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

Mass General Brigham

Status: Completed

Conditions: Prostate Cancer

Treatments: Drug: Androgen deprivation therapy

Study type: Observational

Funder types: Other

Identifiers

NCT00455624

02-256

Details and patient eligibility

About

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.

Full 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).

Enrollment: 60 patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)