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

18 Years
Not Enrolling
Hypogonadism, Metabolic Syndrome, Diabetes, Inflammation

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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

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.

Inclusion Criteria:

- Men 18 years of age or older with prostate cancer

- Planning to undergo long-term (at least 12 months) ADT

- No known history of diabetes

- No history of ADT

Exclusion Criteria:

- History of ADT or any prior diagnosis of hypogonadism

- Fasting glucose or oral glucose tolerance test results in the diabetic range

- Heart failure (NY classification III or IV)

- Testosterone level less than 250 ng/dl on screening

- History of heart attack or open-heart surgery within the past 6 months

- Use of steroids within the past 3 months, including prednisone, cortisone injections,
inhaled steroids (topical steroids are acceptable)

- Use of anabolic steroids (testosterone, DHEA, DHEAS) or any growth promoters (growth
hormone itself or analogs of growth hormone) in the past 12 months

- Liver function tests more than 3 times upper normal limits

- Undergoing intermittent ADT

- Uncontrolled thyroid disease (hyper- or hypo-thyroidism)

- Anemia, defined as hematocrit less than 38%

- Not physically capable of completing the tests

Type of Study:


Study Design:

Observational Model: Cohort, Time Perspective: Prospective

Outcome Measure:

Evaluation for the development of incident diabetes

Outcome Time Frame:

every 3 months

Safety Issue:


Principal Investigator

Josephine M. Egan, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

National Institute on Aging, Intramural Research Program


United States: Federal Government

Study ID:




Start Date:

October 2008

Completion Date:

August 2012

Related Keywords:

  • Hypogonadism
  • Metabolic Syndrome
  • Diabetes
  • Inflammation
  • hormone therapy
  • Hypogonadism
  • Inflammation
  • Metabolic Syndrome X



NIA Clinical Research Unit located at Harbor Hospital Baltimore, Maryland  21225