Patients with prostate cancer on androgen deprivation therapy (ADT). Randomisation between standard treatment with ADT only, and the additional use of metformin with dietary and exercise advice. Aim is to reduce the prevalence of metabolic syndrome in the intervention arm - this is a condition linked to ADT in prostate cancer patients MedDRA version: 9.1 Level: LLT Classification code 10001186 Term: Adenocarcinoma of prostate MedDRA version: 9.1 Level: LLT Classification code 10052066 Term: Me
Conditions
Interventions
Trade Name: Glucophage
Product Name: Metformin
Product Code: Metformin
Pharmaceutical Form: Tablet
Sponsors
Royal Surrey County Hospital
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: Male patients (all will be >18 in the study group) Histologically confirmed adenocarcinoma of the prostate Planned androgen deprivation therapy with LHRH analogue Ability to give adequately informed consent to participate in study WHO Performance status 0-1 Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Pre-existing Diabetes mellitus Renal impairment - serum creatinine > 130 µmol/L, GFR 1.5x upper limit of normal Alcoholism All of the above are contra-indications to metformin therapy.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To reduce the chance of developing metabolic syndrome in prostate cancer patients on androgen deprivation therapy by the use of metformin and dietary/exercise advice.;Primary end point(s): Incidence of hyperglycaemia and abdominal obesity (girth >102cm) after 6 months of intervention with metformin, low GI giet and exercise, compared to baseline. These are the 2 components of metabolic syndrome which are known to be most significantly adversely affected by androgen deprivation therapy.;Secondary Objective: To provide initial information on which to base a larger trial powered to detect survival differences. Metabolic syndrome is known to predispose to a higher risk of cardiovascular disease and diabetes. These conditions are also more common in prostate cancer patients. It is hoped that ultimately this intervention will improve survival in these patients, by reducing the prevalence of these adverse effects of therapy. | — |
Countries
United Kingdom
Outcome results
None listed