Clinical trial NCT03275181: Effect of Androgen Deprivation Therapy on Cardiovascular Function in Prostate Cancer
Official title: Effect of Androgen Deprivation Therapy on Left Ventricular Function in Prostate Cancer Patients and Survivors
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Prostate Cancer
Lead sponsor: Kansas State University
Sponsor class: OTHER
First posted: 2017-09-07
Enrollment: 60
Sex: MALE
Minimum age (years): 21
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Left ventricular ejection fraction
timeFrame: 1 day
measure: Left ventricular strain rate
timeFrame: 1 day
Secondary outcomes:
measure: Cardiac output
timeFrame: 1 day
Other outcomes:
Locations:
city: Manhattan
country: United States
facility: Kansas State University - Clinical Integrative Physiology Laboratory
state: Kansas
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.