Changes in Brown Adipose Tissue Activity In Men Receiving Androgen Deprivation Therapy for Prostate Cancer
| Status: | Completed |
|---|---|
| Conditions: | Prostate Cancer, Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | Any |
| Updated: | 10/21/2012 |
| Start Date: | September 2010 |
| End Date: | September 2013 |
| Contact: | Philip J Saylor, MD |
| Email: | psaylor@partners.org |
| Phone: | 617-724-4000 |
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
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.
- 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.
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
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