NCT03275181

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
18

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Aug 2017

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2017

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

September 5, 2017

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 7, 2017

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2018

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2018

Completed
Last Updated

September 2, 2025

Status Verified

August 1, 2025

Enrollment Period

12 months

First QC Date

September 5, 2017

Last Update Submit

August 25, 2025

Conditions

Prostate Cancer

Outcome Measures

Primary Outcomes (2)

  • Left ventricular ejection fraction

    measure of left ventricular systolic function

    1 day

  • Left ventricular strain rate

    measure of left ventricular systolic and diastolic function

    1 day

Secondary Outcomes (1)

  • Cardiac output

    1 day

Study Arms (3)

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.

Diagnostic Test: Transthoracic EchocardiographyDiagnostic Test: Arterial blood pressureDiagnostic Test: Submaximal Exercise

Prostate cancer patient/survivor without ADT history

Prostate cancer patients or survivors who have never been treated with androgen deprivation therapy.

Diagnostic Test: Transthoracic EchocardiographyDiagnostic Test: Arterial blood pressureDiagnostic Test: Submaximal Exercise

Control

Individuals with no history of prostate caner androgen deprivation therapy. Free of known clinical cardiovascular disease

Diagnostic Test: Transthoracic EchocardiographyDiagnostic Test: Arterial blood pressureDiagnostic Test: Submaximal Exercise

Interventions

Transthoracic EchocardiographyDIAGNOSTIC_TEST

Non-invasive assessment of left ventricle structure and function

ControlProstate cancer patient/survivor with ADT historyProstate cancer patient/survivor without ADT history
Arterial blood pressureDIAGNOSTIC_TEST

Continuously monitored for 5-30 minutes via finger photoplethysmography

ControlProstate cancer patient/survivor with ADT historyProstate cancer patient/survivor without ADT history
Submaximal ExerciseDIAGNOSTIC_TEST

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

ControlProstate cancer patient/survivor with ADT historyProstate cancer patient/survivor without ADT history

Eligibility Criteria

Age21 Years - 80 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kansas State University - Clinical Integrative Physiology Laboratory

Manhattan, Kansas, 66506, United States

Location

Related Publications (3)

  • 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.

    PMID: 20124128BACKGROUND

  • 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.

    PMID: 28117849BACKGROUND

  • 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.

    PMID: 23666791BACKGROUND

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

EchocardiographyArterial Pressure

Condition Hierarchy (Ancestors)

Genital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital Diseases

Intervention Hierarchy (Ancestors)

Cardiac Imaging TechniquesDiagnostic ImagingDiagnostic Techniques and ProceduresDiagnosisUltrasonographyHeart Function TestsDiagnostic Techniques, CardiovascularBlood PressureHemodynamicsCardiovascular Physiological PhenomenaCirculatory and Respiratory Physiological Phenomena

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

September 5, 2017

First Posted

September 7, 2017

Study Start

August 1, 2017

Primary Completion

July 31, 2018

Study Completion

December 31, 2018

Last Updated

September 2, 2025

Record last verified: 2025-08

Data Sharing

IPD Sharing
Will not share

Locations

US(1)