Can a common diabetes drug slow prostate cancer progression?

NCT ID NCT04925063

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Aug 31, 2026 · Last updated Sep 01, 2026 · Updated 1 time

Summary

This trial tests whether adding metformin, a common diabetes drug, to standard hormone therapy can delay cancer progression in men with newly diagnosed metastatic hormone-sensitive prostate cancer. Half the participants receive metformin alongside androgen deprivation therapy (ADT) and abiraterone, while the other half receive ADT and abiraterone alone. The main goal is to see if metformin extends the time before the cancer becomes castration-resistant, meaning it stops responding to hormone therapy. The study also tracks overall survival, radiographic progression, and safety.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
metformin
What this could lead to
If metformin delays progression to castration-resistant prostate cancer, it could extend the time patients live without their cancer worsening, offering a new combination strategy for this condition.
What could go wrong
This is a phase 2 trial, so the benefit is uncertain. Metformin may cause gastrointestinal side effects, and the addition may not improve outcomes over standard therapy.

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Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 266 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jun 2021

Expected to finish

Jan 2027

An estimate. End dates often move.

Lead sponsor

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

18 years and older

Sex

Male participants only

Healthy volunteers

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

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Histologically confirmed and newly diagnosed metastatic hormone-sensitive adenocarcinoma of the prostate without small cell carcinoma or small cell components. * Metastatic adenocarcinoma of the prostate proved by imaging (CT/MRI and/or bone scan). * Patient must give written informed consent before registration and prior to any trial related investigations. * Age ≥18 years. * Serum potassium ≥3.5mmol/ L. * ECOG performance status 0-2 * Ongoing androgen deprivation therapy with drugs or bilateral orchiectomy, and continuous abiraterone plus prednisone. * Patient agrees not to father a child during participation in the trial and during 3 months thereafter. * Patient agrees not to participate other interventional trials. * Patients are able to swallow study drug as whole tablet. Exclusion Criteria: * Diagnosed diabetes or fasting blood-glucose ≥ 6.1mmol/L, or glycosylated hemoglobin ≥ 5.6%. * Previous malignancy within 2 years prior to randomization, with the exception of localized non-melanoma skin cancer and Ta bladder cancer. * Prior treatment for prostate cancer with drugs, radiotherapy and surgery, with the exception below: * ADT within 3 months before randomization, and no evidence of progression. * Palliative radiotherapy or surgery for metastases due to symptoms, at least 4 weeks before randomization. * Major surgery within 4 weeks prior to randomization. * Treatments with 5a-reductase inhibitors, estrogen, cyproterone acetate, and androgen within 4 weeks prior to randomization. * Known or suspected Central nervous system CNS metastases or active leptomeningeal disease. * Equivalent dosage of \>5mg/day prednisone of glucocorticoids for the treatment of prostate cancer within 4 weeks prior to randomization, or treatment with glucocorticoids for other reasons. * Prior treatment for prostate cancer with flutamide, bicalutamide, ketoconazole, abiraterone, enzalutamide, apalutamide, docetaxel chemotherapy, or other interventional drugs for prostate cancer. * Neutrophils \< 1.5 x 109/L, platelets \< 75 x 109/L, hemoglobin \< 100 g/L. * ALT and AST ≥ 2.5 x ULN, bilirubin ≥ 1.5 x ULN. * eGFR\<45 ml/min/1.73m2. * Allergic to metformin or any ingredients of this tablet. * Acute or chronic metabolic acidosis, including diabetic ketoacidosis. * Albumin\< 30 g/L. * Clinically significant cardiovascular disease including: * Myocardial infarction within 6 months prior to randomization. * Uncontrolled angina within 3 months prior to registration. * Congestive heart failure NYHA class III or IV. * History of clinically significant ventricular arrhythmias (e.g. ventricular tachycardia, ventricular fibrillation, torsades de pointes). * History of Mobitz II second or third degree heart block without a permanent pacemaker in place. * Systolic pressure\< 86 mmHg. * Bradycardia, heart rate\<45/min. * Uncontrolled hypertension as indicated by systolic blood pressure \> 170 mmHg OR diastolic blood pressure \> 105 mmHg. * ADT with or without anti-androgens more than 3 months prior to randomization. * Prior treatment with metformin after diagnosis of prostate cancer. * Allergic to metformin or any drugs used in this trial. * Serious underlying medical condition (at the judgment of the investigator) which could impair the ability of the patient to participate in the trial (e.g. uncontrolled or acute severe infection, uncontrolled diabetes). * Active or symptomatic viral hepatitis or chronic liver disease. * History of pituitary or adrenal dysfunction. * Gastrointestinal disorder affecting absorption.

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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.

Contacts and locations

Locations

  • Sun Yat-Sen University Cancer Center

    Guangzhou, Guangdong, 510060, China

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