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

• Status: Completed
• Trial end date: 2019-07-16
• Target enrollment: 0
• Participant gender: Male

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
• Treatments: Abiraterone Acetate; Prednisone

Criteria

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:

1. Prostate pathology results are neuroendocrine prostate cancer.

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.