Actively Recruiting
Neoadjuvant SGLT2 Inhibition in Localized Prostate Cancer
Led by Washington University School of Medicine · Updated on 2025-10-01
24
Participants Needed
1
Research Sites
116 weeks
Total Duration
On this page
Sponsors
W
Washington University School of Medicine
Lead Sponsor
T
The Foundation for Barnes-Jewish Hospital
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Neoadjuvant SGLT2 Inhibition in Localized Prostate Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically or cytologically confirmed localized prostatic adenocarcinoma (excluding primarily neuroendocrine/small cell types).
- Diagnosed with unfavorable intermediate risk, high-risk, or very high-risk prostate cancer based on NCCN criteria.
- Willing and able to undergo baseline prostate MRI with a measurable lesion.
- Planning to have radical prostatectomy as primary treatment.
- At least 18 years old.
- ECOG performance status of 0 or 1.
- Adequate bone marrow and organ function including leukocytes 3.0 K/cumm, absolute neutrophil count 1.5 K/cumm, platelets 100 K/cumm, total bilirubin 1.5 times upper limit of normal, AST/ALT 3.0 times upper limit of normal, and estimated glomerular filtration rate 30 mL/min/1.73m.
- Agree to follow lifestyle considerations during the study.
- Able to understand and willing to sign informed consent.
You will not qualify if you...
- Prior or current treatment with SGLT2 inhibitors or thiazolidinediones.
- Regular use of systemic steroids above 10 mg prednisone daily or equivalent.
- History of other cancers unless treated and disease-free for at least 2 years (except certain skin cancers).
- Stroke or transient ischemic attack within the last 5 years.
- Type 1 diabetes or insulin-requiring diabetes.
- Screening HbA1c greater than 10% unless approved by an endocrinologist.
- Use of other investigational agents.
- History of allergic reactions to dapagliflozin or similar compounds.
- Uncontrolled illnesses including active infection, symptomatic heart failure, unstable angina, arrhythmia, peripheral arterial disease, ketoacidosis, severe kidney disease (eGFR < 30), symptomatic low blood pressure, or frequent urinary or yeast infections.
- HIV patients with CD4 counts below 350 or recent AIDS-related infections.
- Medical devices or conditions that prevent adequate prostate MRI imaging (e.g., hip replacement).
AI-Screening
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Trial Site Locations
Total: 1 location
1
Washington University School of Medicine
St Louis, Missouri, United States, 63110
Actively Recruiting
Research Team
M
Melissa A Reimers, M.D.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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