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.
1 other identifier
interventional
268
1 country
16
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Jul 2014
Longer than P75 for phase_3
16 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 16, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 14, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
July 16, 2019
CompletedFirst Submitted
Initial submission to the registry
August 11, 2019
CompletedFirst Posted
Study publicly available on registry
August 14, 2019
CompletedAugust 14, 2019
April 1, 2016
3.7 years
August 11, 2019
August 13, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
Time to PSA progression (TTPP）
The time interval between the administration of the drug and the progression of serum prostate specific antigen (PSA).
Baseline up to 24 months
Secondary Outcomes (7)
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
- +2 more secondary outcomes
Study Arms (2)
Abiraterone acetate group
EXPERIMENTALSubjects 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 COMPARATORSubjects 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.
Interventions
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.
Eligibility Criteria
You may qualify if:
- \- 1.18 years and older, Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1, Life expectancy ≥ 6 months.
- \. 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.
- \. Has not used opioid analgesics and azole drugs within 4 weeks before the first dose.
- \. Question 3 of the Concise Pain Questionnaire (BPI-SF) scored from 0-3 points.
- \. 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 qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (16)
Peking Union Medical College Hospital
Beijing, Beijing Municipality, 100000, China
Peking University First Hospital
Beijing, Beijing Municipality, 100000, China
Chongqing Cancer Hospital
Chongqing, Chongqing Municipality, 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
Harbin, 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 Municipality, 200000, China
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, 200000, China
RenJi Hospital of Shanghai Jiaotong University School of Medicine
Shanghai, Shanghai Municipality, 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
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 11, 2019
First Posted
August 14, 2019
Study Start
July 16, 2014
Primary Completion
March 14, 2018
Study Completion
July 16, 2019
Last Updated
August 14, 2019
Record last verified: 2016-04