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

Primary Purpose

Metastatic Castration Resistant Prostate Cancer

Status
Completed
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
Abiraterone Acetate
Placebo
Prednisone
Sponsored by
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Metastatic Castration Resistant Prostate Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

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.

Sites / Locations

  • Peking Union Medical College Hospital
  • Peking University First Hospital
  • Chongqing Cancer Hospital
  • Sun-Yat-Sen University Cancer Center
  • The First Affiliated Hospital of Guangxi Medical University
  • Harbin Medical University Cancer Hospital
  • Henan Cancer Hospital
  • Guangzhou Military Region Wuhan General Hospital
  • TongJi medical college of HuaZhong University of Science & Technology Affiliated TongJi Hospital
  • Jiangsu Province Hospital
  • Qilu Hospital of Shandong University
  • Fudan University Medical College Affiliated Huadong Hospital
  • Fudan University Shanghai Cancer Center
  • RenJi Hospital of Shanghai Jiaotong University School of Medicine
  • West China Hospital，Sichuan University
  • The Second Affiliated Hospital of Zhenjiang University School of Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Abiraterone acetate group

Placebo group

Arm Description

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

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.

Outcomes

Primary Outcome Measures

Time to PSA progression (TTPP）
The time interval between the administration of the drug and the progression of serum prostate specific antigen (PSA).

Secondary Outcome Measures

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

Full Information

First Posted
August 11, 2019
Last Updated
August 13, 2019
Sponsor
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT04056754
Brief Title
Study of Abiraterone Acetate in Subjects With Metastatic Castration Resistant Prostate Cancer
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.
Study Type
Interventional

2. Study Status

Record Verification Date
April 2016
Overall Recruitment Status
Completed
Study Start Date
July 16, 2014 (Actual)
Primary Completion Date
March 14, 2018 (Actual)
Study Completion Date
July 16, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metastatic Castration Resistant Prostate Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
268 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Abiraterone acetate group
Arm Type
Experimental
Arm Description
Subjects in this group administered 4 tablets abiraterone acetate once daily and 5mg prednisone twice daily, in 28-day cycle on fasting conditions.
Arm Title
Placebo group
Arm Type
Placebo Comparator
Arm 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.
Intervention Type
Drug
Intervention Name(s)
Abiraterone Acetate
Intervention Description
Subjects administered 4 tablets abiraterone acetate twice daily in 28-day cycle.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Subjects administered 4 tablets abiraterone acetate blank analog tablet twice daily in 28-day cycle.
Intervention Type
Drug
Intervention Name(s)
Prednisone
Intervention Description
Subjects administered 5mg prednisone twice daily in 28-day cycle.
Primary Outcome Measure Information:
Title
Time to PSA progression (TTPP）
Description
The time interval between the administration of the drug and the progression of serum prostate specific antigen (PSA).
Time Frame
Baseline up to 24 months
Secondary Outcome Measure Information:
Title
Prostate specific antigen remission time
Description
It was ≥50% lower than the baseline, and was confirmed as remission after re-testing after ≥4 weeks.
Time Frame
Baseline up to 24 months
Title
Objective Response Rate (ORR)
Description
The percentage of participants with a best overall response defined as complete response (CR) or partial response (PR).
Time Frame
Baseline up to 24 months
Title
Eastern Cooperative Oncology Group (ECOG)
Description
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.
Time Frame
Baseline up to 24 months
Title
Overall Survival (OS)
Description
Time from date of randomization to date of death due to any cause.
Time Frame
Baseline up to 24 months
Title
To pain progression time
Description
Time from the start of medication to the progression of pain.
Time Frame
Baseline up to 24 months
Title
Quality of life assessment scale (FACT-P)
Description
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).
Time Frame
Baseline up to 24 months
Title
Prostate specific antigen remission rate
Description
The remission rate was defined as the proportion of remissions to the total number of people.
Time Frame
Baseline up to 24 months

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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: 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.
Facility Information:
Facility Name
Peking Union Medical College Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100000
Country
China
Facility Name
Peking University First Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100000
Country
China
Facility Name
Chongqing Cancer Hospital
City
Chongqing
State/Province
Chongqing
ZIP/Postal Code
400000
Country
China
Facility Name
Sun-Yat-Sen University Cancer Center
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510000
Country
China
Facility Name
The First Affiliated Hospital of Guangxi Medical University
City
Nanning
State/Province
Guangxi
ZIP/Postal Code
530000
Country
China
Facility Name
Harbin Medical University Cancer Hospital
City
Ha'erbin
State/Province
Heilongjiang
ZIP/Postal Code
150000
Country
China
Facility Name
Henan Cancer Hospital
City
Zhengzhou
State/Province
Henan
ZIP/Postal Code
450000
Country
China
Facility Name
Guangzhou Military Region Wuhan General Hospital
City
Wuhan
State/Province
Hubei
ZIP/Postal Code
430000
Country
China
Facility Name
TongJi medical college of HuaZhong University of Science & Technology Affiliated TongJi Hospital
City
Wuhan
State/Province
Hubei
ZIP/Postal Code
430000
Country
China
Facility Name
Jiangsu Province Hospital
City
Nanjing
State/Province
Jiangsu
ZIP/Postal Code
210000
Country
China
Facility Name
Qilu Hospital of Shandong University
City
Jinan
State/Province
Shandong
ZIP/Postal Code
250000
Country
China
Facility Name
Fudan University Medical College Affiliated Huadong Hospital
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200000
Country
China
Facility Name
Fudan University Shanghai Cancer Center
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200000
Country
China
Facility Name
RenJi Hospital of Shanghai Jiaotong University School of Medicine
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200000
Country
China
Facility Name
West China Hospital，Sichuan University
City
Chengdu
State/Province
Sichuan
ZIP/Postal Code
610000
Country
China
Facility Name
The Second Affiliated Hospital of Zhenjiang University School of Medicine
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310000
Country
China

12. IPD Sharing Statement

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

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