Prospective Study of Insulin Resistance and Cardiovascular Disease Risk During Androgen Deprivation Therapy for Prostate Cancer

This study has been completed.
Dana-Farber Cancer Institute
Brigham and Women's Hospital
Information provided by (Responsible Party):
Matthew R. Smith, MD, PhD, Massachusetts General Hospital Identifier:
First received: April 2, 2007
Last updated: July 9, 2013
Last verified: July 2013
The purpose of this study is to find out if androgen deprivation therapy affects insulin, cardiac risk factors such as cholesterol level, and body fat and muscle.

Condition Intervention
Prostate Cancer
Drug: Androgen deprivation therapy

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Prospective Study of Insulin Resistance and Cardiovascular Disease Risk During Androgen Deprivation Therapy for Prostate Cancer

Resource links provided by NLM:

Further study details as provided by Massachusetts General Hospital:

Primary Outcome Measures:
  • insulin sensitity [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA
Whole blood

Enrollment: 60
Study Start Date: November 2002
Study Completion Date: May 2006
Primary Completion Date: May 2006 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Androgen deprivation therapy
    According to standard medical care
Detailed Description:
  • This is a non-treatment study. This study has no effect on the care the participant will receive.
  • In addition to the participants routine standard medical appointments they will need to make 2 additional outpatient visits for special testing over 12 weeks. These 2 additional outpatient visits will include the following: 1) urine and blood tests, 2) Oral Glucose Tolerance Test (OGTT) 3) Body measurements with a tape measure of your arms, legs, and waist and 4) x-ray evaluations (CT scan and bone density test).

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 identified with prostate cancer.

Inclusion Criteria:

  • Adenocarcinoma of the prostate, clinical stage M0
  • About to initiate GnRH agonist therapy
  • Karnofsky Performance Status 90 or 100
  • Serum creatinine < 2.0mg/dl

Exclusion Criteria:

  • Hormone therapy within 12 months
  • History of diabetes mellitus or glucose intolerance
  • Anabolic agents or metabolic agents known to affect insulin or glucose levels
  • Prior hormone therapy within the past 12 months and planned hormone therapy during the 12 week study (Group 2)
  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 identifier: NCT00455624

United States, Massachusetts
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02115
Massachusetts General Hospital
Boston, Massachusetts, United States, 02215
Sponsors and Collaborators
Massachusetts General Hospital
Dana-Farber Cancer Institute
Brigham and Women's Hospital
Principal Investigator: Matthew Smith, MD, PhD Massachusetts General Hospital
  More Information

Responsible Party: Matthew R. Smith, MD, PhD, Professor of Medicine, Massachusetts General Hospital Identifier: NCT00455624     History of Changes
Other Study ID Numbers: 02-256 
Study First Received: April 2, 2007
Last Updated: July 9, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Massachusetts General Hospital:
androgen deprivation therapy
insulin resistance

Additional relevant MeSH terms:
Cardiovascular Diseases
Insulin Resistance
Prostatic Neoplasms
Genital Diseases, Male
Genital Neoplasms, Male
Glucose Metabolism Disorders
Metabolic Diseases
Neoplasms by Site
Prostatic Diseases
Urogenital Neoplasms
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs processed this record on May 26, 2016