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Metformin for Glucose Intolerance or Increased BMI in Prostate Cancer Patients

This study is looking at whether metformin, a medication commonly used for type 2 diabetes, along with lifestyle changes, can benefit men with prostate cancer who also have high blood sugar (glucose intolerance, meaning an HbA1c of 5.7-6.4%) or a higher body mass index (BMI of 25 or more). You would be randomly assigned to either receive metformin plus advice on lifestyle changes, or just advice on lifestyle changes. The study aims to enroll 100 men with prostate cancer over four years to see if this approach is practical and helpful. The study is currently unclear on its recruitment status.

Study design
This is a randomized study, meaning you would be assigned by chance to one of two groups. The study plans to enroll 100 participants.
What's involved
If you are in the metformin group, you would start with 850 mg daily for two weeks, then increase to 850 mg twice daily. All participants will receive lifestyle modification recommendations. You would be followed for up to 10 years.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for up to 10 years.

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NCT05515978

Pragmatic Trial of Metformin for Glucose Intolerance or Increased BMI in Prostate Cancer Patients

Recruiting
EARLY_PHASE1Ages 18+InterventionalTreatment
University of Colorado, Denver
~100 participants
Updated 2026-06-02 on ClinicalTrials.gov
What's tested:MetforminLifestyle Modification

At a glance

Recruiting sites
4 of 4 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Successful accrual of 100 patients to the pragmatic trial in the first four years
Measured over 4 years

Conditions

Prostate Cancer

Explore related trials

Prostate Carcinoma

Where it's being run

4 sites across 1 states
Colorado4

Study leadership

  • Thomas Flaig, MD · PRINCIPAL_INVESTIGATOR · Colorado Research Center

Who to contact

Emily Buchanan
[email protected]
303-724-5912
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

HbA1c of 5.7 - 6.4 %
BMI≥25 kg/m\^2 5. Have a prostate cancer diagnosis 6. Have a clinical relationship with a participating provider at a UCHealth facility.

What this trial measures

  • Successful accrual of 100 patients to the pragmatic trial in the first four years4 years

    Once there are 6 months of follow-up data on the first 100 patients, a formal analysis will be done to determine the completeness of data and the potential for a powered study. Outcome measure was amended January 2025.