical cardiovascular disease</description>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Transthoracic Echocardiography</intervention_name>
    <description>Non-invasive assessment of left ventricle structure and function</description>
    <arm_group_label>Control</arm_group_label>
    <arm_group_label>Prostate cancer patient/survivor with ADT history</arm_group_label>
    <arm_group_label>Prostate cancer patient/survivor without ADT history</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Arterial blood pressure</intervention_name>
    <description>Continuously monitored for 5-30 minutes via finger photoplethysmography</description>
    <arm_group_label>Control</arm_group_label>
    <arm_group_label>Prostate cancer patient/survivor with ADT history</arm_group_label>
    <arm_group_label>Prostate cancer patient/survivor without ADT history</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Submaximal Exercise</intervention_name>
    <description>Incremental exercise test to 85% predicted maximal heart rate on a recumbent cycle ergometer</description>
    <arm_group_label>Control</arm_group_label>
    <arm_group_label>Prostate cancer patient/survivor with ADT history</arm_group_label>
    <arm_group_label>Prostate cancer patient/survivor without ADT history</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        (Experimental Group #1) Diagnosed prostate cancer patients/survivors who have received&#xD;
        androgen deprivation therapy, (Experimental Group #2) Diagnosed prostate cancer&#xD;
        patients/survivors who have not received androgen deprivation therapy, and (Experimental&#xD;
        Group #3) an aged matched, healthy control group.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Give voluntary consent to participate in the study&#xD;
&#xD;
          -  (Group 1) Diagnosed prostate cancer patient/survivor with a history of androgen&#xD;
             deprivation therapy treatment&#xD;
&#xD;
          -  (Group 2) Diagnosed prostate cancer patient/survivor with no history of androgen&#xD;
             deprivation therapy treatment&#xD;
&#xD;
          -  (Group 3) Cancer free&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  History of clinical cardiovascular disease (Atherosclerotic cardiovascular disease&#xD;
             (ASCVD) defined by history of acute coronary syndromes, myocardial infarction (MI),&#xD;
             stable or unstable angina, coronary or other arterial revascularization, stroke,&#xD;
             transient ischemia attack (TIA), or peripheral arterial disease presumed to be of&#xD;
             atherosclerotic origin)&#xD;
&#xD;
          -  Not met the above criteria&#xD;
&#xD;
          -  Unable to provide informed consent&#xD;
&#xD;
          -  History of smoking (within 6 months) or current smoker&#xD;
&#xD;
          -  Major signs or symptoms suggestive of cardiovascular, pulmonary, or metabolic disease.&#xD;
             These include pain, discomfort in the chest, neck, jaw, arms or other areas that may&#xD;
             result form ischemia; shortness of breath at rest or with mild exertion; Dizziness or&#xD;
             syncope; Orthopnea or paroxysmal nocturnal dyspnea; ankle edema; palpitations or&#xD;
             tachycardia; intermittent claudication; known heart murmur; unusual fatigue or&#xD;
             shortness of breath with usual activities&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>21 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Carl J Ade, PhD</last_name>
    <phone>785-532-1327</phone>
    <email>cade@ksu.edu</email>
  </overall_contact>
  <location>
    <facility>
      <name>Kansas State University - Clinical Integrative Physiology Laboratory</name>
      <address>
        <city>Manhattan</city>
        <state>Kansas</state>
        <zip>66506</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Carl J Ade, PhD</last_name>
      <phone>785-532-1127</phone>
      <email>cade@ksu.edu</email>
    </contact>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>Levine GN, D'Amico AV, Berger P, Clark PE, Eckel RH, Keating NL, Milani RV, Sagalowsky AI, Smith MR, Zakai N; American Heart Association Council on Clinical Cardiology and Council on Epidemiology and Prevention, the American Cancer Society, and the American Urological Association. Androgen-deprivation therapy in prostate cancer and cardiovascular risk: a science advisory from the American Heart Association, American Cancer Society, and American Urological Association: endorsed by the American Society for Radiation Oncology. Circulation. 2010 Feb 16;121(6):833-40. doi: 10.1161/CIRCULATIONAHA.109.192695. Epub 2010 Feb 1. No abstract available.</citation>
    <PMID>20124128</PMID>
  </reference>
  <reference>
    <citation>Veccia A, Maines F, Kinspergher S, Galligioni E, Caffo O. Cardiovascular toxicities of systemic treatments of prostate cancer. Nat Rev Urol. 2017 Jan 24;14(4):230-243. doi: 10.1038/nrurol.2016.273. Online ahead of print.</citation>
    <PMID>28117849</PMID>
  </reference>
  <reference>
    <citation>Gilbert SE, Tew GA, Bourke L, Winter EM, Rosario DJ. Assessment of endothelial dysfunction by flow-mediated dilatation in men on long-term androgen deprivation therapy for prostate cancer. Exp Physiol. 2013 Sep;98(9):1401-10. doi: 10.1113/expphysiol.2013.073353. Epub 2013 May 10.</citation>
    <PMID>23666791</PMID>
  </reference>
  <verification_date>September 2017</verification_date>
  <study_first_submitted>September 5, 2017</study_first_submitted>
  <study_first_submitted_qc>September 5, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 7, 2017</study_first_posted>
  <last_update_submitted>September 5, 2017</last_update_submitted>
  <last_update_submitted_qc>September 5, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">September 7, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Kansas State University</investigator_affiliation>
    <investigator_full_name>Carl Ade, M.S., Ph.D.</investigator_full_name>
    <investigator_title>Assistant Professor</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Prostatic Neoplasms</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT03275181
org study id: Pro8861
nct id: NCT03275181
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The aim of this project is to determine whether androgen deprivation therapy (ADT) decreases
      left ventricular function in prostate cancer patients. If found successful, this may lead to
      improved cardiovascular health via treatment and/or lifestyle interventions in prostate
      cancer populations.
Prostate Cancer is the second most common cancer among American men. Approximately 1 in 7 men
      will be diagnosed with prostate cancer during his lifetime. In prostate cancer patients
      alone, hypotestosteronemia, caused by prostate cancer treatment is associated with visceral
      adiposity, insulin resistance, metabolic syndrome, decreased high-density lipoprotein,
      increased low-density lipoprotein, increased triglycerides, loss of muscle mass, erectile
      disfunction, and a loss of microvascular endothelial function. Recently, several
      population-based studies have reported an association between androgen deprivation therapy
      and an increased risk of cardiovascular events, that include myocardial infarction and
      cardiovascular mortality. Given this link and the growing evidence that androgen-deprivation
      therapy adversely affects traditional risk factors, it is essential to better understand the
      role this type of treatment has on cardiac structure and function. As such, the manifestation
      of cardiovascular toxicities with prostate cancer treatment will initially be subclinical
      (left ventricular function changes in asymptomatic individuals) compared to clinical
      (including coronary symptoms or heart failure) and may develop subacutely (during treatment)
      or chronically.
observational model: Case-Control
time perspective: Prospective
measure: Left ventricular ejection fraction
time frame: 1 day
description: measure of left ventricular systolic function
measure: Left ventricular strain rate
time frame: 1 day
description: measure of left ventricular systolic and diastolic function
measure: Cardiac output
time frame: 1 day
description: measure of cardiac function at rest and during submaximal exercise
arm group label: Prostate cancer patient/survivor with ADT history
description: Prostate cancer patients or survivors who have a treatment history that includes androgen deprivation therapy. This includes 1) orchiectomy (surgical castration), 2) luteinizing hormone-releasing hormone (LHRH) agonists (also called LHRH analogs or Gonadotrophin-releasing hormone (GnRH) agonists), 3) LHRH antagonist, 4) CYP17 inhibitor, or 5) anti-androgen.
arm group label: Prostate cancer patient/survivor without ADT history
description: Prostate cancer patients or survivors who have never been treated with androgen deprivation therapy.
arm group label: Control
description: Individuals with no history of prostate caner androgen deprivation therapy. Free of known clinical cardiovascular disease
intervention type: Diagnostic Test
intervention name: Transthoracic Echocardiography
description: Non-invasive assessment of left ventricle structure and function
arm group label: Control
arm group label: Prostate cancer patient/survivor with ADT history
arm group label: Prostate cancer patient/survivor without ADT history
intervention type: Diagnostic Test
intervention name: Arterial blood pressure
description: Continuously monitored for 5-30 minutes via finger photoplethysmography
arm group label: Control
arm group label: Prostate cancer patient/survivor with ADT history
arm group label: Prostate cancer patient/survivor without ADT history
intervention type: Diagnostic Test
intervention name: Submaximal Exercise
description: Incremental exercise test to 85% predicted maximal heart rate on a recumbent cycle ergometer
arm group label: Control
arm group label: Prostate cancer patient/survivor with ADT history
arm group label: Prostate cancer patient/survivor without ADT history
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: Male
minimum age: 21 Years
maximum age: 80 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Carl J Ade, PhD
phone: 785-532-1327
email: cade@ksu.edu
facility: 
status: Recruiting
contact: 
country: United States
citation: Levine GN, D'Amico AV, Berger P, Clark PE, Eckel RH, Keating NL, Milani RV, Sagalowsky AI, Smith MR, Zakai N; American Heart Association Council on Clinical Cardiology and Council on Epidemiology and Prevention, the American Cancer Society, and the American Urological Association. Androgen-deprivation therapy in prostate cancer and cardiovascular risk: a science advisory from the American Heart Association, American Cancer Society, and American Urological Association: endorsed by the American Society for Radiation Oncology. Circulation. 2010 Feb 16;121(6):833-40. doi: 10.1161/CIRCULATIONAHA.109.192695. Epub 2010 Feb 1. No abstract available.
PMID: 20124128
citation: Veccia A, Maines F, Kinspergher S, Galligioni E, Caffo O. Cardiovascular toxicities of systemic treatments of prostate cancer. Nat Rev Urol. 2017 Jan 24;14(4):230-243. doi: 10.1038/nrurol.2016.273. Online ahead of print.
PMID: 28117849
citation: Gilbert SE, Tew GA, Bourke L, Winter EM, Rosario DJ. Assessment of endothelial dysfunction by flow-mediated dilatation in men on long-term androgen deprivation therapy for prostate cancer. Exp Physiol. 2013 Sep;98(9):1401-10. doi: 10.1113/expphysiol.2013.073353. Epub 2013 May 10.
PMID: 23666791
responsible party type: Principal Investigator
investigator affiliation: Kansas State University
investigator full name: Carl Ade, M.S., Ph.D.
investigator title: Assistant Professor
mesh term: Prostatic Neoplasms
sharing ipd: No