Changes in Brown Adipose Tissue Activity In Men Receiving Androgen Deprivation Therapy for Prostate Cancer

Study Description

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Brief Summary:

Androgen deprivation therapy (ADT) is considered standard of care for prostate cancer. However, changes in the patients metabolism are usually seen as a result of hormone therapy. These changes include increased fat mass, decreased lean mass, weight gain, high blood cholesterol, increased incidence of diabetes, and possibly increased incidence of cardiac events such as heart attack. The researchers of this trial would like to learn if these change in body mass are affected by the presence of brown fat in the body. Brown fat is made up of fat cells that are stored in the body and generate heat to control body temperature. Levels of brown fat are at the highest in newborn babies and decrease over time into adulthood. The researchers of this trial would like to learn more about these changes in metabolism during prostate cancer treatment by studying the changes in brown fat during the first 12 months of hormone therapy.

Condition or disease
Prostate Cancer

Detailed Description:

• Participants will be asked to come into the clinic for additional visits before they begin hormone therapy. The following procedures will be performed: Cold-activated PET/CT scan; body composition DXA scan; blood tests, questionnaires and abdominal fat biopsy.
• During hormone therapy, the participant will return to the clinical once after 3 months, and again after 6 months, to draw blood for laboratory tests.
• After 12 months of hormone therapy, the participant will return to teh clinic to repeat the following procedures: Cold-activated PET/CT scan; body composition DXA scan; blood tests; questionnaires and abdominal fat biopsy.

Study Design

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Study Type :	Observational
Actual Enrollment :	2 participants
Observational Model:	Case-Only
Time Perspective:	Prospective
Official Title:	Prospective Study of Changes in Brown Adipose Tissue (BAT) Activity in Men Receiving Androgen Deprivation Therapy (ADT) With a GnRH Agonist or Antagonist for Prostate Cancer
Study Start Date :	September 2010
Actual Primary Completion Date :	October 2012
Actual Study Completion Date :	October 2012

Groups and Cohorts

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Outcome Measures

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :

1. Change in brown adipose tissue activity [ Time Frame: 1 year ]
   To assess the change in cold-activated borwn adipose tissue (BAT) activity upon initiation of GnRH agoinist or antagoinist therapy among men treated for prostate cancer. The primary endpoint is percent change in cold-activated BAT volumne after 12 months of treatment.

Secondary Outcome Measures :

1. Interval change [ Time Frame: 1 year ]
   To describe interval change in total body weight and body mass during GnRH agonist or antagonist therapy.
2. Interval change [ Time Frame: 1 year ]
   To describe interval change in Total body fat mass as determined by body composition dual energy x-ray absorptiometry (DXA) scan during GnRH agonist or antagonist therapy.
3. Interval change [ Time Frame: 1 year ]
   To describe interval change in abdominal cross sectional subcutaneous fat area at the L4 verterbral body level during GnRH agonist or antagonist therapy.
4. Interval change [ Time Frame: 1 year ]
   To describe interval change in insulin sensitivity (as refelcted by hemoglobin A1C, fasting plasma glucose, and fasting plasma insulin) during GnRH agonist or antagonist therapy.
5. Interval change [ Time Frame: 1 year ]
   To describe interval change in serum lipid profile during GnRH agonist or antagonist therapy.
6. Interval change [ Time Frame: 1 year ]
   To describe interval change in levels of several markers of BAT regulation & activity in abdominal subcutaneous fat during GnRH agonist or antagonist therapy.

Biospecimen Retention:   Samples With DNA

fine needle aspirate biopsies of subcutaneous fat

Eligibility Criteria

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Ages Eligible for Study:	Child, Adult, Senior
Sexes Eligible for Study:	Male
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

Study Population

Men initiating androgen deprivation therapy with a GnRH agoinist or antagonist

Criteria

Inclusion Criteria:

• Adenocarcinoma of the prostate
• Scheduled to initiate GnRH agonist or antagonist treatment with an intended treatment duration of 12 months or greater
• ECOG Performance status of 0 or 1
• Ability to understand and the willingness to sign a written informed consent
• 65 years of age or younger

Exclusion Criteria:

• Diagnosis of diabetes
• Ongoing corticosteroid use
• GnRH agonist or antagonist treatment within the last 2 years
• Ongoing beta-blocker use
• Body mass index of greater than 30

Contacts and Locations

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Locations

United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02214

Sponsors and Collaborators

Massachusetts General Hospital

Investigators

Principal Investigator:	Philip J Saylor, MD	Massachusetts General Hospital

More Information

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party:	Philip J. Saylor, MD, Instructor, Massachusetts General Hospital
ClinicalTrials.gov Identifier:	NCT01226888 History of Changes
Other Study ID Numbers:	10-037
First Posted:	October 22, 2010
Last Update Posted:	November 5, 2012
Last Verified:	November 2012

Keywords provided by Philip J. Saylor, MD, Massachusetts General Hospital:

brown adipose tissue; androgen deprivation therapy

Additional relevant MeSH terms:

Prostatic Neoplasms; Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male	Prostatic Diseases; Androgens; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Physiological Effects of Drugs