An observational study in Prostate Cancer, sponsored by Massachusetts General Hospital. Terminated at 1 site in United States. Open to male participants. Per ClinicalTrials.gov, last updated 2012-11-04.
Sponsored by Massachusetts General Hospital · Observational
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.
6,370 studies on the registry are indexed under Prostatic Neoplasms; 1,400 are open to participants now.
This study's enrollment of 2 is below the median of 200 across 1,181 observational studies indexed under Prostatic Neoplasms.
Browse Prostatic Neoplasms studies →Massachusetts General Hospital is the lead sponsor of 2,536 studies on the registry; 446 are open to participants now.
Of its 214 completed or terminated interventional studies of FDA-regulated products, 161 (75%) have results posted.
Counted across the registry records on this site, refreshed daily.
Men initiating androgen deprivation therapy with a GnRH agoinist or antagonist
Exclusion Criteria:
Change in brown adipose tissue activity
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.
Time frame: 1 year
Interval change
To describe interval change in total body weight and body mass during GnRH agonist or antagonist therapy.
Time frame: 1 year
Interval change
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.
Time frame: 1 year
Interval change
To describe interval change in abdominal cross sectional subcutaneous fat area at the L4 verterbral body level during GnRH agonist or antagonist therapy.
Time frame: 1 year
Interval change
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.
Time frame: 1 year
Interval change
To describe interval change in serum lipid profile during GnRH agonist or antagonist therapy.
Time frame: 1 year
Interval change
To describe interval change in levels of several markers of BAT regulation \& activity in abdominal subcutaneous fat during GnRH agonist or antagonist therapy.
Time frame: 1 year
This study is terminated, as verified in Nov 2012. You cannot join it, but the record below documents what was studied.
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Massachusetts General Hospital