Clinical trial NCT01226888: Changes in Brown Adipose Tissue Activity In Men Receiving Androgen Deprivation Therapy for Prostate Cancer
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 type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Prostate Cancer
Keywords: brown adipose tissue
androgen deprivation therapy
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
First posted: 2010-10-22
Enrollment: 2
Sex: MALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Men initiating androgen deprivation therapy with a GnRH agoinist or antagonist

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.

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.

Eligibility 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

Primary outcomes:
measure: Change in brown adipose tissue activity
timeFrame: 1 year
Secondary outcomes:
measure: Interval change
timeFrame: 1 year
measure: Interval change
timeFrame: 1 year
measure: Interval change
timeFrame: 1 year
measure: Interval change
timeFrame: 1 year
measure: Interval change
timeFrame: 1 year
measure: Interval change
timeFrame: 1 year
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
Study officials:
affiliation: Massachusetts General Hospital
name: Philip J Saylor, MD
role: PRINCIPAL_INVESTIGATOR
References: