Androgen Deprivation Therapy Study

• Status: Terminated
• Trial end date: 2012-08-01
• Target enrollment: 0
• Participant gender: Male

Summary

The purpose of this study is to examine the link between low testosterone and insulin resistance/diabetes in men undergoing androgen deprivation therapy for prostate cancer. The study will also evaluate other cardiovascular risk factors in these men.

• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Institute on Aging (NIA)
• Treatments: Androgens; Pioglitazone

Criteria

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