Status:
ACTIVE_NOT_RECRUITING
The Metformin Active Surveillance Trial (MAST) Study
Lead Sponsor:
University Health Network, Toronto
Conditions:
Prostate Cancer
Eligibility:
MALE
18-79 years
Phase:
PHASE3
Brief Summary
This study aims to see if metformin can delay the time to progression in men with low risk prostate cancer when compared to a placebo.
Eligibility Criteria
Inclusion
- Must be male \> 18 and \< 80 years of age
- Have biopsy proven, low-risk, localized prostate cancer choosing expectant management as primary treatment ≤ 1year. \[For the purposes of assessing subject eligibility a diagnostic biopsy must have included at least 10 cores, ≤1/3 of total number of cores sampled and \< 50% of any one core positive) and must have been obtained within 6 months of screening\]. 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
Exclusion
- Subject that has ever been treated for prostate cancer with any of the following:
- Radiotherapy (external beam or brachytherapy)
- Chemotherapy
- Hormonal therapy (e.g., megestrol, medoxyprogesterone, cyproterone)
- Oral glucocorticoids
- GnRH analogues (e.g., leuprolide, goserelin, degarelix)
- Current and/or previous use of the following medications:
- Use of 5α-reductase inhibitors (eg. Finasteride, Dutasteride) within the past 6 months of screening
- 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:
- Total bilirubin \> 1.8 X institutional upper limit of normal (ULN)
- Aspartate aminotransferase (AST) \> 1.8 X institutional ULN
- Alanine aminotransferase (ALT) \> 1.8 X institutional ULN
- 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
Key Trial Info
Start Date :
October 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 1 2024
Estimated Enrollment :
408 Patients enrolled
Trial Details
Trial ID
NCT01864096
Start Date
October 1 2013
End Date
August 1 2024
Last Update
January 24 2024
Active Locations (12)
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1
Manitoba Cancer Care Centre
Winnipeg, Manitoba, Canada, R3E 0V9
2
CDHA - Victoria Site
Halifax, Nova Scotia, Canada, B2H 1Y6
3
McMaster Institute of Urology-St .Joseph's Healthcare
Hamilton, Ontario, Canada, L8N 4A6
4
Centre for Appled Urologic Research, Kingston General Hospital
Kingston, Ontario, Canada, K7L 3J7