Effect of Androgen Deprivation Therapy on Cardiovascular Function in Prostate Cancer

Prostate Cancer Clinical Trial

Official title:

Effect of Androgen Deprivation Therapy on Left Ventricular Function in Prostate Cancer Patients and Survivors

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03275181
• Other study ID #: Pro8861
• Status: Recruiting
• Phase: N/A
• First received: September 5, 2017
• Last updated: September 5, 2017
• Start date: August 1, 2017
• Est. completion date: December 31, 2018

Study information

• Verified date: September 2017
• Source: Kansas State University
• Contact: Carl J Ade, PhD
• Phone: 785-532-1327
• Email: cade[@]ksu.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: December 31, 2018
• Est. primary completion date: July 31, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 21 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Diagnostic Test:
• 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

Locations

Country	Name	City	State
United States	Kansas State University - Clinical Integrative Physiology Laboratory	Manhattan	Kansas

Sponsors (1)

Lead Sponsor	Collaborator
Kansas State University

Country where clinical trial is conducted

United States, 

References & Publications (3)

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. — View 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. — View 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. [Epub ahead of print] Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Left ventricular ejection fraction	measure of left ventricular systolic function	1 day
Primary	Left ventricular strain rate	measure of left ventricular systolic and diastolic function	1 day
Secondary	Cardiac output	measure of cardiac function at rest and during submaximal exercise	1 day