Trial Outcomes & Findings for Abiraterone With Different Steroid Regimens for Side Effect Related to Mineralcorticoid Excess Prevention in Prostate Cancer Prior to Chemotherapy (NCT NCT01867710)

Last Updated: 2019-07-05

Results Overview

No mineralocorticoid excess is defined as experiencing neither of the 2 mineralocorticoid excess toxicities, that is, neither hypokalemia nor hypertension.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

164 participants

Primary outcome timeframe

Week 24

Results posted on

2019-07-05

Participant Flow

Participant milestones

Participant milestones
Measure	Abiraterone Acetate 1000 mg QD + Prednisone 5 mg BID Participants received abiraterone acetate 1000 milligram (mg) tablet orally once daily (QD) and prednisone 5 mg tablet orally twice daily (BID) up to 156 Weeks. Participants who were progression-free at 156 weeks entered the extension phase of the study and received study treatment until death, radiographic disease progression and/or unequivocal clinical progression, and/or other specific reasons for discontinuation. Participants who ended the extension phase prematurely and participants who did not enter the extension phase entered a follow-up phase until end of study.	Abiraterone Acetate 1000 mg QD + Prednisone 5 mg QD Participants received abiraterone acetate 1000 mg and prednisone 5 mg tablet orally QD up to 156 Weeks. Participants who were progression-free at 156 weeks entered the extension phase of the study and received study treatment until death, radiographic disease progression and/or unequivocal clinical progression, and/or other specific reasons for discontinuation. Participants who ended the extension phase prematurely and participants who did not enter the extension phase entered a follow-up phase until end of study.	Abiraterone Acetate 1000 mg QD + Prednisone 2.5 mg BID Participants received abiraterone acetate 1000 mg tablet orally QD and prednisone 2.5 mg tablet orally BID up to 156 Weeks. Participants who were progression-free at 156 weeks entered the extension phase of the study and received study treatment until death, radiographic disease progression and/or unequivocal clinical progression, and/or other specific reasons for discontinuation. Participants who ended the extension phase prematurely and participants who did not enter the extension phase entered a follow-up phase until end of study.	Abiraterone Acetate 1000 mg QD + Dexamethasone 0.5 mg QD Participants received abiraterone acetate 1000 mg and dexamethasone 0.5 mg tablet orally QD up to 156 Weeks. Participants who were progression-free at 156 weeks entered the extension phase of the study and received study treatment until death, radiographic disease progression and/or unequivocal clinical progression, and/or other specific reasons for discontinuation. Participants who ended the extension phase prematurely and participants who did not enter the extension phase entered a follow-up phase until end of study.
Overall Study STARTED	41	41	40	42
Overall Study Treated	41	41	39	42
Overall Study COMPLETED	0	0	0	0
Overall Study NOT COMPLETED	41	41	40	42

Reasons for withdrawal

Reasons for withdrawal
Measure	Abiraterone Acetate 1000 mg QD + Prednisone 5 mg BID Participants received abiraterone acetate 1000 milligram (mg) tablet orally once daily (QD) and prednisone 5 mg tablet orally twice daily (BID) up to 156 Weeks. Participants who were progression-free at 156 weeks entered the extension phase of the study and received study treatment until death, radiographic disease progression and/or unequivocal clinical progression, and/or other specific reasons for discontinuation. Participants who ended the extension phase prematurely and participants who did not enter the extension phase entered a follow-up phase until end of study.	Abiraterone Acetate 1000 mg QD + Prednisone 5 mg QD Participants received abiraterone acetate 1000 mg and prednisone 5 mg tablet orally QD up to 156 Weeks. Participants who were progression-free at 156 weeks entered the extension phase of the study and received study treatment until death, radiographic disease progression and/or unequivocal clinical progression, and/or other specific reasons for discontinuation. Participants who ended the extension phase prematurely and participants who did not enter the extension phase entered a follow-up phase until end of study.	Abiraterone Acetate 1000 mg QD + Prednisone 2.5 mg BID Participants received abiraterone acetate 1000 mg tablet orally QD and prednisone 2.5 mg tablet orally BID up to 156 Weeks. Participants who were progression-free at 156 weeks entered the extension phase of the study and received study treatment until death, radiographic disease progression and/or unequivocal clinical progression, and/or other specific reasons for discontinuation. Participants who ended the extension phase prematurely and participants who did not enter the extension phase entered a follow-up phase until end of study.	Abiraterone Acetate 1000 mg QD + Dexamethasone 0.5 mg QD Participants received abiraterone acetate 1000 mg and dexamethasone 0.5 mg tablet orally QD up to 156 Weeks. Participants who were progression-free at 156 weeks entered the extension phase of the study and received study treatment until death, radiographic disease progression and/or unequivocal clinical progression, and/or other specific reasons for discontinuation. Participants who ended the extension phase prematurely and participants who did not enter the extension phase entered a follow-up phase until end of study.
Overall Study Death	25	15	27	20
Overall Study Lost to Follow-up	3	4	3	2
Overall Study Withdrawal of consent	2	5	1	2
Overall Study Study Terminated by Sponsor	9	13	8	16
Overall Study Biochemical progression	0	1	0	0
Overall Study Clinical progression	0	0	1	0
Overall Study Disease progression	1	0	0	0
Overall Study Patient decision	0	0	0	1
Overall Study Patient to follow subsequent treatment	0	1	0	0
Overall Study Progressive disease	1	0	0	0
Overall Study Protocol Violation	0	0	0	1
Overall Study PSA-progression	0	1	0	0
Overall Study Study medication no longer effective	0	1	0	0

Baseline Characteristics

Abiraterone With Different Steroid Regimens for Side Effect Related to Mineralcorticoid Excess Prevention in Prostate Cancer Prior to Chemotherapy

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Abiraterone Acetate 1000 mg QD + Prednisone 5 mg BID n=41 Participants Participants received abiraterone acetate 1000 milligram (mg) tablet orally once daily (QD) and prednisone 5 mg tablet orally twice daily (BID) up to 156 Weeks. Participants who were progression-free at 156 weeks entered the extension phase of the study and received study treatment until death, radiographic disease progression and/or unequivocal clinical progression, and/or other specific reasons for discontinuation. Participants who ended the extension phase prematurely and participants who did not enter the extension phase entered a follow-up phase until end of study.	Abiraterone Acetate 1000 mg QD + Prednisone 5 mg QD n=41 Participants Participants received abiraterone acetate 1000 mg and prednisone 5 mg tablet orally QD up to 156 Weeks. Participants who were progression-free at 156 weeks entered the extension phase of the study and received study treatment until death, radiographic disease progression and/or unequivocal clinical progression, and/or other specific reasons for discontinuation. Participants who ended the extension phase prematurely and participants who did not enter the extension phase entered a follow-up phase until end of study.	Abiraterone Acetate 1000 mg QD + Prednisone 2.5 mg BID n=40 Participants Participants received abiraterone acetate 1000 mg tablet orally QD and prednisone 2.5 mg tablet orally BID up to 156 Weeks. Participants who were progression-free at 156 weeks entered the extension phase of the study and received study treatment until death, radiographic disease progression and/or unequivocal clinical progression, and/or other specific reasons for discontinuation. Participants who ended the extension phase prematurely and participants who did not enter the extension phase entered a follow-up phase until end of study.	Abiraterone Acetate 1000 mg QD + Dexamethasone 0.5 mg QD n=42 Participants Participants received abiraterone acetate 1000 mg and dexamethasone 0.5 mg tablet orally QD up to 156 Weeks. Participants who were progression-free at 156 weeks entered the extension phase of the study and received study treatment until death, radiographic disease progression and/or unequivocal clinical progression, and/or other specific reasons for discontinuation. Participants who ended the extension phase prematurely and participants who did not enter the extension phase entered a follow-up phase until end of study.	Total n=164 Participants Total of all reporting groups
Age, Continuous	68.9 years STANDARD_DEVIATION 9.28 • n=5 Participants	69 years STANDARD_DEVIATION 8.44 • n=7 Participants	69.3 years STANDARD_DEVIATION 7.51 • n=5 Participants	71.3 years STANDARD_DEVIATION 8.12 • n=4 Participants	69.6 years STANDARD_DEVIATION 8.35 • n=21 Participants
Sex: Female, Male Female	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Sex: Female, Male Male	41 Participants n=5 Participants	41 Participants n=7 Participants	40 Participants n=5 Participants	42 Participants n=4 Participants	164 Participants n=21 Participants
Region of Enrollment Belgium	8 Participants n=5 Participants	9 Participants n=7 Participants	10 Participants n=5 Participants	14 Participants n=4 Participants	41 Participants n=21 Participants
Region of Enrollment Germany	7 Participants n=5 Participants	10 Participants n=7 Participants	5 Participants n=5 Participants	6 Participants n=4 Participants	28 Participants n=21 Participants
Region of Enrollment United Kingdom	10 Participants n=5 Participants	9 Participants n=7 Participants	8 Participants n=5 Participants	8 Participants n=4 Participants	35 Participants n=21 Participants
Region of Enrollment Hungary	6 Participants n=5 Participants	4 Participants n=7 Participants	6 Participants n=5 Participants	4 Participants n=4 Participants	20 Participants n=21 Participants
Region of Enrollment Italy	10 Participants n=5 Participants	9 Participants n=7 Participants	11 Participants n=5 Participants	19 Participants n=4 Participants	49 Participants n=21 Participants

PRIMARY outcome

Timeframe: Week 24

Population: Safety population included all randomized and treated participants. Here "N" (Number of Participants Analyzed) signifies those participants who were evaluable for this outcome measure.

No mineralocorticoid excess is defined as experiencing neither of the 2 mineralocorticoid excess toxicities, that is, neither hypokalemia nor hypertension.

Outcome measures

Outcome measures
Measure	Abiraterone Acetate 1000 mg QD + Prednisone 5 mg BID n=34 Participants Participants received abiraterone acetate 1000 milligram (mg) tablet orally once daily (QD) and prednisone 5 mg tablet orally twice daily (BID) up to 156 Weeks. Participants who were progression-free at 156 weeks entered the extension phase of the study and received study treatment until death, radiographic disease progression and/or unequivocal clinical progression, and/or other specific reasons for discontinuation. Participants who ended the extension phase prematurely and participants who did not enter the extension phase entered a follow-up phase until end of study.	Abiraterone Acetate 1000 mg QD + Prednisone 5 mg QD n=38 Participants Participants received abiraterone acetate 1000 mg and prednisone 5 mg tablet orally QD up to 156 Weeks. Participants who were progression-free at 156 weeks entered the extension phase of the study and received study treatment until death, radiographic disease progression and/or unequivocal clinical progression, and/or other specific reasons for discontinuation. Participants who ended the extension phase prematurely and participants who did not enter the extension phase entered a follow-up phase until end of study.	Abiraterone Acetate 1000 mg QD + Prednisone 2.5 mg BID n=35 Participants Participants received abiraterone acetate 1000 mg tablet orally QD and prednisone 2.5 mg tablet orally BID up to 156 Weeks. Participants who were progression-free at 156 weeks entered the extension phase of the study and received study treatment until death, radiographic disease progression and/or unequivocal clinical progression, and/or other specific reasons for discontinuation. Participants who ended the extension phase prematurely and participants who did not enter the extension phase entered a follow-up phase until end of study.	Abiraterone Acetate 1000 mg QD + Dexamethasone 0.5 mg QD n=37 Participants Participants received abiraterone acetate 1000 mg and dexamethasone 0.5 mg tablet orally QD up to 156 Weeks. Participants who were progression-free at 156 weeks entered the extension phase of the study and received study treatment until death, radiographic disease progression and/or unequivocal clinical progression, and/or other specific reasons for discontinuation. Participants who ended the extension phase prematurely and participants who did not enter the extension phase entered a follow-up phase until end of study.
Percentage of Participants Experiencing Neither of the 2 Mineralocorticoid Excess Toxicity During the First 24 Weeks of Treatment	70.6 Percentage of Participants Interval 53.8 to 83.2	36.8 Percentage of Participants Interval 23.4 to 52.7	60.0 Percentage of Participants Interval 43.6 to 74.4	70.3 Percentage of Participants Interval 54.2 to 82.5

SECONDARY outcome

Timeframe: Week 12

Population: Intent-to-treat (ITT) population included all randomized participants regardless of whether they received any study treatment. Here "N" (Number of Participants Analyzed) signifies those participants who were evaluable for this outcome measure.

The PSA response is defined as a \>= 50% decline from baseline according to the adapted Prostate Cancer Working Group 2 (PCWG2) criteria. For a PSA response to be confirmed, an additional PSA measurement obtained 4 or more weeks later has to show \>=50% decline from baseline.

Outcome measures

Outcome measures
Measure	Abiraterone Acetate 1000 mg QD + Prednisone 5 mg BID n=35 Participants Participants received abiraterone acetate 1000 milligram (mg) tablet orally once daily (QD) and prednisone 5 mg tablet orally twice daily (BID) up to 156 Weeks. Participants who were progression-free at 156 weeks entered the extension phase of the study and received study treatment until death, radiographic disease progression and/or unequivocal clinical progression, and/or other specific reasons for discontinuation. Participants who ended the extension phase prematurely and participants who did not enter the extension phase entered a follow-up phase until end of study.	Abiraterone Acetate 1000 mg QD + Prednisone 5 mg QD n=34 Participants Participants received abiraterone acetate 1000 mg and prednisone 5 mg tablet orally QD up to 156 Weeks. Participants who were progression-free at 156 weeks entered the extension phase of the study and received study treatment until death, radiographic disease progression and/or unequivocal clinical progression, and/or other specific reasons for discontinuation. Participants who ended the extension phase prematurely and participants who did not enter the extension phase entered a follow-up phase until end of study.	Abiraterone Acetate 1000 mg QD + Prednisone 2.5 mg BID n=36 Participants Participants received abiraterone acetate 1000 mg tablet orally QD and prednisone 2.5 mg tablet orally BID up to 156 Weeks. Participants who were progression-free at 156 weeks entered the extension phase of the study and received study treatment until death, radiographic disease progression and/or unequivocal clinical progression, and/or other specific reasons for discontinuation. Participants who ended the extension phase prematurely and participants who did not enter the extension phase entered a follow-up phase until end of study.	Abiraterone Acetate 1000 mg QD + Dexamethasone 0.5 mg QD n=39 Participants Participants received abiraterone acetate 1000 mg and dexamethasone 0.5 mg tablet orally QD up to 156 Weeks. Participants who were progression-free at 156 weeks entered the extension phase of the study and received study treatment until death, radiographic disease progression and/or unequivocal clinical progression, and/or other specific reasons for discontinuation. Participants who ended the extension phase prematurely and participants who did not enter the extension phase entered a follow-up phase until end of study.
Percentage of Participants With Confirmed Prostate Specific Antigen (PSA) Response Rate [Greater Than or Equal to (>=) 50 Percent (%) Decline From Baseline] at Week 12	57.1 Percentage of Participants Interval 40.9 to 72.0	70.6 Percentage of Participants Interval 53.8 to 83.2	47.2 Percentage of Participants Interval 32.0 to 63.0	79.5 Percentage of Participants Interval 64.5 to 89.2

SECONDARY outcome

Timeframe: Baseline up to the Endpoint (last post-baseline assessment value during 156 weeks of main study treatment period [MSTP])

Population: ITT population included all randomized participants regardless of whether they received any study treatment. Here "N" (Number of Participants Analyzed) signifies those participants who were evaluable for this outcome measure.

BPI-SF is 11-item self-reported questionnaire designed to assess severity and impact of pain on daily functions (pain interference). It includes 4 questions that assess pain intensity/severity (worst, least, average, right now) and 7 questions that assess impact of pain on daily functions (general activity, mood, walking ability, normal work, relations with other people, sleep, enjoyment of life). BPI-SF scores range from 0=No pain to 10=Pain as bad as you can imagine; Higher scores indicate greater pain. Worst pain item has a scale of 0 to 10 with 0 indicating "No pain" and 10 indicating "Pain as bad as you can imagine". Last observation carried forward (LOCF) approach used for endpoint analysis. Last observation defined as last visit with non-missing data for parameter analyzed.

Outcome measures

Outcome measures
Measure	Abiraterone Acetate 1000 mg QD + Prednisone 5 mg BID n=36 Participants Participants received abiraterone acetate 1000 milligram (mg) tablet orally once daily (QD) and prednisone 5 mg tablet orally twice daily (BID) up to 156 Weeks. Participants who were progression-free at 156 weeks entered the extension phase of the study and received study treatment until death, radiographic disease progression and/or unequivocal clinical progression, and/or other specific reasons for discontinuation. Participants who ended the extension phase prematurely and participants who did not enter the extension phase entered a follow-up phase until end of study.	Abiraterone Acetate 1000 mg QD + Prednisone 5 mg QD n=33 Participants Participants received abiraterone acetate 1000 mg and prednisone 5 mg tablet orally QD up to 156 Weeks. Participants who were progression-free at 156 weeks entered the extension phase of the study and received study treatment until death, radiographic disease progression and/or unequivocal clinical progression, and/or other specific reasons for discontinuation. Participants who ended the extension phase prematurely and participants who did not enter the extension phase entered a follow-up phase until end of study.	Abiraterone Acetate 1000 mg QD + Prednisone 2.5 mg BID n=37 Participants Participants received abiraterone acetate 1000 mg tablet orally QD and prednisone 2.5 mg tablet orally BID up to 156 Weeks. Participants who were progression-free at 156 weeks entered the extension phase of the study and received study treatment until death, radiographic disease progression and/or unequivocal clinical progression, and/or other specific reasons for discontinuation. Participants who ended the extension phase prematurely and participants who did not enter the extension phase entered a follow-up phase until end of study.	Abiraterone Acetate 1000 mg QD + Dexamethasone 0.5 mg QD n=38 Participants Participants received abiraterone acetate 1000 mg and dexamethasone 0.5 mg tablet orally QD up to 156 Weeks. Participants who were progression-free at 156 weeks entered the extension phase of the study and received study treatment until death, radiographic disease progression and/or unequivocal clinical progression, and/or other specific reasons for discontinuation. Participants who ended the extension phase prematurely and participants who did not enter the extension phase entered a follow-up phase until end of study.
Change From Baseline to Endpoint in Brief Pain Inventory- Short Form (BPI-SF) Score: Worst Pain	1.6 Units on a scale Standard Deviation 2.43	2.2 Units on a scale Standard Deviation 2.86	2.5 Units on a scale Standard Deviation 2.39	1.3 Units on a scale Standard Deviation 2.28

SECONDARY outcome

Timeframe: Baseline up to the Endpoint (last post-baseline assessment value during 156 weeks of MSTP)

BPI-SF is 11-item self-reported questionnaire designed to assess severity and impact of pain on daily functions (pain interference). It includes 4 questions that assess pain intensity/severity (worst, least, average, right now) and 7 questions that assess impact of pain on daily functions (general activity, mood, walking ability, normal work, relations with other people, sleep, enjoyment of life). BPI-SF scores range from 0=No pain to 10=Pain as bad as you can imagine; Higher scores indicate greater pain. Pain Severity Index is the mean of the 4 pain scores (worst, least, average, and right now) on the BPI-SF; range is 0=No pain to 10=Pain as bad as you can imagine; A higher score indicates greater pain severity. LOCF approach used for endpoint analysis. Last observation is defined as last visit with non-missing data for parameter analyzed.

Outcome measures

Outcome measures
Measure	Abiraterone Acetate 1000 mg QD + Prednisone 5 mg BID n=37 Participants Participants received abiraterone acetate 1000 milligram (mg) tablet orally once daily (QD) and prednisone 5 mg tablet orally twice daily (BID) up to 156 Weeks. Participants who were progression-free at 156 weeks entered the extension phase of the study and received study treatment until death, radiographic disease progression and/or unequivocal clinical progression, and/or other specific reasons for discontinuation. Participants who ended the extension phase prematurely and participants who did not enter the extension phase entered a follow-up phase until end of study.	Abiraterone Acetate 1000 mg QD + Prednisone 5 mg QD n=35 Participants Participants received abiraterone acetate 1000 mg and prednisone 5 mg tablet orally QD up to 156 Weeks. Participants who were progression-free at 156 weeks entered the extension phase of the study and received study treatment until death, radiographic disease progression and/or unequivocal clinical progression, and/or other specific reasons for discontinuation. Participants who ended the extension phase prematurely and participants who did not enter the extension phase entered a follow-up phase until end of study.	Abiraterone Acetate 1000 mg QD + Prednisone 2.5 mg BID n=37 Participants Participants received abiraterone acetate 1000 mg tablet orally QD and prednisone 2.5 mg tablet orally BID up to 156 Weeks. Participants who were progression-free at 156 weeks entered the extension phase of the study and received study treatment until death, radiographic disease progression and/or unequivocal clinical progression, and/or other specific reasons for discontinuation. Participants who ended the extension phase prematurely and participants who did not enter the extension phase entered a follow-up phase until end of study.	Abiraterone Acetate 1000 mg QD + Dexamethasone 0.5 mg QD n=38 Participants Participants received abiraterone acetate 1000 mg and dexamethasone 0.5 mg tablet orally QD up to 156 Weeks. Participants who were progression-free at 156 weeks entered the extension phase of the study and received study treatment until death, radiographic disease progression and/or unequivocal clinical progression, and/or other specific reasons for discontinuation. Participants who ended the extension phase prematurely and participants who did not enter the extension phase entered a follow-up phase until end of study.
Change From Baseline to Endpoint in Brief Pain Inventory- Short Form (BPI-SF) Score: Pain Intensity Subscale	1.31 Units on a scale Standard Deviation 1.788	1.37 Units on a scale Standard Deviation 1.952	1.80 Units on a scale Standard Deviation 2.014	0.97 Units on a scale Standard Deviation 1.610

SECONDARY outcome

Timeframe: Baseline up to the Endpoint (last post-baseline assessment value during 156 weeks of MSTP)

BPI-SF is 11-item self-reported questionnaire designed to assess severity and impact of pain on daily functions (pain interference). It includes 4 questions that assess pain intensity/severity (worst, least, average, right now) and 7 questions that assess impact of pain on daily functions (general activity, mood, walking ability, normal work, relations with other people, sleep, enjoyment of life). BPI-SF scores range from 0=No pain to 10=Pain as bad as you can imagine; Higher scores indicate greater pain. Pain Interference Index is the mean of the scores for the 7 items of the BPI-SF; range is 0=Does not interfere to 10=Completely interferes. LOCF approach used for endpoint analysis. Last observation is defined as last visit with non-missing data for parameter analyzed.

Outcome measures

Outcome measures
Measure	Abiraterone Acetate 1000 mg QD + Prednisone 5 mg BID n=32 Participants Participants received abiraterone acetate 1000 milligram (mg) tablet orally once daily (QD) and prednisone 5 mg tablet orally twice daily (BID) up to 156 Weeks. Participants who were progression-free at 156 weeks entered the extension phase of the study and received study treatment until death, radiographic disease progression and/or unequivocal clinical progression, and/or other specific reasons for discontinuation. Participants who ended the extension phase prematurely and participants who did not enter the extension phase entered a follow-up phase until end of study.	Abiraterone Acetate 1000 mg QD + Prednisone 5 mg QD n=30 Participants Participants received abiraterone acetate 1000 mg and prednisone 5 mg tablet orally QD up to 156 Weeks. Participants who were progression-free at 156 weeks entered the extension phase of the study and received study treatment until death, radiographic disease progression and/or unequivocal clinical progression, and/or other specific reasons for discontinuation. Participants who ended the extension phase prematurely and participants who did not enter the extension phase entered a follow-up phase until end of study.	Abiraterone Acetate 1000 mg QD + Prednisone 2.5 mg BID n=35 Participants Participants received abiraterone acetate 1000 mg tablet orally QD and prednisone 2.5 mg tablet orally BID up to 156 Weeks. Participants who were progression-free at 156 weeks entered the extension phase of the study and received study treatment until death, radiographic disease progression and/or unequivocal clinical progression, and/or other specific reasons for discontinuation. Participants who ended the extension phase prematurely and participants who did not enter the extension phase entered a follow-up phase until end of study.	Abiraterone Acetate 1000 mg QD + Dexamethasone 0.5 mg QD n=37 Participants Participants received abiraterone acetate 1000 mg and dexamethasone 0.5 mg tablet orally QD up to 156 Weeks. Participants who were progression-free at 156 weeks entered the extension phase of the study and received study treatment until death, radiographic disease progression and/or unequivocal clinical progression, and/or other specific reasons for discontinuation. Participants who ended the extension phase prematurely and participants who did not enter the extension phase entered a follow-up phase until end of study.
Change From Baseline to Endpoint in Brief Pain Inventory- Short Form (BPI-SF) Score: Pain Interference Subscale	0.89 Units on a scale Standard Deviation 1.794	1.76 Units on a scale Standard Deviation 2.100	1.52 Units on a scale Standard Deviation 2.180	1.12 Units on a scale Standard Deviation 1.687

SECONDARY outcome

Timeframe: Baseline up to the Endpoint (last post-baseline assessment value during 156 weeks of MSTP)

EQ-5D-5L measures health outcome self-completed by respondents. It consists of EQ-5D-5L descriptive system and EQ visual analogue scale (EQ-VAS). The descriptive system comprises of 5 dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each has 5 levels (1-no problem, 2-slight problems, 3-moderate problems, 4-severe problems, 5-extreme problems). Participant selects answer for each of 5 dimensions considering response that best matches his/her health "today". Responses were used to generate a Health Status Index (HSI). HSI ranges from -0.148 to 0.949 and is anchored at 0 (health state value equal to dead) and 1 (full health). LOCF approach used for endpoint analysis. Last observation is defined as last visit with non-missing data for parameter analyzed.

Outcome measures

Outcome measures
Measure	Abiraterone Acetate 1000 mg QD + Prednisone 5 mg BID n=37 Participants Participants received abiraterone acetate 1000 milligram (mg) tablet orally once daily (QD) and prednisone 5 mg tablet orally twice daily (BID) up to 156 Weeks. Participants who were progression-free at 156 weeks entered the extension phase of the study and received study treatment until death, radiographic disease progression and/or unequivocal clinical progression, and/or other specific reasons for discontinuation. Participants who ended the extension phase prematurely and participants who did not enter the extension phase entered a follow-up phase until end of study.	Abiraterone Acetate 1000 mg QD + Prednisone 5 mg QD n=38 Participants Participants received abiraterone acetate 1000 mg and prednisone 5 mg tablet orally QD up to 156 Weeks. Participants who were progression-free at 156 weeks entered the extension phase of the study and received study treatment until death, radiographic disease progression and/or unequivocal clinical progression, and/or other specific reasons for discontinuation. Participants who ended the extension phase prematurely and participants who did not enter the extension phase entered a follow-up phase until end of study.	Abiraterone Acetate 1000 mg QD + Prednisone 2.5 mg BID n=36 Participants Participants received abiraterone acetate 1000 mg tablet orally QD and prednisone 2.5 mg tablet orally BID up to 156 Weeks. Participants who were progression-free at 156 weeks entered the extension phase of the study and received study treatment until death, radiographic disease progression and/or unequivocal clinical progression, and/or other specific reasons for discontinuation. Participants who ended the extension phase prematurely and participants who did not enter the extension phase entered a follow-up phase until end of study.	Abiraterone Acetate 1000 mg QD + Dexamethasone 0.5 mg QD n=38 Participants Participants received abiraterone acetate 1000 mg and dexamethasone 0.5 mg tablet orally QD up to 156 Weeks. Participants who were progression-free at 156 weeks entered the extension phase of the study and received study treatment until death, radiographic disease progression and/or unequivocal clinical progression, and/or other specific reasons for discontinuation. Participants who ended the extension phase prematurely and participants who did not enter the extension phase entered a follow-up phase until end of study.
Change From Baseline to Endpoint in EuroQol-5 Dimension-5 Level (EQ-5D-5L): Index Score	-0.0694 Units on a scale Standard Deviation 0.18402	-0.0638 Units on a scale Standard Deviation 0.17772	-0.0728 Units on a scale Standard Deviation 0.18113	-0.0359 Units on a scale Standard Deviation 0.13515

SECONDARY outcome

Timeframe: Baseline up to the Endpoint (last post-baseline assessment value during 156 weeks of MSTP)

EQ-5D-5L measures health outcome self-completed by respondents. It consists of EQ-5D-5L descriptive system and EQ visual analogue scale (EQ-VAS). EQ-VAS self-rating records the respondent's own assessment of his/her overall health status at time of completion, on scale of 0 (the worst health you can imagine) to 100 (the best health you can imagine). LOCF approach used for endpoint analysis. Last observation is defined as last visit with non-missing data for parameter analyzed.

Outcome measures

Outcome measures
Measure	Abiraterone Acetate 1000 mg QD + Prednisone 5 mg BID n=38 Participants Participants received abiraterone acetate 1000 milligram (mg) tablet orally once daily (QD) and prednisone 5 mg tablet orally twice daily (BID) up to 156 Weeks. Participants who were progression-free at 156 weeks entered the extension phase of the study and received study treatment until death, radiographic disease progression and/or unequivocal clinical progression, and/or other specific reasons for discontinuation. Participants who ended the extension phase prematurely and participants who did not enter the extension phase entered a follow-up phase until end of study.	Abiraterone Acetate 1000 mg QD + Prednisone 5 mg QD n=37 Participants Participants received abiraterone acetate 1000 mg and prednisone 5 mg tablet orally QD up to 156 Weeks. Participants who were progression-free at 156 weeks entered the extension phase of the study and received study treatment until death, radiographic disease progression and/or unequivocal clinical progression, and/or other specific reasons for discontinuation. Participants who ended the extension phase prematurely and participants who did not enter the extension phase entered a follow-up phase until end of study.	Abiraterone Acetate 1000 mg QD + Prednisone 2.5 mg BID n=37 Participants Participants received abiraterone acetate 1000 mg tablet orally QD and prednisone 2.5 mg tablet orally BID up to 156 Weeks. Participants who were progression-free at 156 weeks entered the extension phase of the study and received study treatment until death, radiographic disease progression and/or unequivocal clinical progression, and/or other specific reasons for discontinuation. Participants who ended the extension phase prematurely and participants who did not enter the extension phase entered a follow-up phase until end of study.	Abiraterone Acetate 1000 mg QD + Dexamethasone 0.5 mg QD n=37 Participants Participants received abiraterone acetate 1000 mg and dexamethasone 0.5 mg tablet orally QD up to 156 Weeks. Participants who were progression-free at 156 weeks entered the extension phase of the study and received study treatment until death, radiographic disease progression and/or unequivocal clinical progression, and/or other specific reasons for discontinuation. Participants who ended the extension phase prematurely and participants who did not enter the extension phase entered a follow-up phase until end of study.
Change From Baseline to Endpoint in EuroQol-5 Dimension-5 Level (EQ-5D-5L): EQ-VAS	-4.5 Units on a scale Standard Deviation 18.11	-5.0 Units on a scale Standard Deviation 16.82	-6.6 Units on a scale Standard Deviation 15.09	-3.1 Units on a scale Standard Deviation 13.00

SECONDARY outcome

Timeframe: Baseline up to the Endpoint (last post-baseline assessment value during 156 weeks of MSTP)

Population: ITT population included all randomized participants regardless of whether they received any study treatment. Here,'n'(number of participants analyzed) signifies the number of participants analyzed in specific category.

FACT-P is a 39-item participant rated questionnaire which consists of 5 subscales assessing physical well-being (7 items; score range 0-28), social/family well-being (7 items; score range 0-28), emotional well-being (6 items; score range 0-24), functional well-being (7 items; score range 0-28), prostate-specific concerns (12 items; score range 0-48). Each item rated on 0 to 4 Likert type scale, then combined to produce subscale scores for each domain, as well as global quality of life (QoL) score that ranges from 0 to 156. Higher scores represent better QoL. Additional Concerns subscale has 12 items, each with a score 0-6 making a total subscale range 0-72 (higher scores are better). Missing data imputed as per FACT-P Ver4 scoring system (sum of item scores\*number of items in subscale/number of items answered).

Outcome measures

Outcome measures
Measure	Abiraterone Acetate 1000 mg QD + Prednisone 5 mg BID n=41 Participants Participants received abiraterone acetate 1000 milligram (mg) tablet orally once daily (QD) and prednisone 5 mg tablet orally twice daily (BID) up to 156 Weeks. Participants who were progression-free at 156 weeks entered the extension phase of the study and received study treatment until death, radiographic disease progression and/or unequivocal clinical progression, and/or other specific reasons for discontinuation. Participants who ended the extension phase prematurely and participants who did not enter the extension phase entered a follow-up phase until end of study.	Abiraterone Acetate 1000 mg QD + Prednisone 5 mg QD n=41 Participants Participants received abiraterone acetate 1000 mg and prednisone 5 mg tablet orally QD up to 156 Weeks. Participants who were progression-free at 156 weeks entered the extension phase of the study and received study treatment until death, radiographic disease progression and/or unequivocal clinical progression, and/or other specific reasons for discontinuation. Participants who ended the extension phase prematurely and participants who did not enter the extension phase entered a follow-up phase until end of study.	Abiraterone Acetate 1000 mg QD + Prednisone 2.5 mg BID n=40 Participants Participants received abiraterone acetate 1000 mg tablet orally QD and prednisone 2.5 mg tablet orally BID up to 156 Weeks. Participants who were progression-free at 156 weeks entered the extension phase of the study and received study treatment until death, radiographic disease progression and/or unequivocal clinical progression, and/or other specific reasons for discontinuation. Participants who ended the extension phase prematurely and participants who did not enter the extension phase entered a follow-up phase until end of study.	Abiraterone Acetate 1000 mg QD + Dexamethasone 0.5 mg QD n=42 Participants Participants received abiraterone acetate 1000 mg and dexamethasone 0.5 mg tablet orally QD up to 156 Weeks. Participants who were progression-free at 156 weeks entered the extension phase of the study and received study treatment until death, radiographic disease progression and/or unequivocal clinical progression, and/or other specific reasons for discontinuation. Participants who ended the extension phase prematurely and participants who did not enter the extension phase entered a follow-up phase until end of study.
Change From Baseline to Endpoint in Functional Assessment of Cancer Therapy-Prostate (FACT-P) Questionnaire Score Physical Well-Being	-0.98 Units on a scale Standard Deviation 3.930	-2.20 Units on a scale Standard Deviation 4.449	-2.46 Units on a scale Standard Deviation 4.124	-1.04 Units on a scale Standard Deviation 3.268
Change From Baseline to Endpoint in Functional Assessment of Cancer Therapy-Prostate (FACT-P) Questionnaire Score Social/Family Well-Being	-0.01 Units on a scale Standard Deviation 3.679	0.61 Units on a scale Standard Deviation 3.794	-0.78 Units on a scale Standard Deviation 5.177	-1.97 Units on a scale Standard Deviation 5.749
Change From Baseline to Endpoint in Functional Assessment of Cancer Therapy-Prostate (FACT-P) Questionnaire Score Emotional Well-Being	-1.46 Units on a scale Standard Deviation 4.785	-0.89 Units on a scale Standard Deviation 3.289	-1.66 Units on a scale Standard Deviation 3.915	-0.02 Units on a scale Standard Deviation 3.542
Change From Baseline to Endpoint in Functional Assessment of Cancer Therapy-Prostate (FACT-P) Questionnaire Score Functional Well-Being	-1.13 Units on a scale Standard Deviation 4.575	-2.19 Units on a scale Standard Deviation 5.767	-2.67 Units on a scale Standard Deviation 5.957	-2.95 Units on a scale Standard Deviation 6.698
Change From Baseline to Endpoint in Functional Assessment of Cancer Therapy-Prostate (FACT-P) Questionnaire Score Global Score	-4.73 Units on a scale Standard Deviation 18.248	-6.62 Units on a scale Standard Deviation 17.118	-10.39 Units on a scale Standard Deviation 20.798	-5.77 Units on a scale Standard Deviation 18.322
Change From Baseline to Endpoint in Functional Assessment of Cancer Therapy-Prostate (FACT-P) Questionnaire Score Additional Concerns	-1.29 Units on a scale Standard Deviation 7.694	-2.35 Units on a scale Standard Deviation 6.342	-3.96 Units on a scale Standard Deviation 6.492	-0.72 Units on a scale Standard Deviation 6.080

SECONDARY outcome

Timeframe: Up to 4.9 years

Population: Efficacy analysis set included ITT population- all randomized participants regardless of whether they received any study treatment.

PFS: Time from randomization to one of following: radiographic progression (RP), clinical progression (CP) or death. RP- per PCWG2 criteria and modified RECIST as time from randomization to one of following: 1) considered to have progressed by bone scan if: a) first scan with \>=2 new lesions compared to baseline at \<12 weeks from randomization and confirmed by second scan \>=6 weeks later with \>=2 additional new lesions, b) first scan with \>=2 new lesions compared to baseline at \>=12 weeks from randomization and new lesions on next bone scan \>=6 weeks later; 2) Progression of soft tissue lesions per modified RECIST; CP: cancer pain requiring initiation of chronic use of opiate analgesia (oral use for \>=3 weeks; parenteral use for \>=7 days), Or immediate need to initiate cytotoxic chemotherapy or either radiation therapy or surgical intervention for complications due to tumor progression, even in absence of RP, Or deterioration in ECOG performance status to grade 3 or above.

Outcome measures

Outcome measures
Measure	Abiraterone Acetate 1000 mg QD + Prednisone 5 mg BID n=41 Participants Participants received abiraterone acetate 1000 milligram (mg) tablet orally once daily (QD) and prednisone 5 mg tablet orally twice daily (BID) up to 156 Weeks. Participants who were progression-free at 156 weeks entered the extension phase of the study and received study treatment until death, radiographic disease progression and/or unequivocal clinical progression, and/or other specific reasons for discontinuation. Participants who ended the extension phase prematurely and participants who did not enter the extension phase entered a follow-up phase until end of study.	Abiraterone Acetate 1000 mg QD + Prednisone 5 mg QD n=41 Participants Participants received abiraterone acetate 1000 mg and prednisone 5 mg tablet orally QD up to 156 Weeks. Participants who were progression-free at 156 weeks entered the extension phase of the study and received study treatment until death, radiographic disease progression and/or unequivocal clinical progression, and/or other specific reasons for discontinuation. Participants who ended the extension phase prematurely and participants who did not enter the extension phase entered a follow-up phase until end of study.	Abiraterone Acetate 1000 mg QD + Prednisone 2.5 mg BID n=40 Participants Participants received abiraterone acetate 1000 mg tablet orally QD and prednisone 2.5 mg tablet orally BID up to 156 Weeks. Participants who were progression-free at 156 weeks entered the extension phase of the study and received study treatment until death, radiographic disease progression and/or unequivocal clinical progression, and/or other specific reasons for discontinuation. Participants who ended the extension phase prematurely and participants who did not enter the extension phase entered a follow-up phase until end of study.	Abiraterone Acetate 1000 mg QD + Dexamethasone 0.5 mg QD n=42 Participants Participants received abiraterone acetate 1000 mg and dexamethasone 0.5 mg tablet orally QD up to 156 Weeks. Participants who were progression-free at 156 weeks entered the extension phase of the study and received study treatment until death, radiographic disease progression and/or unequivocal clinical progression, and/or other specific reasons for discontinuation. Participants who ended the extension phase prematurely and participants who did not enter the extension phase entered a follow-up phase until end of study.
Progression-Free Survival (PFS)	16.16 Months Interval 9.95 to 23.75	12.68 Months Interval 7.66 to 29.47	8.51 Months Interval 5.62 to 15.44	21.22 Months Interval 15.08 to 38.44

SECONDARY outcome

Timeframe: Up to 156 weeks

Population: Efficacy analysis set included ITT population- all randomized participants regardless of whether they received any study treatment.

Time to PSA progression was defined as time interval from the date of randomization to the date of the first prostate-specific antigen (PSA) progression as defined in the protocol-specific Prostate Specific Antigen Working Group 2 (PSAWG2) criteria during the main study treatment period. PCWG2 defines PSA progression as the date that a 25 percent (%) or greater increase and an absolute increase of 2 nanogram per milliliter (ng/mL) or more from the nadir is documented, which is confirmed by a second value obtained 3 or more weeks later.

Outcome measures

Outcome measures
Measure	Abiraterone Acetate 1000 mg QD + Prednisone 5 mg BID n=41 Participants Participants received abiraterone acetate 1000 milligram (mg) tablet orally once daily (QD) and prednisone 5 mg tablet orally twice daily (BID) up to 156 Weeks. Participants who were progression-free at 156 weeks entered the extension phase of the study and received study treatment until death, radiographic disease progression and/or unequivocal clinical progression, and/or other specific reasons for discontinuation. Participants who ended the extension phase prematurely and participants who did not enter the extension phase entered a follow-up phase until end of study.	Abiraterone Acetate 1000 mg QD + Prednisone 5 mg QD n=41 Participants Participants received abiraterone acetate 1000 mg and prednisone 5 mg tablet orally QD up to 156 Weeks. Participants who were progression-free at 156 weeks entered the extension phase of the study and received study treatment until death, radiographic disease progression and/or unequivocal clinical progression, and/or other specific reasons for discontinuation. Participants who ended the extension phase prematurely and participants who did not enter the extension phase entered a follow-up phase until end of study.	Abiraterone Acetate 1000 mg QD + Prednisone 2.5 mg BID n=40 Participants Participants received abiraterone acetate 1000 mg tablet orally QD and prednisone 2.5 mg tablet orally BID up to 156 Weeks. Participants who were progression-free at 156 weeks entered the extension phase of the study and received study treatment until death, radiographic disease progression and/or unequivocal clinical progression, and/or other specific reasons for discontinuation. Participants who ended the extension phase prematurely and participants who did not enter the extension phase entered a follow-up phase until end of study.	Abiraterone Acetate 1000 mg QD + Dexamethasone 0.5 mg QD n=42 Participants Participants received abiraterone acetate 1000 mg and dexamethasone 0.5 mg tablet orally QD up to 156 Weeks. Participants who were progression-free at 156 weeks entered the extension phase of the study and received study treatment until death, radiographic disease progression and/or unequivocal clinical progression, and/or other specific reasons for discontinuation. Participants who ended the extension phase prematurely and participants who did not enter the extension phase entered a follow-up phase until end of study.
Time to Prostate-Specific Antigen (PSA) Progression	10.38 Months Interval 10.05 to 20.99	10.22 Months Interval 7.39 to 26.84	4.83 Months Interval 2.79 to 10.15	18.56 Months Interval 10.15 to Here 'NA' represents that upper limit of 95% Confidence Interval (CI) was not estimable due to a limited number of events and the small sample size.

SECONDARY outcome

Timeframe: Up to 4.9 years

Population: Efficacy analysis set included ITT population- all randomized participants regardless of whether they received any study treatment. Population included participants with measurable disease at baseline.

ORR was defined as the percentage of participants with measurable disease at baseline achieving a complete response (CR) or partial response (PR) according to modified response evaluation criteria in solid tumors (RECIST) criteria. RECIST criteria for CR: disappearance of all target lesions and non-target lesions , any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm and normalization of tumor marker level. All lymph nodes must be non-pathological in size (\<10 millimetre \[mm\] short axis). PR: At least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD.

Outcome measures

Outcome measures
Measure	Abiraterone Acetate 1000 mg QD + Prednisone 5 mg BID n=19 Participants Participants received abiraterone acetate 1000 milligram (mg) tablet orally once daily (QD) and prednisone 5 mg tablet orally twice daily (BID) up to 156 Weeks. Participants who were progression-free at 156 weeks entered the extension phase of the study and received study treatment until death, radiographic disease progression and/or unequivocal clinical progression, and/or other specific reasons for discontinuation. Participants who ended the extension phase prematurely and participants who did not enter the extension phase entered a follow-up phase until end of study.	Abiraterone Acetate 1000 mg QD + Prednisone 5 mg QD n=18 Participants Participants received abiraterone acetate 1000 mg and prednisone 5 mg tablet orally QD up to 156 Weeks. Participants who were progression-free at 156 weeks entered the extension phase of the study and received study treatment until death, radiographic disease progression and/or unequivocal clinical progression, and/or other specific reasons for discontinuation. Participants who ended the extension phase prematurely and participants who did not enter the extension phase entered a follow-up phase until end of study.	Abiraterone Acetate 1000 mg QD + Prednisone 2.5 mg BID n=10 Participants Participants received abiraterone acetate 1000 mg tablet orally QD and prednisone 2.5 mg tablet orally BID up to 156 Weeks. Participants who were progression-free at 156 weeks entered the extension phase of the study and received study treatment until death, radiographic disease progression and/or unequivocal clinical progression, and/or other specific reasons for discontinuation. Participants who ended the extension phase prematurely and participants who did not enter the extension phase entered a follow-up phase until end of study.	Abiraterone Acetate 1000 mg QD + Dexamethasone 0.5 mg QD n=16 Participants Participants received abiraterone acetate 1000 mg and dexamethasone 0.5 mg tablet orally QD up to 156 Weeks. Participants who were progression-free at 156 weeks entered the extension phase of the study and received study treatment until death, radiographic disease progression and/or unequivocal clinical progression, and/or other specific reasons for discontinuation. Participants who ended the extension phase prematurely and participants who did not enter the extension phase entered a follow-up phase until end of study.
Objective Response Rate (ORR)	42.1 Percentage of participants	38.9 Percentage of participants	60.0 Percentage of participants	56.3 Percentage of participants

SECONDARY outcome

Timeframe: Up to 156 weeks

Population: Efficacy analysis set included ITT population- all randomized participants regardless of whether they received any study treatment.

Time to opiate use for cancer-related pain is defined the time interval from the date of randomization to the first date of opiate use for cancer pain.

Outcome measures

Outcome measures
Measure	Abiraterone Acetate 1000 mg QD + Prednisone 5 mg BID n=41 Participants Participants received abiraterone acetate 1000 milligram (mg) tablet orally once daily (QD) and prednisone 5 mg tablet orally twice daily (BID) up to 156 Weeks. Participants who were progression-free at 156 weeks entered the extension phase of the study and received study treatment until death, radiographic disease progression and/or unequivocal clinical progression, and/or other specific reasons for discontinuation. Participants who ended the extension phase prematurely and participants who did not enter the extension phase entered a follow-up phase until end of study.	Abiraterone Acetate 1000 mg QD + Prednisone 5 mg QD n=41 Participants Participants received abiraterone acetate 1000 mg and prednisone 5 mg tablet orally QD up to 156 Weeks. Participants who were progression-free at 156 weeks entered the extension phase of the study and received study treatment until death, radiographic disease progression and/or unequivocal clinical progression, and/or other specific reasons for discontinuation. Participants who ended the extension phase prematurely and participants who did not enter the extension phase entered a follow-up phase until end of study.	Abiraterone Acetate 1000 mg QD + Prednisone 2.5 mg BID n=40 Participants Participants received abiraterone acetate 1000 mg tablet orally QD and prednisone 2.5 mg tablet orally BID up to 156 Weeks. Participants who were progression-free at 156 weeks entered the extension phase of the study and received study treatment until death, radiographic disease progression and/or unequivocal clinical progression, and/or other specific reasons for discontinuation. Participants who ended the extension phase prematurely and participants who did not enter the extension phase entered a follow-up phase until end of study.	Abiraterone Acetate 1000 mg QD + Dexamethasone 0.5 mg QD n=42 Participants Participants received abiraterone acetate 1000 mg and dexamethasone 0.5 mg tablet orally QD up to 156 Weeks. Participants who were progression-free at 156 weeks entered the extension phase of the study and received study treatment until death, radiographic disease progression and/or unequivocal clinical progression, and/or other specific reasons for discontinuation. Participants who ended the extension phase prematurely and participants who did not enter the extension phase entered a follow-up phase until end of study.
Time to Opiate Use for Cancer-related Pain	NA Months Here "NA (not available)" signifies that median and 95% Confidence Interval (CI) were not estimable due to a limited number of events and the small sample size.	NA Months Here "NA (not available)" signifies that median and 95% Confidence Interval (CI) were not estimable due to a limited number of events and the small sample size.	NA Months Here "NA (not available)" signifies that median and 95% Confidence Interval (CI) were not estimable due to a limited number of events and the small sample size.	NA Months Here "NA (not available)" signifies that median and 95% Confidence Interval (CI) were not estimable due to a limited number of events and the small sample size.

SECONDARY outcome

Timeframe: Up to 156 weeks

Population: Efficacy analysis set included ITT population- all randomized participants regardless of whether they received any study treatment.

Time to deterioration in ECOG Performance Status, the time interval from the date of randomization to the first date in which at least one point change (worsening) in the ECOG is observed during the main study treatment period. The ECOG performance status is a grade scale to measure quality of life (QoL). Scores run from 0 to 5, with 0 denoting perfect health and 5 denoting death.

Outcome measures

Outcome measures
Measure	Abiraterone Acetate 1000 mg QD + Prednisone 5 mg BID n=41 Participants Participants received abiraterone acetate 1000 milligram (mg) tablet orally once daily (QD) and prednisone 5 mg tablet orally twice daily (BID) up to 156 Weeks. Participants who were progression-free at 156 weeks entered the extension phase of the study and received study treatment until death, radiographic disease progression and/or unequivocal clinical progression, and/or other specific reasons for discontinuation. Participants who ended the extension phase prematurely and participants who did not enter the extension phase entered a follow-up phase until end of study.	Abiraterone Acetate 1000 mg QD + Prednisone 5 mg QD n=41 Participants Participants received abiraterone acetate 1000 mg and prednisone 5 mg tablet orally QD up to 156 Weeks. Participants who were progression-free at 156 weeks entered the extension phase of the study and received study treatment until death, radiographic disease progression and/or unequivocal clinical progression, and/or other specific reasons for discontinuation. Participants who ended the extension phase prematurely and participants who did not enter the extension phase entered a follow-up phase until end of study.	Abiraterone Acetate 1000 mg QD + Prednisone 2.5 mg BID n=40 Participants Participants received abiraterone acetate 1000 mg tablet orally QD and prednisone 2.5 mg tablet orally BID up to 156 Weeks. Participants who were progression-free at 156 weeks entered the extension phase of the study and received study treatment until death, radiographic disease progression and/or unequivocal clinical progression, and/or other specific reasons for discontinuation. Participants who ended the extension phase prematurely and participants who did not enter the extension phase entered a follow-up phase until end of study.	Abiraterone Acetate 1000 mg QD + Dexamethasone 0.5 mg QD n=42 Participants Participants received abiraterone acetate 1000 mg and dexamethasone 0.5 mg tablet orally QD up to 156 Weeks. Participants who were progression-free at 156 weeks entered the extension phase of the study and received study treatment until death, radiographic disease progression and/or unequivocal clinical progression, and/or other specific reasons for discontinuation. Participants who ended the extension phase prematurely and participants who did not enter the extension phase entered a follow-up phase until end of study.
Time to Deterioration in Eastern Cooperative Oncology Group (ECOG) Performance Score by 1 Point	NA Months Here 'NA' (not available)" signifies that median and 95% Confidence Interval (CI) were not estimable due to a limited number of events and the small sample size.	NA Months Here 'NA' (not available)" signifies that median and 95% Confidence Interval (CI) were not estimable due to a limited number of events and the small sample size.	NA Months Here 'NA' (not available)" signifies that median and 95% Confidence Interval (CI) were not estimable due to a limited number of events and the small sample size.	NA Months Interval 23.95 to Here 'NA' (not available)" signifies that median and upper limit of 95% Confidence Interval (CI) were not estimable due to a limited number of events and the small sample size.

SECONDARY outcome

Timeframe: Up to 156 weeks

Population: Efficacy analysis set included ITT population- all randomized participants regardless of whether they received any study treatment.

Overall survival was defined as the time interval from the date of randomization to the date of death from any cause.

Outcome measures

Outcome measures
Measure	Abiraterone Acetate 1000 mg QD + Prednisone 5 mg BID n=41 Participants Participants received abiraterone acetate 1000 milligram (mg) tablet orally once daily (QD) and prednisone 5 mg tablet orally twice daily (BID) up to 156 Weeks. Participants who were progression-free at 156 weeks entered the extension phase of the study and received study treatment until death, radiographic disease progression and/or unequivocal clinical progression, and/or other specific reasons for discontinuation. Participants who ended the extension phase prematurely and participants who did not enter the extension phase entered a follow-up phase until end of study.	Abiraterone Acetate 1000 mg QD + Prednisone 5 mg QD n=41 Participants Participants received abiraterone acetate 1000 mg and prednisone 5 mg tablet orally QD up to 156 Weeks. Participants who were progression-free at 156 weeks entered the extension phase of the study and received study treatment until death, radiographic disease progression and/or unequivocal clinical progression, and/or other specific reasons for discontinuation. Participants who ended the extension phase prematurely and participants who did not enter the extension phase entered a follow-up phase until end of study.	Abiraterone Acetate 1000 mg QD + Prednisone 2.5 mg BID n=40 Participants Participants received abiraterone acetate 1000 mg tablet orally QD and prednisone 2.5 mg tablet orally BID up to 156 Weeks. Participants who were progression-free at 156 weeks entered the extension phase of the study and received study treatment until death, radiographic disease progression and/or unequivocal clinical progression, and/or other specific reasons for discontinuation. Participants who ended the extension phase prematurely and participants who did not enter the extension phase entered a follow-up phase until end of study.	Abiraterone Acetate 1000 mg QD + Dexamethasone 0.5 mg QD n=42 Participants Participants received abiraterone acetate 1000 mg and dexamethasone 0.5 mg tablet orally QD up to 156 Weeks. Participants who were progression-free at 156 weeks entered the extension phase of the study and received study treatment until death, radiographic disease progression and/or unequivocal clinical progression, and/or other specific reasons for discontinuation. Participants who ended the extension phase prematurely and participants who did not enter the extension phase entered a follow-up phase until end of study.
Overall Survival	34.07 Months Interval 26.38 to 48.49	48.43 Months Interval 39.95 to Here 'NA' (not available) signifies that upper limit of 95% Confidence Interval (CI) was not estimable due to a limited number of events and the small sample size.	27.96 Months Interval 23.66 to 40.51	42.81 Months Interval 30.23 to Here 'NA' (not available) signifies that upper limit of 95% Confidence Interval (CI) was not estimable due to a limited number of events and the small sample size.

SECONDARY outcome

Timeframe: Up to 4.9 years

Population: Efficacy analysis set included ITT population- all randomized participants regardless of whether they received any study treatment.

Time to next prostate cancer therapy is defined as the time interval from the date of randomization to the date of initiation of first next therapy for prostate cancer.

Outcome measures

Outcome measures
Measure	Abiraterone Acetate 1000 mg QD + Prednisone 5 mg BID n=41 Participants Participants received abiraterone acetate 1000 milligram (mg) tablet orally once daily (QD) and prednisone 5 mg tablet orally twice daily (BID) up to 156 Weeks. Participants who were progression-free at 156 weeks entered the extension phase of the study and received study treatment until death, radiographic disease progression and/or unequivocal clinical progression, and/or other specific reasons for discontinuation. Participants who ended the extension phase prematurely and participants who did not enter the extension phase entered a follow-up phase until end of study.	Abiraterone Acetate 1000 mg QD + Prednisone 5 mg QD n=41 Participants Participants received abiraterone acetate 1000 mg and prednisone 5 mg tablet orally QD up to 156 Weeks. Participants who were progression-free at 156 weeks entered the extension phase of the study and received study treatment until death, radiographic disease progression and/or unequivocal clinical progression, and/or other specific reasons for discontinuation. Participants who ended the extension phase prematurely and participants who did not enter the extension phase entered a follow-up phase until end of study.	Abiraterone Acetate 1000 mg QD + Prednisone 2.5 mg BID n=40 Participants Participants received abiraterone acetate 1000 mg tablet orally QD and prednisone 2.5 mg tablet orally BID up to 156 Weeks. Participants who were progression-free at 156 weeks entered the extension phase of the study and received study treatment until death, radiographic disease progression and/or unequivocal clinical progression, and/or other specific reasons for discontinuation. Participants who ended the extension phase prematurely and participants who did not enter the extension phase entered a follow-up phase until end of study.	Abiraterone Acetate 1000 mg QD + Dexamethasone 0.5 mg QD n=42 Participants Participants received abiraterone acetate 1000 mg and dexamethasone 0.5 mg tablet orally QD up to 156 Weeks. Participants who were progression-free at 156 weeks entered the extension phase of the study and received study treatment until death, radiographic disease progression and/or unequivocal clinical progression, and/or other specific reasons for discontinuation. Participants who ended the extension phase prematurely and participants who did not enter the extension phase entered a follow-up phase until end of study.
Time to Next Prostate Cancer Therapy	20.14 Months Interval 13.27 to 26.91	19.48 Months Interval 12.09 to 33.08	16.66 Months Interval 9.26 to 22.47	28.29 Months Interval 20.83 to 38.9

Adverse Events

Abiraterone Acetate 1000 mg QD + Prednisone 5 mg BID

Serious events: 12 serious events

Other events: 39 other events

Deaths: 0 deaths

Abiraterone Acetate 1000 mg QD + Prednisone 5 mg QD

Serious events: 10 serious events

Other events: 36 other events

Deaths: 0 deaths

Abiraterone Acetate 1000 mg QD + Prednisone 2.5 mg BID

Serious events: 11 serious events

Other events: 37 other events

Deaths: 0 deaths

Abiraterone Acetate 1000 mg QD + Dexamethasone 0.5 mg QD

Serious events: 18 serious events

Other events: 39 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Additional Information

Medical Affairs Director

Janssen Pharmaceutica N.V

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee A copy of the manuscript must be provided to the sponsor for review at least 60 days before submission for publication or presentation. If requested in writing, such publication will be withheld for up to an additional 60 days.
Publication restrictions are in place

Restriction type: OTHER