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Metformin for Prostate Cancer

Phase-Based Progress Estimates
2
Effectiveness
3
Safety
Prostate CancerMetformin - Drug
Eligibility
18 - 79
Male
What conditions do you have?
Select

Study Summary

This trial will test whether metformin can improve outcomes for men with low-risk prostate cancer.

Eligible Conditions
  • Prostate Cancer

Treatment Effectiveness

Effectiveness Progress

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

Similar Trials

1
Metformin
1
Metformin
1
Insulin

Study Objectives

1 Primary · 9 Secondary · Reporting Duration: 3 years

3 years
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
Change from baseline in prostate cancer diagnosis at repeat biopsy
Change in Gleason Score at repeat biopsy
Change in clinical stage of prostate cancer based on digital rectal examination
Time to pathological progression
Time to primary therapy for prostate cancer
Time to progression
To determine the safety and incidence of (serious) adverse events from the administration of 36 months of metformin to men with early stage prostate cancer

Trial Safety

Safety Progress

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

Similar Trials

1
Metformin
1
Metformin
2
Insulin

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%.

Trial Design

2 Treatment Groups

Metformin
1 of 2
Placebo
1 of 2

Experimental Treatment

Non-Treatment Group

408 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 · 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: 3 years

Who is running the clinical trial?

University Health Network, TorontoLead Sponsor
1,382 Previous Clinical Trials
473,067 Total Patients Enrolled
62 Trials studying Prostate Cancer
14,964 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
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

Eligibility Criteria

Age 18 - 79 · Male Participants · 10 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
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.
Patient must be male > 18 and < 80 years of age.
You have a Gleason score of ≤ 6 on any biopsy.
You have a serum PSA level of less than 10 ng/mL.
You have a hemoglobin A1c level of at least 6.5%.
References

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