Actively Recruiting
Pilot Clinical Trial of 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
N/A
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
Researchers are studying patients with localized prostate adenocarcinoma who are at unfavorable intermediate, high, or very high risk according to NCCN criteria. This pilot clinical trial is evaluating the safety and tolerability of dapagliflozin taken daily before radical prostatectomy. The study aims to determine if four weeks of dapagliflozin before surgery is safe and well-tolerated, and to assess its effects on tumor shrinkage and necrosis as seen on imaging and pathology. Participants will receive dapagliflozin at a dose of 10 mg by mouth once daily, starting about six weeks before their scheduled prostatectomy. The drug is taken for 28 days leading up to the surgery. This study is an open-label, phase 1 trial conducted by Washington University School of Medicine. The treatment period is followed by surgery to remove the prostate and evaluate tumor changes. During the study, participants will undergo prostate MRI scans before and after treatment to measure tumor size changes. Researchers will monitor for side effects and safety using standardized criteria from the first day of treatment through 30 days after surgery. Blood tests will assess glucose, C-peptide, HbA1c, and glucagon levels from screening to day 29. Participants are expected to complete most of the dapagliflozin doses and proceed to surgery approximately six weeks after starting treatment.
CONDITIONS
Brief 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
- Belonging to unfavorable intermediate, high-risk, or very high-risk groups as defined by NCCN criteria
- Willing and able to have a prostate MRI with a measurable lesion
- Planning to undergo radical prostatectomy as primary treatment
- At least 18 years of age
- ECOG performance status of 0 or 1
- Adequate bone marrow and organ function
- Agreement to follow lifestyle considerations during the study
- Ability and willingness to provide informed consent
You will not qualify if you...
- Current or previous treatment with SGLT2 inhibitors or thiazolidinediones
- Regular use of systemic steroids exceeding 10 mg prednisone daily
- History of other malignancies unless all treatment completed over 2 years ago
- Stroke or transient ischemic attack within the last 5 years
- Type 1 diabetes or insulin-requiring diabetes mellitus
- Screening HbA1c higher than 10% unless approved by an endocrinologist
- Use of other investigational agents
- Allergic reactions to dapagliflozin or similar compounds
- Uncontrolled illnesses including infection, heart failure, unstable angina, arrhythmia, peripheral arterial disease, ketoacidosis, severe kidney disease, symptomatic hypotension, frequent urinary or yeast infections
- Low CD4+ T-cell count under 350 cells/mcL or recent AIDS-defining infection
- Pelvic instrumentation or medical devices that interfere with prostate MRI evaluation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - 4 weeks
Participants take dapagliflozin 10 mg by mouth once daily for 4 weeks prior to planned prostatectomy.
Daily dosing for 28 days
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.
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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