Metformin And Longevity (METAL)
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|ClinicalTrials.gov Identifier: NCT02511665|
Recruitment Status : Unknown
Verified July 2015 by Guy's and St Thomas' NHS Foundation Trust.
Recruitment status was: Not yet recruiting
First Posted : July 30, 2015
Last Update Posted : July 30, 2015
|Condition or disease||Intervention/treatment||Phase|
|Prostate Cancer||Drug: Metformin Radiation: PET-MRI Scan Drug: Placebo||Phase 4|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||185 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Primary Purpose:||Basic Science|
|Official Title:||METformin And Longevity (METAL): A Window of Opportunity Study Investigating Biological Effects of Metformin in Localised Prostate Cancer|
|Study Start Date :||July 2015|
|Estimated Primary Completion Date :||July 2017|
|Estimated Study Completion Date :||July 2017|
Metformin given , 1g twice a day for 4 weeks until prostatectomy +/- one week
Other Name: Glucophage
Placebo Comparator: Placebo
placebo given , 1g twice a day for 4 weeks until prostatectomy +/- one week
5 patients in this arm will all receive metformin and undergo two additional PET- MRI scans, one before and one after treatment
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
- Assessment of the difference in expression levels of markers of the FASN/AMPK pathway pre and post treatment between the placebo and metformin arms. [ Time Frame: 24 months ]
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): NCT02511665
|London, United Kingdom, SE1 9RT|
|Contact: Danielle Crawley, MBBS 02071887904 email@example.com|
|Principal Investigator:||Sarah Rudman, MBBS BSc PhD||Guy's and St Thomas NHS Trust|