Pilot Clinical Trial of Neoadjuvant SGLT2 Inhibition in Localized Prostate Cancer
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.
Arms & interventions
- DrugDapagliflozin
-The 10 mg dose is reflective of current clinical practice for diabetes and heart failure
Outcome measures
Primary
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)
Proportion of patients who are able to successfully complete at least 80% of the planned dapagliflozin doses and undergo radical prostatectomy
The study will be feasible if at least 19 of the 24 enrolled subjects are able to complete at least 80% of the planned dapagliflozin doses and undergo radical prostatectomy as scheduled.
Time frame: At approximately 6 weeks
Secondary
MRI quantified change in tumor size from screening to post-treatment
Time frame: At the time of pre-operative prostate MRI (estimated to be at week 6)
Degree of tumor necrosis/shrinking
Time frame: From screening to time of radical prostatectomy (estimated to be at week 6)
Change in plasma glucose
Time frame: From screening to day 29
Change in C-peptide
Time frame: From screening to day 29
Change in HbA1C
Time frame: From screening to day 29
Change in glucagon
Time frame: From screening to day 29
Eligibility criteria
Study locations (1)
Washington University School of Medicine
St Louis, Missouri, 63110