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

Western Sydney Local Health District

Status and phase

Completed

Phase 2

Conditions

Hypercholesterolemia

Metabolic Syndrome

Treatments

Drug: Metformin

Study type

Interventional

Funder types

Other

Identifiers

NCT01077479

HGWH009

Details and patient eligibility

About

The main purpose of this study is to assess the efficacy of metformin in abrogating androgen deprivation therapy (ADT) induced insulin resistance as measured by homeostasis model assessment (HOMAIR) in men with non-metastatic prostate cancer.

Enrollment

28 patients

Sex

Male

Ages

18+ years old

Volunteers

No Healthy Volunteers

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 only)
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 recorded.
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