Effect of Androgen Deprivation Therapy on Cardiovascular Function in Prostate Cancer
- Conditions
- Prostate Cancer
- Interventions
- Diagnostic Test: Transthoracic EchocardiographyDiagnostic Test: Arterial blood pressureDiagnostic Test: Submaximal Exercise
- Registration Number
- NCT03275181
- Lead Sponsor
- 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.
- 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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- Male
- Target Recruitment
- 60
- 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
- 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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Prostate cancer patient/survivor without ADT history Transthoracic Echocardiography Prostate cancer patients or survivors who have never been treated with androgen deprivation therapy. Prostate cancer patient/survivor with ADT history Arterial blood pressure 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. Prostate cancer patient/survivor without ADT history Arterial blood pressure Prostate cancer patients or survivors who have never been treated with androgen deprivation therapy. Prostate cancer patient/survivor without ADT history Submaximal Exercise Prostate cancer patients or survivors who have never been treated with androgen deprivation therapy. Control Submaximal Exercise Individuals with no history of prostate caner androgen deprivation therapy. Free of known clinical cardiovascular disease Prostate cancer patient/survivor with ADT history Transthoracic Echocardiography 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. Control Transthoracic Echocardiography Individuals with no history of prostate caner androgen deprivation therapy. Free of known clinical cardiovascular disease Control Arterial blood pressure Individuals with no history of prostate caner androgen deprivation therapy. Free of known clinical cardiovascular disease Prostate cancer patient/survivor with ADT history Submaximal Exercise 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.
- Primary Outcome Measures
Name Time Method Left ventricular strain rate 1 day measure of left ventricular systolic and diastolic function
Left ventricular ejection fraction 1 day measure of left ventricular systolic function
- Secondary Outcome Measures
Name Time Method Cardiac output 1 day measure of cardiac function at rest and during submaximal exercise
Trial Locations
- Locations (1)
Kansas State University - Clinical Integrative Physiology Laboratory
🇺🇸Manhattan, Kansas, United States