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

Does Androgen Suppression Treatment In Prostate Cancer Reduce Myocardial Blood Flow Reserve?

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.

Study Overview

• Status: Completed
• Conditions: Prostate Cancer
• Intervention / Treatment: Radiation: PET scan and 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.

• Study Type: Interventional
• Enrollment (Actual): 181
• Phase: Phase 4

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Ottawa, Ontario, Canada, K1Y 4W7
      • University of Ottawa Heart Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	6 - 9 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	6 - 9 months

Collaborators and Investigators

• Sponsor: Ottawa Heart Institute Research Corporation
• Investigators: Principal Investigator: Terrence Ruddy, MD, Ottawa Heart Institute Research Corporation

Study record dates

Study Major Dates

• Study Start: July 1, 2008
• Primary Completion (Actual): September 1, 2011
• Study Completion (Actual): September 1, 2011

Study Registration Dates

• First Submitted: October 28, 2010
• First Submitted That Met QC Criteria: October 28, 2010
• First Posted (Estimate): October 29, 2010

Study Record Updates

• Last Update Posted (Actual): April 24, 2017
• Last Update Submitted That Met QC Criteria: April 21, 2017
• Last Verified: April 1, 2017

More Information

Terms related to this study

• Keywords: Endothelial dysfunction; Coronary Artery Disease; Androgen Suppression Therapy; Hormonal Toxicity; Quantitative PET; Myocardial blood flow; Coronary blood flow reserve
• Additional Relevant MeSH Terms: Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Genital Neoplasms, Male; Prostatic Diseases; Prostatic Neoplasms
• Other Study ID Numbers: 2008341-01H