Study to Monitor the Effects of Androgen Suppression Treatment on the Heart (AST)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Prostate Cancer Research Foundation of Canada
Information provided by (Responsible Party):
Terrence Ruddy, University of Ottawa Heart Institute
ClinicalTrials.gov Identifier:
NCT01230905
First received: October 28, 2010
Last updated: March 5, 2014
Last verified: March 2014
  Purpose

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.


Condition Intervention Phase
Prostate Cancer
Radiation: PET scan and ultrasound
Phase 4

Study Type: Interventional
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?

Resource links provided by NLM:


Further study details as provided by University of Ottawa Heart Institute:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.



Enrollment: 181
Study Start Date: July 2008
Estimated Study Completion Date: February 2015
Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   40 Years to 80 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01230905

Locations
Canada, Ontario
University of Ottawa Heart Institute
Ottawa, Ontario, Canada, K1Y 4W7
Sponsors and Collaborators
University of Ottawa Heart Institute
Prostate Cancer Research Foundation of Canada
Investigators
Principal Investigator: Terrence Ruddy, MD University of Ottawa Heart Institute
  More Information

No publications provided

Responsible Party: Terrence Ruddy, Principal Investigator, University of Ottawa Heart Institute
ClinicalTrials.gov Identifier: NCT01230905     History of Changes
Other Study ID Numbers: HI Protocol #2008341-01H
Study First Received: October 28, 2010
Last Updated: March 5, 2014
Health Authority: Canada: Health Canada

Keywords provided by University of Ottawa Heart Institute:
Androgen Suppression Therapy
Hormonal Toxicity
Quantitative PET
Myocardial blood flow
Coronary blood flow reserve
Endothelial dysfunction
Coronary Artery Disease

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases
Androgens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 20, 2014