NCT04887935

Neoadjuvant SGLT2 Inhibition in Localized Prostate Cancer

Pilot Clinical Trial of Neoadjuvant SGLT2 Inhibition in Localized Prostate Cancer

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 24 (estimated)
• Sponsor: Washington University School of Medicine · Academic / Other
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Prostate Cancer
• Cancer of Prostate

Interventions

Type	Name	Description
DRUG	Dapagliflozin	-The 10 mg dose is reflective of current clinical practice for diabetes and heart failure

Timeline

• Start date: 2024-06-04
• Primary completion: 2026-08-31
• Completion: 2026-08-31
• First posted: 2021-05-14
• Last updated: 2025-10-01

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study