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

University Health Network, Toronto12 sites in 1 country408 target enrollmentOctober 2013

ConditionsProstate Cancer

InterventionsMetformin Placebo

DrugsMetformin Placebo

Overview

Phase: Phase 3
Intervention: Metformin
Conditions: Prostate Cancer
Sponsor: University Health Network, Toronto
Enrollment: 408
Locations: 12
Primary Endpoint: Time to progression
Status: Active, not recruiting
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials Related News

Overview

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.

Registry

clinicaltrials.gov

Start Date

October 2013

End Date

August 2024

Last Updated

2 years ago

Study Type

Interventional

Study Design

Parallel

Sex

Male

Investigators

Sponsor

University Health Network, Toronto

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•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

Exclusion Criteria

•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

Arms & Interventions

Metformin

Metformin 850 mg, twice daily for 36 months

Intervention: Metformin

Placebo

Placebo tablets, 2teice daily for 36 months

Intervention: Placebo

Outcomes

Primary Outcomes

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 Outcomes

Change from baseline in prostate cancer diagnosis at repeat biopsy(3 years)
Change from baseline in disease-related patient anxiety(3 years)
Assess the prognostic and predictive value of prostate cancer biomarkers(3 years)
Time to pathological progression(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(3 years)
Time to primary therapy for prostate cancer(3 years)
Change from baseline in decisional satisfaction and decisional conflict(3 years)
Change in Gleason Score at repeat biopsy(3 years)
Change in clinical stage of prostate cancer based on digital rectal examination(3 years)