Clinical trial · Observational
Effect of Androgen Deprivation Therapy on Cardiovascular Function in Prostate Cancer
Effect of Androgen Deprivation Therapy on Left Ventricular Function in Prostate Cancer Patients and Survivors
NCT03275181CI-TRIAL-00094365completedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Arterial blood pressure | Diagnostic Test | — | UNRESOLVED |
| Submaximal Exercise | Diagnostic Test | — | UNRESOLVED |
| Transthoracic Echocardiography | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- label
- Prostate cancer patient/survivor with ADT history
- description
- 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.
- interventionNames
- Diagnostic Test: Transthoracic Echocardiography
- Diagnostic Test: Arterial blood pressure
- Diagnostic Test: Submaximal Exercise
- label
- Prostate cancer patient/survivor without ADT history
- description
- Prostate cancer patients or survivors who have never been treated with androgen deprivation therapy.
- interventionNames
- Diagnostic Test: Transthoracic Echocardiography
- Diagnostic Test: Arterial blood pressure
- Diagnostic Test: Submaximal Exercise
- label
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 21 Years
- Maximum age
- 80 Years
Show eligibility criteria text
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
References
Publications (3)
- BACKGROUNDLevine 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 20124128
- BACKGROUNDVeccia 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 28117849
- BACKGROUNDGilbert 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 23666791