A Safety and Efficacy Study of Abiraterone Acetate in Participants With Prostate Cancer Who Have Failed Hormone Therapy

The PSA response was measured according to PSA working group (PSAWG) criteria. All participants achieving a fall in PSA of greater than 50 percent from baseline, which has been confirmed by a second measurement at least 4 weeks after initial documentation, fulfill criteria for confirmed PSA response.

Time frame: Baseline, Week 12

Population: All participants who were enrolled in the study and received 1000 milligram abiraterone acetate therapy with or without dexamethasone (including participants who received 1000 mg AA monotherapy). Here 'N' (number of participants analyzed) signifies those participants evaluable for this measure.

Number of participants with objective response based on assessment of confirmed CR or confirmed PR according to RECIST. Confirmed CR defined as disappearance of all target lesions. Confirmed PR defined as greater than or equal to 30 percent decrease in sum of the LD of the target lesions taking as a reference the baseline sum LD according to RECIST. Confirmed responses are those that persist on repeat imaging study greater than or equal to 4 weeks after initial documentation of response.

Time frame: Baseline up to end of study (1160 days)

Population: Duration of response was not analyzed as majority of participants with objective tumor response were lost to follow-up.

Duration of PSA response in participants on abiraterone acetate therapy was measured as the duration between PSA 50 percent decline date and PSA progression date as defined by the PSAWG criteria.

Time frame: Baseline up to end of study (1160 days)

Population: All participants who were enrolled in the study and received 1000 milligram abiraterone acetate therapy with or without dexamethasone (including participants who received 1000 mg AA monotherapy). Here 'N' (number of participants analyzed) signifies those participants evaluable for this measure.

Number of participants with objective response based on assessment of confirmed complete response (CR) or confirmed partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST). Confirmed CR defined as disappearance of all target lesions. Confirmed PR defined as greater than or equal to 30 percent decrease in sum of the longest dimensions (LD) of the target lesions taking as a reference the baseline sum LD according to RECIST. Confirmed responses are those that persist on repeat imaging study greater than or equal to 4 weeks after initial documentation of response.

Time frame: Baseline up to end of study (1160 days)

Population: All participants who were enrolled in the study and received 1000 milligram abiraterone acetate therapy with or without dexamethasone (including participants who received 1000 mg AA monotherapy). Here 'N' (number of participants analyzed) signifies those participants evaluable for this measure.

Overall survival was the duration from enrollment to death. For participants who are alive, overall survival was censored at the last contact.

Time frame: Baseline up to end of study (1160 days)

Population: Data was not analyzed due to high number of participants censored for survival.

Disease progression was defined as greater than 25 percent increase in sum of longest diameter of target lesions compared to baseline.

Time frame: Baseline up to end of study (1160 days)

Population: Data was not analyzed because at the time to progression, participants also received dexamethasone treatment, making it impractical to accurately define disease progression.

AUC (0 - ∞)= Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0 - ∞). It is obtained from AUC (0 - t) plus AUC (t - ∞).

Time frame: Pre-dose on Day 1, 8 and 15 of Cycle 1, Day 1 of Cycle 2, Day 1 of Cycle 3; 1, 2, 4, 6, 8, 24, 48 and 72 hours after first dose was given

Population: Included all participants who enrolled into the study regardless of the amount of the trial medication received. Here 'N' (number of participants analyzed) signifies those participants evaluable for this measure.

Area under the plasma concentration time-curve from time zero to the last quantifiable concentration (AUClast).

Time frame: Pre-dose on Day 1, 8 and 15 of Cycle 1, Day 1 of Cycle 2, Day 1 of Cycle 3; 1, 2, 4, 6, 8, 24, 48 and 72 hours after first dose was given

Population: Included all participants who enrolled into the study regardless of the amount of the trial medication received. Here 'N' (number of participants analyzed) signifies those participants evaluable for this measure.

The Cmax is defined as maximum observed analyte concentration.

Time frame: Pre-dose on Day 1, 8 and 15 of Cycle 1, Day 1 of Cycle 2, Day 1 of Cycle 3; 1, 2, 4, 6, 8, 24, 48 and 72 hours after first dose was given

Population: Included all participants who enrolled into the study regardless of the amount of the trial medication received. Here 'N' (number of participants analyzed) signifies those participants evaluable for this measure.

Time frame: Pre-dose on Day 1, 8 and 15 of Cycle 1, Day 1 of Cycle 2, Day 1 of Cycle 3; 1, 2, 4, 6, 8, 24, 48 and 72 hours after first dose was given

Population: Data was not statistically summarized but reported in individual participant listing as per planned analysis.

Time frame: Baseline, Cycle 2, 4, 8, 12

Population: Data was reported in individual participant listings but not summarized due to statistical constraints.

An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to 28 days after last dose that were absent before treatment or that worsened relative to pretreatment state.

Time frame: Baseline up to 30 days after the last dose of study medication

Population: Included all participants who received any amount of the study medication.

Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.

Time frame: Pre-dose on Day 1, 8 and 15 of Cycle 1, Day 1 of Cycle 2, Day 1 of Cycle 3; 1, 2, 4, 6, 8, 24, 48 and 72 hours after first dose was given

Population: Included all participants who enrolled into the study regardless of the amount of the trial medication received. Here 'N' (number of participants analyzed) signifies those participants evaluable for this measure.

Concentration of testosterone in blood was measured in nanogram per deciliter (ng/dL).

Time frame: Baseline, Cycle 2 (within 3 days prior to Day 29)

Population: All participants who were enrolled in the study and received 1000 mg abiraterone acetate therapy with or without dexamethasone (including participants who received 1000 mg AA monotherapy). Here 'N' (number of participants analyzed) signifies participants evaluable for this measure and 'n' signifies participants evaluable at specified time point.

Concentration of Cortisol, Aldosterone, Corticosterone, 11-Deoxycortisol, Deoxycorticosterone and Dehydroepiandrostenedione Sulphate (DHEA-S) in blood was measured in nanogram per deciliter (ng/dL).

Time frame: Baseline, Cycle 2 (within 3 days prior to Day 29)

Population: All participants who were enrolled in the study and received 1000 mg abiraterone acetate therapy with or without dexamethasone (including participants who received 1000 mg AA monotherapy). Here 'N' (number of participants analyzed) signifies participants evaluable for this measure and 'n' signifies participants evaluable at specified time point.

The actual sampling time of last measurable (non-below the limit of quantification \[BQL\]) analyte concentration. The analyte concentration associated with Tlast is referred to as Clast.

Time frame: Pre-dose on Day 1, 8 and 15 of Cycle 1, Day 1 of Cycle 2, Day 1 of Cycle 3; 1, 2, 4, 6, 8, 24, 48 and 72 hours after first dose was given

Population: Data was not statistically summarized but reported in individual participant listing as per planned analysis.

The time from start of study treatment to the development/worsening of pain due to prostate cancer requiring one or more of the following treatments: 1- Opioid therapy (therapy with morphine like medicines for 10 out of 14 consecutive days); 2- Glucocorticoid therapy; 3- Initiation of \>= 5 mg of prednisolone for 10 out of 14 consecutive days; 4- Radionuclide therapy; 5- Radiation therapy (x-ray or cobalt treatment); 6- Chemotherapy (treatment of disease by chemical agents). Participants who do not experience prostate cancer pain were censored on their last day on study. Time to prostate cancer pain progression was measured by Kaplan-Meier method.

Time frame: Baseline up to 12 cycles

Population: Median time was not reached as data was not matured at the time of the analysis, hence no data could be reported.

The Tmax is defined as actual sampling time to reach maximum observed plasma concentration. The analyte concentration associated with Tmax is referred to as Cmax.

Time frame: Pre-dose on Day 1, 8 and 15 of Cycle 1, Day 1 of Cycle 2, Day 1 of Cycle 3; 1, 2, 4, 6, 8, 24, 48 and 72 hours after first dose was given

Population: Included all participants who enrolled into the study regardless of the amount of the trial medication received. Here 'N' (number of participants analyzed) signifies those participants evaluable for this measure.