Prospective Study of Insulin Resistance and Cardiovascular Disease Risk During Androgen Deprivation Therapy for Prostate Cancer

Prostate Cancer Clinical Trial

Official title:

Prospective Study of Insulin Resistance and Cardiovascular Disease Risk During Androgen Deprivation Therapy for Prostate Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00455624
• Other study ID #: 02-256
• Status: Completed
• Phase: N/A
• First received: April 2, 2007
• Last updated: July 9, 2013
• Start date: November 2002
• Est. completion date: May 2006

Study information

• Verified date: July 2013
• Source: Massachusetts General Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: May 2006
• Est. primary completion date: May 2006
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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)

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Cardiovascular Diseases
• Insulin Resistance
• Prostate Cancer
• Prostatic Neoplasms

Intervention

Drug:
• Androgen deprivation therapy
According to standard medical care

Locations

Country	Name	City	State
United States	Dana-Farber Cancer Institute	Boston	Massachusetts
United States	Massachusetts General Hospital	Boston	Massachusetts

Sponsors (3)

Lead Sponsor	Collaborator
Massachusetts General Hospital	Brigham and Women's Hospital, Dana-Farber Cancer Institute

Country where clinical trial is conducted

United States, 

References & Publications (1)

Smith MR, Lee H, Nathan DM. Insulin sensitivity during combined androgen blockade for prostate cancer. J Clin Endocrinol Metab. 2006 Apr;91(4):1305-8. Epub 2006 Jan 24. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	insulin sensitity		12 weeks	No