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

Primary Purpose

Cardiovascular Injury, Prostate Carcinoma

Status

Active

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Magnetic Resonance Imaging

Exercise Intervention

Perfusion Magnetic Resonance Imaging

Exercise Intervention

Spectroscopy

Laboratory Biomarker Analysis

About this trial

This is an interventional diagnostic trial for Cardiovascular Injury focused on measuring ADT, Prostate cancer

Eligibility Criteria

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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

Sites / Locations

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

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Diagnostic (cardiac MRI, skeletal muscle PMRS)

Arm Description

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.

Outcomes

Primary Outcome Measures

Heart rate (bpm)

Maximal rate of oxygen consumption

Cardiac muscle mass

Ventricular performance assessed by cardiac stress MRI

Myocardial perfusion reserve assessed by cardiac stress MRI

Skeletal muscle energetics assessed by PMRS

Secondary Outcome Measures

Full Information

NCT ID

NCT02722525

First Posted

November 18, 2015

Last Updated

May 13, 2022

Sponsor

Ohio State University Comprehensive Cancer Center

Collaborators

Pelontonia

1. Study Identification

Unique Protocol Identification Number

NCT02722525

Brief Title

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

Official Title

Impact of Anti-androgen Treatment on Cardiac Function

Study Type

Interventional

2. Study Status

Record Verification Date

May 2022

Overall Recruitment Status

Active, not recruiting

Study Start Date

December 2014 (Actual)

Primary Completion Date

November 13, 2017 (Actual)

Study Completion Date

December 31, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Ohio State University Comprehensive Cancer Center

Collaborators

Pelontonia

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Cardiovascular Injury, Prostate Carcinoma

Keywords

ADT, Prostate cancer

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

23 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Diagnostic (cardiac MRI, skeletal muscle PMRS)

Arm Type

Experimental

Arm Description

Intervention Type

Procedure

Intervention Name(s)

Magnetic Resonance Imaging

Other Intervention Name(s)

Magnetic Resonance Imaging Scan, MRI, MRI Scan, NMRI

Intervention Description

Undergo treadmill stress CMR

Intervention Type

Behavioral

Intervention Name(s)

Exercise Intervention

Intervention Description

Complete treadmill exercise

Intervention Type

Procedure

Intervention Name(s)

Perfusion Magnetic Resonance Imaging

Other Intervention Name(s)

PW-MRI

Intervention Description

Undergo gadopentetate dimeglumine perfusion MRI

Intervention Type

Behavioral

Intervention Name(s)

Exercise Intervention

Intervention Description

Complete resistive lower extremity exercise

Intervention Type

Procedure

Intervention Name(s)

Spectroscopy

Intervention Description

Undergo skeletal muscle PMRS

Intervention Type

Other

Intervention Name(s)

Laboratory Biomarker Analysis

Intervention Description

Correlative studies

Primary Outcome Measure Information:

Title

Heart rate (bpm)

Time Frame