Metformin and Lifestyle Modification Arm for Prostate Cancer

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
UCHealth-Metro Denver, Denver, CO
Prostate Cancer+2 More
Lifestyle Modification - Behavioral
Eligibility
18+
Male
What conditions do you have?
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Study Summary

Metformin is used widely in the treatment of type 2 diabetes. It has off-label indications for use in the prevention of diabetes and in hyperinsulinar obesity. In medical practices, the implementation of metformin for these off-label indications is variable, often at the level of the provider. Multiple retrospective investigations have also shown a clinical benefit in men with prostate cancer who are incidentally treated with metformin. This pragmatic study will test the feasibility of enrolling patients who have glucose intolerance (as defined by HbA1c of 5.7-6.4%) and/or who have increased BMI (BMI greater than or equal to 25 kg/m2) to a randomized pragmatic study of metformin plus lifestyle modification information versus lifestyle modification information only. For purposes of the scope of this project and the study's feasibility, this will be implemented in a group of prostate cancer patients, who may have additional benefits from metformin.

Eligible Conditions

  • Prostate Cancer

Treatment Effectiveness

Study Objectives

1 Primary · 26 Secondary · Reporting Duration: 10 years

10 years
Adherence: To determine the number and proportion of patients who adhere to the assigned treatment plan.
Effectiveness: Measure the effectiveness of metformin prescribed in a pragmatic trial on radiographic progression of prostate cancer.
Effectiveness: To determine the effectiveness of metformin prescribed on a pragmatic trial ion overall and prostate cancer specific survival.
2 years
Determine the number of additional diabetes medications initiated
Determine the number of new diagnoses of diabetes
Effectiveness: 1a: To determine the effectiveness of metformin prescribed in a pragmatic trial on Blood Pressure
Effectiveness: 1a: To determine the effectiveness of metformin prescribed in a pragmatic trial on Body Mass Index
Effectiveness: 1a: To determine the effectiveness of metformin prescribed in a pragmatic trial on Glucose Levels
Effectiveness: 1a: To determine the effectiveness of metformin prescribed in a pragmatic trial on HbA1C
Effectiveness: 1a: To determine the effectiveness of metformin prescribed in a pragmatic trial on Weight
Effectiveness: 1a: To determine the effectiveness of metformin prescribed in a pragmatic trial on key physiologic parameters - BMI
Effectiveness: 1a: To determine the effectiveness of metformin prescribed in a pragmatic trial on key physiologic parameters - HbA1C
Effectiveness: 1a: To determine the effectiveness of metformin prescribed in a pragmatic trial on key physiologic parameters - Weight
Effectiveness: 1a: To determine the effectiveness of metformin prescribed in a pragmatic trial on key physiologic parameters - blood glucose levels
Effectiveness: 1a: To determine the effectiveness of metformin prescribed in a pragmatic trial on key physiologic parameters - blood pressure
Effectiveness: 1b: To determine the effectiveness of metformin prescribed in a pragmatic trial on the development of diabetes.
Effectiveness: Measure the effectiveness of metformin prescribed in a pragmatic trial on rate of major adverse cardiac events (MACE).
Effectiveness: Measure the effectiveness of metformin prescribed in a pragmatic trial on rate of major adverse limb events (MALE).
Effectiveness: Measure the effectiveness of metformin prescribed on a pragmatic trial in progression-free survival defined as doubling of PSA level or all-cause mortality.
Effectiveness: Measure the effectiveness of metformin prescribed on a pragmatic trial on PSA response of prostate cancer.
Implementation: To determine the accuracy of TriNetX in predicting the number of eligible patients identified each month.
Implementation: To determine the accuracy of the Epic screening process to identify
Implementation: To determine the effectiveness of different approaches to presenting the consent to patients in MHC/Epic.
Implementation: To determine the time period required to identify and enroll 200 eligible patients
Reach: To determine the proportion of patients approached who enroll and the characteristics and representativeness of those enrolled.
Safety: To determine the safety, assessed by Adverse Events, of providing metformin via this pragmatic approach.
Two years
Successful accrual of 200 patients to the pragmatic trial in the first two years

Trial Safety

Trial Design

2 Treatment Groups

Metformin and Lifestyle Modification Arm
1 of 2
Lifestyle Modification Only Arm
1 of 2
Active Control
Non-Treatment Group

200 Total Participants · 2 Treatment Groups

Primary Treatment: Metformin and Lifestyle Modification Arm · Has Placebo Group · Phase < 1

Metformin and Lifestyle Modification ArmActiveComparator Group · 2 Interventions: Lifestyle Modification, Metformin · Intervention Types: Behavioral, Drug
Lifestyle Modification Only Arm
Behavioral
PlaceboComparator Group · 1 Intervention: Lifestyle Modification · Intervention Types: Behavioral

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 10 years
Closest Location: UCHealth-Metro Denver · Denver, CO
Photo of Denver 1Photo of Denver 2Photo of Denver 3
N/AFirst Recorded Clinical Trial
2 TrialsResearching Prostate Cancer
0 CompletedClinical Trials

Who is running the clinical trial?

University of Colorado, DenverLead Sponsor
1,554 Previous Clinical Trials
1,910,328 Total Patients Enrolled
11 Trials studying Prostate Cancer
2,527 Patients Enrolled for Prostate Cancer
Thomas Flaig, MDPrincipal InvestigatorColorado Research Center

Eligibility Criteria

Age 18+ · Male Participants · 7 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You are provided with a document that you can sign and date.
You are a male aged ≥18 years of age.
HbA1c of 5.7 - 6.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.