An Efficacy and Safety Study of Abiraterone Acetate and Prednisone in Participants With Prostate Cancer Who Failed Androgen Deprivation and Docetaxel-Based Chemotherapy

The PSA response was evaluated according to Prostate-Specific Antigen Working Group (PSAWG) criterion, which is, greater than or equal to 50 percent decrease in PSA from Baseline during the study, which would be subsequently confirmed by a measurement that is at least 4 or more weeks after initial documentation of PSA response.

Time frame: Day 1 of each cycle (of 28 days each) up to Cycle 12

Population: Per protocol population defined as participants who had received at least one dose of abiraterone acetate and must had PSA evaluation/tumor assessment at Baseline and at least 1 post-baseline, and had received a minimum of 3 cycles of study treatment.

Overall survival is defined as the interval from the date of the first dose of abiraterone acetate to the date of death.

Time frame: Every 3 months until death or up to 60 months

Population: Per protocol population defined as participants who had received at least one dose of abiraterone acetate and must had PSA evaluation/tumor assessment at Baseline and at least 1 post-baseline, and had received a minimum of 3 cycles of study treatment.

Clinical benefit was defined as an observation of at least 1 of the following: PSA response by PSAWG criteria; radiographic response by RECIST criteria; stable disease by RECIST criteria lasting 6 months; or improvement by at least 1 unit in ECOG performance status.

Time frame: Baseline, Day 1 of Cycle 4, 7 and 10, and thereafter every third cycle until first documented disease progression or up to 60 months

Population: Per protocol population defined as participants who had received at least one dose of abiraterone acetate and must had PSA evaluation/tumor assessment at Baseline and at least 1 post-baseline, and had received a minimum of 3 cycles of study treatment.

Percentage of participants with radiographic objective response is defined as the percentage of participants with complete response (CR) or partial response (PR) as best overall response based on reconciled radiographic disease assessment according to RECIST Version 1.0. The CR is disappearance of all lesions. The PR is at least 30 percent decrease in sum of the longest diameter of target lesions or persistence of one or more non-target lesion(s) or/and maintenance of tumor marker level above the normal limits.

Time frame: Baseline, Day 1 of Cycle 4, 7 and 10, and thereafter every third cycle until first documented disease progression or up to 60 months

Population: Per protocol population defined as participants who had received at least 1 dose of abiraterone acetate and must had PSA evaluation/tumor assessment at Baseline and at least 1 post-baseline, and had received a minimum of 3 cycles of study treatment. N (number of participants analyzed) =participants who were evaluable for this measure.

The PSA-PFS is defined as time to first PSA failure (that is, two consecutive increases in PSA of 50 percent and greater than or equal to 5 nanogram per milliliter, as per Prostate-Specific Antigen Working Group \[PSAWG\] criterion) or death or the start of secondary anti-tumor therapy, whichever occurs first. If a PSA progression or death does not occur, subject will be censored at the last PSA evaluation.

Time frame: Baseline and Day 1 of each cycle until first documented disease progression or up to 60 months

Population: Per protocol population defined as participants who had received at least one dose of abiraterone acetate and must had PSA evaluation/tumor assessment at Baseline and at least 1 post-baseline, and had received a minimum of 3 cycles of study treatment.

The RAD-PFS is defined as the time from randomization to the earliest objective evidence of radiographic progression or death due to any cause. Progression is defined using Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.0, as at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since the treatment started or the appearance of one or more new lesions.

Time frame: Baseline, Day 1 of Cycle 4, 7 and 10, and thereafter every third cycle until first documented disease progression or up to 60 months

ECOG performance status score ranges from 0 to 5 where 0=fully active, perform all pre-disease activities without restriction. 1=restricted in physically strenuous activity but ambulatory, carry out work of a light or sedentary nature, 2=ambulatory, capable of self-care, unable to carry out any work activities, up and about more than (\>) 50 percent of waking hours, 3=capable of limited self-care, confined to bed or chair \>50 percent of waking hours, 4=completely disabled, not capable of any self-care, totally confined to bed or chair and 5=dead.

Time frame: Baseline and Day 1 of each cycle until first documented disease progression or up to 60 months

Population: Per protocol population defined as participants who had received at least one dose of abiraterone acetate and must had PSA evaluation/tumor assessment at Baseline and at least 1 post-baseline, and had received a minimum of 3 cycles of study treatment. 'N' (number of participants analyzed) = participants who were evaluable for this measure.

The time interval from first dose of abiraterone acetate to the date of PSA progression as defined by the Prostate-Specific Antigen Working Group (PSAWG) criteria. If a PSA progression does not occur, subject will be censored at the last PSA evaluation.

Time frame: Day 8 of Cycle 1, thereafter Day 1 of each cycle up to end of study (60 months)

Population: Per protocol population defined as participants who had received at least one dose of abiraterone acetate and must had PSA evaluation/tumor assessment at Baseline and at least 1 post-baseline, and had received a minimum of 3 cycles of study treatment.

Time to radiographic progression is defined as the time from first dose until the first radiographic progression date that was confirmed.

Time frame: Baseline, Day 1 of Cycle 4, 7 and 10, and thereafter every third cycle until first documented disease progression or up to 60 months

Population: Per protocol population defined as participants who had received at least one dose of abiraterone acetate and must had PSA evaluation/tumor assessment at Baseline and at least 1 post-baseline, and had received a minimum of 3 cycles of study treatment.