What side effects are associated with this type of intervention?

Common treatments for prostate cancer, such as lutetium Lu 177 vipivotide tetraxetan and cabazitaxel, have known side effects. Lutetium Lu 177 vipivotide tetraxetan can cause myelosuppression, nephrotoxicity, and salivary gland toxicity, including pain, swelling, and dry mouth. Cabazitaxel is associated with higher rates of grade 3 or 4 adverse events, including diarrhea, fatigue, and social functioning issues. While SGLT2 inhibitors like dapagliflozin are not standard treatments for prostate cancer, they are generally well-tolerated but can cause side effects such as urinary tract infections, genital infections, and dehydration.

What prior FDA approvals exist?

The FDA has approved several treatments for prostate cancer, including androgen receptor pathway inhibitors like apalutamide, enzalutamide, and darolutamide, which are used in combination with androgen deprivation therapy (ADT) and sometimes docetaxel. These treatments have shown significant benefits in overall survival and progression-free survival in patients with metastatic castration-sensitive prostate cancer (CSPC). Additionally, abiraterone combined with ADT has been approved for its efficacy in increasing overall survival in both nonmetastatic and metastatic prostate cancer. While dapagliflozin, an SGLT2 inhibitor, is being studied for its safety and tolerability in high-risk localized prostate cancer, it is not yet FDA-approved for this indication.

What other types of research exist?

Promising alternatives to Dapagliflozin for prostate cancer patients in 2024 include GLP-1 receptor agonists such as liraglutide, semaglutide, and dulaglutide. These medications have demonstrated efficacy in glycemic control and potential cardiovascular benefits. Additionally, DPP-4 inhibitors like linagliptin, which does not require dose adjustment in renal impairment, may also be considered.

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SGLT2 Inhibition for High-Risk Prostate Cancer

Q: What is the mechanism of action of this treatment?

The most common treatments for prostate cancer include androgen deprivation therapy (ADT) and second-generation androgen receptor inhibitors like enzalutamide and abiraterone. ADT works by reducing the levels of androgens (male hormones) that can stimulate the growth of prostate cancer cells. Second-generation androgen receptor inhibitors block the androgen receptor, preventing androgens from promoting cancer cell growth. These treatments are crucial for prostate cancer patients as they can significantly slow disease progression and improve survival rates. While SGLT2 inhibitors like dapagliflozin are primarily used for diabetes management, they are being explored for potential benefits in prostate cancer due to their effects on metabolic pathways and cancer cell metabolism.

Phase 1

Recruiting

Led By Melissa A Reimers, M.D.

Research Sponsored by Washington University School of Medicine

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

ECOG performance status ≤ 1.

Patients with high risk or very high risk prostatic adenocarcinoma as defined by NCCN criteria.

Must not have

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.

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.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up at approximately 6 weeks

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing if dapagliflozin, a diabetes drug, is safe and well-tolerated for patients with advanced prostate cancer. The medication helps lower blood sugar by making the kidneys remove it through urine.

Who is the study for?

Men over 18 with high-risk or very high risk localized prostate cancer, who are planning a radical prostatectomy and can undergo an MRI. They must have normal organ function and controlled type 2 diabetes (if diabetic). Exclusions include insulin-requiring diabetes, recent strokes, other active cancers, severe illnesses that could interfere with the study, or past use of certain diabetes drugs.

What is being tested?

The trial is testing if taking Dapagliflozin daily for four weeks before surgery is safe and tolerable for patients with aggressive prostate cancer. The drug's effects will be monitored using a BIOSENSE Meter to ensure patient safety during the pre-surgery period.

What are the potential side effects?

Potential side effects of Dapagliflozin may include dehydration, low blood pressure, kidney problems, increased cholesterol levels, urinary tract infections and possible allergic reactions in those sensitive to its components.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am fully active and can carry on all pre-disease activities without restriction.

Select...

My prostate cancer is classified as high or very high risk.

Select...

My prostate cancer is considered very high risk based on its stage or specific features.

Select...

I am willing and able to have a prostate MRI, and I have a measurable prostate lesion.

Select...

My prostate cancer is confirmed and not mainly neuroendocrine/small cell type.

Select...

My prostate cancer is considered high risk due to its stage, grade, or PSA level.

Select...

I am planning to have surgery to remove my prostate cancer.

Select...

I am 18 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I am taking more than 10 mg of prednisone or its equivalent daily.

Select...

I do not have any severe ongoing illnesses like heart problems, serious infections, or severe kidney disease.

Select...

I have HIV but my CD4+ T-cell count is above 350 and I haven't had any major infections in the last year.

Select...

I have been treated with SGLT2 inhibitors or thiazolidinediones.

Select...

I have had a stroke or a mini-stroke in the past 5 years.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ at approximately 6 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~at approximately 6 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and at approximately 6 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Proportion of patients who are able to successfully complete at least 80% of the planned dapagliflozin doses and undergo radical prostatectomy

Side effects data

From 2018 Phase 4 trial • 30 Patients • NCT03006471

20%

Cervicovaginal infection

13%

Urinary tract infections

100%

80%

60%

40%

20%

Study treatment Arm

Dapagliflozin

Placebo

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: DapagliflozinExperimental Treatment1 Intervention

* 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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Dapagliflozin

2014

Completed Phase 4

~64440

0 / 13Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for prostate cancer include androgen deprivation therapy (ADT) and second-generation androgen receptor inhibitors like enzalutamide and abiraterone. ADT works by reducing the levels of androgens (male hormones) that can stimulate the growth of prostate cancer cells. Second-generation androgen receptor inhibitors block the androgen receptor, preventing androgens from promoting cancer cell growth. These treatments are crucial for prostate cancer patients as they can significantly slow disease progression and improve survival rates. While SGLT2 inhibitors like dapagliflozin are primarily used for diabetes management, they are being explored for potential benefits in prostate cancer due to their effects on metabolic pathways and cancer cell metabolism.