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

Terminated

• Conditions: Prostate Cancer

• Registration Number: NCT01226888
• Lead Sponsor: Massachusetts General Hospital

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.

Study Timeline

• Study Start: 2010-09
• Study First Submitted: 2010-10-04
• Study First Submitted QC: 2010-10-21
• Study First Posted: 2010-10-22
• Primary Completion: 2012-10
• Study Completion: 2012-10
• Status Verified: 2012-11
• Last Update Submitted: 2012-11-02
• Last Update Posted: 2012-11-04

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Male
• Target Recruitment: 2

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in brown adipose tissue activity	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

Name	Time	Method
Interval change	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.

Trial Locations

Locations (1)

Massachusetts General Hospital; 🇺🇸 Boston, Massachusetts, United States