Study to Monitor the Effects of Androgen Suppression Treatment on the Heart (AST)
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 Design:||Intervention Model: Single Group Assignment
Masking: Double Blind (Investigator, Outcomes Assessor)
Primary Purpose: Screening
|Official Title:||Does Androgen Suppression Treatment In Prostate Cancer Reduce Myocardial Blood Flow Reserve?|
- myocardial flow reserve [ Time Frame: 6 - 9 months ] [ Designated as safety issue: No ]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.
- Regional myocardial perfusion [ Time Frame: 6 - 9 months ] [ Designated as safety issue: No ]
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.
|Study Start Date:||July 2008|
|Estimated Study Completion Date:||March 2016|
|Primary Completion Date:||September 2011 (Final data collection date for primary outcome measure)|
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
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01230905
|University of Ottawa Heart Institute|
|Ottawa, Ontario, Canada, K1Y 4W7|
|Principal Investigator:||Terrence Ruddy, MD||Ottawa Heart Institute Research Corporation|