Effect of Androgen Deprivation Therapy on Cardiovascular Function in Prostate Cancer

NCT ID: NCT03275181

Last Updated: 2025-09-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

18 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-08-01

Study Completion Date

2018-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Prostate Cancer

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Transthoracic Echocardiography

Intervention Type DIAGNOSTIC_TEST

Non-invasive assessment of left ventricle structure and function

Arterial blood pressure

Intervention Type DIAGNOSTIC_TEST

Continuously monitored for 5-30 minutes via finger photoplethysmography

Submaximal Exercise

Intervention Type DIAGNOSTIC_TEST

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.

Transthoracic Echocardiography

Intervention Type DIAGNOSTIC_TEST

Non-invasive assessment of left ventricle structure and function

Arterial blood pressure

Intervention Type DIAGNOSTIC_TEST

Continuously monitored for 5-30 minutes via finger photoplethysmography

Submaximal Exercise

Intervention Type DIAGNOSTIC_TEST

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

Transthoracic Echocardiography

Intervention Type DIAGNOSTIC_TEST

Non-invasive assessment of left ventricle structure and function

Arterial blood pressure

Intervention Type DIAGNOSTIC_TEST

Continuously monitored for 5-30 minutes via finger photoplethysmography

Submaximal Exercise

Intervention Type DIAGNOSTIC_TEST

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Transthoracic Echocardiography

Non-invasive assessment of left ventricle structure and function

Intervention Type DIAGNOSTIC_TEST

Arterial blood pressure

Continuously monitored for 5-30 minutes via finger photoplethysmography

Intervention Type DIAGNOSTIC_TEST

Submaximal Exercise

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

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

21 Years

Maximum Eligible Age

80 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Kansas State University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Carl Ade, M.S., Ph.D.

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Kansas State University - Clinical Integrative Physiology Laboratory

Manhattan, Kansas, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type BACKGROUND
PMID: 20124128 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 28117849 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 23666791 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

Pro8861

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.