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Metastatic Prostate CancerPhase 2NCT04925063

The Effect of Metformin in Patients With Newly Diagnosed mHSPC

A Phase 2 study testing Metformin in people with Metastatic Prostate Cancer, run by Sun Yat-sen University at 1 site in China.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

The purpose of this study is to assess the effect of the addition of metformin to abiraterone on survival in patients with newly diagnosed metastatic hormone-sensitive prostate cancer. Read more about this study

Who is it for?
Ages 18 years and older, men only
Conditions the study is for
Metastatic Prostate Cancer
What is being tested?
Metformin
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
266 participants
Where
1 siteChina
Study dates
16 Jun 2021to 31 Jan 2027
Phase
Phase 2
Are there results?
Not yet: the study is under way

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 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
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  • 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.

Who cannot join

  • 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.
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  • 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.

Trial locations and contacts

1 site in 1 country.

China1 site

  • Sun Yat-Sen University Cancer Center

    Guangzhou, Guangdong, 510060

Other trials in China

About this study

Official title: A Prospective, Randomized Trial Comparing Metformin Plus Androgen Deprivation Therapy (ADT) and Abiraterone With ADT Plus Abiraterone in Newly Diagnosed Metastatic Hormone-Sensitive Prostate Cancer

The purpose of this study is to assess the effect of the addition of metformin to abiraterone on survival in patients with newly diagnosed metastatic hormone-sensitive prostate cancer. The half the patients will receive metformin in combination with androgen deprivation therapy (ADT) and abiraterone, and the other half will receive ADT and abiraterone only.

Read the detailed description

Metastatic hormone-sensitive prostate cancer (mHSPC) can be treated with androgen-deprivation therapy (ADT) alone, ADT plus abiraterone, ADT plus enzalutamide, ADT plus apalutamide, ADT plus docetaxel. However, most patients eventually progress to castration-resistant prostate cancer (CRPC) and die of the disease. Therefore, there is still a need to improve the therapeutic effect for mHSPC.

Many studies have shown that metabolic syndrome and its components are associated with increased development and progression of aggressive prostate cancer. Metformin, a common well-tolerated oral biguanide prescribed for type II diabetes, could be used to decrease the risk of prostate cancer development and improve the efficacy of treatment. Some studies reported that metformin could enhance the effectiveness of ADT, and improve recurrence-free survival, overall survival and cancer-specific survival. A prospective randomized study reported that metformin potentially lengthen time to CRPC in advanced prostate cancer patients when combined with ADT especially in those with high risk localized prostate cancer, clinically node positive and in those with low tumor volume metastatic hormone-sensitive patients.

After extensive research, there is no published results from prospective randomized trials evaluating the effect of metformin in combination with ADT and abiraterone among patients with newly diagnosed mHSPC.

Being tested
Metformin
Keywords
metastatic hormone sensitive prostate cancer; abiraterone; metformin
Medical subject headings
Prostatic Neoplasms

What participants receive

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

  • MetforminDrug

    Also called Metformin Hydrochloride Sustained Release Tablets

    The starting daily dose of metformin is 500mg once daily, and add a dose of 500mg per week until the target dose of 2000mg once daily if tolerated. Metformin will be continued until disease progression.

Study groups in NCT04925063
Study groupRoleWhat they receive
Metformin+ADT+abirateroneExperimentalDrug: Metformin The starting daily dose of metformin is 500mg once daily, to be increased to 2000mg once daily if tolerated until disease progression Drug: Abiraterone Abiraterone 1000mg once daily until disease progression
Receives: Drug: Metformin
ADT+abirateroneNo interventionDrug: Abiraterone Abiraterone 1000mg once daily until disease progression

What is being measured

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

  1. Castration-resistant prostate cancer free survival

    Duration from randomization to time till development of CRPC (Castration-resistant prostate cancer). CRPC is defined by disease progression despite castration level of testosterone and may present as either a biochemical progression and/or radiological progression.

    Measured: 5 years

Secondary outcomes (3)

  1. Overall Survival

    Overall survival is defined from randomization until death due to any reason.

    Measured: 5 years

  2. Radiographic progression-free survival

    Radiographic progression-free survival is defined from randomization until radiographic progression.

    Measured: 5 years

  3. Safety

    Adverse events will be assessed according to NCI-CTC AE 5.0.

    Measured: 5 years

Timeline

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

  1. First posted14 Jun 2021
  2. Study start16 Jun 2021
  3. Primary completion30 Aug 2026 (estimated)
  4. Study completion31 Jan 2027 (estimated)

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 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
266 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04925063
Sponsor's protocol ID
2021-FXY-078
Status last verified
Aug 2026
First submitted
8 Jun 2021
Last updated
31 Aug 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Metformin in people with Metastatic Prostate Cancer, run by Sun Yat-sen University at 1 site in China.

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 10 inclusion and 32 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: under way, not looking for participants, as of the sponsor's last update on 31 Aug 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 China. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

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?

Castration-resistant prostate cancer free survival (time frame: 5 years). 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 NCT04925063.

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 31 Aug 2026.

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