Could a common diabetes drug help fight prostate cancer?
NCT ID NCT07310433
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This phase 2 trial tests whether adding dapagliflozin, a diabetes medication, to standard hormone therapy improves outcomes for men with metastatic castrate-resistant prostate cancer. About 60 participants will be randomly assigned to receive either the combination or standard care alone. The study aims to see if the combination delays cancer progression and is safe.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Dapagliflozin (a diabetes drug) combined with standard hormone therapy
- What this could lead to
- If successful, this could point toward a new combination treatment that improves tumor control for men with advanced prostate cancer.
- What could go wrong
- This is a small, early-phase trial (60 people) and the drug is being repurposed, so results may not be conclusive or generalizable. Side effects from the combination are not yet fully known.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 60 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Jun 2026
An estimate. Start dates often move.
- Expected to finish
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Oct 2030
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Male participants only
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Age of 18 years and above * Histologically or cytologically confirmed diagnosis of prostatic adenocarcinoma without neuroendocrine/ small cell histology; * PCa progression while receiving ADT (or post bilateral orchiectomy) within 6 months before screening: two consecutive rising PSA levels, radiographic soft tissue or bone progression; * Current evidence of metastatic disease by radiological scan; * Decided to receive any of the NHA (including Abiraterone Acetate, Enzalutamide, Apalutamide or Darolutamide) under standard of care setting, or started NHA for no more than 28 days at the time of treatment period start; * Ongoing androgen deprivation with serum testosterone \<50 ng/dL (\<1.7 nM); * Naïve of taxane-based chemotherapy regimens; * Eastern Cooperative Oncology Group (ECOG) performance status ≤ 1; * Normal hematologic and organ function as defined below: (a) leukocytes ≥ 3,000/mcL; (b) absolute neutrophil count ≥ 1,500/mcL; (c) platelets ≥ 100,000/mcL; (d) total bilirubin ≤ 1.5 x institutional upper limit of normal (IULN); (e) AST(SGOT)/ALT(SGPT) ≤ 3.0 x IULN; (f) estimated glomerular filtration rate eGFR ≥ 30 mL/min/1.73m2; * Ability to understand and willingness to sign an IRB-approved written informed consent document. Exclusion Criteria: * Current or previous treatment with SGLT2 inhibitors or thiazolidinedione; * Presence of type 1 diabetes mellitus, insulin-requiring diabetes mellitus or poorly controlled diabetes mellitus (i.e., HbA1c \> 10%, unless approved by endocrinologist); * Presence of malignancies other than prostate cancer within two years prior to study enrollment; * Disease progressed during or after treatment with one NHA; * A history of allergic reactions attributed to compounds of similar chemical or biologic composition to dapagliflozin; * Clinically significant abnormal serum potassium or sodium level; * Presence of uncontrolled comorbidities including but not limited to ongoing or active infection (e.g., HIV, HBV, HCV and tuberculosis), symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, peripheral arterial disease, ketoacidosis, severe kidney disease, symptomatic hypotension, and chronic/frequent urinary tract infections or yeast infections; * Participation in another clinical trial with therapeutic intent within 28 days prior to enrollment; * Inability to swallow capsules/tablets * Any medical conditions that might deem unsafe or contraindicated for inclusion in the clinical trial, per investigator's discretion
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
2 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Huashan Hospital
Shanghai, China
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Ruijin Hospital
Shanghai, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- New PET tracer targets ACP3 to spot prostate cancer
- Can a One-Week radiation course match four weeks for prostate cancer?
- Can a new PET tracer spot hidden prostate cancer spread?
- Can a gel cushion shield the rectum during prostate radiation?
- A scanner in the operating room could show surgeons exactly where prostate cancer remains