Trial Information

Metabolic and Cardiovascular Complications in Men With Prostate Cancer Undergoing Long-term Androgen Deprivation Therapy

Lowering of testosterone levels, by medications or surgery (Androgen Deprivation Therapy or
ADT), is commonly used in the treatment of prostate cancer. The adverse effects of low
testosterone include decreased sex drive, impotence, decreased lean body mass and muscle
strength, increased fat mass, decreased quality of life and osteoporosis.

An increase in body fat and decrease in lean body mass may contribute to a decrease in the
body's ability to use insulin effectively, leading to insulin resistance and diabetes. Low
testosterone levels are also associated with elevated total cholesterol, LDL-cholesterol and
triglycerides.

Two groups of non-diabetic men will be studied:

1. Men with known history of prostate cancer who were treated with surgery and/or
radiation therapy and are now in remission and not receiving androgen deprivation
therapy (non-ADT group).

2. Men with newly diagnosed or known history of prostate cancer who are being advised by
their physicians to begin androgen deprivation therapy (ADT group).

The non-ADT group and half of the ADT group will be observed for the development of insulin
resistance/diabetes. The other half of the ADT group will receive a diabetes medication
called Pioglitazone (Actos) to evaluate any beneficial effects of this medication in the
prevention of metabolic dysfunction.

The study will consist of a screening visit and 6 additional study visits throughout one
year. Procedures during this study include blood draws, MRI, CT, DEXA scan, insulin clamp
procedures, oral glucose tolerance tests, carotid IMT, pulse wave velocity,
neuropsychological testing, physical exams and an optional muscle biopsy.