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Prostate CancerPhase 3MASTNCT01864096

The Metformin Active Surveillance Trial (MAST) Study

A Phase 3 study testing Metformin in people with Prostate Cancer, run by University Health Network, Toronto at 12 sites in Canada.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 79 years, men only
Conditions the study is for
Prostate Cancer
What is being tested?
Metformin
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
408 participants
Where
12 sitesCanada
Study dates
Oct 2013to Aug 2024
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 79 years
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
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  • 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

Who cannot join

  • 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)
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  • 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

Trial locations and contacts

12 sites in 1 country.

12 sites in 1 country

Canada12 sites

  • Alberta Urology Institute

    Edmonton

  • CDHA - Victoria Site

    Halifax, Nova Scotia, B2H 1Y6

  • McMaster Institute of Urology-St .Joseph's Healthcare

    Hamilton, Ontario, L8N 4A6

  • Centre for Appled Urologic Research, Kingston General Hospital

    Kingston, Ontario, K7L 3J7

  • London Health Sciences Centre-Victoria Hospital

    London, Ontario, N6A 5W9

  • Centre L'Hopitalie de l'Universite de Montreal

    Montreal, Quebec, H2L 4M1

  • MUHC - Montreal General Hospital

    Montreal, Quebec

  • Ottawa Hospital Research Institute (The Ottawa Hospital)

    Ottawa, Ontario, K1H 8L6

  • Centre de Recherche du CHUS

    Sherbrooke, Quebec, J1J 3H5

  • Sunnybrook Research Institute

    Toronto, Ontario, M4N 3M5

  • Princess Margaret Cancer Centre

    Toronto, Ontario, M5G 2M9

  • Manitoba Cancer Care Centre

    Winnipeg, Manitoba, R3E 0V9

Other trials in Canada

About this study

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

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
Being tested
Metformin, Placebo
Keywords
localized, prostate, cancer, metformin, active surveillance
Medical subject headings
Prostatic Neoplasms, Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • MetforminDrug

    Also called Metformin hydrochloride

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

  • PlaceboDrug

    Also called Placebo tablet

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

Study groups in NCT01864096
Study groupRoleWhat they receive
MetforminExperimentalMetformin 850 mg, twice daily for 36 months
Receives: Drug: Metformin
PlaceboPlacebo comparatorPlacebo tablets, 2teice daily for 36 months
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Time to progression

    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:
    3. >1/3 of total amount of cores involved ii. At least 50% of any one core involved iii. Gleason pattern 4 or higher

    Measured: 3 years

Secondary outcomes (9)

  1. Time to primary therapy for prostate cancer

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

    Measured: 3 years

  2. Time to pathological progression

    Measured: 3 years

  3. Change from baseline in disease-related patient anxiety

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

    Measured: 3 years

  4. Change from baseline in decisional satisfaction and decisional conflict

    Measured by the Decisional Regret scale

    Measured: 3 years

  5. Change from baseline in prostate cancer diagnosis at repeat biopsy

    Measured: 3 years

  6. Change in Gleason Score at repeat biopsy

    Measured: 3 years

  7. Change in clinical stage of prostate cancer based on digital rectal examination

    Measured: 3 years

  8. Assess the prognostic and predictive value of prostate cancer biomarkers

    Using biomarkers in tissue, blood and urine samples

    Measured: 3 years

  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

    Measured: 3 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 May 2013 (estimated)
  2. Study startOct 2013
  3. Primary completion16 Feb 2024 (estimated)
  4. Study completionAug 2024 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
408 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01864096
Sponsor's protocol ID
MAST 01
Acronym
MAST
Status last verified
Jan 2024
First submitted
23 May 2013
Last updated
24 Jan 2024
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Metformin in people with Prostate Cancer, run by University Health Network, Toronto at 12 sites in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 27 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 24 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 12 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Time to progression (time frame: 3 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01864096.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jan 2024.

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The Metformin Active Surveillance Trial (MAST) Study | AzTrials