Effect of Androgen Deprivation Therapy on Cardiovascular Function in Prostate Cancer

Kansas State University

Status

Completed

Conditions

Prostate Cancer

Treatments

Diagnostic Test: Arterial blood pressure

Diagnostic Test: Submaximal Exercise

Diagnostic Test: Transthoracic Echocardiography

Study type

Observational

Funder types

Other

Identifiers

NCT03275181

Pro8861

Details and patient eligibility

About

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.

Full 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.

Enrollment

18 patients

Sex

Male

Ages

21 to 80 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

18 participants in 3 patient groups

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.

Treatment:

Diagnostic Test: Transthoracic Echocardiography

Diagnostic Test: Submaximal Exercise

Diagnostic Test: Arterial blood pressure

Prostate cancer patient/survivor without ADT history

Description:

Prostate cancer patients or survivors who have never been treated with androgen deprivation therapy.

Treatment:

Diagnostic Test: Transthoracic Echocardiography

Diagnostic Test: Submaximal Exercise

Diagnostic Test: Arterial blood pressure

Control