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Completed

NCT Number: NCT03275181

Effect of Androgen Deprivation Therapy on Cardiovascular Function in Prostate Cancer

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.

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Key information

Age range

21 year–80 year

Sex eligibility

Male

Study type

Observational

Primary location

Kansas State University - Clinical Integrative Physiology Laboratory

Manhattan, Kansas, 66506, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Transthoracic echocardiography

Diagnostic Test

Non-invasive assessment of left ventricle structure and function

Arterial blood pressure

Diagnostic Test

Continuously monitored for 5-30 minutes via finger photoplethysmography

Submaximal Exercise

Diagnostic Test

Incremental exercise test to 85% predicted maximal heart rate on a recumbent cycle ergometer

Primary outcomes

  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 outcomes

  1. Cardiac output

    Time frame: 1 day

    measure of cardiac function at rest and during submaximal exercise

Sponsors and collaborators

Lead sponsor

Kansas State University

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Sep 7, 2017
Registry last updated
Sep 2, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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