Androgen Deprivation Therapy Study - Full Text View

Sponsored by:	National Institute on Aging (NIA)
Information provided by:	National Institute on Aging (NIA)
ClinicalTrials.gov Identifier:	NCT00743327

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

MedlinePlus related topics: Cancer Diabetes Prostate Cancer

Drug Information available for: Pioglitazone Pioglitazone hydrochloride

U.S. FDA Resources

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

Further study details as provided by National Institute on Aging (NIA):

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

Biospecimen Description:

Serum, Muscle biopsy specimens

Estimated Enrollment:	60
Study Start Date:	October 2008
Estimated Study Completion Date:	October 2010
Estimated Primary Completion Date:	October 2010 (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
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:

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).
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

Contacts

Contact: Denise Melvin, RN	410-350-3924	melvinde@grc.nia.nih.gov
Contact: Recruiter, National Institute on Aging at Harbor Hospital	410-350-3941	NIAStudiesRecruitment@mail.nih.gov

Locations

United States, Maryland
National Institute on Aging / Clinical Research Branch
Baltimore, Maryland, United States, 21225

Sponsors and Collaborators

National Institute on Aging (NIA)

Investigators

Principal Investigator:

Josephine M. Egan, MD

National Institute on Aging, Intramural Research Program

More Information

Publications:

Dockery F, Bulpitt CJ, Agarwal S, Donaldson M, Rajkumar C. Testosterone suppression in men with prostate cancer leads to an increase in arterial stiffness and hyperinsulinaemia. Clin Sci (Lond). 2003 Feb;104(2):195-201.

Smith MR, Lee H, Nathan DM. Insulin sensitivity during combined androgen blockade for prostate cancer. J Clin Endocrinol Metab. 2006 Apr;91(4):1305-8. Epub 2006 Jan 24.

Basaria S, Muller DC, Carducci MA, Egan J, Dobs AS. Hyperglycemia and insulin resistance in men with prostate carcinoma who receive androgen-deprivation therapy. Cancer. 2006 Feb 1;106(3):581-8.

Keating NL, O'Malley AJ, Smith MR. Diabetes and cardiovascular disease during androgen deprivation therapy for prostate cancer. J Clin Oncol. 2006 Sep 20;24(27):4448-56.

Braga-Basaria M, Dobs AS, Muller DC, Carducci MA, John M, Egan J, Basaria S. Metabolic syndrome in men with prostate cancer undergoing long-term androgen-deprivation therapy. J Clin Oncol. 2006 Aug 20;24(24):3979-83.

Responsible Party:	National Institute on Aging, Intramural Research Program ( Josephine M. Egan, MD )
Study ID Numbers:	AG0107
Study First Received:	August 26, 2008
Last Updated:	August 26, 2008
ClinicalTrials.gov Identifier:	NCT00743327
Health Authority:	United States: Federal Government

Keywords provided by National Institute on Aging (NIA):

hormone therapy

Study placed in the following topic categories:

Hypogonadism
Pioglitazone
Gonadal Disorders
Diabetes Mellitus

Endocrine System Diseases
Endocrinopathy
Prostatic Neoplasms
Inflammation

Additional relevant MeSH terms:

Hypoglycemic Agents
Disease
Pathologic Processes

Syndrome
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009