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NOT YET RECRUITING
NCT04925063
PHASE2

The Effect of Metformin in Patients With Newly Diagnosed mHSPC

Sponsor: Sun Yat-sen University

View on ClinicalTrials.gov

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.

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

Key Details

Gender

MALE

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

266

Start Date

2021-06-16

Completion Date

2027-08-31

Last Updated

2021-06-14

Healthy Volunteers

No

Interventions

DRUG

Metformin

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.

Locations (1)

Sun Yat-Sen University Cancer Center

Guangzhou, Guangdong, China