Status:
COMPLETED
Study of Abiraterone Acetate in Subjects With Metastatic Castration Resistant Prostate Cancer
Lead Sponsor:
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Conditions:
Metastatic Castration Resistant Prostate Cancer
Eligibility:
MALE
18+ years
Phase:
PHASE3
Brief 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 s...
Eligibility Criteria
Inclusion
- \- 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
- Prostate pathology results are neuroendocrine prostate cancer.
- Has received cytotoxic chemotherapy or biological therapy for metastatic castration resistant prostate cancer.
- Has contraindications to the use of prednisone.
- A chronic disease that exceeds the prednisone dose in the study.
- Uncontrolled high blood pressure.
- Active or symptomatic viral hepatitis or other chronic liver disease.
- Visceral metastasis or brain metastasis.
- Pituitary or adrenal dysfunction.
- Active autoimmune diseases require the use of hormone therapy.
- Clinically significant heart disease.
- Participated in other clinical trials within 4 weeks.
Key Trial Info
Start Date :
July 16 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 16 2019
Estimated Enrollment :
268 Patients enrolled
Trial Details
Trial ID
NCT04056754
Start Date
July 16 2014
End Date
July 16 2019
Last Update
August 14 2019
Active Locations (16)
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1
Peking Union Medical College Hospital
Beijing, Beijing Municipality, China, 100000
2
Peking University First Hospital
Beijing, Beijing Municipality, China, 100000
3
Chongqing Cancer Hospital
Chongqing, Chongqing Municipality, China, 400000
4
Sun-Yat-Sen University Cancer Center
Guangzhou, Guangdong, China, 510000