NCT04056754

Study of Abiraterone Acetate in Subjects With Metastatic Castration Resistant Prostate Cancer

A Randomised, Double-Blind, Multicentre Phase Ⅲ Study to Evaluate Abiraterone Acetate Versus Placebo Combined With Prednisone in Subjects With Asymptomatic or Mild Symptoms Without Chemotherapy, Metastatic Castration Resistant Prostate Cancer.

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 268 (actual)
• Sponsor: Chia Tai Tianqing Pharmaceutical Group Co., Ltd. · Industry
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Abiraterone acetate is an orally effective CYP17 inhibitor, which is metabolized into abiraterone in the body, and its inhibitory activity against CYP17 is 10-30 times that of ketoconazole. Clinical studies have shown that abiraterone acetate can significantly reduce the level of prostate specific antigen (PSA) in PCa patients, and help to reduce tumors, extending the lifespan of patients with advanced PCa for several years, and the toxicity is acceptable.

Conditions

• Metastatic Castration Resistant Prostate Cancer

Interventions

Type	Name	Description
DRUG	Abiraterone Acetate	Subjects administered 4 tablets abiraterone acetate twice daily in 28-day cycle.
DRUG	Placebo	Subjects administered 4 tablets abiraterone acetate blank analog tablet twice daily in 28-day cycle.
DRUG	Prednisone	Subjects administered 5mg prednisone twice daily in 28-day cycle.

Timeline

• Start date: 2014-07-16
• Primary completion: 2018-03-14
• Completion: 2019-07-16
• First posted: 2019-08-14
• Last updated: 2019-08-14

Locations

16 sites across 1 country: China