Study of Abiraterone Acetate in Subjects With Metastatic Castration Resistant Prostate Cancer
NCT ID: NCT04056754
Last Updated: 2019-08-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
268 participants
INTERVENTIONAL
2014-07-16
2019-07-16
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Abiraterone acetate group
Subjects in this group administered 4 tablets abiraterone acetate once daily and 5mg prednisone twice daily, in 28-day cycle on fasting conditions.
Abiraterone Acetate
Subjects administered 4 tablets abiraterone acetate twice daily in 28-day cycle.
Prednisone
Subjects administered 5mg prednisone twice daily in 28-day cycle.
Placebo group
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.
Placebo
Subjects administered 4 tablets abiraterone acetate blank analog tablet twice daily in 28-day cycle.
Prednisone
Subjects administered 5mg prednisone twice daily in 28-day cycle.
Interventions
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Abiraterone Acetate
Subjects administered 4 tablets abiraterone acetate twice daily in 28-day cycle.
Placebo
Subjects administered 4 tablets abiraterone acetate blank analog tablet twice daily in 28-day cycle.
Prednisone
Subjects administered 5mg prednisone twice daily in 28-day cycle.
Eligibility Criteria
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Inclusion Criteria
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
2. Has received cytotoxic chemotherapy or biological therapy for metastatic castration resistant prostate cancer.
3. Has contraindications to the use of prednisone.
4. A chronic disease that exceeds the prednisone dose in the study.
5. Uncontrolled high blood pressure.
6. Active or symptomatic viral hepatitis or other chronic liver disease.
7. Visceral metastasis or brain metastasis.
8. Pituitary or adrenal dysfunction.
9. Active autoimmune diseases require the use of hormone therapy.
10. Clinically significant heart disease.
11. Participated in other clinical trials within 4 weeks.
18 Years
MALE
No
Sponsors
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Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
INDUSTRY
Responsible Party
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Locations
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Peking Union Medical College Hospital
Beijing, Beijing Municipality, China
Peking University First Hospital
Beijing, Beijing Municipality, China
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
Qilu Hospital of Shandong University
Jinan, Shandong, China
Fudan University Medical College Affiliated Huadong Hospital
Shanghai, Shanghai Municipality, China
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, China
RenJi Hospital of Shanghai Jiaotong University School of Medicine
Shanghai, Shanghai Municipality, China
West China Hospital，Sichuan University
Chengdu, Sichuan, China
The Second Affiliated Hospital of Zhenjiang University School of Medicine
Hangzhou, Zhejiang, China
Countries
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Other Identifiers
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CTTQL-ABTL
Identifier Type: -
Identifier Source: org_study_id
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