Effect of Androgen Deprivation Therapy on Cardiovascular Function in Prostate Cancer

Study Overview
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Brief Summary
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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
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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.

Official Title
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Effect of Androgen Deprivation Therapy on Left Ventricular Function in Prostate Cancer Patients and Survivors

Conditions
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Prostate Cancer

Intervention / Treatment
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* Diagnostic Test: Transthoracic Echocardiography
* Diagnostic Test: Arterial blood pressure
* Diagnostic Test: Submaximal Exercise


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Prostate cancer patient/survivor with ADT history<br>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<br>* Non-invasive assessment of left ventricle structure and function<br>Diagnostic Test: Arterial blood pressure<br>* Continuously monitored for 5-30 minutes via finger photoplethysmography<br>Diagnostic Test: Submaximal Exercise<br>* Incremental exercise test to 85% predicted maximal heart rate on a recumbent cycle ergometer<br>|
| Prostate cancer patient/survivor without ADT history<br>Prostate cancer patients or survivors who have never been treated with androgen deprivation therapy. | Diagnostic Test: Transthoracic Echocardiography<br>* Non-invasive assessment of left ventricle structure and function<br>Diagnostic Test: Arterial blood pressure<br>* Continuously monitored for 5-30 minutes via finger photoplethysmography<br>Diagnostic Test: Submaximal Exercise<br>* Incremental exercise test to 85% predicted maximal heart rate on a recumbent cycle ergometer<br>|
| Control<br>Individuals with no history of prostate caner androgen deprivation therapy. Free of known clinical cardiovascular disease | Diagnostic Test: Transthoracic Echocardiography<br>* Non-invasive assessment of left ventricle structure and function<br>Diagnostic Test: Arterial blood pressure<br>* Continuously monitored for 5-30 minutes via finger photoplethysmography<br>Diagnostic Test: Submaximal Exercise<br>* Incremental exercise test to 85% predicted maximal heart rate on a recumbent cycle ergometer<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Left ventricular ejection fraction | measure of left ventricular systolic function | 1 day | 
| Left ventricular strain rate | measure of left ventricular systolic and diastolic function | 1 day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cardiac output | measure of cardiac function at rest and during submaximal exercise | 1 day |