Prostate Cancer Clinical Trial
Official title:
METformin And Longevity (METAL): A Window of Opportunity Study Investigating Biological Effects of Metformin in Localised Prostate Cancer
This is a randomized, placebo-controlled, double-blind, window of opportunity study investigating the biological mechanism of metformin in prostate cancer.
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.
;
Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Basic Science
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