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Study to Monitor the Effects of Androgen Suppression Treatment on the Heart (AST)

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. Identifier: NCT01230905
Recruitment Status : Completed
First Posted : October 29, 2010
Last Update Posted : April 24, 2017
Information provided by (Responsible Party):
Terrence Ruddy, Ottawa Heart Institute Research Corporation

Brief Summary:
Suppression of effects of androgens with male sex hormones, androgen suppression treatment (AST), has been known to reduce deaths and prolong life in advanced prostate cancer. There have, however, been concerns raised in previous studies that androgen suppression may be associated with increased rate of heart attacks, particularly in older men. This study looks at prostate cancer patients in The Ottawa Hospital Cancer Clinic to see if treating these patients with androgen suppression is associated with a decrease in blood flow to the heart muscles by using Positron Emission Tomography (PET) and brachial artery ultrasound.

Condition or disease Intervention/treatment Phase
Prostate Cancer Radiation: PET scan and ultrasound Phase 4

Detailed Description:

Treatment group: Prior to the initiation of AST, subjects will have a baseline N-13-ammonia PET scan and a brachial artery ultrasound at the University of Ottawa Heart Institute. Blood glucose and a lipid profile will be obtained. These tests will be repeated 6 - 9 months after starting AST.

Cancer control group: The same testing and intervals will be performed. Normals control group: Baseline testing will be done to establish a normal.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 181 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Screening
Official Title: Does Androgen Suppression Treatment In Prostate Cancer Reduce Myocardial Blood Flow Reserve?
Study Start Date : July 2008
Actual Primary Completion Date : September 2011
Actual Study Completion Date : September 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

Arm Intervention/treatment
MPI nuclear scan
Nuclear MPI for CAD for prostate cancer subjects undergoing treatment and development of normal comparison.
Radiation: PET scan and ultrasound
Nuclear rest/stress testing of the heart using N-13-ammonia paired with brachial artery ultrasound

Primary Outcome Measures :
  1. myocardial flow reserve [ Time Frame: 6 - 9 months ]
    The change in global absolute MFR between baseline and follow up PET studies, at a patient level. MFR is defined as the ratio between regional blood flow with maximum vasodilation and baseline regional blood flow.

Secondary Outcome Measures :
  1. Regional myocardial perfusion [ Time Frame: 6 - 9 months ]

    The change in absolute MFR between baseline and follow up tests for the 3 major coronary territories. Territories with severe reduction in flow or no flow on baseline images will be censored from this analysis. Regional myocardial perfusion will be assessed semi-quantitatively by summed stress scores and summed difference scores in each of the PET scans in the treatment and control groups.

    Two-dimensional scans and pulse measures will be taken of the brachial artery with flow-mediated vasodilatation expressed as a percent change in arterial diameter from resting diameter.

Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

Cancer Population:

  1. Diagnosis of prostate cancer
  2. Treatment group: Scheduled to start AST, at Ottawa Hospital under the care of Radiation Oncology, Urology or Medical Oncology.

Control group: no AST scheduled as a treatment option for prostate cancer.

Non-Cancer Control Group

  1. Male with low pre-test likelihood of coronary artery disease
  2. No previous history of cancer.

Exclusion Criteria:

  1. Known coronary disease including any of previous revascularization, history of myocardial infarction, coronary disease with >= 50% stenosis in a major coronary vessel on previous angiography, evidence of previous myocardial infarction on 12-lead electrocardiogram, positive myocardial perfusion scan, previous cardiac PET scan, stress echocardiogram or exercise stress test.
  2. Subjects with a Summed Stress Score of >4 attributed to coronary disease on baseline PET images
  3. Patients previously treated with AST
  4. Patients with a life expectancy of less than 1 year.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01230905

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Canada, Ontario
University of Ottawa Heart Institute
Ottawa, Ontario, Canada, K1Y 4W7
Sponsors and Collaborators
Ottawa Heart Institute Research Corporation
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Principal Investigator: Terrence Ruddy, MD Ottawa Heart Institute Research Corporation
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Responsible Party: Terrence Ruddy, Principal Investigator, Ottawa Heart Institute Research Corporation Identifier: NCT01230905    
Other Study ID Numbers: 2008341-01H
First Posted: October 29, 2010    Key Record Dates
Last Update Posted: April 24, 2017
Last Verified: April 2017
Keywords provided by Terrence Ruddy, Ottawa Heart Institute Research Corporation:
Androgen Suppression Therapy
Hormonal Toxicity
Quantitative PET
Myocardial blood flow
Coronary blood flow reserve
Endothelial dysfunction
Coronary Artery Disease
Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Prostatic Diseases