Metastatic Castration Resistant Prostate Cancer
Conditions
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 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.
Interventions
DRUGAbiraterone Acetate
Subjects administered 4 tablets abiraterone acetate twice daily in 28-day cycle.
DRUGPlacebo
Subjects administered 4 tablets abiraterone acetate blank analog tablet twice daily in 28-day cycle.
DRUGPrednisone
Subjects administered 5mg prednisone twice daily in 28-day cycle.
Sponsors
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time to PSA progression (TTPP） | Baseline up to 24 months | The time interval between the administration of the drug and the progression of serum prostate specific antigen (PSA). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Objective Response Rate (ORR) | Baseline up to 24 months | The percentage of participants with a best overall response defined as complete response (CR) or partial response (PR). |
| Eastern Cooperative Oncology Group (ECOG) | Baseline up to 24 months | 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. |
| Overall Survival (OS) | Baseline up to 24 months | Time from date of randomization to date of death due to any cause. |
| Prostate specific antigen remission time | Baseline up to 24 months | It was ≥50% lower than the baseline, and was confirmed as remission after re-testing after ≥4 weeks. |
| Quality of life assessment scale (FACT-P) | Baseline up to 24 months | 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). |
| Prostate specific antigen remission rate | Baseline up to 24 months | The remission rate was defined as the proportion of remissions to the total number of people. |
| To pain progression time | Baseline up to 24 months | Time from the start of medication to the progression of pain. |
Countries
China
Outcome results
None listed