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Metformin for Prostate Cancer

McGill University Health Center-Cedar Cancer Center, Montreal, Canada
Prostate Cancer+1 More ConditionsMetformin - Drug
Eligibility
18+
Male
What conditions do you have?
Select

Study Summary

This trial is comparing the effects of metformin to a placebo in patients with advanced prostate cancer who are starting or have recently started ADT.

Eligible Conditions
  • Prostate Cancer
  • Metabolic Syndrome

Video Summary

Treatment Effectiveness

Phase-Based Effectiveness

2 of 3
Phase 3
This is further along than 85% of similar trials

Similar Trials

1
Metformin
1
Metformin and Lifestyle Modification Arm
1
Metformin

Study Objectives

1 Primary · 10 Secondary · Reporting Duration: Through study completion, an average of 3 years

12 months
Exercise behavior and sedentary behavior assessed at 12 months of follow-up.
Mean BMI assessed at 12 months of follow-up.
Therapeutic procedure
18 months
Abdominal girth assessed at 18 months of follow-up.
Body mass assessed at 18 months of follow-up.
Duration of time off-treatment in days
Health-related Quality of Life assessed at 18 months of follow-up.
Insulin
Proportion of participants who meet the criteria of elevated blood pressure assessed at 18 months of follow-up.
Proportion of participants who meet the criteria of elevated fasting blood glucose levels assessed at 18 months of follow-up.
Proportion of participants who meet the criteria of elevated triglycerides assessed at 18 months of follow-up.
Proportion of participants who meet the criteria of increased waist circumference assessed at 18 months of follow-up.
Proportion of participants who meet the criteria of reduced high-density lipoprotein cholesterol assessed at 18 months of follow-up.
Therapeutic procedure
Serum insulin levels assessed at 18 months of follow-up.
Testosterone
Time to re-initiation of androgen deprivation therapy (in the subset of patients receiving intermittent therapy)
Treatment-related toxicity
24 months
Exercise behavior and sedentary behavior assessed at 24 months of follow-up.
Mean BMI assessed at 24 months of follow-up.
Therapeutic procedure
36 months
Biochemical progression-free survival
Castration resistant disease-free survival
Distant metastasis disease-free survival
Exercise behavior and sedentary behavior assessed at 36 months of follow-up.
Mean BMI assessed at 36 months of follow-up.
9 months
Proportion of participants who meet the diagnostic criteria for metabolic syndrome after 9 months of study treatment
Year 3
Cardiovascular mortality
Overall survival
Prostate cancer specific survival

Trial Safety

Phase-Based Safety

3 of 3
This is further along than 85% of similar trials

Similar Trials

1
Metformin
1
Metformin and Lifestyle Modification Arm
1
Metformin

Side Effects for

Vildagliptin (LAF237)
13%Nasopharyngitis
10%Hyperhidrosis
9%Tremor
9%Hunger
8%Asthenia
6%Hypoglycaemia
1%Squamous cell carcinoma of the tongue
1%Femoral neck fracture
This histogram enumerates side effects from a completed 2015 Phase 4 trial (NCT02002221) in the Vildagliptin (LAF237) ARM group. Side effects include: Nasopharyngitis with 13%, Hyperhidrosis with 10%, Tremor with 9%, Hunger with 9%, Asthenia with 8%.

Awards & Highlights

Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
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.

Trial Design

2 Treatment Groups

Metformin
1 of 2
Placebo
1 of 2

Experimental Treatment

Non-Treatment Group

300 Total Participants · 2 Treatment Groups

Primary Treatment: Metformin · Has Placebo Group · Phase 3

Metformin
Drug
Experimental Group · 1 Intervention: Metformin · Intervention Types: Drug
Placebo
Drug
PlaceboComparator Group · 1 Intervention: Placebo Oral Tablet · Intervention Types: Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Metformin
FDA approved

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: through study completion, an average of 3 years

Who is running the clinical trial?

British Columbia Cancer AgencyOTHER
166 Previous Clinical Trials
90,246 Total Patients Enrolled
23 Trials studying Prostate Cancer
5,620 Patients Enrolled for Prostate Cancer
Canadian Urologic Oncology GroupLead Sponsor
7 Previous Clinical Trials
749 Total Patients Enrolled
1 Trials studying Prostate Cancer
446 Patients Enrolled for Prostate Cancer
Prostate Cancer CanadaOTHER
9 Previous Clinical Trials
7,358 Total Patients Enrolled
6 Trials studying Prostate Cancer
7,114 Patients Enrolled for Prostate Cancer
Nawaid Usmani, MDStudy ChairUniversity of Alberta
3 Previous Clinical Trials
316 Total Patients Enrolled
Bernie Eigl, MDStudy ChairBritish Columbia Cancer Agency
2 Previous Clinical Trials
78 Total Patients Enrolled

Eligibility Criteria

Age 18+ · Male Participants · 1 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
If you are receiving androgen deprivation therapy, you must have already decided if you will take it continuously or with breaks before joining the study.

Who else is applying?

What state do they live in?
California50.0%
North Carolina50.0%
How old are they?
18 - 65100.0%
What portion of applicants met pre-screening criteria?
Did not meet criteria100.0%
References

Frequently Asked Questions

For what purpose is Metformin most commonly prescribed?

"Metformin is a medication that is regularly prescribed to patients with type 1 diabetes mellitus, polycystic ovary syndrome, and diabetic ketoacidosis." - Anonymous Online Contributor

Unverified Answer

What similar research has been conducted using Metformin?

"Metformin was first studied in clinical trials by George Washington University in 2002. To date, 1260 have completed similar experiments. Right now, there are 180 active studies involving metformin with a high concentration of these being located in Toronto, Canada." - Anonymous Online Contributor

Unverified Answer

Are there any vacancies in this study for new participants?

"Yes, the clinicaltrials.gov website contains information suggesting that this trial is still actively recruiting patients. This particular study was first posted on July 12th, 2018 and was last updated on July 11th, 2022. They are looking for a total of 300 participants spread out across 15 different locations." - Anonymous Online Contributor

Unverified Answer

Are there any sites outside of Canada conducting this research?

"This research is being conducted at 15 different hospitals, including the Princess Margaret Cancer Centre (Princess Margaret Hospital) in Toronto, the Centre Hospitalier de L'Universite de Montreal (CHUM) in Montreal, and Northeast Cancer Centre in Sudbury." - Anonymous Online Contributor

Unverified Answer

What is the Metformin drug's official government rating?

"There is prior clinical data supporting Metformin's safety, so it received a score of 3." - Anonymous Online Contributor

Unverified Answer

Could you give an estimate of how many people are involved in this clinical trial?

"To run this clinical study, we require 300 individuals who meet the pre-specified inclusion criteria. These participants can come from various locations such as Princess Margaret Cancer Centre (Princess Margaret Hospital) in Toronto, Ontario and Centre Hospitalier de L'Universite de Montreal (CHUM) in Montreal, Quebec." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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