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

Prostate Cancer Clinical Trial

— AST  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01230905
• Other study ID #: 2008341-01H
• Status: Completed
• Phase: Phase 4
• First received: October 28, 2010
• Last updated: April 21, 2017
• Start date: July 2008
• Est. completion date: September 2011

Study information

• Verified date: April 2017
• Source: Ottawa Heart Institute Research Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 181
• Est. completion date: September 2011
• Est. primary completion date: September 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 40 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Radiation:
• PET scan and ultrasound
Nuclear rest/stress testing of the heart using N-13-ammonia paired with brachial artery ultrasound

Locations

Country	Name	City	State
Canada	University of Ottawa Heart Institute	Ottawa	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Ottawa Heart Institute Research Corporation

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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