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OncoMatch/Clinical Trials/NCT05515978

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

Is NCT05515978 recruiting? Yes, currently enrolling (May 2026). This Early Phase 1 trial studies Metformin for prostate cancer.

Early Phase 1RecruitingUniversity of Colorado, DenverNCT05515978Data as of May 2026

Treatment: Metformin — 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.

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Extracted eligibility criteria

Cancer type

Prostate Cancer

Lab requirements

Kidney function

Estimated glomerular filtration rate (eGFR) ≥ 50 ml/minute

Liver function

Known Total Bilirubin < 3 mg/dL; no diagnosis of fibrosis or cirrhosis of the liver (ICD10: K74); no diagnosis of alcohol related disorders (ICD10: F10)

Contraindication for metformin use which include any of the following which are exclusionary: Estimated glomerular filtration rate (eGFR) of < 50 ml/minute; Known Total Bilirubin ≥3 mg/dL; Diagnosis of fibrosis or cirrhosis of the liver (ICD10: K74); Diagnosis of alcohol related disorders (ICD10: F10)

Structured fields extracted by AI. May contain errors — verify against the official protocol.

US trial sites

  • Colorado Research Center · Aurora, Colorado
  • UCHealth-Southern Colorado · Colorado Springs, Colorado
  • UCHealth-Metro Denver · Denver, Colorado
  • UCHealth-Northern Colorado · Fort Collins, Colorado

Showing up to 5 US sites. See all sites on ClinicalTrials.gov →

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