Prospective Observation Study of Insulin Sensitivity During and After Gonadotropin Releasing Hormone Agonist Therapy for Prostate Cancer

Completed

Conditions studied: Prostate Cancer

In brief

The purpose of this research study is to find out if a certain type of hormone therapy, gonadotropin-releasing hormone agonist (GnRH agonist), affects the way the body produces and responds to insulin. The investigators will evaluate the changes in insulin sensitivity during and after GnRH agonist treatment for prostate cancer. The investigators are assessing the possibility that treatment-related insulin resistance may contribute to the risk of diabetes and/or cardiovascular disease in men with prostate cancer.

Key facts

Study ID

NCT00456144

Run by

Massachusetts General Hospital

People needed

36

Starts

2006-08-01

Expected to finish

2012-09-01

Last updated by the study team

2013-07-11

Who can join

Age: 18 and older. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• Adenocarcinoma of the prostate, clinical stage M0
• Scheduled to initiate GnRH agonist therapy with intended treatment duration of greater than 24 months (Group A)
• Scheduled for radiation therapy and neoadjuvant GnRH agonist therapy with intended 6 month duration of treatment (Group B)
• Karnofsky Performance Status 90 or 100
• Local or local-regional disease (Group B)

You may not qualify if…

• Prior hormone therapy (GnRH agonist or antiandrogen)
• History of bilateral orchiectomy
• Known diabetes mellitus or glucose intolerance
• Current treatment with anabolic agents or metabolic agents known to affect insulin or glucose levels

Where it is running

• Massachusetts General Hospital — Boston, Massachusetts, United States

Full record on ClinicalTrials.gov

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