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.

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.

Study Overview

• Status: Completed
• Conditions: Metastatic Castration Resistant Prostate Cancer
• Intervention / Treatment: Drug: Abiraterone Acetate; Drug: Prednisone; Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 268
• Phase: Phase 3

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Abiraterone acetate group; 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; Subjects administered 4 tablets abiraterone acetate twice daily in 28-day cycle.; Drug: Prednisone; Subjects administered 5mg prednisone twice daily in 28-day cycle.
Placebo Comparator: Placebo group; 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: Prednisone; Subjects administered 5mg prednisone twice daily in 28-day cycle.; Drug: Placebo; Subjects administered 4 tablets abiraterone acetate blank analog tablet twice daily in 28-day cycle.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
Overall Survival (OS)	Time from date of randomization to date of death due to any cause.	Baseline up to 24 months
To pain progression time	Time from the start of medication to the progression of pain.	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).	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.	Baseline up to 24 months

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): July 16, 2014
• Primary Completion (Actual): March 14, 2018
• Study Completion (Actual): July 16, 2019

Study Registration Dates

• First Submitted: August 11, 2019
• First Submitted That Met QC Criteria: August 13, 2019
• First Posted (Actual): August 14, 2019

Study Record Updates

• Last Update Posted (Actual): August 14, 2019
• Last Update Submitted That Met QC Criteria: August 13, 2019
• Last Verified: April 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Genital Neoplasms, Male; Prostatic Diseases; Prostatic Neoplasms; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Anti-Inflammatory Agents; Antineoplastic Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Antineoplastic Agents, Hormonal; Cytochrome P-450 Enzyme Inhibitors; Hormone Antagonists; Steroid Synthesis Inhibitors; Prednisone; Abiraterone Acetate
• Other Study ID Numbers: CTTQL-ABTL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No