Effect of Androgen Deprivation Therapy on Cardiovascular Function in Prostate Cancer
NCT ID: NCT03275181
Last Updated: 2025-09-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
18 participants
OBSERVATIONAL
2017-08-01
2018-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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CASE_CONTROL
PROSPECTIVE
Study Groups
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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
Non-invasive assessment of left ventricle structure and function
Arterial blood pressure
Continuously monitored for 5-30 minutes via finger photoplethysmography
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.
Transthoracic Echocardiography
Non-invasive assessment of left ventricle structure and function
Arterial blood pressure
Continuously monitored for 5-30 minutes via finger photoplethysmography
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
Transthoracic Echocardiography
Non-invasive assessment of left ventricle structure and function
Arterial blood pressure
Continuously monitored for 5-30 minutes via finger photoplethysmography
Submaximal Exercise
Incremental exercise test to 85% predicted maximal heart rate on a recumbent cycle ergometer
Interventions
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Transthoracic Echocardiography
Non-invasive assessment of left ventricle structure and function
Arterial blood pressure
Continuously monitored for 5-30 minutes via finger photoplethysmography
Submaximal Exercise
Incremental exercise test to 85% predicted maximal heart rate on a recumbent cycle ergometer
Eligibility Criteria
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Inclusion Criteria
* (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
* 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
21 Years
80 Years
MALE
Yes
Sponsors
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Kansas State University
OTHER
Responsible Party
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Carl Ade, M.S., Ph.D.
Assistant Professor
Locations
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Kansas State University - Clinical Integrative Physiology Laboratory
Manhattan, Kansas, United States
Countries
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References
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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.
Other Identifiers
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Pro8861
Identifier Type: -
Identifier Source: org_study_id
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