Androgen Deprivation Therapy Study (ADT)

This study has been terminated.
(No Participants completed study)
Sponsor:
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Institute on Aging (NIA) )
ClinicalTrials.gov Identifier:
NCT00743327
First received: August 26, 2008
Last updated: August 3, 2012
Last verified: August 2012
  Purpose

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.


Condition Intervention
Hypogonadism
Metabolic Syndrome
Diabetes
Inflammation
Drug: Pioglitazone

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Metabolic and Cardiovascular Complications in Men With Prostate Cancer Undergoing Long-term Androgen Deprivation Therapy

Resource links provided by NLM:


Further study details as provided by National Institutes of Health Clinical Center (CC):

Primary Outcome Measures:
  • Evaluation for the development of incident diabetes [ Time Frame: every 3 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Evaluation for other cardiovascular risk factors, markers of inflammation and immunological changes [ Time Frame: every 3 months ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples Without DNA

Serum, Muscle biopsy specimens


Enrollment: 1
Study Start Date: October 2008
Study Completion Date: August 2012
Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
1
Participants receiving ADT and pioglitazone
Drug: Pioglitazone
45mg capsule, once daily for 1 year
Other Name: Actos
2
Participants receiving ADT only
3
Participants not receiving ADT and in remission from prostate cancer

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Community sample of men ages 18 and older with prostate cancer

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00743327

Locations
United States, Maryland
NIA Clinical Research Unit located at Harbor Hospital
Baltimore, Maryland, United States, 21225
Sponsors and Collaborators
Investigators
Principal Investigator: Josephine M. Egan, MD National Institute on Aging, Intramural Research Program
  More Information

Publications:
Responsible Party: National Institutes of Health Clinical Center (CC) ( National Institute on Aging (NIA) )
ClinicalTrials.gov Identifier: NCT00743327     History of Changes
Other Study ID Numbers: AG0107
Study First Received: August 26, 2008
Last Updated: August 3, 2012
Health Authority: United States: Federal Government

Keywords provided by National Institutes of Health Clinical Center (CC):
hormone therapy

Additional relevant MeSH terms:
Hypogonadism
Inflammation
Metabolic Syndrome X
Gonadal Disorders
Endocrine System Diseases
Pathologic Processes
Insulin Resistance
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases
Androgens
Pioglitazone
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Hypoglycemic Agents

ClinicalTrials.gov processed this record on April 16, 2014