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

Completed

• Conditions: Prostate Cancer
• Interventions: Drug: Gonadotropin Releasing Hormone Agonist Therapy

• Registration Number: NCT00456144
• Lead Sponsor: Massachusetts General Hospital

Brief Summary

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.

Detailed Description

* The study will be divided into 2 groups: one group (Cohort A) will consist of men undergoing GnRH agonist therapy for at least 24 months. The second group (Cohort B) will consist of men undergoing the same treatment but who are scheduled to receive only 6 months of treatment.

* The following tests and procedures will be performed when the participant joins the study, then at 3, 6, 12 and 24 months thereafter. (All visits will take place at the General Clinical Research Center (GCRC) at the Massachusetts General Hospital.) Height and weight; blood and urine samples; Oral Glucose Tolerance Test (OGTT), Dual energy X-ray Absorptiometry scan; medical history; and physical examinations.

Study Timeline

• Study Start: 2006-08
• Study First Submitted: 2007-04-02
• Study First Submitted QC: 2007-04-02
• Study First Posted: 2007-04-04
• Primary Completion: 2012-09
• Study Completion: 2012-09
• Status Verified: 2013-07
• Last Update Submitted: 2013-07-09
• Last Update Posted: 2013-07-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 36

Inclusion Criteria

• 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)

Exclusion Criteria

• 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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Group 2	Gonadotropin Releasing Hormone Agonist Therapy	GnRH agonist for 6 months
Group 1	Gonadotropin Releasing Hormone Agonist Therapy	GnRH agonist for 24 months

Trial Locations

Locations (1)

Massachusetts General Hospital; 🇺🇸 Boston, Massachusetts, United States