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The Metformin Active Surveillance Trial (MAST) Study

Sponsor
University Health Network, Toronto (Other)
Overall Status
Recruiting
CT.gov ID
NCT01864096
Collaborator
(none)
408
Enrollment
12
Locations
2
Arms
130
Duration (Months)
34
Patients Per Site
0.3
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
Phase 3

Study Design

Study Type:
Interventional
Anticipated Enrollment :
408 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Triple (Participant, Care Provider, Investigator)
Primary Purpose:
Treatment
Official Title:
A Randomized, Double-Blind, Placebo-Controlled Trial of Metformin in Reducing Progression Among Men on Expectant Management for Low Risk Prostate Cancer: The MAST (Metformin Active Surveillance Trial) Study
Study Start Date :
Oct 1, 2013
Anticipated Primary Completion Date :
Aug 1, 2023
Anticipated Study Completion Date :
Aug 1, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: Metformin

Drug: 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.
Other Names:
  • Metformin hydrochloride

    		•
    Placebo Comparator: Placebo

    Drug: Placebo
    One month run-in of placebo tablet once daily, followed by twice daily for 35 months. Total time is 36 months.
    Other Names:
  • Placebo tablet

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Time to progression [3 years]

      Time to progression - progression is defined as the earliest of the following events: Primary therapy for prostate cancer (e.g. prostatectomy, radiation, hormonal therapy) Pathological progression as defined as one of the following: i. >1/3 of total amount of cores involved ii. At least 50% of any one core involved iii. Gleason pattern 4 or higher

    Secondary Outcome Measures

    1. Time to primary therapy for prostate cancer [3 years]

      Length of time before the participants move on to more radical treatment options (prostatectomy, radiation and/or hormonal therapy)

    2. Time to pathological progression [3 years]

    3. Change from baseline in disease-related patient anxiety [3 years]

      Measured by the Memorial Anxiety Scale for Prostate Cancer (MAX-PC)

    4. Change from baseline in decisional satisfaction and decisional conflict [3 years]

      Measured by the Decisional Regret scale

    5. Change from baseline in prostate cancer diagnosis at repeat biopsy [3 years]

    6. Change in Gleason Score at repeat biopsy [3 years]

    7. Change in clinical stage of prostate cancer based on digital rectal examination [3 years]

    8. Assess the prognostic and predictive value of prostate cancer biomarkers [3 years]

      Using biomarkers in tissue, blood and urine samples

    9. To determine the safety and incidence of (serious) adverse events from the administration of 36 months of metformin to men with early stage prostate cancer [3 years]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 79 Years
    Sexes Eligible for Study:
    Male
    Accepts Healthy Volunteers:
    No
    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)

    1. 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

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

    2. Exposure to metformin within 12 months of screening

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

    4. Known hypersensitivity or intolerance to metformin hydrochloride

    5. 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)

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

    7. 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

    8. 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

    9. 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

    1. Serum creatinine > 1.8 X ULN

    2. 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

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

    4. 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

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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    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
    5 London Health Sciences Centre-Victoria Hospital London Ontario Canada N6A 5W9
    6 Ottawa Hospital Research Institute (The Ottawa Hospital) Ottawa Ontario Canada K1H 8L6
    7 Sunnybrook Research Institute Toronto Ontario Canada M4N 3M5
    8 Princess Margaret Cancer Centre Toronto Ontario Canada M5G 2M9
    9 Centre L'Hopitalie de l'Universite de Montreal Montreal Quebec Canada H2L 4M1
    10 MUHC - Montreal General Hospital Montreal Quebec Canada
    11 Centre de Recherche du CHUS Sherbrooke Quebec Canada J1J 3H5
    12 Alberta Urology Institute Edmonton Canada

    Sponsors and Collaborators

    • University Health Network, Toronto

    Investigators

    • Principal Investigator: Neil Fleshner, MD, MPH, FRCSC, University Health Network: Department of Surgical Oncology (Urology)
    • Principal Investigator: Anthony Joshua, MD, University Health Network: Department of Surgical Oncology (Urology)

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    University Health Network, Toronto
    ClinicalTrials.gov Identifier:
    NCT01864096
    Other Study ID Numbers:
    • MAST 01
    First Posted:
    May 29, 2013
    Last Update Posted:
    Apr 19, 2021
    Last Verified:
    Apr 1, 2021
    Keywords provided by University Health Network, Toronto
    localized
    prostate
    cancer
    metformin
    active surveillance
    Additional relevant MeSH terms:
    Prostatic Neoplasms
    Metformin

    Study Results

    No Results Posted as of Apr 19, 2021