Neoadjuvant SGLT2 Inhibition in Localized Prostate Cancer

Part of paid clinical trials in St Louis, Missouri.

Sponsor
Washington University School of Medicine
Study ID
NCT04887935
Phase
PHASE1
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
MALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Dapagliflozin — DRUG
    -The 10 mg dose is reflective of current clinical practice for diabetes and heart failure

Study Details

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.

Key Dates

Start date
Jun 4, 2024
Status verified
Sep 2025
Primary completion
Aug 31, 2026
Completion
Aug 31, 2026

Study Design

Enrollment
24 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Dapagliflozin
    * Dapagliflozin will be initiated once daily approximately 6 weeks prior to planned prostatectomy * Dapagliflozin will be given at 10 mg by mouth once daily for 4 weeks (days 1-28) prior to prostatectomy.

Primary Outcome Measure

Frequency and severity of toxicities related to dapagliflozin as measured by CTCAE v 5.0 [ Time Frame: From cycle 1 day 1 (the cycle is 28 days in length) through 30 days after prostatectomy (approximately day 64) ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Washington University School of MedicineSt LouisMissouri63110
Melissa A Reimers, M.D.
[email protected]
314-362-5740
Melissa A Reimers, M.D. (PRINCIPAL_INVESTIGATOR)
Linda R Peterson, M.D. (SUB_INVESTIGATOR)
Joseph E Ippolito, M.D., Ph.D. (SUB_INVESTIGATOR)
Woodson W Smelser, M.D. (SUB_INVESTIGATOR)
Janet McGill, M.D. (SUB_INVESTIGATOR)
Jingqin (Rosy) Luo, Ph.D. (SUB_INVESTIGATOR)

Find similar trials in St Louis, MO

By condition
Prostate cancer
By specialty
OncologyProstate oncologyMen's healthUrology
By research site
Washington University School of Medicine· St Louis, MO

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