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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02722525
Recruitment Status : Active, not recruiting
First Posted : March 30, 2016
Last Update Posted : March 13, 2019
Sponsor:
Collaborator:
Pelontonia
Information provided by (Responsible Party):
Steven Clinton, Ohio State University Comprehensive Cancer Center

Tracking Information
First Submitted Date  ICMJE November 18, 2015
First Posted Date  ICMJE March 30, 2016
Last Update Posted Date March 13, 2019
Study Start Date  ICMJE October 2014
Estimated Primary Completion Date February 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 23, 2016)
  • Heart rate (bpm) [ Time Frame: Up to 7 months post ADT initiation ]
  • Maximal rate of oxygen consumption [ Time Frame: Up to 7 months post ADT initiation ]
  • Cardiac muscle mass [ Time Frame: Up to 7 months post ADT initiation ]
  • Ventricular performance assessed by cardiac stress MRI [ Time Frame: Up to 7 months post ADT initiation ]
  • Myocardial perfusion reserve assessed by cardiac stress MRI [ Time Frame: Up to 7 months post ADT initiation ]
  • Skeletal muscle energetics assessed by PMRS [ Time Frame: Up to 7 months post ADT initiation ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Cardiac MRI in Measuring the Impact of Anti-androgen Treatment on Cardiac Function in Patients With Prostate Cancer
Official Title  ICMJE Impact of Anti-androgen Treatment on Cardiac Function
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Condition  ICMJE
  • Cardiovascular Injury
  • Prostate Carcinoma
Intervention  ICMJE
  • Procedure: Magnetic Resonance Imaging
    Undergo treadmill stress CMR
    Other Names:
    • Magnetic Resonance Imaging Scan
    • MRI
    • MRI Scan
    • NMRI
  • Behavioral: Exercise Intervention
    Complete treadmill exercise
  • Radiation: Gadopentetate Dimeglumine
    Undergo gadopentetate dimeglumine perfusion MRI
    Other Names:
    • Gadolinium DTPA
    • Gd-DTPA
    • Magnevist
    • SH L 451 A
    • ZK 93035
  • Procedure: Perfusion Magnetic Resonance Imaging
    Undergo gadopentetate dimeglumine perfusion MRI
    Other Name: PW-MRI
  • Behavioral: Exercise Intervention
    Complete resistive lower extremity exercise
  • Procedure: Spectroscopy
    Undergo skeletal muscle PMRS
  • Other: Laboratory Biomarker Analysis
    Correlative studies
Study Arms  ICMJE 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.
Interventions:
  • Procedure: Magnetic Resonance Imaging
  • Behavioral: Exercise Intervention
  • Radiation: Gadopentetate Dimeglumine
  • Procedure: Perfusion Magnetic Resonance Imaging
  • Behavioral: Exercise Intervention
  • Procedure: Spectroscopy
  • Other: Laboratory Biomarker Analysis
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Estimated Enrollment  ICMJE
 (submitted: March 23, 2016)
30
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE March 2020
Estimated Primary Completion Date February 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE Child, Adult, Older Adult
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02722525
Other Study ID Numbers  ICMJE OSU-14186
NCI-2015-00029 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Steven Clinton, Ohio State University Comprehensive Cancer Center
Study Sponsor  ICMJE Ohio State University Comprehensive Cancer Center
Collaborators  ICMJE Pelontonia
Investigators  ICMJE
Principal Investigator: Steven Clinton, MD, PhD Ohio State University Comprehensive Cancer Center
PRS Account Ohio State University Comprehensive Cancer Center
Verification Date March 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP