Could a common diabetes drug shrink prostate tumors?
NCT ID NCT04887935
First seen Jun 27, 2026 · Last updated Jul 01, 2026 · Updated 2 times
Summary
This early-stage trial is testing whether dapagliflozin (Farxiga), a drug used for diabetes and heart failure, is safe and tolerable when taken for four weeks before prostate removal surgery in men with localized prostate cancer. The study will also look for signs that the drug may shrink tumors or cause cancer cell death. Only 24 men with intermediate- to high-risk prostate cancer will participate.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- dapagliflozin (Farxiga)
- What this could lead to
- If this works, it could point toward a new way to shrink prostate tumors before surgery, potentially improving outcomes.
- What could go wrong
- This is a very early, small pilot study with only 24 men. It primarily tests safety, not effectiveness, so the drug may not shrink tumors or cause significant benefit.
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
-
Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
-
5 people
The number who actually took part.
- Started
-
Jun 2024
- Finished
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Nov 2025
- 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
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18 years and older
- Sex
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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 Hide 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: * Histologically or cytologically confirmed localized prostatic adenocarcinoma. Patients with primarily neuroendocrine/small cell histology will be excluded. * Patients with prostatic adenocarcinoma in one of the following risk groups as defined by NCCN criteria: * Unfavorable intermediate risk. Intermediate risk is defined as having no high-risk or very high-risk factors and having at least one of the following intermediate risk factors (IRFs): * cT2b-cT2c * Grade Group 2 or 3 * PSA 10-20 ng/mL * Unfavorable intermediate risk additionally must have one or more of the following: * 2 or 3 IRFs * Grade Group 3 * ≥50% biopsy cores positive (eg, ≥ 6 of 12 cores) OR * High-risk, which is defined as not meeting very high-risk criteria and having at least one of the following high-risk features: * cT3-cT4 * Grade Group 4 or 5 * PSA \> 20 ng/mL OR * Very high-risk, which is defined as meeting at least two of the following criteria: * cT3-cT4 * Grade Group 4 or 5 * PSA \> 40 ng/mL\\ * Willing and able to undergo prostate MRI at baseline, with a measurable prostate lesion present. * Planning to undergo radical prostatectomy as primary treatment for localized prostate cancer. * At least 18 years of age. * ECOG performance status ≤ 1 * Adequate bone marrow and organ function as defined below: * Leukocytes ≥ 3.0 K/cumm * Absolute neutrophil count ≥ 1.5 K/cumm * Platelets ≥ 100 K/cumm * Total bilirubin ≤ 1.5 x institutional upper limit of normal (IULN) * AST(SGOT)/ALT(SGPT) ≤ 3.0 x IULN * Estimated glomerular filtration rate eGFR ≥ 30 mL/min/1.73m\^2 * Agreement to adhere to Lifestyle Considerations throughout study duration * Ability to understand and willingness to sign an IRB approved written informed consent document (or that of legally authorized representative, if applicable). Exclusion Criteria: * Current or previous treatment with SGLT2i or thiazolidinedione. * Currently receiving regularly scheduled systemic steroids in the form of prednisone or dexamethasone (more than 10 mg prednisone daily or equivalent). Topical steroid ointments or creams for occasional skin rash is allowed. * A history of other malignancy with the exceptions of malignancies for which all treatment was completed at least 2 years before registration with no evidence of disease and locally treated skin squamous or basal cell carcinoma. * History of stroke or transient ischemic attack in the last 5 years. * Patients with type 1 diabetes mellitus will be excluded or patients with insulin-requiring diabetes mellitus will be excluded. Only patients with well-controlled type 2 diabetes mellitus will be allowed. * Screening HbA1c \> 10%, unless approved by endocrinologist. * Currently receiving any other investigational agents. * A history of allergic reactions attributed to compounds of similar chemical or biologic composition to dapagliflozin. * Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, peripheral arterial disease, ketoacidosis, severe kidney disease (estimated glomerular filtration rate eGFR \< 30 mL/min/1.73m2), symptomatic hypotension, and chronic/frequent urinary tract infections or yeast infections. * Patients with HIV are eligible unless their CD4+ T-cell counts are \< 350 cells/mcL or they have a history of AIDS-defining opportunistic infection within the 12 months prior to registration. Concurrent treatment with effective ART according to DHHS treatment guidelines is recommended. * Any evidence of pelvic instrumentation (i.e. hip arthroplasty) that would obscure and/or limit prostate MRI evaluation at the discretion of the investigator, or any type of medical device that would be incompatible with MRI imaging.
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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.
Contacts and locations
Locations
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Washington University School of Medicine
St Louis, Missouri, 63110, United States
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Other studies related to the condition(s) this trial covers.
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