Prostate Cancer
Conditions
Keywords
androgen deprivation therapy, insulin resistance
Brief summary
The purpose of this study is to find out if androgen deprivation therapy affects insulin, cardiac risk factors such as cholesterol level, and body fat and muscle.
Detailed description
* This is a non-treatment study. This study has no effect on the care the participant will receive. * In addition to the participants routine standard medical appointments they will need to make 2 additional outpatient visits for special testing over 12 weeks. These 2 additional outpatient visits will include the following: 1) urine and blood tests, 2) Oral Glucose Tolerance Test (OGTT) 3) Body measurements with a tape measure of your arms, legs, and waist and 4) x-ray evaluations (CT scan and bone density test).
Interventions
DRUGAndrogen deprivation therapy
According to standard medical care
Sponsors
Dana-Farber Cancer Institute
Brigham and Women's Hospital
Massachusetts General Hospital
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Adenocarcinoma of the prostate, clinical stage M0 * About to initiate GnRH agonist therapy * Karnofsky Performance Status 90 or 100 * Serum creatinine \< 2.0mg/dl
Exclusion criteria
* Hormone therapy within 12 months * History of diabetes mellitus or glucose intolerance * Anabolic agents or metabolic agents known to affect insulin or glucose levels * Prior hormone therapy within the past 12 months and planned hormone therapy during the 12 week study (Group 2)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| insulin sensitity | 12 weeks |
Countries
United States
Outcome results
None listed