Clinical trial NCT00456144: Prospective Observation Study of Insulin Sensitivity During and After Gonadotropin Releasing Hormone Agonist Therapy for Prostate Cancer
Official title: Prospective Observation Study of Insulin Sensitivity During and After Gonadotropin Releasing Hormone (GnRH) Agonist Therapy for Prostate Cancer
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Prostate Cancer
Keywords: GnRH
Insulin sensitivity
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
First posted: 2007-04-04
Enrollment: 36
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Men with prostate cancer scheduled to undergo GnRH agonist therapy with intended treatment duration of 6 or 24 months.

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.

Eligibility criteria: 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

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
Study officials:
affiliation: Massachusetts General Hospital
name: Matthew R. Smith, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Saylor PJ, Karoly ED, Smith MR. Prospective study of changes in the metabolomic profiles of men during their first three months of androgen deprivation therapy for prostate cancer. Clin Cancer Res. 2012 Jul 1;18(13):3677-85. doi: 10.1158/1078-0432.CCR-11-3209. Epub 2012 May 15.