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

This study has been terminated.
(Slow accrual)
Sponsor:
Information provided by (Responsible Party):
Philip J. Saylor, MD, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT01226888
First received: October 4, 2010
Last updated: November 2, 2012
Last verified: November 2012
  Purpose

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.


Condition
Prostate Cancer

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
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

Resource links provided by NLM:


Further study details as provided by Massachusetts General Hospital:

Primary Outcome Measures:
  • Change in brown adipose tissue activity [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    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:
  • Interval change [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    To describe interval change in total body weight and body mass during GnRH agonist or antagonist therapy.

  • Interval change [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    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.

  • Interval change [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    To describe interval change in abdominal cross sectional subcutaneous fat area at the L4 verterbral body level during GnRH agonist or antagonist therapy.

  • Interval change [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    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.

  • Interval change [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    To describe interval change in serum lipid profile during GnRH agonist or antagonist therapy.

  • Interval change [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    To describe interval change in levels of several markers of BAT regulation & activity in abdominal subcutaneous fat during GnRH agonist or antagonist therapy.


Biospecimen Retention:   Samples With DNA

fine needle aspirate biopsies of subcutaneous fat


Enrollment: 2
Study Start Date: September 2010
Study Completion Date: October 2012
Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)
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

Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Men initiating androgen deprivation therapy with a GnRH agoinist or antagonist

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01226888

Locations
United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02214
Sponsors and Collaborators
Massachusetts General Hospital
Investigators
Principal Investigator: Philip J Saylor, MD Massachusetts General Hospital
  More Information

No publications provided

Responsible Party: Philip J. Saylor, MD, Instructor, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT01226888     History of Changes
Other Study ID Numbers: 10-037
Study First Received: October 4, 2010
Last Updated: November 2, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Massachusetts General Hospital:
brown adipose tissue
androgen deprivation therapy

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Diseases, Male
Genital Neoplasms, Male
Neoplasms
Neoplasms by Site
Prostatic Diseases
Urogenital Neoplasms
Androgens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on October 20, 2014