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NCT04887935
Neoadjuvant SGLT2 Inhibition in Localized Prostate Cancer
Phase 1 trial testing Dapagliflozin in Prostate Cancer in 24 participants. Currently enrolling.
31 August 2026
Quick facts
| Lead sponsor | Washington University School of Medicine |
|---|---|
| Phase | Phase 1 |
| Status | Recruiting now |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 24 |
| Start date | 4 June 2024 |
| Primary completion | 31 August 2026 |
| Estimated completion | 31 August 2026 |
| Sites | 1 location across United States |
Drugs / interventions tested
- Dapagliflozin (DAPAGLIFLOZIN) — full drug profile →
Conditions studied
- Prostate Cancer — all drugs for Prostate Cancer →
- Cancer of Prostate — all drugs for Cancer of Prostate →
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):
-
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 -
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 -
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 -
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 -
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 -
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 -
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:
- PubMed search for NCT04887935
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Other Washington University School of Medicine trials
Trials by the same sponsor.
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT04887935 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 9 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Washington University School of Medicine
- Last refreshed: 1 October 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04887935.
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