The Metformin Active Surveillance Trial (MAST) Study

NCT ID: NCT01864096

Last Updated: 2024-01-24

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: PHASE3
• Total Enrollment: 408 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-10-31
• Study Completion Date: 2024-08-31

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.

Conditions

Prostate Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Metformin

Metformin 850 mg, twice daily for 36 months

Group Type: EXPERIMENTAL

Metformin

Intervention Type: DRUG

One month run-in of 850mg metformin once daily, followed by 850mg twice daily of metformin for 35 months. Total time is 36 months.

Placebo

Placebo tablets, 2teice daily for 36 months

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

One month run-in of placebo tablet once daily, followed by twice daily for 35 months. Total time is 36 months.

Interventions

Metformin

One month run-in of 850mg metformin once daily, followed by 850mg twice daily of metformin for 35 months. Total time is 36 months.

Intervention Type: DRUG

Placebo

One month run-in of placebo tablet once daily, followed by twice daily for 35 months. Total time is 36 months.

Intervention Type: DRUG

Other Intervention Names

Metformin hydrochloride; Placebo tablet

Eligibility Criteria

Inclusion Criteria

1. Must be male > 18 and < 80 years of age

2. 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

3. Gleason score ≤ 6 [Gleason pattern 4 or above must not be present on any biopsy (initial or entry)]

4. Clinical stage T1c-T2a

5. Serum PSA ≤10 ng/mL (prior to biopsy)

6. Life expectancy greater than 5 years, as judged by the treating clinician/urologist

7. Able to swallow and retain oral medication

8. Hemoglobin A1c < 6.5%

9. Able and willing to participate in the full 3 years of the study

10. Able to understand instructions related to study procedures

11. Able to read and write (health outcome questionnaires are self-administered), understand instructions related to study procedures and give written informed consent

Exclusion Criteria

1. 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)

2. 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

3. Previous or current diagnosis of type 1 or type 2 diabetes

4. Exposure to metformin within 12 months of screening

5. Planned or concurrent use of metformin hydrochloride, sulfonylureas, thiazolidinediones, or insulin for any reason

6. Known hypersensitivity or intolerance to metformin hydrochloride

7. 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)

8. Subject has had prior prostatic surgery including TUNA, TURP, TUIP, laser treatment, thermotherapy, balloon dilatation, prosthesis, and ultrasound ablation within 3 months of screening

9. 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

10. 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

11. 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

12. Serum creatinine > 1.8 X ULN

13. 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

14. History or current evidence of substance abuse, as defined in DSM-IV, within 12 months of screening

15. 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

16. No other concurrent metformin hydrochloride, sulfonylureas, thiazolidinediones, or insulin for any reason

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 79 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

University Health Network, Toronto

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Neil Fleshner, MD, MPH, FRCSC

Role: PRINCIPAL_INVESTIGATOR

University Health Network: Department of Surgical Oncology (Urology)

Anthony Joshua, MD

Role: PRINCIPAL_INVESTIGATOR

University Health Network: Department of Surgical Oncology (Urology)

Locations

Manitoba Cancer Care Centre

Winnipeg, Manitoba, Canada

CDHA - Victoria Site

Halifax, Nova Scotia, Canada

McMaster Institute of Urology-St .Joseph's Healthcare

Hamilton, Ontario, Canada

Centre for Appled Urologic Research, Kingston General Hospital

Kingston, Ontario, Canada

London Health Sciences Centre-Victoria Hospital

London, Ontario, Canada

Ottawa Hospital Research Institute (The Ottawa Hospital)

Ottawa, Ontario, Canada

Sunnybrook Research Institute

Toronto, Ontario, Canada

Princess Margaret Cancer Centre

Toronto, Ontario, Canada

Centre L'Hopitalie de l'Universite de Montreal

Montreal, Quebec, Canada

MUHC - Montreal General Hospital

Montreal, Quebec, Canada

Centre de Recherche du CHUS

Sherbrooke, Quebec, Canada

Alberta Urology Institute

Edmonton, , Canada

Countries

Canada

Other Identifiers

MAST 01

Identifier Type: -

Identifier Source: org_study_id