Prostate Cancer Active Surveillance Metformin Trial
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|ClinicalTrials.gov Identifier: NCT01733836|
Recruitment Status : Withdrawn (The reason for this decision is that this study is being merged with a larger multi-centre study using the same agent in the same population.)
First Posted : November 27, 2012
Last Update Posted : May 24, 2013
|Condition or disease||Intervention/treatment||Phase|
|Prostate Cancer||Drug: Metformin Drug: placebo||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||0 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||A Randomized Double Blind Placebo Controlled Single Institution Phase 2 Study of Metformin in Patients Undergoing Active Surveillance for Prostate Cancer.|
|Study Start Date :||January 2013|
|Estimated Primary Completion Date :||October 2014|
|Estimated Study Completion Date :||October 2014|
|Placebo Comparator: Placebo||
- Primary Clinical Outcome - Inhibition of Prostate Cancer [ Time Frame: 18 months ]To assess the role of metformin on the inhibition of low-risk localized prostate cancer progression in men undergoing active surveillance for prostate cancer.
- Primary Scientific Endpoint - ki67 index [ Time Frame: 18 months ]To assess the effect of metformin on the cell cycle proliferation indices (ki67 index).
- Secondary Endpoint - Cell Cycle Proliferation (CCP) Score [ Time Frame: 18 months ]To assess the effect of metformin on the cell cycle proliferation indices (CCP score)
- Secondary Endpoint - Mechanism of Action [ Time Frame: 18 months ]To assess the effect of metformin on systemic and local signalling axes and morphometric measurements relevant to its mechanism of action.
- Secondary endpoint - Quality of Life [ Time Frame: 18 months ]To assess the impact of metformin on Quality of Life (QoL) indices.
- Secondary Endpoint - Prognostic Panel [ Time Frame: 18 months ]To determine the utility of a prognostic panel of 31 cell cycle progression genes recently validated in prostate cancer.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01733836
|University Health Network|
|Toronto, Ontario, Canada, M5G 2M9|