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

NCT01226888 | Terminated DMC

• 1 other identifier: 10-037
• Study Type: observational
• Target: 2
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Prostate Cancer

Keywords

brown adipose tissue; androgen deprivation therapy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Interval change

  1 year

• Interval change

  1 year

• Interval change

  1 year

• Interval change

  1 year

• Interval change

  1 year

Eligibility Criteria

• Sex: male
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Men initiating androgen deprivation therapy with a GnRH agoinist or antagonist

You may qualify if:

• 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
• years of age or younger

You may not qualify if:

• 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

Sponsors & Collaborators

• Massachusetts General Hospital: lead

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02214, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

fine needle aspirate biopsies of subcutaneous fat

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Officials

• Philip J Saylor, MD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Instructor

Study Record Dates

• First Submitted: October 4, 2010
• First Posted: October 22, 2010
• Study Start: September 1, 2010
• Primary Completion: October 1, 2012
• Study Completion: October 1, 2012
• Last Updated: November 5, 2012

Record last verified: 2012-11

Locations

US (1)