The Metformin Active Surveillance Trial (MAST) Study (MAST)

January 23, 2024 updated by: University Health Network, Toronto

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
408

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

  • Name: Heidi Wagner, BSc, PA (ASPC)
  • Phone Number: 2354 (416) 946-4501
  • Email: heidi.wagner@uhn.ca

Study Locations

  • Canada
      • Edmonton, Canada
        • Alberta Urology Institute
    • Manitoba
      • Winnipeg, Manitoba, Canada, R3E 0V9
        • Manitoba Cancer Care Centre
    • Nova Scotia
      • Halifax, Nova Scotia, Canada, B2H 1Y6
        • CDHA - Victoria Site
    • Ontario
      • Hamilton, Ontario, Canada, L8N 4A6
        • McMaster Institute of Urology-St .Joseph's Healthcare
      • Kingston, Ontario, Canada, K7L 3J7
        • Centre for Appled Urologic Research, Kingston General Hospital
      • London, Ontario, Canada, N6A 5W9
        • London Health Sciences Centre-Victoria Hospital
      • Ottawa, Ontario, Canada, K1H 8L6
        • Ottawa Hospital Research Institute (The Ottawa Hospital)
      • Toronto, Ontario, Canada, M5G 2M9
        • Princess Margaret Cancer Centre
      • Toronto, Ontario, Canada, M4N 3M5
        • Sunnybrook Research Institute
    • Quebec
      • Montreal, Quebec, Canada, H2L 4M1
        • Centre L'Hopitalie de l'Universite de Montreal
      • Montreal, Quebec, Canada
        • MUHC - Montreal General Hospital
      • Sherbrooke, Quebec, Canada, J1J 3H5
        • Centre de Recherche du CHUS

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 79 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Metformin
Metformin 850 mg, twice daily for 36 months
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
Placebo tablets, 2teice daily for 36 months
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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Time to progression
Time Frame: 3 years

Time to progression - progression is defined as the earliest of the following events:

  1. Primary therapy for prostate cancer (e.g. prostatectomy, radiation, hormonal therapy)
  2. 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
3 years

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Time to primary therapy for prostate cancer
Time Frame: 3 years
Length of time before the participants move on to more radical treatment options (prostatectomy, radiation and/or hormonal therapy)
3 years
Time to pathological progression
Time Frame: 3 years
3 years
Change from baseline in disease-related patient anxiety
Time Frame: 3 years
Measured by the Memorial Anxiety Scale for Prostate Cancer (MAX-PC)
3 years
Change from baseline in decisional satisfaction and decisional conflict
Time Frame: 3 years
Measured by the Decisional Regret scale
3 years
Change from baseline in prostate cancer diagnosis at repeat biopsy
Time Frame: 3 years
3 years
Change in Gleason Score at repeat biopsy
Time Frame: 3 years
3 years
Change in clinical stage of prostate cancer based on digital rectal examination
Time Frame: 3 years
3 years
Assess the prognostic and predictive value of prostate cancer biomarkers
Time Frame: 3 years
Using biomarkers in tissue, blood and urine samples
3 years
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
Time Frame: 3 years
3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University Health Network, Toronto

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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 record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 1, 2013

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 16, 2024

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 1, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 23, 2013

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 23, 2013

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 29, 2013

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 24, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 23, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • MAST 01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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