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

NCT ID: NCT01077479

Last Updated: 2014-05-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 28 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-02-28
• Study Completion Date: 2013-06-30

Brief Summary

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.

Conditions

Metabolic Syndrome; Hypercholesterolemia

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Metformin

Group Type: EXPERIMENTAL

Metformin

Intervention Type: DRUG

Metformin 1500mg nocte for 6 months

Interventions

Metformin

Metformin 1500mg nocte for 6 months

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Western Sydney Local Health District

OTHER

Sponsor Role: lead

Responsible Party

Howard Gurney

A/Prof Howard Gurney

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Howard Gurney, MBBS, FRACP

Role: PRINCIPAL_INVESTIGATOR

Westmead Cancer Care Centre

Locations

Westmead Hospital

Sydney, New South Wales, Australia

Countries

Australia

Other Identifiers

HGWH009

Identifier Type: -

Identifier Source: org_study_id