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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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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

Conditions
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Prostate Cancer

Participation Criteria
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Eligibility Criteria
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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
Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Interval change | To describe interval change in total body weight and body mass during GnRH agonist or antagonist therapy. | 1 year | 
| 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 | 
| 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 | 
| 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 | 
| Interval change | To describe interval change in serum lipid profile during GnRH agonist or antagonist therapy. | 1 year | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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brown adipose tissue, androgen deprivation therapy