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Cardiovascular InjuryNCT02722525

Cardiac MRI in Measuring the Impact of Anti-androgen Treatment on Cardiac Function in Patients With Prostate Cancer

A study testing Magnetic Resonance Imaging, Exercise Intervention and Perfusion Magnetic Resonance Imaging in people with Cardiovascular Injury and Prostate Carcinoma, run by Ohio State University Comprehensive Cancer Center at 1 site in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

Learning about the impact of anti-androgen treatment has on cardiac function in patients with prostate cancer may help plan treatment and help patients live more comfortably. This pilot clinical trial will utilize cardiac magnetic resonance imaging (MRI) before a patient starts hormone therapy and after 4 to 7 months… Read more about this study

Who is it for?
Any age, men only
Conditions the study is for
Cardiovascular Injury, Prostate Carcinoma
What is being tested?
Magnetic Resonance Imaging, Exercise Intervention and Perfusion Magnetic Resonance Imaging
Could I receive a placebo?
No, everyone receives an active treatment
How many people
23 participants
Where
1 siteUnited States
Study dates
Dec 2014to 31 Dec 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

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 Any age
  • Men only
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • 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
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  • 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

Who cannot join

  • 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
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  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center

    Columbus, Ohio, 43210

Other trials in United States

About this study

Official title: Impact of Anti-androgen Treatment on Cardiac Function

Learning about the impact of anti-androgen treatment has on cardiac function in patients with prostate cancer may help plan treatment and help patients live more comfortably. This pilot clinical trial will utilize cardiac magnetic resonance imaging (MRI) before a patient starts hormone therapy and after 4 to 7 months of hormone therapy. The objective is to measure the impact of hormone therapy (anti-androgen treatment) on cardiac function in patients with prostate cancer.

Read the detailed description

PRIMARY OBJECTIVES:

  1. Determine the impact of a minimum of 4 months of full androgen deprivation therapy (ADT) on cardiac and skeletal muscle structure and performance using novel cardiovascular magnetic resonance (CMR) approach.

OUTLINE:

Study participants will undergo a treadmill stress CMR focused on cardiac muscle comprised of resting MRI over 10-15 minutes followed by treadmill exercise until peak stress. Patients then undergo MRI and gadopentetate dimeglumine (Gd-diethylenetriamine penta-acetic acid [DTPA]) perfusion imaging immediately after exercise and after a 6-8 minute recovery period. Within 24 hours of treadmill CMR exam, patients also undergo skeletal muscle phosphorus magnetic resonance spectroscopy (PMRS) while at rest, during, and in the recovery phase of resistive lower extremity exercise which patients complete over 30 seconds. Both procedures are performed before initiation of ADT treatment (baseline) and 4-7 months after initiation of ADT treatment.

Being tested
Magnetic Resonance Imaging, Exercise Intervention, Perfusion Magnetic Resonance Imaging, Spectroscopy, Laboratory Biomarker Analysis
Keywords
ADT, Prostate cancer
Medical subject headings
Prostatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Magnetic Resonance ImagingProcedure or surgery

    Also called Magnetic Resonance Imaging Scan, MRI, MRI Scan, NMRI

    Undergo treadmill stress CMR

  • Exercise InterventionBehavioural

    Complete treadmill exercise

  • Perfusion Magnetic Resonance ImagingProcedure or surgery

    Also called PW-MRI

    Undergo gadopentetate dimeglumine perfusion MRI

  • Exercise InterventionBehavioural

    Complete resistive lower extremity exercise

  • SpectroscopyProcedure or surgery

    Undergo skeletal muscle PMRS

  • Laboratory Biomarker AnalysisOther

    Correlative studies

Study groups in NCT02722525
Study groupRoleWhat they receive
Diagnostic (cardiac MRI, skeletal muscle PMRS)ExperimentalPatients undergo a treadmill stress CMR focused on cardiac muscle comprised of resting MRI over 10-15 minutes followed by treadmill exercise until peak stress. Patients then undergo MRI and gadopentetate dimeglumine perfusion imaging immediately after exercise and after a 6-8 minute recovery period. Within 24 hours of treadmill CMR exam, patients also undergo skeletal muscle PMRS while at rest, during, and in the recovery phase of resistive lower extremity exercise which patients complete over 30 seconds. Both procedures are performed before initiation of ADT treatment (baseline) and 4-7 months after initiation of ADT treatment.
Receives: Procedure: Magnetic Resonance Imaging; Behavioral: Exercise Intervention; Procedure: Perfusion Magnetic Resonance Imaging; Procedure: Spectroscopy; Other: Laboratory Biomarker Analysis

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Heart rate (bpm)

    Measured: Up to 7 months post ADT initiation

  2. Maximal rate of oxygen consumption

    Measured: Up to 7 months post ADT initiation

  3. Cardiac muscle mass

    Measured: Up to 7 months post ADT initiation

  4. Ventricular performance assessed by cardiac stress MRI

    Measured: Up to 7 months post ADT initiation

  5. Myocardial perfusion reserve assessed by cardiac stress MRI

    Measured: Up to 7 months post ADT initiation

  6. Skeletal muscle energetics assessed by PMRS

    Measured: Up to 7 months post ADT initiation

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Mar 2016 (estimated)
  2. Study startDec 2014
  3. Primary completion13 Nov 2017
  4. Study completion31 Dec 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Diagnosis
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
23 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02722525
Sponsor's protocol ID
OSU-14186
Other IDs
NCI-2015-00029
Status last verified
Mar 2026
First submitted
18 Nov 2015
Last updated
23 Mar 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Magnetic Resonance Imaging, Exercise Intervention and Perfusion Magnetic Resonance Imaging in people with Cardiovascular Injury and Prostate Carcinoma, run by Ohio State University Comprehensive Cancer Center 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 10 inclusion and 9 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: under way, not looking for participants, as of the sponsor's last update on 23 Mar 2026. 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?

This study is still under way. Results are not available in the source record yet.

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?

Heart rate (bpm) (time frame: Up to 7 months post ADT initiation). The study lists 6 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 NCT02722525.

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 23 Mar 2026.

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