OncoMatch/Clinical Trials/NCT04887935
Neoadjuvant SGLT2 Inhibition in Localized Prostate Cancer
Is NCT04887935 recruiting? Yes, currently enrolling (Jun 2026). This Phase 1 trial studies Dapagliflozin for prostate cancer.
Treatment: Dapagliflozin — 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.
Check if I qualifyExtracted eligibility criteria
Treatments studied
Other
Cancer type
Prostate Cancer
Disease stage
Required: Stage LOCALIZED (NCCN)
Patients with prostatic adenocarcinoma in one of the following risk groups as defined by NCCN criteria: Unfavorable intermediate risk, High-risk, Very high-risk
Performance status
ECOG 0–1(Restricted strenuous activity)
Demographics
Prior therapy
Cannot have received: SGLT2 inhibitor
Current or previous treatment with SGLT2i
Cannot have received: thiazolidinedione
Current or previous treatment with...thiazolidinedione
Lab requirements
Blood counts
Leukocytes ≥ 3.0 K/cumm; Absolute neutrophil count ≥ 1.5 K/cumm; Platelets ≥ 100 K/cumm
Kidney function
Estimated glomerular filtration rate eGFR ≥ 30 mL/min/1.73m^2
Liver function
Total bilirubin ≤ 1.5 x institutional upper limit of normal (IULN); AST(SGOT)/ALT(SGPT) ≤ 3.0 x IULN
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
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Washington University School of Medicine · St Louis, Missouri
Showing up to 5 US sites.
See all sites on ClinicalTrials.gov →Frequently asked questions
Is NCT04887935 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior SGLT2 inhibitor, thiazolidinedione disqualifies patients from enrollment.
What disease stage is eligible?
Stage LOCALIZED is required.
Is this trial open to female patients?
No. This trial enrolls male patients only.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualifyRelated pages