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SGLT2 Inhibition for High-Risk Prostate Cancer
Phase 1
Waitlist Available
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.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through 24 months
Awards & highlights
Study Summary
This trial is testing whether a diabetes drug is safe to use in men with high-risk prostate cancer before surgery.
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.Check my eligibility
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.See study design
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 belowSelect...
I am fully active and can carry on all pre-disease activities without restriction.
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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.
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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.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ through 24 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through 24 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Frequency and severity of toxicities related to dapagliflozin as measured by CTCAE v 5.0
Number of patients enrolled in 24 months
Secondary outcome measures
Change in HbA1C
Change in ketones
Change in plasma glucose
+2 moreSide effects data
From 2018 Phase 4 trial • 30 Patients • NCT0300647120%
Cervicovaginal infection
13%
Urinary tract infections
100%
80%
60%
40%
20%
0%
Study treatment Arm
Dapagliflozin
Placebo
Trial Design
1Treatment groups
Experimental Treatment
Group I: DapagliflozinExperimental Treatment2 Interventions
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
~64880
Find a Location
Who is running the clinical trial?
The Foundation for Barnes-Jewish HospitalOTHER
37 Previous Clinical Trials
6,811 Total Patients Enrolled
2 Trials studying Prostate Cancer
600 Patients Enrolled for Prostate Cancer
Washington University School of MedicineLead Sponsor
1,931 Previous Clinical Trials
2,299,685 Total Patients Enrolled
17 Trials studying Prostate Cancer
4,247 Patients Enrolled for Prostate Cancer
Melissa A Reimers, M.D.Principal InvestigatorWashington University School of Medicine
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You are currently taking any experimental drugs for other studies.I am fully active and can carry on all pre-disease activities without restriction.My prostate cancer is classified as high or very high risk.I do not have any implants that would interfere with an MRI of my prostate.My prostate cancer is considered very high risk based on its stage or specific features.I am taking more than 10 mg of prednisone or its equivalent daily.I am willing and able to have a prostate MRI, and I have a measurable prostate lesion.I do not have any severe ongoing illnesses like heart problems, serious infections, or severe kidney disease.My prostate cancer is confirmed and not mainly neuroendocrine/small cell type.I have HIV but my CD4+ T-cell count is above 350 and I haven't had any major infections in the last year.My prostate cancer is considered high risk due to its stage, grade, or PSA level.I am planning to have surgery to remove my prostate cancer.I have well-controlled type 2 diabetes without needing insulin.You have had allergic reactions to drugs similar to dapagliflozin.I am 18 years old or older.I had another cancer but was treated successfully over 2 years ago, except for minor skin cancers.I have been treated with SGLT2 inhibitors or thiazolidinediones.I have had a stroke or a mini-stroke in the past 5 years.
Research Study Groups:
This trial has the following groups:- Group 1: Dapagliflozin
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
To what extent could Dapagliflozin be a health hazard to patients?
"The safety of Dapagliflozin has been deemed to be a score 1, as Phase 1 trials have only begun and thus data regarding efficacy is limited."
Answered by AI
Is this an inaugural clinical trial in its field?
"Since 2014, the pharmaceutical giant AstraZeneca has conducted a series of trials studying dapagliflozin. The initial trial in 2014 involved 700 participants and after receiving N/A drug approval, 63 active studies have been initiated across 50 countries and 235 cities."
Answered by AI
How extensive is the sample size of this medical experiment?
"This clinical trial has since ended its recruitment period. It was initially posted on December 31st 2022 and the last update to it occurred on November 10th 2022. For those looking for similar studies, there are currently 1,321 trials seeking patient with prostate cancer and 63 trials recruiting Dapagliflozin participants."
Answered by AI
Are there any vacancies available in this clinical trial?
"Recruitment for this trial has concluded. It was first posted on December 31st 2022 and last updated November 10th of that same year. There are currently 1321 studies seeking participants with prostate cancer, as well as 63 trials looking for individuals to take part in Dapagliflozin research."
Answered by AI
What are the primary indications for using Dapagliflozin?
"Dapagliflozin is a common pharmaceutical solution to treat diverse conditions, like diet and exercise programs of those with inadequate response to monotherapy."
Answered by AI
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