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Biguanide
Metformin for Prostate Cancer (MAST Trial)
Winnipeg, Canada
Phase 3
Waitlist Available
Led By Neil Fleshner, MD, MPH, FRCSC
Research Sponsored by University Health Network, Toronto
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
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)]
Must not have
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)
Subject has had prior prostatic surgery including TUNA, TURP, TUIP, laser treatment, thermotherapy, balloon dilatation, prosthesis, and ultrasound ablation within 3 months of screening
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 years
Awards & highlights
All Individual Drugs Already Approved
Approved for 20 Other Conditions
Pivotal Trial
Summary
This trial will test whether metformin can improve outcomes for men with low-risk prostate cancer.
Who is the study for?
Men aged 18-80 with low-risk, localized prostate cancer opting for expectant management can join. They must have a Gleason score ≤6, PSA ≤10 ng/mL, life expectancy >5 years, and be able to take oral meds. Exclusions include diabetes, recent substance abuse, certain medications within the last 6 months, and serious health conditions.
What is being tested?
The MAST Study is testing if metformin can slow down prostate cancer progression compared to a placebo in men choosing not to undergo immediate treatment. Participants will either receive metformin or a placebo pill without knowing which one they're taking.
What are the potential side effects?
Metformin may cause digestive issues like nausea or diarrhea, potential vitamin B12 deficiency over time, and very rarely lactic acidosis (a build-up of lactate in the body), especially if there are underlying kidney problems.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I chose to monitor my low-risk prostate cancer without immediate treatment for less than a year.
Select...
My prostate cancer has a Gleason score of 6 or less, with no pattern 4 or above.
Select...
I can swallow and keep down pills.
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I am a man aged between 18 and 80.
Select...
My cancer is in an early stage, but it's growing.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have received treatment for prostate cancer, including radiotherapy, chemotherapy, hormonal therapy, oral glucocorticoids, or GnRH analogues.
Select...
I had prostate surgery less than 3 months ago.
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I have not participated in any drug trials within the last 30 days.
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I am not currently taking diabetes medications like metformin, sulfonylureas, thiazolidinediones, or insulin.
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I haven't had a heart attack, stroke, or serious heart issues in the last 6 months.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 3 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 years
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Time to progression
Secondary study objectives
Assess the prognostic and predictive value of prostate cancer biomarkers
Change from baseline in decisional satisfaction and decisional conflict
Change from baseline in disease-related patient anxiety
+1 moreSide effects data
From 2015 Phase 4 trial • 156 Patients • NCT0200222113%
Nasopharyngitis
10%
Hyperhidrosis
9%
Hunger
9%
Tremor
8%
Asthenia
6%
Hypoglycaemia
1%
Femoral neck fracture
1%
Squamous cell carcinoma of the tongue
100%
80%
60%
40%
20%
0%
Study treatment Arm
Vildagliptin (LAF237)
Placebo
Awards & Highlights
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Approved for 20 Other Conditions
This treatment demonstrated efficacy for 20 other conditions.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: MetforminExperimental Treatment1 Intervention
Metformin 850 mg, twice daily for 36 months
Group II: PlaceboPlacebo Group1 Intervention
Placebo tablets, 2teice daily for 36 months
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Metformin
FDA approved
Find a Location
Closest Location:Manitoba Cancer Care Centre· Winnipeg, Canada
Who is running the clinical trial?
University Health Network, TorontoLead Sponsor
1,553 Previous Clinical Trials
525,680 Total Patients Enrolled
66 Trials studying Prostate Cancer
15,759 Patients Enrolled for Prostate Cancer
Neil Fleshner, MD, MPH, FRCSCPrincipal InvestigatorUniversity Health Network: Department of Surgical Oncology (Urology)
2 Previous Clinical Trials
90 Total Patients Enrolled
2 Trials studying Prostate Cancer
90 Patients Enrolled for Prostate Cancer
Anthony Joshua, MDPrincipal InvestigatorUniversity Health Network: Department of Surgical Oncology (Urology)
1 Previous Clinical Trials
10 Total Patients Enrolled
1 Trials studying Prostate Cancer
10 Patients Enrolled for Prostate Cancer
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have used drugs or alcohol excessively in the past year, as defined in the DSM-IV.I can swallow and keep down pills.I have received treatment for prostate cancer, including radiotherapy, chemotherapy, hormonal therapy, oral glucocorticoids, or GnRH analogues.I had prostate surgery less than 3 months ago.I have had cancer before, but it was either skin cancer, stage I melanoma, bladder cancer, or another type that was treated over 5 years ago with no current signs of disease.I am a man aged between 18 and 80.I chose to monitor my low-risk prostate cancer without immediate treatment for less than a year.My prostate cancer has a Gleason score of 6 or less, with no pattern 4 or above.I have not participated in any drug trials within the last 30 days.I am not currently taking diabetes medications like metformin, sulfonylureas, thiazolidinediones, or insulin.You have a medical or mental health condition that could affect the results of the study or put you at extra risk.My cancer is in an early stage, but it's growing.I haven't had a heart attack, stroke, or serious heart issues in the last 6 months.
Research Study Groups:
This trial has the following groups:- Group 1: Placebo
- Group 2: Metformin
Awards:
This trial has 3 awards, including:- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- Approved for 20 Other Conditions - This treatment demonstrated efficacy for 20 other conditions.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.