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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Abiraterone acetate group | Experimental | Subjects in this group administered 4 tablets abiraterone acetate once daily and 5mg prednisone twice daily, in 28-day cycle on fasting conditions. |
|
| Placebo group | Placebo Comparator | Subjects in this group administered 4 tablets abiraterone acetate blank analog tablet once daily and 5mg prednisone twice daily, in 28-day cycle on fasting conditions. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Abiraterone Acetate | Drug | Subjects administered 4 tablets abiraterone acetate twice daily in 28-day cycle. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Time to PSA progression (TTPP) | The time interval between the administration of the drug and the progression of serum prostate specific antigen (PSA). | Baseline up to 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| Prostate specific antigen remission time | It was ≥50% lower than the baseline, and was confirmed as remission after re-testing after ≥4 weeks. | Baseline up to 24 months |
| Objective Response Rate (ORR) |
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Inclusion Criteria:
- 1.18 years and older, Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1, Life expectancy ≥ 6 months.
2. Prostate cancer. 3. Serum testosterone <50 ng/dL (or 1.7 nmol/L). 4. Prostate cancer progression or lesion metastasis. 5. Restriction of antiandrogen therapy. 6. Restriction of Radiation therapy. 7. The treatment period of ketoconazole for prostate cancer was not exceed 7 days.
8. Has not used opioid analgesics and azole drugs within 4 weeks before the first dose.
9. Question 3 of the Concise Pain Questionnaire (BPI-SF) scored from 0-3 points.
10. Adequate laboratory indicators. 11. Must be able to swallow tablets. 12. No pregnant or breastfeeding women, and a negative pregnancy test. 13. Understood and signed an informed consent form.
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peking Union Medical College Hospital | Beijing | Beijing Municipality | 100000 | China | ||
| Peking University First Hospital |
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| Placebo | Drug | Subjects administered 4 tablets abiraterone acetate blank analog tablet twice daily in 28-day cycle. |
|
| Prednisone | Drug | Subjects administered 5mg prednisone twice daily in 28-day cycle. |
|
The percentage of participants with a best overall response defined as complete response (CR) or partial response (PR).
| 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. | Baseline up to 24 months |
| Overall Survival (OS) | Time from date of randomization to date of death due to any cause. | Baseline up to 24 months |
| To pain progression time | Time from the start of medication to the progression of pain. | 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). | 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. | Baseline up to 24 months |
| Beijing |
| Beijing Municipality |
| 100000 |
| China |
| Chongqing Cancer Hospital | Chongqing | Chongqing Municipality | 400000 | China |
| Sun-Yat-Sen University Cancer Center | Guangzhou | Guangdong | 510000 | China |
| The First Affiliated Hospital of Guangxi Medical University | Nanning | Guangxi | 530000 | China |
| Harbin Medical University Cancer Hospital | Harbin | Heilongjiang | 150000 | China |
| Henan Cancer Hospital | Zhengzhou | Henan | 450000 | China |
| Guangzhou Military Region Wuhan General Hospital | Wuhan | Hubei | 430000 | China |
| TongJi medical college of HuaZhong University of Science & Technology Affiliated TongJi Hospital | Wuhan | Hubei | 430000 | China |
| Jiangsu Province Hospital | Nanjing | Jiangsu | 210000 | China |
| Qilu Hospital of Shandong University | Jinan | Shandong | 250000 | China |
| Fudan University Medical College Affiliated Huadong Hospital | Shanghai | Shanghai Municipality | 200000 | China |
| Fudan University Shanghai Cancer Center | Shanghai | Shanghai Municipality | 200000 | China |
| RenJi Hospital of Shanghai Jiaotong University School of Medicine | Shanghai | Shanghai Municipality | 200000 | China |
| West China Hospital,Sichuan University | Chengdu | Sichuan | 610000 | China |
| The Second Affiliated Hospital of Zhenjiang University School of Medicine | Hangzhou | Zhejiang | 310000 | China |
| ID | Term |
|---|---|
| D000069501 | Abiraterone Acetate |
| D011241 | Prednisone |
| ID | Term |
|---|---|
| D000736 | Androstenes |
| D000731 | Androstanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D011244 | Pregnadienediols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
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