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

This study has been completed.
Sponsor:
Collaborators:
Dana-Farber Cancer Institute
Brigham and Women's Hospital
Information provided by (Responsible Party):
Matthew R. Smith, MD, PhD, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT00455624
First received: April 2, 2007
Last updated: July 9, 2013
Last verified: July 2013
  Purpose

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).
  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 identified with prostate cancer.

Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00455624

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

Publications:
Responsible Party: Matthew R. Smith, MD, PhD, Professor of Medicine, Massachusetts General Hospital
ClinicalTrials.gov 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
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases
Androgens
Insulin
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Hypoglycemic Agents

ClinicalTrials.gov processed this record on April 22, 2014