Prostate cancer Treatment's hidden heart impact revealed
NCT ID NCT02722525
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study looks at how hormone therapy (anti-androgen treatment) for prostate cancer affects the heart. Researchers will use heart MRI scans before and after 4-7 months of treatment in 23 men. The goal is to understand changes in heart function, not to treat the cancer itself.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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23 people
The number who actually took part.
- Started
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Dec 2014
- Expected to finish
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Dec 2026
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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Children (under 18), adults (18 to 64) and older adults (65 and over)
- Sex
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Male participants only
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Have biopsy proven carcinoma of the prostate * Be planning to begin a course of at least 4 months of ADT; the ADT is defined as: (a) surgical castration; (b) gonadotropin-releasing hormone (GNRH) antagonist alone; (c) GNRH antagonist with oral androgen receptor blockade, and (d) GNRH antagonist, oral androgen receptor blockade, and 5-alpha reductase inhibitors; we will not include men with only oral anti-androgen therapy such as 5-alpha reductase inhibitors alone or oral anti-androgens alone * Have an ECOG (Eastern Cooperative Oncology Group) performance status of 0-1 * Have plasma total cholesterol \< 200 mg/dL * Have plasma triglycerides \< 200 mg/dL * Have BUN/Cr (Blood urea nitrogen and serum creatinine) without clinically significant abnormalities after review by the study physicians * Liver enzymes without clinically significant abnormalities after review by the study physicians * CBC (complete blood count) without clinically significant abnormalities after review by the study physicians * PT/PTT/INR (prothrombin time/partial thromboplastin time) without clinically significant abnormalities after review by the study physicians * Voluntarily agree to participate and sign an informed consent document Exclusion Criteria: * Have an active malignancy other than prostate cancer that requires therapy * Not be undergoing evaluation and workup for active cardiovascular disease; men with treated and stable cardiovascular disease may participate * Have plasma total cholesterol \> 200 mg/dL or plasma triglycerides \> 200 mg/dL * Have a calculated glomerular filtration rate (GFR) =\< 30 mL/min/1.73 m\^2 * Are not free of unstable angina, arrhythmia, or severe systemic disease that would make moderate intensity exercise participation unsafe * Have any contra-indications to magnetic resonance (MR) examination such as allergy to MRI contrast media (gadolinium-DTPA \[gadopentetate dimeglumine\]), metallic foreign objects within the body, orbital metal, cerebral aneurysm clip, pacemaker, defibrillator, neurostimulator, any other medical metallic implant, claustrophobia, inability to lie flat for 30 minutes, and weight exceeding 300 pounds; if an MR contraindication is discovered during scanning that was overlooked during the screening process, the procedure will be stopped immediately and the subject will be removed from the scanner * Are receiving any form of renal replacement therapy or have a calculated glomerular filtration rate (GFR) \< 30 mL/min/1.75 m²; results of serum creatinine testing will be reviewed for calculation of glomerular filtration rate (GFR); patients without a serum creatinine level drawn within the prior 3 months will have this drawn upon enrollment * Have uncontrolled hypertension and resting blood pressure exceeding 140/80 mmHg * In addition, subjects with any contraindications to exercise testing according to American Heart Association guidelines will not be enrolled; nonetheless, the cardiovascular magnetic resonance (CMR) cardiologist supervising the research portion of the exam will also evaluate each subject for evidence of any contra-indications; the absolute contra-indications include acute myocardial infarction, high-risk unstable angina, uncontrolled cardiac arrhythmias, active endocarditis, symptomatic severe aortic stenosis, decompensated symptomatic heart failure, acute pulmonary embolus or pulmonary infarction, acute non-cardiac disorder that may be aggravated by exercise, acute myocarditis or pericarditis, physical disability that would preclude safe and adequate test performance, and inability to provide consent; the relative contra-indications include left main coronary stenosis, moderate stenotic valvular heart disease, electrolyte abnormalities, tachyarrhythmias or bradyarrhythmias, atrial fibrillation with uncontrolled ventricular rate, hypertrophic cardiomyopathy, and high-degree atrioventricular node block; subjects with uncontrolled hypertension and resting blood pressure exceeding 140/80 mmHg will be excluded
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center
Columbus, Ohio, 43210, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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