Pilot Clinical Trial of Neoadjuvant SGLT2 Inhibition in Localized Prostate Cancer

Who is this study for? Patients with Prostate Cancer
What treatments are being studied? Dapagliflozin+BIOSENSE Meter
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1
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
Participation Requirements
Sex: Male
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

⁃ High-risk, which is defined as not meeting very high-risk criteria and having at least one of the following high-risk features:

• cT3-cT4

∙ Grade Group 4 or 5

∙ PSA \> 20 ng/mL OR

⁃ Very high-risk, which is defined as meeting at least two of the following criteria:

• cT3-cT4

∙ Grade Group 4 or 5

∙ PSA \> 40 ng/mL\

• Willing and able to undergo prostate MRI at baseline, with a measurable prostate lesion present.

• Planning to undergo radical prostatectomy as primary treatment for localized prostate cancer.

• At least 18 years of age.

• ECOG performance status ≤ 1

• Adequate bone marrow and organ function as defined below:

‣ Leukocytes ≥ 3.0 K/cumm

⁃ Absolute neutrophil count ≥ 1.5 K/cumm

⁃ Platelets ≥ 100 K/cumm

⁃ Total bilirubin ≤ 1.5 x institutional upper limit of normal (IULN)

⁃ AST(SGOT)/ALT(SGPT) ≤ 3.0 x IULN

⁃ Estimated glomerular filtration rate eGFR ≥ 30 mL/min/1.73m\^2

• Agreement to adhere to Lifestyle Considerations throughout study duration

• Ability to understand and willingness to sign an IRB approved written informed consent document (or that of legally authorized representative, if applicable).

Locations
United States
Missouri
Washington University School of Medicine
RECRUITING
St Louis
Contact Information
Primary
Melissa A Reimers, M.D.
mreimers@wustl.edu
314-362-5740
Time Frame
Start Date: 2024-06-04
Estimated Completion Date: 2026-08-31
Participants
Target number of participants: 24
Treatments
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.
Authors
George Andriole
Related Therapeutic Areas
Sponsors
Leads: Washington University School of Medicine
Collaborators: The Foundation for Barnes-Jewish Hospital

This content was sourced from clinicaltrials.gov