Neoadjuvant SGLT2 Inhibition in Localized Prostate Cancer
Trial Parameters
Brief Summary
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.
Eligibility Criteria
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