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


N/A
18 Years
N/A
Not Enrolling
Male
Prostate Cancer

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Trial Information

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


- 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.


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

Type of Study:

Observational

Study Design:

Observational Model: Case-Only, Time Perspective: Prospective

Principal Investigator

Matthew R. Smith, MD, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Massachusetts General Hospital

Authority:

United States: Institutional Review Board

Study ID:

06-086

NCT ID:

NCT00456144

Start Date:

August 2006

Completion Date:

September 2012

Related Keywords:

  • Prostate Cancer
  • GnRH
  • Insulin sensitivity
  • Prostatic Neoplasms
  • Insulin Resistance

Name

Location

Massachusetts General HospitalBoston, Massachusetts  02114-2617