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


Phase 4
40 Years
80 Years
Open (Enrolling)
Male
Prostate Cancer

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Trial Information

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


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.


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.

Type of Study:

Interventional

Study Design:

Intervention Model: Single Group Assignment, Masking: Double Blind (Investigator, Outcomes Assessor), Primary Purpose: Screening

Outcome Measure:

myocardial flow reserve

Outcome Description:

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.

Outcome Time Frame:

6 - 9 months

Safety Issue:

No

Principal Investigator

Terrence Ruddy, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Ottawa Heart Institute

Authority:

Canada: Health Canada

Study ID:

HI Protocol #2008341-01H

NCT ID:

NCT01230905

Start Date:

July 2008

Completion Date:

February 2014

Related Keywords:

  • Prostate Cancer
  • Androgen Suppression Therapy
  • Hormonal Toxicity
  • Quantitative PET
  • Myocardial blood flow
  • Coronary blood flow reserve
  • Endothelial dysfunction
  • Coronary Artery Disease
  • Prostatic Neoplasms

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