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Changes in Brown Adipose Tissue Activity In Men Receiving Androgen Deprivation Therapy for Prostate Cancer
This study has been terminated.
(Slow accrual)
Sponsor:
Massachusetts General Hospital
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
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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:
Genetics Home Reference related topics:
prostate cancer
MedlinePlus related topics:
Prostate Cancer
U.S. FDA Resources
Further study details as provided by Philip J. Saylor, MD, Massachusetts General Hospital:
Primary Outcome Measures:
- Change in brown adipose tissue activity [ Time Frame: 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:
- Interval change [ Time Frame: 1 year ]To describe interval change in total body weight and body mass during GnRH agonist or antagonist therapy.
- Interval change [ Time Frame: 1 year ]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 ]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 ]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 ]To describe interval change in serum lipid profile during GnRH agonist or antagonist therapy.
- Interval change [ Time Frame: 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.
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) |
- 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| Ages Eligible for Study: | Child, Adult, Senior |
| Sexes 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
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01226888
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
| 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 |
Keywords provided by Philip J. Saylor, MD, Massachusetts General Hospital:
|
brown adipose tissue androgen deprivation therapy |
Additional relevant MeSH terms:
|
Prostatic Neoplasms Genital Neoplasms, Male Urogenital Neoplasms Neoplasms by Site Neoplasms Genital Diseases, Male |
Prostatic Diseases Androgens Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs |
ClinicalTrials.gov processed this record on July 28, 2017