NCT02511665

Metformin And Longevity

METformin And Longevity (METAL): A Window of Opportunity Study Investigating Biological Effects of Metformin in Localised Prostate Cancer

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 185 (estimated)
• Sponsor: Guy's and St Thomas' NHS Foundation Trust · Academic / Other
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a randomized, placebo-controlled, double-blind, window of opportunity study investigating the biological mechanism of metformin in prostate cancer.

Detailed description

A potential role for metformin in prostate cancer has been suggested and given its wide availability, tolerable side effect profile and safety record it may represent a therapeutic option for men with prostate cancer. However, the mechanism of action by which metformin exerts its anti-cancer effect has yet to be fully characterised. This 'window of opportunity' trial provides an opportunity to investigate this by comparing baseline prostate biopsies with post-treatment surgical specimen by focussing on assessment of the FASN/AMPK axis. Patients with newly-diagnosed, early stage, prostate cancer scheduled for radical prostatectomy will either enter the main study and be randomised 1:1 to receive metformin (2g daily over 2 divided doses; Arm A) or placebo four weeks prior to prostatectomy (standard of care; Arm B). Or a subset of five patients will enter the exploratory PET-MRI Substudy . These five patients will all receive metformin and will undergo an additional two PET-MRI Scans. Prostate tissue (at baseline from biopsy and post treatment from prostatectomy) will be used for analysis of p-AMPK, p-ACC, FASN by immunohistochemistry and proliferation will be measured using Ki67 and TUNEL in both metformin and placebo groups.

Conditions

• Prostate Cancer

Interventions

Type	Name	Description
DRUG	Metformin	Given metformin
RADIATION	PET-MRI Scan	Patients will under go 2 PET-MRI scans in the PET-MRI substudy arm one before treatment with metformin and one after
DRUG	Placebo	Given placebo

Timeline

• Start date: 2015-07-01
• Primary completion: 2017-07-01
• Completion: 2017-07-01
• First posted: 2015-07-30
• Last updated: 2015-07-30

Locations

1 site across 1 country: United Kingdom