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CompletedNCT03275181Updated Sep 2, 2025

Effect of Androgen Deprivation Therapy on Cardiovascular Function in Prostate Cancer

An observational study in Prostate Cancer, sponsored by Kansas State University. Completed at 1 site in United States. Open to male participants aged 21 Years to 80 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-09-02.

Sponsored by Kansas State University · Observational

Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
18
Ages
21 Years to 80 Years
Sex
Male
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Study 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.

Read the 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.

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Conditions studied

  • Prostate Cancer

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Who can participate

Ages eligible
21 Years to 80 Years
Sexes eligible
Male
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.

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

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
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Study design

Observational model
Case-control
Time perspective
Prospective
Enrollment
18 participants (actual)
Patient registry
No

Groups and cohorts

  • 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 · Diagnostic Test: Arterial blood pressure · Diagnostic Test: Submaximal Exercise

  • 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 · Diagnostic Test: Arterial blood pressure · Diagnostic Test: Submaximal Exercise

  • Control

    Individuals with no history of prostate caner androgen deprivation therapy. Free of known clinical cardiovascular disease

    Diagnostic Test: Transthoracic Echocardiography · Diagnostic Test: Arterial blood pressure · Diagnostic Test: Submaximal Exercise

Interventions

  • Diagnostic testTransthoracic Echocardiography

    Non-invasive assessment of left ventricle structure and function

  • Diagnostic testArterial blood pressure

    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

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What researchers measure

Primary outcomes

  1. Left ventricular ejection fraction

    measure of left ventricular systolic function

    Time frame: 1 day

  2. Left ventricular strain rate

    measure of left ventricular systolic and diastolic function

    Time frame: 1 day

Secondary outcomes

  1. Cardiac output

    measure of cardiac function at rest and during submaximal exercise

    Time frame: 1 day

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Study locations

1 site
  • Kansas State University - Clinical Integrative Physiology Laboratory
    Manhattan, Kansas 66506, United States
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References and documents

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. PubMed 20124128 ↗
  • 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. PubMed 28117849 ↗
  • 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. PubMed 23666791 ↗

Individual participant data

Plan to share: No

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Registry details

Key details

Study ID
NCT03275181
Lead sponsor
Kansas State University
Responsible party
Carl Ade, M.S., Ph.D. (Assistant Professor, Kansas State University) — Principal investigator
First posted
Sep 7, 2017
Start date
Aug 1, 2017
Primary completion
Jul 31, 2018
Completion
Dec 31, 2018
Last update
Sep 2, 2025

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2025. You cannot join it, but the record below documents what was studied.

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