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NCT04887935

Neoadjuvant SGLT2 Inhibition in Localized Prostate Cancer

Recruiting now Phase 1 Last updated 1 October 2025
What this trial tests

Phase 1 trial testing Dapagliflozin in Prostate Cancer in 24 participants. Currently enrolling.

Timeline
4 June 2024
Primary endpoint
31 August 2026
31 August 2026

Quick facts

Lead sponsorWashington University School of Medicine
PhasePhase 1
StatusRecruiting now
Study typeINTERVENTIONAL
Allocationna
Designsingle group
Maskingnone
Primary purposetreatment
Enrollment24
Start date4 June 2024
Primary completion31 August 2026
Estimated completion31 August 2026
Sites1 location across United States

Drugs / interventions tested

Conditions studied

Sponsor

Washington University School of Medicine

Who can join

18 and older, male only, with Prostate Cancer or Cancer of Prostate. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

7 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Exploring the Role of SGLT2 Inhibitors in Cancer: Mechanisms of Action and Therapeutic Opportunities.
    Pandey A, Alcaraz M, Saggese P, Soto A, et al · · 2025 · cited 21× · PMID 39941833 · DOI 10.3390/cancers17030466
  2. The effect of SGLT2 inhibition on prostate cancer: Mendelian randomization and observational analysis using electronic healthcare and cohort data.
    Zheng J, Lu J, Qi J, Yang Q, et al · · 2024 · cited 14× · PMID 39168098 · DOI 10.1016/j.xcrm.2024.101688
  3. Sodium-glucose cotransporter 2 inhibitors and the cancer patient: from diabetes to cardioprotection and beyond.
    Camilli M, Viscovo M, Maggio L, Bonanni A, et al · · 2025 · cited 9× · PMID 38935171 · DOI 10.1007/s00395-024-01059-9
  4. Solute Carrier transporters in tumor metabolism and immune modulation: implications for therapy.
    Zhou J, Wen W, Xu Y, Yu J, et al · · 2026 · PMID 41832499 · DOI 10.1186/s12967-026-07918-4
  5. SGLT2 Inhibitors in Combination Therapies for Tumors: A Novel Approach to Synergistic Treatment Strategies.
    Su H, Li X, Wang S, Yang X, et al · · 2025 · PMID 41477177 · DOI 10.2147/dddt.s556231
  6. Treatment Intensification Prior to Radical Prostatectomy for Clinically Localized Prostate Cancer.
    Perez Kerkvliet CJ, Leong JY, Thompson RAM, Zarrabi KK, et al · · 2025 · PMID 40647555 · DOI 10.3390/cancers17132258
  7. Mendelian randomization revealing the protective effect of sodium-glucose cotransporter 2 inhibition on prostate cancer with verified evidence from electronic healthcare and biological data
    Zheng J, Lu J, Qi J, Yang Q, et al · · 2023 · DOI 10.1101/2023.10.10.23296790

Verify or expand the search:

Other trials of Dapagliflozin

Trials testing the same drug.

Other recruiting trials for Prostate Cancer

Currently open trials in the same condition.

Other Washington University School of Medicine trials

Trials by the same sponsor.

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Data sources for this page

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