RecruitingPhase 1NCT04887935

Neoadjuvant SGLT2 Inhibition in Localized Prostate Cancer

Pilot Clinical Trial of Neoadjuvant SGLT2 Inhibition in Localized Prostate Cancer


Sponsor

Washington University School of Medicine

Enrollment

24 participants

Start Date

Jun 4, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

This is a pilot study of the tolerability and safety of neoadjuvant dapagliflozin for patients with unfavorable intermediate, high-risk, or very high-risk prostatic adenocarcinoma prior to radical prostatectomy. The primary hypothesis is that four weeks of daily dapagliflozin prior to surgery is well-tolerated and safe to use in this patient population. The investigators also hypothesize that dapagliflozin will be efficacious in resulting in tumor shrinkage on pre-operative imaging and will result in tumor necrosis at prostatectomy.


Eligibility

Sex: MALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether a class of diabetes medication called SGLT2 inhibitors (specifically dapagliflozin) taken before prostate surgery can slow cancer growth in men with localized high-risk prostate cancer. Researchers are looking at changes in the prostate tumor before and after the drug is taken. **You may be eligible if...** - You are 18 or older with confirmed prostate cancer classified as unfavorable intermediate, high-risk, or very high-risk - You are planning to have your prostate surgically removed (radical prostatectomy) as your primary treatment - You have a measurable tumor on prostate MRI - You have adequate blood counts and organ function - Your blood sugar is reasonably controlled (if you have type 2 diabetes) **You may NOT be eligible if...** - You have previously used SGLT2 inhibitors or thiazolidinedione diabetes drugs - You have type 1 or insulin-dependent diabetes - You have had a stroke or TIA in the last 5 years - You have severe kidney disease (low kidney filtration rate) - You have frequent urinary tract or yeast infections - You have had another cancer in the past 2 years (with exceptions) - You have pelvic metal implants that would interfere with MRI Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGDapagliflozin

-The 10 mg dose is reflective of current clinical practice for diabetes and heart failure


Locations(1)

Washington University School of Medicine

St Louis, Missouri, United States

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NCT04887935


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