The Metformin Active Surveillance Trial (MAST) Study

NCT01864096 | Unknown Phase 3 DMC

• 1 other identifier: MAST 01
• Study Type: interventional
• Target: 408
• Locations: 1 country
• Sites: 12

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.

Conditions

Prostate Cancer

Keywords

localized; prostate; cancer; metformin; active surveillance

Outcome Measures

Primary Outcomes (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: 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 Outcomes (9)

• Time to primary therapy for prostate cancer

  3 years

• Time to pathological progression

  3 years

• Change from baseline in disease-related patient anxiety

  3 years

• Change from baseline in decisional satisfaction and decisional conflict

  3 years

• Change from baseline in prostate cancer diagnosis at repeat biopsy

  3 years

Study Arms (2)

Metformin

EXPERIMENTAL

Metformin 850 mg, twice daily for 36 months

Drug: Metformin

Placebo

PLACEBO COMPARATOR

Placebo tablets, 2teice daily for 36 months

Drug: Placebo

Interventions

Metformin DRUG

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

Also known as: Metformin hydrochloride

Metformin

Placebo DRUG

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

Also known as: Placebo tablet

Placebo

Eligibility Criteria

• Age: 18 Years - 79 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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

You may not qualify if:

• 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)
• 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

Sponsors & Collaborators

• University Health Network, Toronto: lead

Study Sites (12)

Manitoba Cancer Care Centre

Winnipeg, Manitoba, R3E 0V9, Canada

Location

CDHA - Victoria Site

Halifax, Nova Scotia, B2H 1Y6, Canada

Location

McMaster Institute of Urology-St .Joseph's Healthcare

Hamilton, Ontario, L8N 4A6, Canada

Location

Centre for Appled Urologic Research, Kingston General Hospital

Kingston, Ontario, K7L 3J7, Canada

Location

London Health Sciences Centre-Victoria Hospital

London, Ontario, N6A 5W9, Canada

Location

Ottawa Hospital Research Institute (The Ottawa Hospital)

Ottawa, Ontario, K1H 8L6, Canada

Location

Sunnybrook Research Institute

Toronto, Ontario, M4N 3M5, Canada

Location

Princess Margaret Cancer Centre

Toronto, Ontario, M5G 2M9, Canada

Location

Centre L'Hopitalie de l'Universite de Montreal

Montreal, Quebec, H2L 4M1, Canada

Location

MUHC - Montreal General Hospital

Montreal, Quebec, Canada

Location

Centre de Recherche du CHUS

Sherbrooke, Quebec, J1J 3H5, Canada

Location

Alberta Urology Institute

Edmonton, Canada

Location

MeSH Terms

Conditions

Prostatic Neoplasms; Neoplasms

Interventions

Metformin

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Biguanides; Guanidines; Amidines; Organic Chemicals

Study Officials

• 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)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 23, 2013
• First Posted: May 29, 2013
• Study Start: October 1, 2013
• Primary Completion: February 16, 2024
• Study Completion: August 1, 2024
• Last Updated: January 24, 2024

Record last verified: 2024-01

Locations

CA (12)