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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
268
Subjects administered 4 tablets abiraterone acetate twice daily in 28-day cycle.
Subjects administered 4 tablets abiraterone acetate blank analog tablet twice daily in 28-day cycle.
Subjects administered 5mg prednisone twice daily in 28-day cycle.
Peking Union Medical College Hospital
Beijing, Beijing Municipality, China
Peking University First Hospital
Beijing, Beijing Municipality, China
Time to PSA progression (TTPP)
The time interval between the administration of the drug and the progression of serum prostate specific antigen (PSA).
Time frame: Baseline up to 24 months
Prostate specific antigen remission time
It was ≥50% lower than the baseline, and was confirmed as remission after re-testing after ≥4 weeks.
Time frame: Baseline up to 24 months
Objective Response Rate (ORR)
The percentage of participants with a best overall response defined as complete response (CR) or partial response (PR).
Time frame: Baseline up to 24 months
Eastern Cooperative Oncology Group (ECOG)
The ECOG scoring standard is an indicator of the general health status and tolerance to treatment from the patient's physical strength. ECOG physical status score standard from 0 to 5. Starting with the dose until the score increases from the baseline.
Time frame: Baseline up to 24 months
Overall Survival (OS)
Time from date of randomization to date of death due to any cause.
Time frame: Baseline up to 24 months
To pain progression time
Time from the start of medication to the progression of pain.
Time frame: Baseline up to 24 months
Quality of life assessment scale (FACT-P)
Functional Assessment of Cancer Therapy- Prostate Cancer (FACT-P) total score, Functional Assessment of Cancer Therapy- General (FACT-G) total score, trial outcome index, functional well-being, physical well-being, prostate cancer subscale, and Functional Assessment of Cancer Therapy (FACT) Advanced Prostate Symptom Index-6 (FAPSI-6).
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Chongqing Cancer Hospital
Chongqing, Chongqing Municipality, China
Sun-Yat-Sen University Cancer Center
Guangzhou, Guangdong, China
The First Affiliated Hospital of Guangxi Medical University
Nanning, Guangxi, China
Harbin Medical University Cancer Hospital
Harbin, Heilongjiang, China
Henan Cancer Hospital
Zhengzhou, Henan, China
Guangzhou Military Region Wuhan General Hospital
Wuhan, Hubei, China
TongJi medical college of HuaZhong University of Science & Technology Affiliated TongJi Hospital
Wuhan, Hubei, China
Jiangsu Province Hospital
Nanjing, Jiangsu, China
...and 6 more locations
Time frame: Baseline up to 24 months
Prostate specific antigen remission rate
The remission rate was defined as the proportion of remissions to the total number of people.
Time frame: Baseline up to 24 months