Prostate Cancer Clinical Trial

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

Summary

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.

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Full 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.

View Eligibility Criteria

Eligibility 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

Study is for people with:

Prostate Cancer

Estimated Enrollment:

2

Study ID:

NCT01226888

Recruitment Status:

Terminated

Sponsor:

Massachusetts General Hospital

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There is 1 Location for this study

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Massachusetts General Hospital
Boston Massachusetts, 02214, United States

How clear is this clinincal trial information?

Study is for people with:

Prostate Cancer

Estimated Enrollment:

2

Study ID:

NCT01226888

Recruitment Status:

Terminated

Sponsor:


Massachusetts General Hospital

How clear is this clinincal trial information?

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