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Could a common diabetes drug help prostate cancer patients?

NCT ID NCT05515978

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study looks at whether metformin, a drug used for diabetes, can help prostate cancer patients who have high blood sugar or are overweight. About 100 men will either take metformin plus get lifestyle advice, or just get lifestyle advice. The main goal is to see if it's possible to run this kind of study, not yet to prove the drug works.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Metformin (a diabetes drug)
What this could lead to
If successful, this could show that metformin helps manage weight and blood sugar in prostate cancer patients, potentially improving their overall health.
What could go wrong
This is a very early feasibility study with only 100 participants. It is not designed to prove metformin affects prostate cancer itself, and results may not apply to all patients.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Early phase 1

The earliest testing in people: a first look at safety, in a very small group.

Participants

About 100 people

The number the study aims to enrol. It can still change while the study runs.

Started

Oct 2022

Expected to finish

Nov 2036

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Male participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: In order to be eligible to participate in this study, an individual must meet all of the following criteria. The patients will be screening for eligibility and offered an electronic consent via the Epic medical record and the patient portal (My Health Connection - MHC) or otherwise through Epic: 1. Provision to sign and date the consent form in MHC or otherwise via Epic. 2. Subjects must have an MHC Account to participate in the study 3. Be a male aged ≥18 years of age on day of signing the informed consent. 4. Impaired glucose tolerance and/or overweight, and appropriate to receive metformin, meeting at least one of the following in the last year (timing relative to the consent presentation not start of therapy): * 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. Exclusion Criteria: 1. On therapy for diabetes including any of the following alone or in combination medications (diet controlled or managed diabetes is allowed - e.g. diagnosis of Diabetes, but without an active prescription for anti-glycemic medication): 1. Metformin 2. Insulin 3. Glipizide 4. Glyburide 5. Glimepiride 6. Pioglitazone 7. Rosiglitazone 8. Sitagliptin 9. Saxagliptin 10. Linagliptin 11. Alogliptin 12. Canagliflozin 13. Dapagliflozin 14. Empagliflozin 15. Ertugliflozin 16. Liraglutide 17. Dulaglutide 18. Semaglutide 19. Exenatide 20. Lixisenatide 21. Nateglinide 22. Repaglinide 23. Tirzepatide 2. Contraindication for metformin use which include any of the following which are exclusionary (in Epic will use most recent lab values): 1. Estimated glomerular filtration rate (eGFR) of \< 50 ml/minute (calculated according to the formula utilized within Epic). 2. Known Total Bilirubin ≥3 mg/dL) 3. Diagnosis of fibrosis or cirrhosis of the liver (ICD10: K74) 4. Diagnosis of alcohol related disorders (ICD10: F10) 5. Metformin allergy in Epic (ICD10: T50.995A) 3. Non-English-speaking patient until Spanish language consent form and relevant materials can be made available. Due to the novel aspect of this trial, we plan to get some experience in treating approximately the first 50 patients, make any changes needed in the study operations and then implement a Spanish consent, as feasible. 4. Taking any medication with a known class D or higher drug interaction with metformin, including: 1. Cimetidine 2. Dolutegravir 3. Patiromer 4. Ranolazine 5. Tafenoquine 5. The use of any carbonic anhydrase inhibitors since they are a risk factor for lactic acidosis, including: 1. Topiramate 2. Dichlorphenamide 3. Acetazolamide 4. Methazolamide 5. Dorzolamide 6. Brinzolamide 7. Dichlorphenamide 8. Sultiame 9. Zonisamide 10. Indisulam 6. Any treating investigator concern, related to tolerance, safety, adherence or for any other reason

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    4 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Colorado Research Center

    RECRUITING

    Aurora, Colorado, 80045, United States

  • UCHealth-Metro Denver

    RECRUITING

    Denver, Colorado, 80217-3364, United States

  • UCHealth-Northern Colorado

    RECRUITING

    Fort Collins, Colorado, 80521, United States

  • UCHealth-Southern Colorado

    RECRUITING

    Colorado Springs, Colorado, 80863, United States

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