A Phase 3 interventional study of Abiraterone Acetate and Placebo in Metastatic Castration Resistant Prostate Cancer, sponsored by Chia Tai Tianqing Pharmaceutical Group Co., Ltd.. Completed at 16 sites in China. Open to male participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-08-14.
Sponsored by Chia Tai Tianqing Pharmaceutical Group Co., Ltd. (part of Sino Biopharmaceutical Limited) · Phase 3, Interventional, and Treatment
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.
Chia Tai Tianqing Pharmaceutical Group Co., Ltd. is the lead sponsor of 320 studies on the registry; 76 are open to participants now.
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- 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:
Subjects in this group administered 4 tablets abiraterone acetate once daily and 5mg prednisone twice daily, in 28-day cycle on fasting conditions.
Drug: Abiraterone Acetate · Drug: Prednisone
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.
Drug: Placebo · Drug: Prednisone
Subjects administered 4 tablets abiraterone acetate twice daily in 28-day cycle.
Subjects administered 4 tablets abiraterone acetate blank analog tablet twice daily in 28-day cycle.
Subjects administered 5mg prednisone twice daily in 28-day cycle.
Time to PSA progression (TTPP）
The time interval between the administration of the drug and the progression of serum prostate specific antigen (PSA).
Time frame: Baseline up to 24 months
Prostate specific antigen remission time
It was ≥50% lower than the baseline, and was confirmed as remission after re-testing after ≥4 weeks.
Time frame: Baseline up to 24 months
Objective Response Rate (ORR)
The percentage of participants with a best overall response defined as complete response (CR) or partial response (PR).
Time frame: Baseline up to 24 months
Eastern Cooperative Oncology Group (ECOG)
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.
Time frame: Baseline up to 24 months
Overall Survival (OS)
Time from date of randomization to date of death due to any cause.
Time frame: Baseline up to 24 months
To pain progression time
Time from the start of medication to the progression of pain.
Time frame: Baseline up to 24 months
Quality of life assessment scale (FACT-P)
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).
Time frame: Baseline up to 24 months
Prostate specific antigen remission rate
The remission rate was defined as the proportion of remissions to the total number of people.
Time frame: Baseline up to 24 months
This study is completed, as verified in Apr 2016. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Abiraterone Acetate
Chia Tai Tianqing Pharmaceutical Group Co., Ltd. →