Status:
COMPLETED
Prospective Study of Insulin Resistance and Cardiovascular Disease Risk During Androgen Deprivation Therapy for Prostate Cancer
Lead Sponsor:
Massachusetts General Hospital
Collaborating Sponsors:
Dana-Farber Cancer Institute
Brigham and Women's Hospital
Conditions:
Prostate Cancer
Eligibility:
MALE
18+ years
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 add...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
November 1 2002
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
May 1 2006
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT00455624
Start Date
November 1 2002
End Date
May 1 2006
Last Update
July 11 2013
Active Locations (2)
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1
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02115
2
Massachusetts General Hospital
Boston, Massachusetts, United States, 02215