This study is a randomized trial examining the administration of a combination of biguanide metformin and atorvastatin ("Lipitor") to men who are experiencing rising prostate-specific antigen (PSA) levels, despite having undergone radical therapy (surgery and/or radiation).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
One month run-in of 850 mg metformin once daily, followed by 850 mg twice daily of metformin until progression.
Atorvastatin 20 mg once daily until progression.
One month of one placebo tablet (corresponding to metformin) once daily, followed by one placebo tablet twice daily until progression.
Princess Margaret Cancer Centre
Toronto, Ontario, Canada
Time to disease progression (defined as PSA rise to 10 ng/mL or greater, development of clinically overt metastases) or patient/physician desire for androgen deprivation therapy.
Time frame: From date of randomization until the date of progression or patient/physician desire for androgen deprivation therapy, whichever comes first, assessed up to 36 months.
Time to androgen deprivation therapy
Time frame: From date of randomization until the date of progression or patient/physician desire for androgen deprivation therapy, whichever comes first, assessed up to 36 months.
Time to PSA progression
Time frame: From date of randomization until the date of progression or patient/physician desire for androgen deprivation therapy, whichever comes first, assessed up to 36 months.
Time to disease progression
Time frame: From date of randomization until the date of progression or patient/physician desire for androgen deprivation therapy, whichever comes first, assessed up to 36 months.
Body mass index
Relationship between body mass index and response to anti-metabolic and anti-cholesterol therapy
Time frame: From date of randomization until the date of progression or patient/physician desire for androgen deprivation therapy, whichever comes first, assessed up to 36 months.
Circulating glycated hemoglobin levels
Relationship between circulating glycated hemoglobin levels and response to anti-metabolic and anti-cholesterol therapy
Time frame: From date of randomization until the date of progression or patient/physician desire for androgen deprivation therapy, whichever comes first, assessed up to 36 months.
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One placebo tablet (corresponding to atorvastatin) once daily until progression.
C-peptide levels
Relationship between C-peptide levels and response to anti-metabolic and anti-cholesterol therapy
Time frame: From date of randomization until the date of progression or patient/physician desire for androgen deprivation therapy, whichever comes first, assessed up to 36 months.
Adipokine levels
Relationship between adipokine levels and response to anti-metabolic and anti-cholesterol therapy
Time frame: From date of randomization until the date of progression or patient/physician desire for androgen deprivation therapy, whichever comes first, assessed up to 36 months.
LDL/HDL cholesterol levels
Relationship between LDL/HDL cholesterol levels and response to anti-metabolic and anti-cholesterol therapy
Time frame: From date of randomization until the date of progression or patient/physician desire for androgen deprivation therapy, whichever comes first, assessed up to 36 months.
Triglyceride levels
Relationship between triglyceride levels and response to anti-metabolic and anti-cholesterol therapy
Time frame: From date of randomization until the date of progression or patient/physician desire for androgen deprivation therapy, whichever comes first, assessed up to 36 months.
Incidence of adverse events during administration of metformin and atorvastatin to men with prostate cancer.
Assessment of incidence of adverse events from the administration of metformin and atorvastatin to men with prostate cancer.
Time frame: From date of randomization until the date of progression or patient/physician desire for androgen deprivation therapy, whichever comes first, assessed up to 36 months.