Prospective Study of Insulin Resistance and Cardiovascular Disease Risk During Androgen Deprivation Therapy for Prostate Cancer

• Status: Completed
• Trial end date: 2006-05-01
• Target enrollment: 0
• Participant gender: Male

Summary

The purpose of this study is to find out if androgen deprivation therapy affects insulin, cardiac risk factors such as cholesterol level, and body fat and muscle.

• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Massachusetts General Hospital
• Collaborators: Brigham and Women's Hospital; Dana-Farber Cancer Institute
• Treatments: Androgens; Ascorbic Acid; Estrogens, Conjugated (USP); Insulin; Methyltestosterone

Criteria

Inclusion Criteria:

• Adenocarcinoma of the prostate, clinical stage M0

• About to initiate GnRH agonist therapy

• Karnofsky Performance Status 90 or 100

• Serum creatinine < 2.0mg/dl

Exclusion Criteria:

• Hormone therapy within 12 months

• History of diabetes mellitus or glucose intolerance

• Anabolic agents or metabolic agents known to affect insulin or glucose levels

• Prior hormone therapy within the past 12 months and planned hormone therapy during the 12 week study (Group 2)