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

Primary Purpose

Prostate Cancer

Status
Completed
Phase
Phase 4
Locations
Canada
Study Type
Interventional
Intervention
PET scan and ultrasound
Sponsored by
Ottawa Heart Institute Research Corporation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Prostate Cancer focused on measuring Androgen Suppression Therapy, Hormonal Toxicity, Quantitative PET, Myocardial blood flow, Coronary blood flow reserve, Endothelial dysfunction, Coronary Artery Disease

Eligibility Criteria

40 Years - 80 Years (Adult, Older Adult)MaleAccepts Healthy Volunteers

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.

Sites / Locations

  • University of Ottawa Heart Institute

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

MPI nuclear scan

Arm Description

Nuclear MPI for CAD for prostate cancer subjects undergoing treatment and development of normal comparison.

Outcomes

Primary Outcome Measures

myocardial flow reserve
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

Regional myocardial perfusion
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.

Full Information

First Posted
October 28, 2010
Last Updated
April 21, 2017
Sponsor
Ottawa Heart Institute Research Corporation
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1. Study Identification

Unique Protocol Identification Number
NCT01230905
Brief Title
Study to Monitor the Effects of Androgen Suppression Treatment on the Heart
Acronym
AST
Official Title
Does Androgen Suppression Treatment In Prostate Cancer Reduce Myocardial Blood Flow Reserve?
Study Type
Interventional

2. Study Status

Record Verification Date
April 2017
Overall Recruitment Status
Completed
Study Start Date
July 2008 (undefined)
Primary Completion Date
September 2011 (Actual)
Study Completion Date
September 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ottawa Heart Institute Research Corporation

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer
Keywords
Androgen Suppression Therapy, Hormonal Toxicity, Quantitative PET, Myocardial blood flow, Coronary blood flow reserve, Endothelial dysfunction, Coronary Artery Disease

7. Study Design

Primary Purpose
Screening
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
181 (Actual)

8. Arms, Groups, and Interventions

Arm Title
MPI nuclear scan
Arm Type
Other
Arm Description
Nuclear MPI for CAD for prostate cancer subjects undergoing treatment and development of normal comparison.
Intervention Type
Radiation
Intervention Name(s)
PET scan and ultrasound
Intervention Description
Nuclear rest/stress testing of the heart using N-13-ammonia paired with brachial artery ultrasound
Primary Outcome Measure Information:
Title
myocardial flow reserve
Description
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.
Time Frame
6 - 9 months
Secondary Outcome Measure Information:
Title
Regional myocardial perfusion
Description
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.
Time Frame
6 - 9 months

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Cancer Population: Diagnosis of prostate cancer 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 Male with low pre-test likelihood of coronary artery disease No previous history of cancer. Exclusion Criteria: 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. Subjects with a Summed Stress Score of >4 attributed to coronary disease on baseline PET images Patients previously treated with AST Patients with a life expectancy of less than 1 year.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Terrence Ruddy, MD
Organizational Affiliation
Ottawa Heart Institute Research Corporation
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Ottawa Heart Institute
City
Ottawa
State/Province
Ontario
ZIP/Postal Code
K1Y 4W7
Country
Canada

12. IPD Sharing Statement

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Study to Monitor the Effects of Androgen Suppression Treatment on the Heart

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