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

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ClinicalTrials.gov Identifier: NCT00456144
Recruitment Status : Completed
First Posted : April 4, 2007
Last Update Posted : July 11, 2013
Sponsor:
Collaborator:
National Institutes of Health (NIH)
Information provided by (Responsible Party):
Matthew R. Smith, MD, PhD, 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.

Condition or disease Intervention/treatment
Prostate Cancer Drug: Gonadotropin Releasing Hormone Agonist Therapy

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 Type : Observational
Actual Enrollment : 36 participants
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
Study Start Date : August 2006
Actual Primary Completion Date : September 2012
Actual Study Completion Date : September 2012

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Group/Cohort Intervention/treatment
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



Biospecimen Retention:   Samples With DNA
Whole blood Urine


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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00456144


Locations
United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02215
Sponsors and Collaborators
Massachusetts General Hospital
National Institutes of Health (NIH)
Investigators
Principal Investigator: Matthew R. Smith, MD, PhD Massachusetts General Hospital

Publications of Results:
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
First Posted: April 4, 2007    Key Record Dates
Last Update Posted: July 11, 2013
Last Verified: July 2013

Keywords provided by Matthew R. Smith, MD, PhD, Massachusetts General Hospital:
GnRH
Insulin sensitivity

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