OncoMatch/Clinical Trials/NCT04887935
Neoadjuvant SGLT2 Inhibition in Localized Prostate Cancer
Is NCT04887935 recruiting? Yes, currently enrolling (May 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
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)
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
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