Study of Abiraterone Acetate in Subjects With Metastatic Castration Resistant Prostate Cancer
- Conditions
- Metastatic Castration Resistant Prostate Cancer
- Interventions
- Registration Number
- NCT04056754
- Lead Sponsor
- Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 268
- 1.18 years and older, Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1, Life expectancy ≥ 6 months.
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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.
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Has not used opioid analgesics and azole drugs within 4 weeks before the first dose.
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Question 3 of the Concise Pain Questionnaire (BPI-SF) scored from 0-3 points.
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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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Abiraterone acetate group Abiraterone Acetate Subjects in this group administered 4 tablets abiraterone acetate once daily and 5mg prednisone twice daily, in 28-day cycle on fasting conditions. Placebo group Placebo 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. Abiraterone acetate group Prednisone Subjects in this group administered 4 tablets abiraterone acetate once daily and 5mg prednisone twice daily, in 28-day cycle on fasting conditions. Placebo group 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.
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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.
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.
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.
Overall Survival (OS) Baseline up to 24 months Time from date of randomization to date of death due to any cause.
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).
To pain progression time Baseline up to 24 months Time from the start of medication to the progression of pain.
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).
Trial Locations
- Locations (16)
TongJi medical college of HuaZhong University of Science & Technology Affiliated TongJi Hospital
🇨🇳Wuhan, Hubei, China
Jiangsu Province Hospital
🇨🇳Nanjing, Jiangsu, China
The First Affiliated Hospital of Guangxi Medical University
🇨🇳Nanning, Guangxi, China
Qilu Hospital of Shandong University
🇨🇳Jinan, Shandong, China
Peking Union Medical College Hospital
🇨🇳Beijing, Beijing, China
RenJi Hospital of Shanghai Jiaotong University School of Medicine
🇨🇳Shanghai, Shanghai, China
West China Hospital，Sichuan University
🇨🇳Chengdu, Sichuan, China
The Second Affiliated Hospital of Zhenjiang University School of Medicine
🇨🇳Hangzhou, Zhejiang, China
Peking University First Hospital
🇨🇳Beijing, Beijing, China
Sun-Yat-Sen University Cancer Center
🇨🇳Guangzhou, Guangdong, China
Henan Cancer Hospital
🇨🇳Zhengzhou, Henan, China
Chongqing Cancer Hospital
🇨🇳Chongqing, Chongqing, China
Harbin Medical University Cancer Hospital
🇨🇳Ha'erbin, Heilongjiang, China
Guangzhou Military Region Wuhan General Hospital
🇨🇳Wuhan, Hubei, China
Fudan University Shanghai Cancer Center
🇨🇳Shanghai, Shanghai, China
Fudan University Medical College Affiliated Huadong Hospital
🇨🇳Shanghai, Shanghai, China