E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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 Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10001186 |
E.1.2 | Term | Adenocarcinoma of prostate |
|
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10052066 |
E.1.2 | Term | Metabolic syndrome |
|
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
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. |
|
E.2.2 | Secondary objectives of the trial |
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. |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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
|
|
E.4 | Principal exclusion criteria |
Pre-existing Diabetes mellitus
Renal impairment - serum creatinine > 130 µmol/L, GFR < 40 mls/min
Cardiac failure
Respiratory failure
Myocardial infarction within 6 months
Hepatic impairment - LFTs >1.5x upper limit of normal
Alcoholism
All of the above are contra-indications to metformin therapy. |
|
E.5 End points |
E.5.1 | 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. |
|
E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | Yes |
E.6.3 | Therapy | No |
E.6.4 | Safety | No |
E.6.5 | Efficacy | No |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Information not present in EudraCT |
E.8.2.2 | Placebo | Information not present in EudraCT |
E.8.2.3 | Other | Yes |
E.8.2.3.1 | Comparator description |
standard treatment without metformin, diet and exercise |
|
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
|
The trial closes at the last 6-month visit of the last recruited patient. Aim to recruit 40 patients. |
|
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 1 |
E.8.9.1 | In the Member State concerned months | 6 |
E.8.9.1 | In the Member State concerned days | |