Prostate CancerNCT03275181
Effect of Androgen Deprivation Therapy on Cardiovascular Function in Prostate Cancer
An observational study of Prostate Cancer, run by Kansas State University at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 21 to 80 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- Transthoracic Echocardiography, Arterial blood pressure and Submaximal Exercise
- How many people
- 18 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Aug 2017to 31 Dec 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 80 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Kansas State University - Clinical Integrative Physiology Laboratory
Manhattan, Kansas, 66506
About this study
Official title: Effect of Androgen Deprivation Therapy on Left Ventricular Function in Prostate Cancer Patients and Survivors
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.
- Conditions
- Prostate Cancer
- Being tested
- Transthoracic Echocardiography, Arterial blood pressure, Submaximal Exercise
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transthoracic EchocardiographyDiagnostic test
Non-invasive assessment of left ventricle structure and function
Arterial blood pressureDiagnostic test
Continuously monitored for 5-30 minutes via finger photoplethysmography
Submaximal ExerciseDiagnostic test
Incremental exercise test to 85% predicted maximal heart rate on a recumbent cycle ergometer
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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 Receives: Diagnostic Test: Transthoracic Echocardiography; Diagnostic Test: Arterial blood pressure; Diagnostic Test: Submaximal Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Left ventricular ejection fraction
measure of left ventricular systolic function
Measured: 1 day
Left ventricular strain rate
measure of left ventricular systolic and diastolic function
Measured: 1 day
Secondary outcomes (1)
Cardiac output
measure of cardiac function at rest and during submaximal exercise
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Sep 2017
- Study start1 Aug 2017
- Primary completion31 Jul 2018
- Study completion31 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kansas State University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Carl Ade, M.S., Ph.D., Kansas State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03275181
- Sponsor's protocol ID
- Pro8861
- Status last verified
- Aug 2025
- First submitted
- 5 Sep 2017
- Last updated
- 2 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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 20124128Veccia 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 28117849Gilbert 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
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Androgen Deprivation Therapy on Left Ventricular Function in Prostate Cancer Patients and Survivors
- ClinicalTrials.gov ID
- NCT03275181
- Acronym / sponsor ID
- Pro8861
- Conditions
- Prostate Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Kansas State UniversityUniversity, hospital or other
- Study start
- 1 Aug 2017 (actual)
- Primary completion
- 31 Jul 2018 (actual)
- Study completion
- 31 Dec 2018 (actual)
- First posted
- 7 Sep 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Prostate cancer patient/survivor with ADT history | – | Diagnostic Test: Transthoracic Echocardiography, Diagnostic Test: Arterial blood pressure, Diagnostic Test: Submaximal ExerciseProstate 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. |
| Prostate cancer patient/survivor without ADT history | – | Diagnostic Test: Transthoracic Echocardiography, Diagnostic Test: Arterial blood pressure, Diagnostic Test: Submaximal ExerciseProstate cancer patients or survivors who have never been treated with androgen deprivation therapy. |
| Control | – | Diagnostic Test: Transthoracic Echocardiography, Diagnostic Test: Arterial blood pressure, Diagnostic Test: Submaximal ExerciseIndividuals with no history of prostate caner androgen deprivation therapy. Free of known clinical cardiovascular disease |
Who may qualify
- Ages
- 21 to 80 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transthoracic EchocardiographyNon-invasive assessment of left ventricle structure and function | Diagnostic test | Control, Prostate cancer patient/survivor with ADT history, Prostate cancer patient/survivor without ADT history |
| Arterial blood pressureContinuously monitored for 5-30 minutes via finger photoplethysmography | Diagnostic test | Control, Prostate cancer patient/survivor with ADT history, Prostate cancer patient/survivor without ADT history |
| Submaximal ExerciseIncremental exercise test to 85% predicted maximal heart rate on a recumbent cycle ergometer | Diagnostic test | Control, Prostate cancer patient/survivor with ADT history, Prostate cancer patient/survivor without ADT history |
Primary outcome
Left ventricular ejection fraction
Time frame: 1 day
measure of left ventricular systolic function
Left ventricular strain rate
Time frame: 1 day
measure of left ventricular systolic and diastolic function
1 secondary outcome
Cardiac output
Time frame: 1 day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Sep 2025.
- Background: PubMed 20124128Levine 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.
- Background: PubMed 28117849Veccia 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.
- Background: PubMed 23666791Gilbert 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Prostate Cancer, run by Kansas State University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Left ventricular ejection fraction (time frame: 1 day). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03275181, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Sep 2025.