Changes in Brown Adipose Tissue Activity In Men Receiving Androgen Deprivation Therapy for Prostate Cancer
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ClinicalTrials.gov Identifier: NCT01226888 |
Recruitment Status
:
Terminated
(Slow accrual)
First Posted
: October 22, 2010
Last Update Posted
: November 5, 2012
|
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Condition or disease |
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Prostate Cancer |
- 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 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 |

- 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.
- Interval change [ Time Frame: 1 year ]To describe interval change in total body weight and body mass during GnRH agonist or antagonist therapy.
- 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.
- 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.
- 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.
- Interval change [ Time Frame: 1 year ]To describe interval change in serum lipid profile during GnRH agonist or antagonist therapy.
- 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

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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01226888
United States, Massachusetts | |
Massachusetts General Hospital | |
Boston, Massachusetts, United States, 02214 |
Principal Investigator: | Philip J Saylor, MD | Massachusetts General Hospital |
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 Key Record Dates |
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 |