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

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.

Study Overview

• Status: Completed
• Conditions: Prostate Cancer
• Intervention / Treatment: Diagnostic test: Transthoracic Echocardiography; Diagnostic test: Arterial blood pressure; Diagnostic test: Submaximal Exercise

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 Type: Observational
• Enrollment (Actual): 18

Contacts and Locations

Study Locations

• United States
  • Kansas
    • Manhattan, Kansas, United States, 66506
      • Kansas State University - Clinical Integrative Physiology Laboratory

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

(Experimental Group #1) Diagnosed prostate cancer patients/survivors who have received androgen deprivation therapy, (Experimental Group #2) Diagnosed prostate cancer patients/survivors who have not received androgen deprivation therapy, and (Experimental Group #3) an aged matched, healthy control group.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Kansas State University

Publications and helpful links

General Publications

• Levine GN, D'Amico AV, Berger P, Clark PE, Eckel RH, Keating NL, Milani RV, Sagalowsky AI, Smith MR, Zakai N; American Heart Association Council on Clinical Cardiology and Council on Epidemiology and Prevention, the American Cancer Society, and the American Urological Association. Androgen-deprivation therapy in prostate cancer and cardiovascular risk: a science advisory from the American Heart Association, American Cancer Society, and American Urological Association: endorsed by the American Society for Radiation Oncology. Circulation. 2010 Feb 16;121(6):833-40. doi: 10.1161/CIRCULATIONAHA.109.192695. Epub 2010 Feb 1. No abstract available.
• Veccia A, Maines F, Kinspergher S, Galligioni E, Caffo O. Cardiovascular toxicities of systemic treatments of prostate cancer. Nat Rev Urol. 2017 Jan 24;14(4):230-243. doi: 10.1038/nrurol.2016.273. Online ahead of print.
• Gilbert SE, Tew GA, Bourke L, Winter EM, Rosario DJ. Assessment of endothelial dysfunction by flow-mediated dilatation in men on long-term androgen deprivation therapy for prostate cancer. Exp Physiol. 2013 Sep;98(9):1401-10. doi: 10.1113/expphysiol.2013.073353. Epub 2013 May 10.

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2017
• Primary Completion (Actual): July 31, 2018
• Study Completion (Actual): December 31, 2018

Study Registration Dates

• First Submitted: September 5, 2017
• First Submitted That Met QC Criteria: September 5, 2017
• First Posted (Actual): September 7, 2017

Study Record Updates

• Last Update Posted (Estimated): September 2, 2025
• Last Update Submitted That Met QC Criteria: August 25, 2025
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Prostatic Diseases; Male Urogenital Diseases; Prostatic Neoplasms; Diagnostic Techniques and Procedures; Diagnosis; Circulatory and Respiratory Physiological Phenomena; Diagnostic Imaging; Diagnostic Techniques, Cardiovascular; Heart Function Tests; Cardiac Imaging Techniques; Ultrasonography; Hemodynamics; Cardiovascular Physiological Phenomena; Blood Pressure; Arterial Pressure; Echocardiography
• Other Study ID Numbers: Pro8861

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No