← Back to Search

Metformin for Prostate Cancer (PREMIUM Trial)

Phase 2
Waitlist Available
Led By Nawaid Usmani, MD
Research Sponsored by AHS Cancer Control Alberta
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at 6, 12, 24 and 36 months follow-up
Awards & highlights

PREMIUM Trial Summary

In current clinical practice, an acceptable standard treatment for locally advanced prostate cancer is radiation therapy in combination with hormone therapy (called Treatment B or Group B in this study). However, despite our best treatments, there is a risk that the prostate cancer may eventually return. As well, the hormonal therapy that is given to treat the prostate cancer is known to cause some harmful effects, with some patients using the hormones gaining weight, developing diabetes, having increased cholesterol levels, having increased blood pressure, and/or heart problems. This study is looking at whether Metformin, a drug that is commonly used to treat diabetes, can prevent patients from developing some of the harmful effects of the hormonal therapy. In treating diabetes, Metformin is known to decrease patients' sugar levels and also prevents patients from gaining weight, decreases their cholesterol levels, decreases the number of heart problems and allows patients to live longer. As a result, the researchers in this study are hopeful that Metformin will also be beneficial for men with prostate cancer on hormonal therapy by preventing them from developing these problems.

Eligible Conditions
  • Prostate Cancer

PREMIUM Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at 6, 12, 24 and 36 months follow-up
This trial's timeline: 3 weeks for screening, Varies for treatment, and at 6, 12, 24 and 36 months follow-up for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Mean body weight at 12 months of follow-up
Secondary outcome measures
Prevalence and incidence of Metabolic Syndrome

Side effects data

From 2015 Phase 4 trial • 156 Patients • NCT02002221
13%
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

PREMIUM Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: MetforminExperimental Treatment1 Intervention
Metformin 500 mg PO TID x 30-36 months
Group II: PlaceboPlacebo Group1 Intervention
Identical placebo TID x 30-36 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?

AHS Cancer Control AlbertaLead Sponsor
182 Previous Clinical Trials
36,129 Total Patients Enrolled
16 Trials studying Prostate Cancer
2,210 Patients Enrolled for Prostate Cancer
Nawaid Usmani, MDPrincipal InvestigatorCross Cancer Institute
3 Previous Clinical Trials
380 Total Patients Enrolled
1 Trials studying Prostate Cancer
168 Patients Enrolled for Prostate Cancer

Frequently Asked Questions

~8 spots leftby Apr 2025