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Metformin in Preventing Androgen Deprivation Therapy Induced Insulin Resistance and Metabolic Syndrome

Phase 2
18 Years
Open (Enrolling)
Metabolic Syndrome, Hypercholesterolemia

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Trial Information

Metformin in Preventing Androgen Deprivation Therapy Induced Insulin Resistance and Metabolic Syndrome

Inclusion Criteria:

- ≥ 18 years of age

- ECOG ≤ 1

- Histologically confirmed prostate cancer of early or locally advanced stage, or
metastatic prostate cancer with bone involvement only (≤ 5 sites of bone metastases

- Plan to receive ≥ 6 months continuous androgen deprivation therapy by a GnRH agonist

- Patients who are to receive antiandrogens with GnRH agonists are not excluded from
the study. But the form, dose and duration of antiandrogen treatment should be

- Adequate renal function (Creatinine ≤ 177mMol/L and GFR >30 mls/min )

- Adequate hepatic function (Bilirubin must be ≤ 1.5 x upper limit of normal range, ALT
and ALP must be ≤ 2.5 x upper limit of normal)

Exclusion Criteria:

- Visceral involvement

- > 5 sites of bone metastases

- History of confirmed diabetes mellitus (patients with impaired fasting glucose or
impaired glucose intolerance will not be excluded) 12

- Treatment with medications that may alter glucose or insulin level within 3 months
(including insulin, oral hypoglycemic agents, systemic corticosteroid of any dosage,
atypical antipsychotic drugs of any dose)

- Malignant disease other than prostate cancer at the time of enrolment

- Bilateral orchiectomy

- Previous androgen deprivation therapy by a GnRH agonist or anti-androgen within last
12 months(patient who had a GnRH agonist more than 12 months ago are allowed if their
testosterone levels are in the normal range at the time of recruitment)

- Chemotherapy within 6 months

- History of lactic acidosis

- Cardiac or respiratory insufficiency, severe infection that is likely to increase the
risk of lactic acidosis

- Medical or psychiatric conditions that compromise the patient's ability to give
informed consent

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Outcome Measure:

The percentage change in insulin resistance measured by homeostasis model assessment (HOMAIR) from baseline to 12 and 24 weeks

Outcome Time Frame:

12 and 24 weeks

Safety Issue:


Principal Investigator

Howard Gurney, MBBS, FRACP

Investigator Role:

Principal Investigator

Investigator Affiliation:

Westmead Cancer Care Centre


Australia: Human Research Ethics Committee

Study ID:




Start Date:

February 2010

Completion Date:

June 2013

Related Keywords:

  • Metabolic Syndrome
  • Hypercholesterolemia
  • body fat mass gain
  • Insulin resistance
  • Hypercholesterolemia
  • Insulin Resistance
  • Metabolic Syndrome X