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
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 2
- 试验地点
- 1
- 主要终点
- Change in brown adipose tissue activity
研究概览
简要总结
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.
详细描述
- 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.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Change in brown adipose tissue activity
时间窗: 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.
次要结局
- Interval change(1 year)
研究者
Philip J. Saylor, MD
Instructor
Massachusetts General Hospital