Effect of Androgen Deprivation Therapy on Cardiovascular Function in Prostate Cancer

Completed

• Conditions: Prostate Cancer

• 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.

Study Timeline

• Study Start: 2017-08-01
• Study First Submitted: 2017-09-05
• Study First Submitted QC: 2017-09-05
• Study First Posted: 2017-09-07
• Primary Completion: 2018-07-31
• Study Completion: 2018-12-31
• Status Verified: 2025-08
• Last Update Submitted: 2025-08-25
• Last Update Posted: 2025-09-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 18

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

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