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

Completed

Conditions studied: Prostate Cancer

In brief

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.

Key facts

Study ID

NCT00455624

Run by

Massachusetts General Hospital

People needed

60

Starts

2002-11-01

Expected to finish

2006-05-01

Last updated by the study team

2013-07-11

Who can join

Age: 18 and older. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• Adenocarcinoma of the prostate, clinical stage M0
• About to initiate GnRH agonist therapy
• Karnofsky Performance Status 90 or 100
• Serum creatinine < 2.0mg/dl

You may not qualify if…

• 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)

Where it is running

• Dana-Farber Cancer Institute — Boston, Massachusetts, United States
• Massachusetts General Hospital — Boston, Massachusetts, United States

Full record on ClinicalTrials.gov

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