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Biguanide

Metformin for Prostate Cancer Patients with Glucose Intolerance or Overweight

Phase < 1

Recruiting

Led By Thomas Flaig, MD

Research Sponsored by University of Colorado, Denver

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be a male aged ≥18 years of age on day of signing the informed consent

Be older than 18 years old

Must not have

Taking any medication with a known class D or higher drug interaction with metformin, including: Cimetidine, Dolutegravir, Patiromer, Ranolazine, Tafenoquine

The use of any carbonic anhydrase inhibitors since they are a risk factor for lactic acidosis, including: Topiramate, Dichlorphenamide, Acetazolamide, Methazolamide, Dorzolamide, Brinzolamide, Dichlorphenamide, Sultiame, Zonisamide, Indisulam

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 10 years

Summary

This trial will test if it is feasible to enroll prostate cancer patients who have glucose intolerance or are overweight to a study where they receive metformin to see if it has any benefits.

Who is the study for?

Men over 18 with prostate cancer and either glucose intolerance (HbA1c of 5.7-6.4%) or a BMI≥25 kg/m2 can join this study if they have an MHC Account, consent to participate, and are under the care of a participating UCHealth provider. They must not be on certain drugs that interact badly with metformin, have severe kidney issues, liver diseases like cirrhosis or fibrosis, alcohol disorders, or allergies to metformin.

What is being tested?

This trial is checking if adding metformin to lifestyle changes helps control blood sugar better than just lifestyle advice in men with prostate cancer who also have high blood sugar levels or are overweight. Participants will randomly receive either both treatments or only lifestyle modification information.

What are the potential side effects?

Metformin may cause stomach upset like diarrhea, nausea; it can also lead to low vitamin B12 levels and rarely might cause a dangerous condition called lactic acidosis where too much acid builds up in the body.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am a man aged 18 or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am not on medications that badly interact with metformin.

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I have not taken any medication that increases the risk of lactic acidosis.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 10 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~10 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 10 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Successful accrual of 200 patients to the pragmatic trial in the first two years

Secondary study objectives

Adherence: To determine the number and proportion of patients who adhere to the assigned treatment plan.

Determine the number of additional diabetes medications initiated

Determine the number of new diagnoses of diabetes

+23 more

Trial Design

2Treatment groups

Active Control

Placebo Group

Group I: Metformin and Lifestyle Modification ArmActive Control2 Interventions

For the metformin arm: metformin will be obtained as a standard of care medication from the patient's general pharmacy. This will be given for a clinical indication (e.g. prediabetes or overweight/obese). It will not be supplied by the study, but billed to Medicare, self pay or 3rd party payer. Lifestyle modification and prediabetes information will be provided via MHC or other electronic means on a quarterly basis.

Group II: Lifestyle Modification Only ArmPlacebo Group1 Intervention

Patients randomized to this arm will receive standard lifestyle modification recommendations. This will include the general recommendation to increase exercise level mildly, after discussing with the medical provider. There is a potential low-level risk in increasing one's exercise levels.

0 / 3Eligibility criteria met