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

NCT00456144 | Completed

• 1 other identifier: 06-086
• Study Type: observational
• Target: 36
• Locations: 1 country
• Sites: 1

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.

Conditions

Prostate Cancer

Keywords

GnRH; Insulin sensitivity

Study Arms (2)

Group 1

GnRH agonist for 24 months

Drug: Gonadotropin Releasing Hormone Agonist Therapy

Group 2

GnRH agonist for 6 months

Drug: Gonadotropin Releasing Hormone Agonist Therapy

Interventions

Gonadotropin Releasing Hormone Agonist Therapy DRUG

Given either for 24 months and 6 months

Group 1; Group 2

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

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

Sponsors & Collaborators

• Massachusetts General Hospital: lead
• National Institutes of Health (NIH): collaborator

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02215, United States

Location

Related Publications (1)

• 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.

  PMID: 22589396 RESULT

Biospecimen

Retention: SAMPLES WITH DNA

Whole blood Urine

MeSH Terms

Conditions

Prostatic Neoplasms; Insulin Resistance

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Matthew R. Smith, MD, PhD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Genitourinary Malignancies Program

Study Record Dates

• First Submitted: April 2, 2007
• First Posted: April 4, 2007
• Study Start: August 1, 2006
• Primary Completion: September 1, 2012
• Study Completion: September 1, 2012
• Last Updated: July 11, 2013

Record last verified: 2013-07

Locations

US (1)