Metastatic Prostate CancerPhase 2NCT04926155
The Effect of Metformin in Patients With Metastatic Castration-resistant Prostate Cancer
A Phase 2 study testing Metformin in people with Metastatic Prostate Cancer, run by Sun Yat-sen University at 1 site in China.
Trial summary
The purpose of this study is to assess the effect of the addition of metformin to abiraterone on survival in patients with metastatic castration-resistant prostate cancer (mCRPC). 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
- 234 participants
- Where
- 1 siteChina
- Study dates
- 23 Jun 2021to 31 Aug 2024
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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).
- Patients must meet the criteria of CRPC.
- No prior treatment with chemotherapy and new-generation hormonal therapy including abiraterone, enzalutamide, apalutamide.
- Patient must give written informed consent before registration and prior to any trial related investigations.
- Age ≥18 years.
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- 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.
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.
- 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 >10mg/day prednisone of glucocorticoids for the treatment of prostate cancer within 4 weeks prior to randomization, or treatment with glucocorticoids for other reasons.
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- 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.
- 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.
About this study
Official title: A Prospective, Randomized Trial Comparing Metformin Plus Androgen Deprivation Therapy (ADT) and Abiraterone With ADT Plus Abiraterone in Metastatic Castration-resistant Prostate Cancer
The purpose of this study is to assess the effect of the addition of metformin to abiraterone on survival in patients with metastatic castration-resistant prostate cancer (mCRPC). 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 castration-resistant prostate cancer (mCRPC) can be treated with ADT plus abiraterone, ADT plus enzalutamide, ADT plus cabazitaxel, ADT plus docetaxel, ADT plus olaparib. However, patients have short overall survival after progression to CRPC, although multiple options are available for mCRPC. Therefore, there is still a need to improve the therapeutic effect for mCRPC.
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 mCRPC.
- Conditions
- Metastatic Prostate Cancer
- Being tested
- Metformin
- Keywords
- mCRPC; 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 group | Role | What they receive |
|---|---|---|
| Metformin+ADT+abiraterone | Experimental | Patients in this arm will be treatet with metformin plus ADT and abiraterone Receives: Drug: Metformin |
| ADT+abiraterone | No intervention | Patients in this arm will be treatet with ADT and 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.
Progression-free survival defined from randomization to time till biochemical progression or radiographic progression
Measured: start of treatment to disease progression, up to 36 months
Secondary outcomes (3)
Overall survival defined from randomization until death due to any reason
Measured: start of treatment to death, up to 36 months
Radiographic progression-free survival defined from randomization until radiographic progression
Measured: start of treatment to radiographic progression, up to 36 months
Adverse events which will be assessed according to NCI-CTC AE 5.0
Measured: start of treatment to study completion, up to 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2021
- Study start23 Jun 2021 (estimated)
- Primary completion30 Apr 2024 (estimated)
- Study completion31 Aug 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic Prostate CancerStudies of the same condition, open and under way.
- More trials run by Sun Yat-sen UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- 234 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yonghong Li, Sun Yat-sen University
- Investigators
- Yonghong Li, M.D., Principal investigator, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04926155
- Sponsor's protocol ID
- 2021-FXY-072
- Status last verified
- Jun 2021
- First submitted
- 11 Jun 2021
- Last updated
- 14 Jun 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Randomized Trial Comparing Metformin Plus Androgen Deprivation Therapy (ADT) and Abiraterone With ADT Plus Abiraterone in Metastatic Castration-resistant Prostate Cancer
- ClinicalTrials.gov ID
- NCT04926155
- Acronym / sponsor ID
- 2021-FXY-072
- Conditions
- Metastatic Prostate Cancer
- Keywords
- mCRPC; abiraterone; metformin
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 234 participants (estimated)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- 23 Jun 2021 (estimated)
- Primary completion
- 30 Apr 2024 (estimated)
- Study completion
- 31 Aug 2024 (estimated)
- First posted
- 14 Jun 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to assess the effect of the addition of metformin to abiraterone on survival in patients with metastatic castration-resistant prostate cancer (mCRPC). 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.
Detailed description
Metastatic castration-resistant prostate cancer (mCRPC) can be treated with ADT plus abiraterone, ADT plus enzalutamide, ADT plus cabazitaxel, ADT plus docetaxel, ADT plus olaparib. However, patients have short overall survival after progression to CRPC, although multiple options are available for mCRPC. Therefore, there is still a need to improve the therapeutic effect for mCRPC.
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 mCRPC.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Metformin+ADT+abiraterone | Experimental | Drug: MetforminPatients in this arm will be treatet with metformin plus ADT and abiraterone |
| ADT+abiraterone | No intervention | –Patients in this arm will be treatet with ADT and abiraterone, Abiraterone 1000mg once daily until disease progression. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 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).
- Patients must meet the criteria of CRPC.
- No prior treatment with chemotherapy and new-generation hormonal therapy including abiraterone, enzalutamide, apalutamide.
- Patient must give written informed consent before registration and prior to any trial related investigations.
Key exclusion criteria (26 listed)
- 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.
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MetforminAlso: Metformin Hydrochloride Sustained Release TabletsThe 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. | Drug | Metformin+ADT+abiraterone |
Primary outcome
Progression-free survival defined from randomization to time till biochemical progression or radiographic progression
Time frame: start of treatment to disease progression, up to 36 months
3 secondary outcomes
Overall survival defined from randomization until death due to any reason
Time frame: start of treatment to death, up to 36 months
Radiographic progression-free survival defined from randomization until radiographic progression
Time frame: start of treatment to radiographic progression, up to 36 months
Adverse events which will be assessed according to NCI-CTC AE 5.0
Time frame: start of treatment to study completion, up to 36 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jun 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yonghong Li, M.D. principal investigator
Sun Yat-sen University
1 site in 1 country: see every site and its status.
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 12 inclusion and 26 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: status not confirmed, as of the sponsor's last update on 14 Jun 2021. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yonghong Li, M.D. (86-13711376697, liyongh@sysucc.org.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression-free survival defined from randomization to time till biochemical progression or radiographic progression (time frame: start of treatment to disease progression, up to 36 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 14 Jun 2021.