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Prostate CancerPhase 1NCT04887935

Neoadjuvant SGLT2 Inhibition in Localized Prostate Cancer

A Phase 1 study testing Dapagliflozin in people with Prostate Cancer and Cancer of Prostate, run by Washington University School of Medicine at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older, men only
Conditions the study is for
Prostate Cancer, Cancer of Prostate
What is being tested?
Dapagliflozin
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
5 participants
Where
1 siteUnited States
Study dates
4 Jun 2024to 26 Nov 2025
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
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  • 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).

Who cannot join

  • 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.
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  • 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.
  • Any evidence of pelvic instrumentation (i.e. hip arthroplasty) that would obscure and/or limit prostate MRI evaluation at the discretion of the investigator, or any type of medical device that would be incompatible with MRI imaging.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Washington University School of Medicine

    St Louis, Missouri, 63110

Other trials in United States

About this study

Official title: Pilot Clinical Trial of Neoadjuvant SGLT2 Inhibition in Localized Prostate Cancer

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.

Being tested
Dapagliflozin
Medical subject headings
Prostatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • DapagliflozinDrug

    Also called Farxiga

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

Study groups in NCT04887935
Study groupRoleWhat they receive
DapagliflozinExperimental* 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.
Receives: Drug: Dapagliflozin

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Frequency and severity of toxicities related to dapagliflozin as measured by CTCAE v 5.0

    Measured: From cycle 1 day 1 (the cycle is 28 days in length) through 30 days after prostatectomy (approximately day 64)

  2. 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.

    Measured: At approximately 6 weeks

Secondary outcomes (6)

  1. MRI quantified change in tumor size from screening to post-treatment

    Measured: At the time of pre-operative prostate MRI (estimated to be at week 6)

  2. Degree of tumor necrosis/shrinking

    Measured: From screening to time of radical prostatectomy (estimated to be at week 6)

  3. Change in plasma glucose

    Measured: From screening to day 29

  4. Change in C-peptide

    Measured: From screening to day 29

  5. Change in HbA1C

    Measured: From screening to day 29

  6. Change in glucagon

    Measured: From screening to day 29

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 May 2021
  2. Study start4 Jun 2024
  3. Primary completion26 Nov 2025
  4. Study completion26 Nov 2025

Why it stopped: Low accrual

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
5 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04887935
Sponsor's protocol ID
202107070
Status last verified
Jun 2026
First submitted
10 May 2021
Last updated
30 Jun 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • Zheng J, Lu J, Qi J, Yang Q, Zhao H, Liu H, Chen Z, Huang L, Ye Y, Xu M, Xu Y, Wang T, Li M, Zhao Z, Zheng R, Wang S, Lin H, Hu C, Ling Chui CS, Au Yeung SL, Luo S, Dimopoulou O, Dixon P, Harrison S, Liu Y, Robinson J, Yarmolinsky J, Haycock P, Yuan J, Lewis S, Yuan Z, Gaunt TR, Smith GD, Ning G, Martin RM, Cui B, Wang W, Bi Y. The effect of SGLT2 inhibition on prostate cancer: Mendelian randomization and observational analysis using electronic healthcare and cohort data. Cell Rep Med. 2024 Aug 20;5(8):101688. doi: 10.1016/j.xcrm.2024.101688.

    PubMed 39168098

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Dapagliflozin in people with Prostate Cancer and Cancer of Prostate, run by Washington University School of Medicine at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 31 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 30 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: Low accrual). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the 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)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04887935, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jun 2026.

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