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

Metastatic Castration Resistant Prostate Cancer Clinical Trial

Official title:

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04056754
• Other study ID #: CTTQL-ABTL
• Status: Completed
• Phase: Phase 3
• Start date: July 16, 2014
• Est. completion date: July 16, 2019

Study information

• Verified date: April 2016
• Source: Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 268
• Est. completion date: July 16, 2019
• Est. primary completion date: March 14, 2018
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Metastatic Castration Resistant Prostate Cancer
• Prostatic Neoplasms

Intervention

Drug:
• Abiraterone Acetate
Subjects administered 4 tablets abiraterone acetate twice daily in 28-day cycle.
• Placebo
Subjects administered 4 tablets abiraterone acetate blank analog tablet twice daily in 28-day cycle.
• Prednisone
Subjects administered 5mg prednisone twice daily in 28-day cycle.

Locations

Country	Name	City	State
China	Peking Union Medical College Hospital	Beijing	Beijing
China	Peking University First Hospital	Beijing	Beijing
China	West China Hospital,Sichuan University	Chengdu	Sichuan
China	Chongqing Cancer Hospital	Chongqing	Chongqing
China	Sun-Yat-Sen University Cancer Center	Guangzhou	Guangdong
China	Harbin Medical University Cancer Hospital	Ha'erbin	Heilongjiang
China	The Second Affiliated Hospital of Zhenjiang University School of Medicine	Hangzhou	Zhejiang
China	Qilu Hospital of Shandong University	Jinan	Shandong
China	Jiangsu Province Hospital	Nanjing	Jiangsu
China	The First Affiliated Hospital of Guangxi Medical University	Nanning	Guangxi
China	Fudan University Medical College Affiliated Huadong Hospital	Shanghai	Shanghai
China	Fudan University Shanghai Cancer Center	Shanghai	Shanghai
China	RenJi Hospital of Shanghai Jiaotong University School of Medicine	Shanghai	Shanghai
China	Guangzhou Military Region Wuhan General Hospital	Wuhan	Hubei
China	TongJi medical college of HuaZhong University of Science & Technology Affiliated TongJi Hospital	Wuhan	Hubei
China	Henan Cancer Hospital	Zhengzhou	Henan

Sponsors (1)

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

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Prostate specific antigen remission time	It was =50% lower than the baseline, and was confirmed as remission after re-testing after =4 weeks.	Baseline up to 24 months
Secondary	Objective Response Rate (ORR)	The percentage of participants with a best overall response defined as complete response (CR) or partial response (PR).	Baseline up to 24 months
Secondary	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.	Baseline up to 24 months
Secondary	Overall Survival (OS)	Time from date of randomization to date of death due to any cause.	Baseline up to 24 months
Secondary	To pain progression time	Time from the start of medication to the progression of pain.	Baseline up to 24 months
Secondary	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).	Baseline up to 24 months
Secondary	Prostate specific antigen remission rate	The remission rate was defined as the proportion of remissions to the total number of people.	Baseline up to 24 months