To determine whether the use of metformin in patients with low-risk prostate cancer can delay progression to clinically significant prostate cancer.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
University Health Network
Toronto, Ontario, Canada
Primary Clinical Outcome - Inhibition of Prostate Cancer
To assess the role of metformin on the inhibition of low-risk localized prostate cancer progression in men undergoing active surveillance for prostate cancer.
Time frame: 18 months
Primary Scientific Endpoint - ki67 index
To assess the effect of metformin on the cell cycle proliferation indices (ki67 index).
Time frame: 18 months
Secondary Endpoint - Cell Cycle Proliferation (CCP) Score
To assess the effect of metformin on the cell cycle proliferation indices (CCP score)
Time frame: 18 months
Secondary Endpoint - Mechanism of Action
To assess the effect of metformin on systemic and local signalling axes and morphometric measurements relevant to its mechanism of action.
Time frame: 18 months
Secondary endpoint - Quality of Life
To assess the impact of metformin on Quality of Life (QoL) indices.
Time frame: 18 months
Secondary Endpoint - Prognostic Panel
To determine the utility of a prognostic panel of 31 cell cycle progression genes recently validated in prostate cancer.
Time frame: 18 months
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