Skip to main content
OpenTrials
Completed

NCT Number: NCT01230905

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Prostate Cancer Arterial Occlusive Diseases Arteriosclerosis Cardiovascular Diseases Coronary Artery Disease Coronary Disease Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Heart Diseases Male Urogenital Diseases Myocardial Ischemia Neoplasms Neoplasms by Site Prostatic Diseases Prostatic Neoplasms Urogenital Diseases Urogenital Neoplasms Vascular Diseases

Age range

40 year–80 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 4

Primary location

University of Ottawa Heart Institute

Ottawa, Ontario, K1Y 4W7, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

PET scan and ultrasound

Radiation

Nuclear rest/stress testing of the heart using N-13-ammonia paired with brachial artery ultrasound

Primary outcomes

  1. myocardial flow reserve

    Time frame: 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 outcomes

  1. Regional myocardial perfusion

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Ottawa Heart Institute Research Corporation

Other

Registry information

Official study title

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

Acronym: AST

Important dates

Study start
2008
Primary completion
2011
Study completion
2011
First posted
Oct 29, 2010
Registry last updated
Apr 24, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.