The purpose of this study is to demonstrate the safety and effectiveness of abiraterone acetate when co-administered with prednisone in patients with chemo-naive metastatic castration resistant prostate Cancer (mCRPC).
This is a multinational, multicenter, randomized (the study drug is assigned by chance), double-blind (neither physician nor patient knows the treatment that the patient receives), placebo-controlled (an inactive substance that is compared with a drug to test whether the drug has a real effect in a clinical trial) study. All patients will be randomly assigned in a 1:1 ratio between the abiraterone acetate group (abiraterone acetate and prednisone) and the placebo group (placebo and prednisone). The study will consist of a screening phase (within 28 days prior randomization on Cycle 1, Day 1), a treatment phase (28-day cycles until disease progression), and a follow-up phase (all patients will be contacted for every 3 months up to Month 60, focusing primarily on survival status). Patients will receive either abiraterone acetate 1,000 mg daily and prednisone 5 mg twice daily or placebo and prednisone 5 mg twice daily.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
313
Placebo: Form=tablet, route=oral. Four tablets daily on an empty stomach. Prednisone: Type=exact number, unit=mg, number=5, form=tablet, route=oral, twice daily.
Abiraterone acetate: Type=exact number, unit=mg, number=250, form=tablet, route=oral. Four tablets daily on an empty stomach Prednisone: Type=exact number, unit=mg, number=5, form=tablet, route=oral, twice daily
Unnamed facility
Beijing, China
Unnamed facility
Chengdu, China
Unnamed facility
Chongqing, China
Time to prostate specific antigen (PSA) progression (TTPP)
Measured from the time interval from the date of randomization to the date of the PSA progression based on prostate cancer clinical trials working group 2 (PCWG2) criteria
Time frame: 14 months
Overall survival
The percentage of people in a study or treatment group who are alive from date of randomization to date of death
Time frame: 5 years
Time to initiation of cytotoxic chemotherapy
Date of randomization to date of initiation of chemotherapy
Time frame: 5 years
Prostate specific antigen (PSA) response rate
Proportion of patients achieving a PSA decline 50% according to prostate cancer clinical trials working group 2 (PCWG2) criteria
Time frame: 14 months
Objective response rate
Measurable disease based on modified response evaluation criteria in solid tumors (RECIST) criteria and baseline lymph node size must be 2.0 cm to be considered target or evaluable lesion for RECIST criteria
Time frame: 14 months
Quality of life (QoL) total score and each subscale score
Assessed by functional assessment of cancer therapy-prostate (FACT-P)
Time frame: 14 months
Time to pain progression
Assessed by the Brief Pain Inventory Short Form (BPI-SF) and analgesic score
Time frame: 14 months
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Unnamed facility
Guangzhou, China
Unnamed facility
Hangzhou, China
Unnamed facility
Jinan, China
Unnamed facility
Nanjing, China
Unnamed facility
Shanghai, China
Unnamed facility
Tianjin, China
Unnamed facility
Wuhan, China
...and 12 more locations
Time to Eastern Cooperative Oncology Group (ECOG) performance status score determination
ECOG performance status score 0 (Fully active, able to carry on all pre-disease performance without restriction) versus 1 (Restricted in physically strenuous activity but ambulatory and able to carry out work on a light or sedentary nature, eg, light housework, office work)
Time frame: 14 months
Collection of safety data including adverse events
Time frame: 5 years