Skip to content

Effect of Androgen Deprivation Therapy on Cardiovascular Function in Prostate Cancer

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03275181
Enrollment
18
Registered
2017-09-07
Start date
2017-08-01
Completion date
2018-12-31
Last updated
2025-09-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Prostate Cancer

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.

Interventions

DIAGNOSTIC_TESTTransthoracic Echocardiography

Non-invasive assessment of left ventricle structure and function

Continuously monitored for 5-30 minutes via finger photoplethysmography

DIAGNOSTIC_TESTSubmaximal Exercise

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

Sponsors

Kansas State University
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
MALE
Age
21 Years to 80 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Left ventricular ejection fraction1 daymeasure of left ventricular systolic function
Left ventricular strain rate1 daymeasure of left ventricular systolic and diastolic function

Secondary

MeasureTime frameDescription
Cardiac output1 daymeasure of cardiac function at rest and during submaximal exercise

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026