The Effect of Metformin in Patients With Newly Diagnosed mHSPC

NCT04925063 | Not Yet Recruiting Phase 2 DMC

• 1 other identifier: 2021-FXY-078
• Study Type: interventional
• Target: 266
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Metastatic Prostate Cancer

Keywords

metastatic hormone sensitive prostate cancer; abiraterone; metformin

Outcome Measures

Primary Outcomes (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.

  5 years

Secondary Outcomes (3)

• Overall Survival

  5 years

• Radiographic progression-free survival

  5 years

• Safety

  5 years

Study Arms (2)

Metformin+ADT+abiraterone

EXPERIMENTAL

Drug: 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

Drug: Metformin

ADT+abiraterone

NO INTERVENTION

Drug: Abiraterone Abiraterone 1000mg once daily until disease progression

Interventions

Metformin DRUG

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.

Also known as: Metformin Hydrochloride Sustained Release Tablets

Metformin+ADT+abiraterone

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sun Yat-sen University: lead

Study Sites (1)

Sun Yat-Sen University Cancer Center

Guangzhou, Guangdong, 510060, China

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Metformin

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Biguanides; Guanidines; Amidines; Organic Chemicals

Central Study Contacts

Yonghong Li, M.D.

CONTACT

86-13711376697; liyongh@sysucc.org.cn

Zhenyu Yang, M.D.

CONTACT

86-13902290670; yangzy@sysucc.org.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prinicipal Investigator

Study Record Dates

• First Submitted: June 8, 2021
• First Posted: June 14, 2021
• Study Start: June 16, 2021
• Primary Completion (Estimated): April 30, 2027
• Study Completion (Estimated): August 31, 2027
• Last Updated: June 14, 2021

Record last verified: 2021-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)