| Critètes d'éligibilité |
- Must be male > 18 and < 80 years of age
- Have biopsy proven, low-risk, localized prostate cancer choosing expectant management as primary treatment ≤ 1year. [For the purposes of assessing subject eligibility a diagnostic biopsy must have included at least 10 cores, < 3 cores positive and < 50% of any one core positive) and must have been obtained within 6 months of screening]. Initial diagnosis of T1a/T1b obtained during a TURP is not allowed
- Gleason score ≤ 6 [Gleason pattern 4 or above must not be present on any biopsy (initial or entry)]
- Clinical stage T1c-T2a
- Serum PSA ≤10 ng/mL (prior to biopsy)
- Life expectancy greater than 5 years, as judged by the treating clinician/urologist
- Able to swallow and retain oral medication
- Hemoglobin A1c < 6.5%
- Able and willing to participate in the full 3 years of the study
- Able to understand instructions related to study procedures
- Able to read and write (health outcome questionnaires are self-administered), understand instructions related to study procedures and give written informed consent
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| Critètes d'exclusion |
- Subject that has ever been treated for prostate cancer
- Current and/or previous use of the following medications:
1-Use of 5α-reductase inhibitors (eg. Finasteride, Dutasteride) within the past 6 months of creening
2-Drugs with antiandrogenic properties (e.g., flutamide, bicalutamide, ketoconazole, progestational agents) within 6 months prior to screening
- Previous or current diagnosis of type 1 or type 2 diabetes
- Exposure to metformin within 12 months of screening
- Planned or concurrent use of metformin hydrochloride, sulfonylureas, thiazolidinediones, or insulin for any reason
- Known hypersensitivity or intolerance to metformin hydrochloride
- Any condition associated with increased risk of metformin hydrochloride-associated lactic acidosis (e.g. congestive heart failure defines as NYHA class III or IV, history of any type of acidosis, habitual intake of ≥ 4 alcoholic beverages per day)
- Subject has had prior prostatic surgery including TUNA, TURP, TUIP, laser treatment, thermotherapy, balloon dilatation, prosthesis, and ultrasound ablation within 3 months of screening
- Participation in any investigational or marketed drug trial within 30 days prior to screening or anytime during the study period. This includes any interventional or exercise trials
- Any unstable serious co-existing medical condition(s) including, but not limited to, myocardial infarction, coronary bypass surgery, unstable angina, cardiac arrhythmias, clinically evident congestive heart failure, or cerebrovascular accident within 6 months prior to Screening visit
- Abnormal liver function test:
1-Total bilirubin > 1.8 X institutional upper limit of normal (ULN)
2-Aspartate aminotransferase (AST) > 1.8 X institutional ULN
3-Alanine aminotransferase (ALT) > 1.8 X institutional ULN
4-Alkaline phosphatase (ALP) > 1.8 X institutional ULN
- Serum creatinine > 1.8 X ULN
- History of other malignancies, with the exception of adequately treated nonmelanoma skin cancer, stage I melanoma, NMIBC or other solid tumors curatively treated with no evidence of disease for at least 5 years
- History or current evidence of substance abuse, as defined in DSM-IV, within 12 months of screening
- History of any illness (including psychiatric) that, in the opinion of the investigator, might confound the results of the study or pose additional risk to the subject
- No other concurrent metformin hydrochloride, sulfonylureas, thiazolidinediones, or insulin for any reason
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Groupe d'étude en oncologie du Québec