Is NCT05515978 recruiting in Colorado Springs, CO?

Yes, NCT05515978 is currently recruiting participants at its Colorado Springs, CO location. This prostate cancer clinical trial is actively enrolling qualified participants.

How do I join the prostate cancer clinical trial in Colorado Springs?

To join this clinical trial in Colorado Springs, complete the eligibility form on this page. A study coordinator will contact you to discuss next steps and determine if you qualify.

Is participation in this Colorado Springs clinical trial free?

Yes, all study-related care is provided at no cost to qualified participants. Many studies also offer compensation for time and travel expenses.

Prostate Cancer Clinical Trial in Colorado Springs, CO

About This Prostate Cancer Study in Colorado Springs

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.

Sponsor: University of Colorado, Denver

Who Can Participate

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:

Provision to sign and date the consent form in MHC or otherwise via Epic.

Subjects 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.

Exclusion Criteria

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):

Glimepiride

Pioglitazone

Rosiglitazone

Sitagliptin

Saxagliptin

Linagliptin

Canagliflozin

Dapagliflozin

Empagliflozin

Ertugliflozin

Liraglutide

Dulaglutide

Semaglutide

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 patients, make any changes needed in the study operations and then implement a Spanish consent, as feasible.

Taking any medication with a known class D or higher drug interaction with metformin, including:

Dolutegravir

Tafenoquine

The use of any carbonic anhydrase inhibitors since they are a risk factor for lactic acidosis, including:

Dichlorphenamide

Acetazolamide

Methazolamide

Dorzolamide

Brinzolamide

Dichlorphenamide

Any treating investigator concern, related to tolerance, safety, adherence or for any other reason

Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility.

Frequently Asked Questions

Q:Is this study available in Colorado Springs?

Yes, this clinical trial (NCT05515978) has an active research site in Colorado Springs, CO that is currently enrolling participants.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. This study has been reviewed and approved, and participants are closely monitored by medical professionals. You can withdraw at any time.

Q:Will I be compensated?

Many clinical trials offer compensation for your time and travel expenses. Specific compensation details will be discussed during the screening process. All study-related medical care is provided at no cost.

Q:Can I leave the trial if I change my mind?

Absolutely. Participation is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty.

Still have questions? Our study coordinators are here to help.

Prostate Cancer Treatment Options in Colorado Springs, CO

If you're searching for prostate cancer treatment options in Colorado Springs, CO, this clinical trial (NCT05515978) may be an excellent opportunity. Clinical trials provide access to cutting-edge treatments that aren't yet available to the general public, often at no cost to participants.

Our Colorado Springs research site is actively enrolling participants for this clinical trial. You'll receive care from experienced prostate cancer specialists who are at the forefront of medical research. All study-related care, including examinations, treatments, and monitoring, is provided at no cost to qualified participants.

Looking for more options? Browse all prostate cancer clinical trials near you to find additional studies recruiting in your area.

Prostate Cancer Clinical Trial in Colorado Springs, CO

Expert Care in Colorado Springs

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No-Cost Care

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