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

Prostate Cancer Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01226888
• Other study ID #: 10-037
• Status: Terminated
• Phase: N/A
• First received: October 4, 2010
• Last updated: November 2, 2012
• Start date: September 2010
• Est. completion date: October 2012

Study information

• Verified date: November 2012
• Source: Massachusetts General Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 2
• Est. completion date: October 2012
• Est. primary completion date: October 2012
• Accepts healthy volunteers: No
• Gender: Male
• Age group: N/A and older

Eligibility

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

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Locations

Country	Name	City	State
United States	Massachusetts General Hospital	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Massachusetts General Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	1 year	No
Secondary	Interval change	To describe interval change in total body weight and body mass during GnRH agonist or antagonist therapy.	1 year	No
Secondary	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.	1 year	No
Secondary	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.	1 year	No
Secondary	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.	1 year	No
Secondary	Interval change	To describe interval change in serum lipid profile during GnRH agonist or antagonist therapy.	1 year	No
Secondary	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.	1 year	No