Study to Monitor the Effects of Androgen Suppression Treatment on the Heart (AST)
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
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|
|Study Completion Date:||September 2011|
|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|