Clinical Trials /

The Metformin Active Surveillance Trial (MAST) Study

NCT01864096

Description:

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.

Related Conditions:
  • Prostate Carcinoma
Recruiting Status:

Recruiting

Phase:

Phase 3

Trial Eligibility

Document

Title

  • Brief Title: The Metformin Active Surveillance Trial (MAST) 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

Clinical Trial IDs

  • ORG STUDY ID: MAST 01
  • NCT ID: NCT01864096

Conditions

  • Prostate Cancer

Interventions

DrugSynonymsArms
MetforminMetformin hydrochlorideMetformin
PlaceboPlacebo tabletPlacebo

Purpose

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.

Trial Arms

NameTypeDescriptionInterventions
MetforminExperimental
  • Metformin
PlaceboPlacebo Comparator
  • Placebo

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
      
Maximum Eligible Age:79 Years
Minimum Eligible Age:18 Years
Eligible Gender:Male
Healthy Volunteers:No

Primary Outcome Measures

Measure:Time to progression
Time Frame:3 years
Safety Issue:
Description: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

Measure:Time to primary therapy for prostate cancer
Time Frame:3 years
Safety Issue:
Description:Length of time before the participants move on to more radical treatment options (prostatectomy, radiation and/or hormonal therapy)
Measure:Time to pathological progression
Time Frame:3 years
Safety Issue:
Description:
Measure:Change from baseline in disease-related patient anxiety
Time Frame:3 years
Safety Issue:
Description:Measured by the Memorial Anxiety Scale for Prostate Cancer (MAX-PC)
Measure:Change from baseline in decisional satisfaction and decisional conflict
Time Frame:3 years
Safety Issue:
Description:Measured by the Decisional Regret scale
Measure:Change from baseline in prostate cancer diagnosis at repeat biopsy
Time Frame:3 years
Safety Issue:
Description:
Measure:Change in Gleason Score at repeat biopsy
Time Frame:3 years
Safety Issue:
Description:
Measure:Change in clinical stage of prostate cancer based on digital rectal examination
Time Frame:3 years
Safety Issue:
Description:
Measure:Assess the prognostic and predictive value of prostate cancer biomarkers
Time Frame:3 years
Safety Issue:
Description:Using biomarkers in tissue, blood and urine samples
Measure: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
Safety Issue:
Description:

Details

Phase:Phase 3
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:University Health Network, Toronto

Trial Keywords

  • localized
  • prostate
  • cancer
  • metformin
  • active surveillance

Last Updated

April 19, 2021