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New treatment option for Prostate Cancer
Official title Pragmatic Trial of Metformin for Glucose Intolerance or Increased BMI in Prostate Cancer Patients
ClinicalTrials.gov ID: NCT05515978
What this study is testing
What is Metformin?
Metformin is an investigational medicine, given as an once-daily treatment applied to the skin, being studied as a potential treatment for prostate cancer.
Also referred to as Glucophage, Riomet.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
- Time commitment: about 10 years
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older, men only
You may be able to join if
- 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...
- Provision to sign and date the consent form in MHC or otherwise via Epic.
- people must have an MHC Account to participate in the study
- Be a male aged ≥18 years of age on day of signing the informed consent.
- Impaired glucose tolerance and/or overweight, and appropriate to receive metformin, meeting at least one of the following in the last year (timing...
You likely can't join if
- On therapy for diabetes including any of the following alone or in combination medications (diet controlled or managed diabetes is allowed - e.g...
- Metformin
- Insulin
- Glipizide
- Glyburide
- Glimepiride
See the full eligibility 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...
- Provision to sign and date the consent form in MHC or otherwise via Epic.
- people must have an MHC Account to participate in the study
- Be a male aged ≥18 years of age on day of signing the informed consent.
- 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
- Have a prostate cancer diagnosis
- Have a clinical relationship with a participating provider at a UCHealth facility.
- 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...
- Metformin
- Insulin
- Glipizide
- Glyburide
- Glimepiride
- Pioglitazone
- Rosiglitazone
- Sitagliptin
- Saxagliptin
- Linagliptin
- Alogliptin
- Canagliflozin
- Dapagliflozin
- Empagliflozin
- Ertugliflozin
- Liraglutide
- Dulaglutide
- Semaglutide
- Exenatide
- Lixisenatide
- Nateglinide
- Repaglinide
- Tirzepatide
- Contraindication for metformin use which include any of the following which are exclusionary (in Epic will use most recent lab values):
- Estimated glomerular filtration rate (eGFR) of \< 50 ml/minute (calculated according to the formula utilized within Epic).
- Known Total Bilirubin ≥3 mg/dL)
- Diagnosis of fibrosis or cirrhosis of the liver (ICD10: K74)
- Diagnosis of alcohol related disorders (ICD10: F10)
- Metformin allergy in Epic (ICD10: T50.995A)
- 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...
- 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
- Any treating investigator concern, related to tolerance, safety, adherence or for any other reason
The study team makes the final eligibility decision.
Where it's taking place
- Aurora, Colorado, United States
- Colorado Springs, Colorado, United States
- Denver, Colorado, United States
- Fort Collins, Colorado, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 10 years per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling male, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Aurora, Colorado, United States; Colorado Springs, Colorado, United States; Denver, Colorado, United States; Fort Collins, Colorado, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.