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

NCT01230905 | Completed Phase 4

• 1 other identifier: 2008341-01H
• Study Type: interventional
• Target: 181
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Prostate Cancer

Keywords

Androgen Suppression Therapy; Hormonal Toxicity; Quantitative PET; Myocardial blood flow; Coronary blood flow reserve; Endothelial dysfunction; Coronary Artery Disease

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Regional myocardial perfusion

  6 - 9 months

Study Arms (1)

MPI nuclear scan

OTHER

Nuclear MPI for CAD for prostate cancer subjects undergoing treatment and development of normal comparison.

Radiation: PET scan and ultrasound

Interventions

PET scan and ultrasound RADIATION

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

MPI nuclear scan

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ottawa Heart Institute Research Corporation: lead

Study Sites (1)

University of Ottawa Heart Institute

Ottawa, Ontario, K1Y 4W7, Canada

Location

MeSH Terms

Conditions

Prostatic Neoplasms; Coronary Artery Disease

Interventions

Magnetic Resonance Spectroscopy; High-Energy Shock Waves

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Spectrum Analysis; Chemistry Techniques, Analytical; Investigative Techniques; Ultrasonic Waves; Sound; Radiation, Nonionizing; Radiation; Physical Phenomena

Study Officials

• Terrence Ruddy, MD

  Ottawa Heart Institute Research Corporation

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 28, 2010
• First Posted: October 29, 2010
• Study Start: July 1, 2008
• Primary Completion: September 1, 2011
• Study Completion: September 1, 2011
• Last Updated: April 24, 2017

Record last verified: 2017-04

Locations

CA (1)