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

Phase 4

Completed

• Conditions: Prostate Cancer
• Interventions: Radiation: PET scan and ultrasound

• Registration Number: NCT01230905
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2008-07
• Study First Submitted: 2010-10-28
• Study First Submitted QC: 2010-10-28
• Study First Posted: 2010-10-29
• Primary Completion: 2011-09
• Study Completion: 2011-09
• Status Verified: 2017-04
• Last Update Submitted: 2017-04-21
• Last Update Posted: 2017-04-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 181

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
MPI nuclear scan	PET scan and ultrasound	Nuclear MPI for CAD for prostate cancer subjects undergoing treatment and development of normal comparison.

Primary Outcome Measures

Name	Time	Method
myocardial flow reserve	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

Name	Time	Method
Regional myocardial perfusion	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.

Trial Locations

Locations (1)

University of Ottawa Heart Institute; 🇨🇦 Ottawa, Ontario, Canada