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The Metformin Active Surveillance Trial (MAST) Study | Clinical Trials | Clareo Health

UNKNOWNPHASE3

The Metformin Active Surveillance Trial (MAST) Study

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

NCT01864096•University Health Network, Toronto

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - 79 years

Sex

MALE

Healthy Volunteers

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
+1 more criteria

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
+17 more criteria

Locations (12)

Manitoba Cancer Care Centre

Winnipeg, Manitoba, Canada

CDHA - Victoria Site

Halifax, Nova Scotia, Canada

McMaster Institute of Urology-St .Joseph's Healthcare

Hamilton, Ontario, Canada

Centre for Appled Urologic Research, Kingston General Hospital

Kingston, Ontario, Canada

London Health Sciences Centre-Victoria Hospital

London, Ontario, Canada

Ottawa Hospital Research Institute (The Ottawa Hospital)

Ottawa, Ontario, Canada

Sunnybrook Research Institute

Toronto, Ontario, Canada

Princess Margaret Cancer Centre

Toronto, Ontario, Canada

Centre L'Hopitalie de l'Universite de Montreal

Montreal, Quebec, Canada

MUHC - Montreal General Hospital

Montreal, Quebec, Canada

Key Dates

Start Date

October 1, 2013

Primary Completion Date

February 16, 2024

Completion Date

August 1, 2024

Last Updated

January 24, 2024

Enrollment

408

ESTIMATED participants

Conditions

Prostate Cancer

Interventions

Metformin

DRUG

Placebo

DRUG

Measuring the Effects of Talazoparib in Patients With Advanced Cancer and DNA Repair Variations

NCT04550494

Anatomic Stage III Breast Cancer AJCC v8Anatomic Stage IV Breast Cancer AJCC v8+29 more

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RECRUITINGPHASE2

A Study of FG-3246 in Participants With Metastatic Castration-Resistant Prostate Cancer (mCRPC)

NCT06842498

Metastatic Castration-Resistant Prostate Cancer

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 24, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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The Metformin Active Surveillance Trial (MAST) Study

Inclusion Criteria

Exclusion Criteria

Measuring the Effects of Talazoparib in Patients With Advanced Cancer and DNA Repair Variations

A Study of FG-3246 in Participants With Metastatic Castration-Resistant Prostate Cancer (mCRPC)

Testing the Safety and Effectiveness of Radiation-based Treatment (Lutetium Lu 177 Dotatate) for Metastatic Prostate Cancer That Has Neuroendocrine Cells

PSMA-PET: Deep Radiomic Biomarkers of Progression and Response Prediction in Prostate Cancer

Study of Dato-DXd as Monotherapy and in Combination With Anti-cancer Agents in Patients With Advanced Solid Tumours (TROPION-PanTumor03)

Phase 2a Study of High-Dose Testosterone Followed by Radioligand Therapy in mCRPC