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

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ClinicalTrials.gov Identifier: NCT01864096
Recruitment Status : Recruiting
First Posted : May 29, 2013
Last Update Posted : April 19, 2021
Information provided by (Responsible Party):
University Health Network, Toronto

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
Prostate Cancer Drug: Metformin Drug: Placebo Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated 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 : October 2013
Estimated Primary Completion Date : August 2023
Estimated Study Completion Date : August 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

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 Name: 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 Name: Placebo tablet

Primary Outcome Measures :
  1. 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

Secondary Outcome Measures :
  1. 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)

  2. Time to pathological progression [ Time Frame: 3 years ]
  3. Change from baseline in disease-related patient anxiety [ Time Frame: 3 years ]
    Measured by the Memorial Anxiety Scale for Prostate Cancer (MAX-PC)

  4. Change from baseline in decisional satisfaction and decisional conflict [ Time Frame: 3 years ]
    Measured by the Decisional Regret scale

  5. Change from baseline in prostate cancer diagnosis at repeat biopsy [ Time Frame: 3 years ]
  6. Change in Gleason Score at repeat biopsy [ Time Frame: 3 years ]
  7. Change in clinical stage of prostate cancer based on digital rectal examination [ Time Frame: 3 years ]
  8. Assess the prognostic and predictive value of prostate cancer biomarkers [ Time Frame: 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 [ Time Frame: 3 years ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 79 Years   (Adult, Older Adult)
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)
  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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01864096

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Contact: Miran Kenk, PhD 416-946-4501 ext 3431 miran.kenk@uhn.ca
Contact: Heidi Wagner, BSc, PA (ASPC) (416) 946-4501 ext 2354 heidi.wagner@uhn.ca

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Canada, Manitoba
Manitoba Cancer Care Centre Recruiting
Winnipeg, Manitoba, Canada, R3E 0V9
Principal Investigator: Darrel Drachenberg, MD         
Canada, Nova Scotia
CDHA - Victoria Site Recruiting
Halifax, Nova Scotia, Canada, B2H 1Y6
Principal Investigator: Ricardo Rendon, MD         
Canada, Ontario
McMaster Institute of Urology-St .Joseph's Healthcare Recruiting
Hamilton, Ontario, Canada, L8N 4A6
Principal Investigator: Bobby Shayegan, MD         
Centre for Appled Urologic Research, Kingston General Hospital Recruiting
Kingston, Ontario, Canada, K7L 3J7
Principal Investigator: Michael Leveridge, MD         
London Health Sciences Centre-Victoria Hospital Recruiting
London, Ontario, Canada, N6A 5W9
Principal Investigator: Jonathan Izawa, MD         
Ottawa Hospital Research Institute (The Ottawa Hospital) Recruiting
Ottawa, Ontario, Canada, K1H 8L6
Principal Investigator: Rodney Breau, MD         
Sunnybrook Research Institute Recruiting
Toronto, Ontario, Canada, M4N 3M5
Principal Investigator: Laurence Klotz, MD         
Princess Margaret Cancer Centre Recruiting
Toronto, Ontario, Canada, M5G 2M9
Principal Investigator: Neil Fleshner, MD         
Principal Investigator: Anthony Joshua, MD         
Canada, Quebec
Centre L'Hopitalie de l'Universite de Montreal Recruiting
Montreal, Quebec, Canada, H2L 4M1
Principal Investigator: Fred Saad, MD         
MUHC - Montreal General Hospital Recruiting
Montreal, Quebec, Canada
Principal Investigator: Simon Tanguay         
Centre de Recherche du CHUS Recruiting
Sherbrooke, Quebec, Canada, J1J 3H5
Contact: Elsie Morneau, BSN    819-346-1110 ext 12827    emorneau.chus@ssss.gouv.qc.ca   
Principal Investigator: Patrick Richard, MD         
Alberta Urology Institute Recruiting
Edmonton, Canada
Contact: Adrian Fairey, FRCSC, MD, MSc.         
Sponsors and Collaborators
University Health Network, Toronto
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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)
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Responsible Party: University Health Network, Toronto
ClinicalTrials.gov Identifier: NCT01864096    
Other Study ID Numbers: MAST 01
First Posted: May 29, 2013    Key Record Dates
Last Update Posted: April 19, 2021
Last Verified: April 2021
Keywords provided by University Health Network, Toronto:
active surveillance
Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Prostatic Diseases
Hypoglycemic Agents
Physiological Effects of Drugs