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Biguanide
Metformin for Prostate Cancer (MAST Trial)
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)]
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 years
Awards & highlights
MAST 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.Check my eligibility
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.See study design
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.
MAST Trial 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.
Select...
I am a man aged between 18 and 80.
Select...
My cancer is in an early stage, but it's growing.
MAST Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 3 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Time to progression
Secondary outcome measures
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
+6 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
MAST 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
Who is running the clinical trial?
University Health Network, TorontoLead Sponsor
1,468 Previous Clinical Trials
484,111 Total Patients Enrolled
63 Trials studying Prostate Cancer
14,992 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:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- Approved for 20 Other Conditions - This treatment demonstrated efficacy for 20 other conditions.
- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How can I become a test subject for this research?
"The prerequisites for this clinical trial are that the patient must have prostate cancer and be between 18-79 years old. This research is looking for around 408 individuals in total."
Answered by AI
Is Metformin a common medication in clinical trials?
"There are a total of 180 clinical trials underway that are investigating the use of metformin. Of those, 46 are in Phase 3. Although many of the studies for metformin are based in Rockville, Maryland, there are a total of 1677 locations running studies for this treatment."
Answered by AI
Are subjects being actively sought for this research project?
"That is correct, the trial is currently ongoing. As stated on clinicaltrials.gov, the trial was first posted on October 1st, 2013 and was last edited on April 16th, 2021. The trial is looking for 408 participants across 12 different sites."
Answered by AI
Does this research project restrict participants to a certain age group?
"According to the eligibility requirements, patients enrolling in this trial must be between 18 and 79 years old. However, there are 99 other trials for people under 18 and 1481 for patients over 65."
Answered by AI
How many research facilities are participating in this trial?
"In addition to MUHC - Montreal General Hospital in Montreal, Quebec, Sunnybrook Research Institute in Toronto, Nova Scotia, and Centre de Recherche du CHUS in Sherbrooke, Manitoba, this study is also taking place at 12 other sites."
Answered by AI
Could you please touch on any possible dangers of Metformin?
"There is both pre-existing clinical data supporting Metformin's safety as well as multiple rounds of data from this Phase 3 trial, so it received a score of 3."
Answered by AI
What are the most popular off-label uses for Metformin?
"Metformin is a medication that is regularly used to treat exercise, but it can also be prescribed for type 1 diabetes mellitus, diabetic ketoacidosis, and polycystic ovary syndrome."
Answered by AI
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