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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


N/A
N/A
N/A
Not Enrolling
Male
Prostate Cancer

Thank you

Trial Information

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


- 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

Type of Study:

Observational

Study Design:

Observational Model: Case-Only, Time Perspective: Prospective

Outcome Measure:

Change in brown adipose tissue activity

Outcome Description:

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.

Outcome Time Frame:

1 year

Safety Issue:

No

Principal Investigator

Philip J Saylor, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Massachusetts General Hospital

Authority:

United States: Institutional Review Board

Study ID:

10-037

NCT ID:

NCT01226888

Start Date:

September 2010

Completion Date:

October 2012

Related Keywords:

  • Prostate Cancer
  • brown adipose tissue
  • androgen deprivation therapy
  • Prostatic Neoplasms

Name

Location

Massachusetts General HospitalBoston, Massachusetts  02114-2617