Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Age
18–any
Sex
MALE
Healthy volunteers
Not accepted
You may be eligible if
\- 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.
You may not be if
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.