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

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Matthew R. Smith, MD, PhD, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT00456144
First received: April 2, 2007
Last updated: July 9, 2013
Last verified: July 2013
  Purpose

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.


Condition Intervention
Prostate Cancer
Drug: Gonadotropin Releasing Hormone Agonist Therapy

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Prospective Observation Study of Insulin Sensitivity During and After Gonadotropin Releasing Hormone (GnRH) Agonist Therapy for Prostate Cancer

Resource links provided by NLM:


Further study details as provided by Massachusetts General Hospital:

Biospecimen Retention:   Samples With DNA

Whole blood Urine


Enrollment: 36
Study Start Date: August 2006
Study Completion Date: September 2012
Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Group 1
GnRH agonist for 24 months
Drug: Gonadotropin Releasing Hormone Agonist Therapy
Given either for 24 months and 6 months
Group 2
GnRH agonist for 6 months
Drug: Gonadotropin Releasing Hormone Agonist Therapy
Given either for 24 months and 6 months

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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.

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00456144

Locations
United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02215
Sponsors and Collaborators
Massachusetts General Hospital
Investigators
Principal Investigator: Matthew R. Smith, MD, PhD Massachusetts General Hospital
  More Information

Publications:
Responsible Party: Matthew R. Smith, MD, PhD, Director, Genitourinary Malignancies Program, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT00456144     History of Changes
Other Study ID Numbers: 06-086
Study First Received: April 2, 2007
Last Updated: July 9, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Massachusetts General Hospital:
GnRH
Insulin sensitivity

Additional relevant MeSH terms:
Insulin Resistance
Prostatic Neoplasms
Genital Diseases, Male
Genital Neoplasms, Male
Glucose Metabolism Disorders
Hyperinsulinism
Metabolic Diseases
Neoplasms
Neoplasms by Site
Prostatic Diseases
Urogenital Neoplasms
Hormones
Insulin
Hormones, Hormone Substitutes, and Hormone Antagonists
Hypoglycemic Agents
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on October 29, 2014