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Neoadjuvant SGLT2 Inhibition in Localized Prostate Cancer | Clinical Trials | Clareo Health

RECRUITINGPHASE1

Neoadjuvant SGLT2 Inhibition in Localized Prostate Cancer

Pilot Clinical Trial of Neoadjuvant SGLT2 Inhibition in Localized Prostate Cancer

NCT04887935•Washington University School of Medicine

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

Age

18 - No limit years

Sex

MALE

Healthy Volunteers

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
+21 more criteria

Exclusion Criteria

•Current or previous treatment with SGLT2i or thiazolidinedione.
•Currently receiving regularly scheduled systemic steroids in the form of prednisone or dexamethasone (more than 10 mg prednisone daily or equivalent). Topical steroid ointments or creams for occasional skin rash is allowed.
•A history of other malignancy with the exceptions of malignancies for which all treatment was completed at least 2 years before registration with no evidence of disease and locally treated skin squamous or basal cell carcinoma.
•History of stroke or transient ischemic attack in the last 5 years.
•Patients with type 1 diabetes mellitus will be excluded or patients with insulin-requiring diabetes mellitus will be excluded. Only patients with well-controlled type 2 diabetes mellitus will be allowed.
•Screening HbA1c \> 10%, unless approved by endocrinologist.
•Currently receiving any other investigational agents.
•A history of allergic reactions attributed to compounds of similar chemical or biologic composition to dapagliflozin.
•Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, peripheral arterial disease, ketoacidosis, severe kidney disease (estimated glomerular filtration rate eGFR \< 30 mL/min/1.73m2), symptomatic hypotension, and chronic/frequent urinary tract infections or yeast infections.
•Patients with HIV are eligible unless their CD4+ T-cell counts are \< 350 cells/mcL or they have a history of AIDS-defining opportunistic infection within the 12 months prior to registration. Concurrent treatment with effective ART according to DHHS treatment guidelines is recommended.
+1 more criteria

Locations (1)

Washington University School of Medicine

St Louis, Missouri, United States

Key Dates

Start Date

June 4, 2024

Primary Completion Date

August 31, 2026

Completion Date

August 31, 2026

Last Updated

October 1, 2025

Enrollment

ESTIMATED participants

Conditions

Prostate CancerCancer of Prostate

Interventions

Dapagliflozin

DRUG

Contacts

Melissa A Reimers, M.D.

CONTACT

314-362-5740 mreimers@wustl.edu

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NCT06842498

Metastatic Castration-Resistant Prostate Cancer

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RECRUITINGPHASE2

Testing the Safety and Effectiveness of Radiation-based Treatment (Lutetium Lu 177 Dotatate) for Metastatic Prostate Cancer That Has Neuroendocrine Cells

NCT05691465

Metastatic Prostate Adenocarcinoma With Neuroendocrine DifferentiationMetastatic Prostate Neuroendocrine Carcinoma+2 more

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: October 1, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Neoadjuvant SGLT2 Inhibition in Localized Prostate Cancer

Inclusion Criteria

Exclusion Criteria

A Study of FG-3246 in Participants With Metastatic Castration-Resistant Prostate Cancer (mCRPC)

Testing the Safety and Effectiveness of Radiation-based Treatment (Lutetium Lu 177 Dotatate) for Metastatic Prostate Cancer That Has Neuroendocrine Cells

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Study of Dato-DXd as Monotherapy and in Combination With Anti-cancer Agents in Patients With Advanced Solid Tumours (TROPION-PanTumor03)

PSMA-PET: Deep Radiomic Biomarkers of Progression and Response Prediction in Prostate Cancer

Phase 2a Study of High-Dose Testosterone Followed by Radioligand Therapy in mCRPC