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Trial record 62 of 1543 for:    Androgens

Effect of Androgen Deprivation Therapy on Cardiovascular Function in Prostate Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03275181
Recruitment Status : Unknown
Verified September 2017 by Carl Ade, M.S., Ph.D., Kansas State University.
Recruitment status was:  Recruiting
First Posted : September 7, 2017
Last Update Posted : September 7, 2017
Sponsor:
Information provided by (Responsible Party):
Carl Ade, M.S., Ph.D., Kansas State University

Brief Summary:
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.

Condition or disease Intervention/treatment
Prostate Cancer Diagnostic Test: Transthoracic Echocardiography Diagnostic Test: Arterial blood pressure Diagnostic Test: Submaximal Exercise

Detailed Description:
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.

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Study Type : Observational
Estimated Enrollment : 60 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Effect of Androgen Deprivation Therapy on Left Ventricular Function in Prostate Cancer Patients and Survivors
Actual Study Start Date : August 1, 2017
Estimated Primary Completion Date : July 31, 2018
Estimated Study Completion Date : December 31, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

Group/Cohort Intervention/treatment
Prostate cancer patient/survivor with ADT history
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.
Diagnostic Test: Transthoracic Echocardiography
Non-invasive assessment of left ventricle structure and function

Diagnostic Test: Arterial blood pressure
Continuously monitored for 5-30 minutes via finger photoplethysmography

Diagnostic Test: Submaximal Exercise
Incremental exercise test to 85% predicted maximal heart rate on a recumbent cycle ergometer

Prostate cancer patient/survivor without ADT history
Prostate cancer patients or survivors who have never been treated with androgen deprivation therapy.
Diagnostic Test: Transthoracic Echocardiography
Non-invasive assessment of left ventricle structure and function

Diagnostic Test: Arterial blood pressure
Continuously monitored for 5-30 minutes via finger photoplethysmography

Diagnostic Test: Submaximal Exercise
Incremental exercise test to 85% predicted maximal heart rate on a recumbent cycle ergometer

Control
Individuals with no history of prostate caner androgen deprivation therapy. Free of known clinical cardiovascular disease
Diagnostic Test: Transthoracic Echocardiography
Non-invasive assessment of left ventricle structure and function

Diagnostic Test: Arterial blood pressure
Continuously monitored for 5-30 minutes via finger photoplethysmography

Diagnostic Test: Submaximal Exercise
Incremental exercise test to 85% predicted maximal heart rate on a recumbent cycle ergometer




Primary Outcome Measures :
  1. Left ventricular ejection fraction [ Time Frame: 1 day ]
    measure of left ventricular systolic function

  2. Left ventricular strain rate [ Time Frame: 1 day ]
    measure of left ventricular systolic and diastolic function


Secondary Outcome Measures :
  1. Cardiac output [ Time Frame: 1 day ]
    measure of cardiac function at rest and during submaximal exercise



Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
(Experimental Group #1) Diagnosed prostate cancer patients/survivors who have received androgen deprivation therapy, (Experimental Group #2) Diagnosed prostate cancer patients/survivors who have not received androgen deprivation therapy, and (Experimental Group #3) an aged matched, healthy control group.
Criteria

Inclusion Criteria:

  • Give voluntary consent to participate in the study
  • (Group 1) Diagnosed prostate cancer patient/survivor with a history of androgen deprivation therapy treatment
  • (Group 2) Diagnosed prostate cancer patient/survivor with no history of androgen deprivation therapy treatment
  • (Group 3) Cancer free

Exclusion Criteria:

  • History of clinical cardiovascular disease (Atherosclerotic cardiovascular disease (ASCVD) defined by history of acute coronary syndromes, myocardial infarction (MI), stable or unstable angina, coronary or other arterial revascularization, stroke, transient ischemia attack (TIA), or peripheral arterial disease presumed to be of atherosclerotic origin)
  • Not met the above criteria
  • Unable to provide informed consent
  • History of smoking (within 6 months) or current smoker
  • Major signs or symptoms suggestive of cardiovascular, pulmonary, or metabolic disease. These include pain, discomfort in the chest, neck, jaw, arms or other areas that may result form ischemia; shortness of breath at rest or with mild exertion; Dizziness or syncope; Orthopnea or paroxysmal nocturnal dyspnea; ankle edema; palpitations or tachycardia; intermittent claudication; known heart murmur; unusual fatigue or shortness of breath with usual activities

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03275181


Contacts
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Contact: Carl J Ade, PhD 785-532-1327 cade@ksu.edu

Locations
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United States, Kansas
Kansas State University - Clinical Integrative Physiology Laboratory Recruiting
Manhattan, Kansas, United States, 66506
Contact: Carl J Ade, PhD    785-532-1127    cade@ksu.edu   
Sponsors and Collaborators
Kansas State University

Publications:
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Responsible Party: Carl Ade, M.S., Ph.D., Assistant Professor, Kansas State University
ClinicalTrials.gov Identifier: NCT03275181     History of Changes
Other Study ID Numbers: Pro8861
First Posted: September 7, 2017    Key Record Dates
Last Update Posted: September 7, 2017
Last Verified: September 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Androgens
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs