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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Prostate Carcinoma; Cardiovascular Injury
• Intervention / Treatment: Other: Laboratory Biomarker Analysis; Procedure: Magnetic Resonance Imaging; Behavioral: Exercise Intervention; Procedure: Perfusion Magnetic Resonance Imaging; Behavioral: Exercise Intervention; Procedure: Spectroscopy

Detailed Description

PRIMARY OBJECTIVES:

I. 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.

• Study Type: Interventional
• Enrollment (Actual): 23
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Columbus, Ohio, United States, 43210
      • Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Diagnostic (cardiac MRI, skeletal muscle PMRS); Patients 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.

Other: Laboratory Biomarker Analysis; Correlative studies; Procedure: Magnetic Resonance Imaging; Undergo treadmill stress CMR; Other Names: MRI; Magnetic Resonance Imaging Scan; MRI Scan; NMRI; Behavioral: Exercise Intervention; Complete treadmill exercise; Procedure: Perfusion Magnetic Resonance Imaging; Undergo gadopentetate dimeglumine perfusion MRI; Other Names: PW-MRI; Behavioral: Exercise Intervention; Complete resistive lower extremity exercise; Procedure: Spectroscopy; Undergo skeletal muscle PMRS

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Heart rate (bpm)	Up to 7 months post ADT initiation
Maximal rate of oxygen consumption	Up to 7 months post ADT initiation
Cardiac muscle mass	Up to 7 months post ADT initiation
Ventricular performance assessed by cardiac stress MRI	Up to 7 months post ADT initiation
Myocardial perfusion reserve assessed by cardiac stress MRI	Up to 7 months post ADT initiation
Skeletal muscle energetics assessed by PMRS	Up to 7 months post ADT initiation

Collaborators and Investigators

• Sponsor: Ohio State University Comprehensive Cancer Center
• Collaborators: Pelontonia
• Investigators: Principal Investigator: Steven Clinton, MD, PhD, Ohio State University Comprehensive Cancer Center

Publications and helpful links

Helpful Links

• The Jamesline

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2014
• Primary Completion (Actual): November 13, 2017
• Study Completion (Estimated): December 31, 2026

Study Registration Dates

• First Submitted: November 18, 2015
• First Submitted That Met QC Criteria: March 23, 2016
• First Posted (Estimated): March 30, 2016

Study Record Updates

• Last Update Posted (Actual): March 23, 2026
• Last Update Submitted That Met QC Criteria: March 20, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: Prostate cancer; ADT
• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Prostatic Diseases; Male Urogenital Diseases; Prostatic Neoplasms; Investigative Techniques; Chemistry Techniques, Analytical; Magnetic Resonance Spectroscopy; Spectrum Analysis
• Other Study ID Numbers: OSU-14186; NCI-2015-00029 (Registry Identifier: CTRP (Clinical Trial Reporting Program))

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No