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

A Randomised, Double-Blind, Multicentre Phase Ⅲ Study to Evaluate Abiraterone Acetate Versus Placebo Combined With Prednisone in Subjects With Asymptomatic or Mild Symptoms Without Chemotherapy, Metastatic Castration Resistant Prostate Cancer.

Sponsors

Lead Sponsor: Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

Source 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.

Overall Status Completed
Start Date July 16, 2014
Completion Date July 16, 2019
Primary Completion Date March 14, 2018
Phase Phase 3
Study Type Interventional
Primary Outcome
Measure Time Frame
Time to PSA progression (TTPP) Baseline up to 24 months
Secondary Outcome
Measure Time Frame
Prostate specific antigen remission time Baseline up to 24 months
Objective Response Rate (ORR) Baseline up to 24 months
Eastern Cooperative Oncology Group (ECOG) Baseline up to 24 months
Overall Survival (OS) Baseline up to 24 months
To pain progression time Baseline up to 24 months
Quality of life assessment scale (FACT-P) Baseline up to 24 months
Prostate specific antigen remission rate Baseline up to 24 months
Enrollment 268
Condition
Intervention

Intervention Type: Drug

Intervention Name: Abiraterone Acetate

Description: Subjects administered 4 tablets abiraterone acetate twice daily in 28-day cycle.

Arm Group Label: Abiraterone acetate group

Intervention Type: Drug

Intervention Name: Placebo

Description: Subjects administered 4 tablets abiraterone acetate blank analog tablet twice daily in 28-day cycle.

Arm Group Label: Placebo group

Intervention Type: Drug

Intervention Name: Prednisone

Description: Subjects administered 5mg prednisone twice daily in 28-day cycle.

Eligibility

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.

Gender: Male

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: No

Location
Facility:
Peking Union Medical College Hospital | Beijing, Beijing, 100000, China
Peking University First Hospital | Beijing, Beijing, 100000, China
Chongqing Cancer Hospital | Chongqing, Chongqing, 400000, China
Sun-Yat-Sen University Cancer Center | Guangzhou, Guangdong, 510000, China
The First Affiliated Hospital of Guangxi Medical University | Nanning, Guangxi, 530000, China
Harbin Medical University Cancer Hospital | Ha'erbin, Heilongjiang, 150000, China
Henan Cancer Hospital | Zhengzhou, Henan, 450000, China
Guangzhou Military Region Wuhan General Hospital | Wuhan, Hubei, 430000, China
TongJi medical college of HuaZhong University of Science & Technology Affiliated TongJi Hospital | Wuhan, Hubei, 430000, China
Jiangsu Province Hospital | Nanjing, Jiangsu, 210000, China
Qilu Hospital of Shandong University | Jinan, Shandong, 250000, China
Fudan University Medical College Affiliated Huadong Hospital | Shanghai, Shanghai, 200000, China
Fudan University Shanghai Cancer Center | Shanghai, Shanghai, 200000, China
RenJi Hospital of Shanghai Jiaotong University School of Medicine | Shanghai, Shanghai, 200000, China
West China Hospital,Sichuan University | Chengdu, Sichuan, 610000, China
The Second Affiliated Hospital of Zhenjiang University School of Medicine | Hangzhou, Zhejiang, 310000, China
Location Countries

China

Verification Date

April 2016

Responsible Party

Type: Sponsor

Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Label: Abiraterone acetate group

Type: Experimental

Description: Subjects in this group administered 4 tablets abiraterone acetate once daily and 5mg prednisone twice daily, in 28-day cycle on fasting conditions.

Label: Placebo group

Type: Placebo Comparator

Description: 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.

Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

Primary Purpose: Treatment

Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Source: ClinicalTrials.gov