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

NCT02722525 | Active Not Recruiting

• 2 other identifiers: OSU-14186NCI-2015-00029
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 1

Brief 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 of hormone therapy. The objective is to measure the impact of hormone therapy (anti-androgen treatment) on cardiac function in patients with prostate cancer.

Conditions

Cardiovascular Injury; Prostate Carcinoma

Keywords

ADT; Prostate cancer

Outcome Measures

Primary Outcomes (6)

• 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

Study Arms (1)

Diagnostic (cardiac MRI, skeletal muscle PMRS)

EXPERIMENTAL

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.

Procedure: Magnetic Resonance Imaging; Behavioral: Exercise Intervention; Procedure: Perfusion Magnetic Resonance Imaging; Procedure: Spectroscopy; Other: Laboratory Biomarker Analysis

Interventions

Magnetic Resonance Imaging PROCEDURE

Undergo treadmill stress CMR

Also known as: Magnetic Resonance Imaging Scan, MRI, MRI Scan, NMRI

Diagnostic (cardiac MRI, skeletal muscle PMRS)

Exercise Intervention BEHAVIORAL

Complete treadmill exercise

Diagnostic (cardiac MRI, skeletal muscle PMRS)

Perfusion Magnetic Resonance Imaging PROCEDURE

Undergo gadopentetate dimeglumine perfusion MRI

Also known as: PW-MRI

Diagnostic (cardiac MRI, skeletal muscle PMRS)

Spectroscopy PROCEDURE

Undergo skeletal muscle PMRS

Diagnostic (cardiac MRI, skeletal muscle PMRS)

Laboratory Biomarker Analysis OTHER

Correlative studies

Diagnostic (cardiac MRI, skeletal muscle PMRS)

Eligibility Criteria

• Sex: male
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ohio State University Comprehensive Cancer Center: lead
• Pelontonia: collaborator

Study Sites (1)

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

Columbus, Ohio, 43210, United States

Location

Related Links

• The Jamesline

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Magnetic Resonance Spectroscopy; Spectrum Analysis

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Chemistry Techniques, Analytical; Investigative Techniques

Study Officials

• Steven Clinton, MD, PhD

  Ohio State University Comprehensive Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 18, 2015
• First Posted: March 30, 2016
• Study Start: December 1, 2014
• Primary Completion: November 13, 2017
• Study Completion (Estimated): December 31, 2026
• Last Updated: March 23, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)