A Study of Abiraterone Acetate Plus Low-Dose Prednisone Plus Androgen Deprivation Therapy (ADT) Versus ADT Alone in Newly Diagnosed Participants With High-Risk, Metastatic Hormone-Naive Prostate Cancer (mHNPC)

• ClinicalTrials.gov Identifier: NCT01715285
• Recruitment Status: Completed
• First Posted: October 26, 2012
• Results First Posted: October 15, 2018
• Last Update Posted: March 13, 2023
• Sponsor: Janssen Research & Development, LLC
• Information provided by (Responsible Party): Janssen Research & Development, LLC

• Study Type: Interventional
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Triple (Participant, Care Provider, Investigator); Primary Purpose: Treatment
• Condition: Prostate Neoplasms
• Interventions: Drug: Abiraterone acetate; Drug: Prednisone; Other: Androgen deprivation therapy (ADT); Drug: Abiraterone acetate Placebo; Drug: Prednisone Placebo
• Enrollment: 1209

Participant Flow

Recruitment Details
Pre-assignment Details	1209 participants were enrolled and 1199 were randomized to treatment groups.10 participants from Russian site were excluded from the analysis due to noncompliance with International Conference on Harmonization Good Clinical Practice guidelines at site. The remaining 1199 randomized participants comprised the intent-to-treat population.

Arm/Group Title	Abiraterone Acetate+Prednisone+ADT	Placebo + ADT	DB Period Placebo to Open-label Extension (OLE) Abiraterone Acetate
Arm/Group Description	Participants received abiraterone acetate tablet at a total dose of 1000 milligram (mg) plus 5 mg capsule of prednisone orally once daily until disease progression, withdrawal of consent or unacceptable toxicity. Stable regimen of androgen deprivation therapy (ADT) was administered.	Participants received placebo matched to abiraterone acetate plus prednisone orally once daily until disease progression, withdrawal of consent or unacceptable toxicity. Stable regimen of ADT was administered.	Participants who were originally randomized to the Placebo group were permitted to crossover to Abiraterone Acetate plus Prednisone treatment in open-label extension phase to receive abiraterone acetate tablet at a total dose of 1000 mg plus 5 mg capsule of prednisone orally once daily until disease progression, withdrawal of consent or unacceptable toxicity.
Period Title: Double Blind Period (Up to 23 Months)
Started	597	602	0
Completed	0	0	0
Not Completed	597	602	0
Reason Not Completed
Adverse Event	53	31	0
Death	43	25	0
Lost to Follow-up	3	2	0
Physician Decision	21	23	0
Withdrawal by Subject	52	47	0
Progressive Disease	254	388	0
Noncompliance With Study Drug	4	2	0
Placebo Cross-Over	0	72	0
Other	167	12	0
Period Title: OLE Phase (Up to 15.6 Months)
Started	0	0	72 [1]
Completed	0	0	0
Not Completed	0	0	72
Reason Not Completed
Death	0	0	4
Other	0	0	60
Progressive Disease	0	0	1
Withdrawal by Subject	0	0	6
Adverse Event	0	0	1
[1] Post unblinding, participants crossed over to OLE Phase.

Baseline Characteristics

Arm/Group Title		Abiraterone Acetate+Prednisone+ADT	Placebo + ADT	Total
Arm/Group Description		Participants received abiraterone acetate tablet at a total dose of 1000 milligram (mg) plus 5 mg capsule of prednisone orally once daily until disease progression, withdrawal of consent or unacceptable toxicity. Stable regimen of androgen deprivation therapy (ADT) was administered.	Participants received placebo matched to abiraterone acetate plus prednisone orally once daily until disease progression, withdrawal of consent or unacceptable toxicity. Stable regimen of ADT was administered.	Total of all reporting groups
Overall Number of Baseline Participants		597	602	1199
Baseline Analysis Population Description		Intent-to-Treat (ITT) analysis set included all participants randomized into the study and who were classified according to their assigned treatment group, regardless of the actual treatment received. .
Age, Categorical; Measure Type: Count of Participants; Unit of measure: Participants
<=18 years	Number Analyzed	597 participants	602 participants	1199 participants
	<=18 years	0 0.0%	0 0.0%	0 0.0%
	Between 18 and 65 years	221 37.0%	233 38.7%	454 37.9%
	>=65 years	376 63.0%	369 61.3%	745 62.1%
Age, Continuous; Mean (Standard Deviation); Unit of measure: Years
	Number Analyzed	597 participants	602 participants	1199 participants
		67.3 (8.48)	66.8 (8.72)	67.1 (8.6)
Sex: Female, Male; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	597 participants	602 participants	1199 participants
	Female	0 0.0%	0 0.0%	0 0.0%
	Male	597 100.0%	602 100.0%	1199 100.0%
Region of Enrollment; Measure Type: Count of Participants; Unit of measure: Participants	Number Analyzed	597 participants	602 participants	1199 participants
Argentina		8 1.3%	8 1.3%	16 1.3%
Australia		4 0.7%	4 0.7%	8 0.7%
Belgium		6 1.0%	7 1.2%	13 1.1%
Brazil		28 4.7%	28 4.7%	56 4.7%
Bulgaria		1 0.2%	1 0.2%	2 0.2%
Canada		16 2.7%	17 2.8%	33 2.8%
Chile		3 0.5%	4 0.7%	7 0.6%
China		69 11.6%	68 11.3%	137 11.4%
Colombia		10 1.7%	7 1.2%	17 1.4%
Czech Republic		9 1.5%	7 1.2%	16 1.3%
Denmark		13 2.2%	15 2.5%	28 2.3%
Finland		4 0.7%	5 0.8%	9 0.8%
France		7 1.2%	7 1.2%	14 1.2%
Germany		4 0.7%	4 0.7%	8 0.7%
Hungary		17 2.8%	17 2.8%	34 2.8%
Israel		14 2.3%	16 2.7%	30 2.5%
Italy		19 3.2%	20 3.3%	39 3.3%
Japan		35 5.9%	35 5.8%	70 5.8%
Malaysia		4 0.7%	2 0.3%	6 0.5%
Mexico		19 3.2%	19 3.2%	38 3.2%
Netherlands		6 1.0%	4 0.7%	10 0.8%
New Zeland		6 1.0%	5 0.8%	11 0.9%
Poland		20 3.4%	22 3.7%	42 3.5%
Portugal		19 3.2%	20 3.3%	39 3.3%
Romania		22 3.7%	21 3.5%	43 3.6%
Russian Federation		89 14.9%	95 15.8%	184 15.3%
Slovakia		17 2.8%	14 2.3%	31 2.6%
South Africa		10 1.7%	10 1.7%	20 1.7%
South Korea		16 2.7%	16 2.7%	32 2.7%
Spain		16 2.7%	17 2.8%	33 2.8%
Sweden		11 1.8%	11 1.8%	22 1.8%
Turkey		18 3.0%	17 2.8%	35 2.9%
Ukraine		39 6.5%	40 6.6%	79 6.6%
United Kingdom		18 3.0%	19 3.2%	37 3.1%

Outcome Measures

1. Primary Outcome

Title	Radiographic Progression-Free Survival (PFS)
Description	Radiographic PFS was defined as the time (in months) interval from randomization to the first date of radiographic progression or death. Radiographic progression included progression by bone scan (according to modified Prostate Cancer Working Group 2 [PCWG2] criteria), defined as at least 2 new lesions on bone scan and progression of soft tissue lesions by computed tomography (CT) or magnetic resonance imaging (MRI) (according to Response Evaluation Criteria in Solid Tumors [RECIST] 1.1 criteria). As per the RECIST 1.1 guideline, progression requires a 20 percent (%) increase in the sum of diameters of all target lesions and a minimum absolute increase of 5 millimeter (mm) in the sum as compared to nadir sum of diameter.
Time Frame	Up to 44 months

Outcome Measure Data

Analysis Population Description

Intention to treat (ITT) analysis set included all subjects randomized into the study and who were classified according to their assigned treatment group, regardless of the actual treatment received.

Arm/Group Title	Abiraterone Acetate+Prednisone+ADT	Placebo + ADT
Arm/Group Description:	Participants received abiraterone acetate tablet at a total dose of 1000 milligram (mg) plus 5 mg capsule of prednisone orally once daily until disease progression, withdrawal of consent or unacceptable toxicity. Stable regimen of androgen deprivation therapy (ADT) was administered.	Participants received placebo matched to abiraterone acetate plus prednisone orally once daily until disease progression, withdrawal of consent or unacceptable toxicity. Stable regimen of ADT was administered.
Overall Number of Participants Analyzed	597	602
Median (95% Confidence Interval); Unit of Measure: Months
	33.02 [1]; (29.57 to NA)	14.78; (14.69 to 18.27)

[1]

Here 'NA' represents that upper limit of 95% CI was not estimable due to lesser number of events.

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Abiraterone Acetate+Prednisone+ADT, Placebo + ADT
	Comments	[Not Specified]
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.0001
	Comments	[Not Specified]
	Method	Log Rank
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Hazard Ratio (HR)
	Estimated Value	0.466
	Confidence Interval	(2-Sided) 95%; 0.394 to 0.550
	Estimation Comments	[Not Specified]

2. Primary Outcome

Title	Overall Survival (OS)
Description	Overall survival was defined as the time from randomization to date of death from any cause.
Time Frame	Up to 66 months

Outcome Measure Data

Analysis Population Description

ITT analysis set included all subjects randomized into the study and who were classified according to their assigned treatment group, regardless of the actual treatment received.

Arm/Group Title	Abiraterone Acetate+Prednisone+ADT	Placebo + ADT
Arm/Group Description:	Participants received abiraterone acetate tablet at a total dose of 1000 milligram (mg) plus 5 mg capsule of prednisone orally once daily until disease progression, withdrawal of consent or unacceptable toxicity. Stable regimen of androgen deprivation therapy (ADT) was administered.	Participants received placebo matched to abiraterone acetate plus prednisone orally once daily until disease progression, withdrawal of consent or unacceptable toxicity. Stable regimen of ADT was administered.
Overall Number of Participants Analyzed	597	602
Median (95% Confidence Interval); Unit of Measure: months
	53.32 [1]; (48.23 to NA)	36.53; (33.54 to 39.95)

[1]

Here 'NA' represents that upper limit of 95% CI was not estimable due to lesser number of events.

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Abiraterone Acetate+Prednisone+ADT, Placebo + ADT
	Comments	[Not Specified]
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	< 0.0001
	Comments	[Not Specified]
	Method	Log Rank
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Hazard Ratio (HR)
	Estimated Value	0.661
	Confidence Interval	(2-Sided) 95%; 0.564 to 0.775
	Estimation Comments	[Not Specified]

3. Secondary Outcome

Title	Time to Initiation of Chemotherapy
Description	Time to initiation of chemotherapy was defined as the time (in months) interval from the date of randomization to the date of initiation of cytotoxic chemotherapy for prostate cancer.
Time Frame	Up to 66 months

Outcome Measure Data

Analysis Population Description

ITT analysis set included all subjects randomized into the study and who were classified according to their assigned treatment group, regardless of the actual treatment received.

Arm/Group Title	Abiraterone Acetate+Prednisone+ADT	Placebo + ADT
Arm/Group Description:	Participants received abiraterone acetate tablet at a total dose of 1000 milligram (mg) plus 5 mg capsule of prednisone orally once daily until disease progression, withdrawal of consent or unacceptable toxicity. Stable regimen of androgen deprivation therapy (ADT) was administered.	Participants received placebo matched to abiraterone acetate plus prednisone orally once daily until disease progression, withdrawal of consent or unacceptable toxicity. Stable regimen of ADT was administered.
Overall Number of Participants Analyzed	597	602
Median (95% Confidence Interval); Unit of Measure: months
	NA [1]; (62.62 to NA)	57.59 [2]; (38.18 to NA)

[1]

Here, 'NA' indicates that the median and upper limit of 95% CI was not estimated due to lesser number of events.

[2]

Here, 'NA' indicates that the upper limit of 95% CI was not estimated due to lesser number of events.

4. Secondary Outcome

Title	Time to Subsequent Therapy for Prostate Cancer
Description	Time to subsequent therapy was defined as the time (in months) interval from the date of randomization to the date of initiation of subsequent therapy for prostate cancer.
Time Frame	Up to 66 months

Outcome Measure Data

Analysis Population Description

ITT analysis set included all subjects randomized into the study and who were classified according to their assigned treatment group, regardless of the actual treatment received.

Arm/Group Title	Abiraterone Acetate+Prednisone+ADT	Placebo + ADT
Arm/Group Description:	Participants received abiraterone acetate tablet at a total dose of 1000 milligram (mg) plus 5 mg capsule of prednisone orally once daily until disease progression, withdrawal of consent or unacceptable toxicity. Stable regimen of androgen deprivation therapy (ADT) was administered.	Participants received placebo matched to abiraterone acetate plus prednisone orally once daily until disease progression, withdrawal of consent or unacceptable toxicity. Stable regimen of ADT was administered.
Overall Number of Participants Analyzed	597	602
Median (95% Confidence Interval); Unit of Measure: Months
	54.87 [1]; (46.42 to NA)	21.22; (18.56 to 23.49)

[1]

Here 'NA' indicates that the upper limit of 95% CI was not estimated due to lesser number of events.

5. Secondary Outcome

Title	Time to Pain Progression
Description	Time to pain progression was defined as the time (in months) interval from randomization to the first date a participant experienced a greater than or equal to (>=) 30 percent (%) increase in Brief Pain Inventory-Short Form (BPI-SF) from baseline in the BPI-SF worst pain intensity (Item 3) observed at 2 consecutive evaluations (>=4) weeks apart. BPI-SF was an 11-item questionnaire, designed to assess severity and impact of pain on daily functions. Total score ranged from 0 to 10 with 0 representing "no pain" and 10 representing" pain as bad as you can imagine.
Time Frame	Up to 66 months

Outcome Measure Data

Analysis Population Description

ITT analysis set included all subjects randomized into the study and who were classified according to their assigned treatment group, regardless of the actual treatment received.

Arm/Group Title	Abiraterone Acetate+Prednisone+ADT	Placebo + ADT
Arm/Group Description:	Participants received abiraterone acetate tablet at a total dose of 1000 milligram (mg) plus 5 mg capsule of prednisone orally once daily until disease progression, withdrawal of consent or unacceptable toxicity. Stable regimen of androgen deprivation therapy (ADT) was administered.	Participants received placebo matched to abiraterone acetate plus prednisone orally once daily until disease progression, withdrawal of consent or unacceptable toxicity. Stable regimen of ADT was administered.
Overall Number of Participants Analyzed	597	602
Median (95% Confidence Interval); Unit of Measure: Months
	47.41 [1]; (33.15 to NA)	16.62; (11.07 to 23.95)

[1]

Here 'NA' represents that upper limit of 95% CI was not estimable due to lesser number of events.

6. Secondary Outcome

Title	Time to Skeletal-Related Event
Description	Time to skeletal-related event was defined as the earliest of the following: clinical or pathological fracture, spinal cord compression, palliative radiation to bone, or surgery to bone.
Time Frame	Up to 66 months

Outcome Measure Data

Analysis Population Description

ITT analysis set included all subjects randomized into the study and who were classified according to their assigned treatment group, regardless of the actual treatment received.

Arm/Group Title	Abiraterone Acetate+Prednisone+ADT	Placebo + ADT
Arm/Group Description:	Participants received abiraterone acetate tablet at a total dose of 1000 milligram (mg) plus 5 mg capsule of prednisone orally once daily until disease progression, withdrawal of consent or unacceptable toxicity. Stable regimen of androgen deprivation therapy (ADT) was administered.	Participants received placebo matched to abiraterone acetate plus prednisone orally once daily until disease progression, withdrawal of consent or unacceptable toxicity. Stable regimen of ADT was administered.
Overall Number of Participants Analyzed	597	602
Median (95% Confidence Interval); Unit of Measure: months
	NA [1]; (NA to NA)	NA [1]; (NA to NA)

[1]

Here 'NA' represents that median, upper limit and lower limit of 95% CI was not estimable due to lesser number of events.

7. Secondary Outcome

Title	Time to Prostate-Specific Antigen (PSA) Progression
Description	Time to PSA progression was defined as the time (in months) interval from the date of randomization to the date of PSA progression, according to PCWG2 criteria. 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.
Time Frame	Up to 66 months

Outcome Measure Data

Analysis Population Description

ITT analysis set included all subjects randomized into the study and who were classified according to their assigned treatment group, regardless of the actual treatment received.

Arm/Group Title	Abiraterone Acetate+Prednisone+ADT	Placebo + ADT
Arm/Group Description:	Participants received abiraterone acetate tablet at a total dose of 1000 milligram (mg) plus 5 mg capsule of prednisone orally once daily until disease progression, withdrawal of consent or unacceptable toxicity. Stable regimen of androgen deprivation therapy (ADT) was administered.	Participants received placebo matched to abiraterone acetate plus prednisone orally once daily until disease progression, withdrawal of consent or unacceptable toxicity. Stable regimen of ADT was administered.
Overall Number of Participants Analyzed	597	602
Median (95% Confidence Interval); Unit of Measure: Months
	33.31; (29.44 to 46.09)	7.43; (7.20 to 9.20)

Adverse Events

Time Frame	From Day 1 up to 30 days post last dose (that is, for DB period: up to 23 months and OLE period: up to 15.6 months), deaths were collected from baseline up to end of study (up to 66 months).
Adverse Event Reporting Description	Safety analysis set included all participants randomized into the study and who received any part of study drug. Only 72 deaths out of all cause mortalities contributed to discontinuation.
Arm/Group Title	Abiraterone Acetate+Prednisone+ADT	Placebo + ADT	DB Period Placebo to Open-label Extension (OLE) Abiraterone Acetate
Arm/Group Description	Participants received abiraterone acetate tablet at a total dose of 1000 milligram (mg) plus 5 mg capsule of prednisone orally once daily until disease progression, withdrawal of consent or unacceptable toxicity. Stable regimen of androgen deprivation therapy (ADT) was administered.	Participants received placebo matched to abiraterone acetate plus prednisone orally once daily until disease progression, withdrawal of consent or unacceptable toxicity. Stable regimen of ADT was administered.	Participants who were originally randomized to the Placebo group were permitted to crossover to Abiraterone Acetate plus Prednisone treatment in open-label extension phase to receive abiraterone acetate tablet at a total dose of 1000 mg plus 5 mg capsule of prednisone orally once daily until disease progression, withdrawal of consent or unacceptable toxicity.
All-Cause Mortality
	Abiraterone Acetate+Prednisone+ADT	Placebo + ADT	DB Period Placebo to Open-label Extension (OLE) Abiraterone Acetate
	Affected / at Risk (%)	Affected / at Risk (%)	Affected / at Risk (%)
Total	275/597 (46.06%)	339/602 (56.31%)	4/72 (5.56%)
Serious Adverse Events
	Abiraterone Acetate+Prednisone+ADT	Placebo + ADT	DB Period Placebo to Open-label Extension (OLE) Abiraterone Acetate
	Affected / at Risk (%)	Affected / at Risk (%)	Affected / at Risk (%)
Total	192/597 (32.16%)	151/602 (25.08%)	4/72 (5.56%)
Blood and lymphatic system disorders
Anaemia * 1	6/597 (1.01%)	6/602 (1.00%)	1/72 (1.39%)
Lymphadenitis * 1	0/597 (0.00%)	1/602 (0.17%)	0/72 (0.00%)
Lymphadenopathy * 1	0/597 (0.00%)	1/602 (0.17%)	0/72 (0.00%)
Neutropenia * 1	0/597 (0.00%)	1/602 (0.17%)	0/72 (0.00%)
Thrombocytopenia * 1	2/597 (0.34%)	0/602 (0.00%)	0/72 (0.00%)
Cardiac disorders
Acute Coronary Syndrome * 1	5/597 (0.84%)	0/602 (0.00%)	0/72 (0.00%)
Acute Myocardial Infarction * 1	1/597 (0.17%)	0/602 (0.00%)	0/72 (0.00%)
Angina Pectoris * 1	3/597 (0.50%)	0/602 (0.00%)	0/72 (0.00%)
Atrial Fibrillation * 1	2/597 (0.34%)	0/602 (0.00%)	0/72 (0.00%)
Atrial Flutter * 1	2/597 (0.34%)	0/602 (0.00%)	0/72 (0.00%)
Cardiac Failure * 1	3/597 (0.50%)	0/602 (0.00%)	0/72 (0.00%)
Cardiac Failure Acute * 1	2/597 (0.34%)	0/602 (0.00%)	0/72 (0.00%)
Cardiac Failure Chronic * 1	1/597 (0.17%)	0/602 (0.00%)	0/72 (0.00%)
Coronary Artery Disease * 1	1/597 (0.17%)	0/602 (0.00%)	0/72 (0.00%)
Mitral Valve Incompetence * 1	1/597 (0.17%)	0/602 (0.00%)	0/72 (0.00%)
Myocardial Infarction * 1	3/597 (0.50%)	0/602 (0.00%)	0/72 (0.00%)
Myocardial Ischaemia * 1	1/597 (0.17%)	1/602 (0.17%)	0/72 (0.00%)
Pericardial Effusion * 1	0/597 (0.00%)	1/602 (0.17%)	0/72 (0.00%)
Sinus Node Dysfunction * 1	1/597 (0.17%)	0/602 (0.00%)	0/72 (0.00%)
Congenital, familial and genetic disorders
Phimosis * 1	1/597 (0.17%)	0/602 (0.00%)	0/72 (0.00%)
Eye disorders
Cataract * 1	1/597 (0.17%)	0/602 (0.00%)	0/72 (0.00%)
Glaucoma * 1	1/597 (0.17%)	0/602 (0.00%)	0/72 (0.00%)
Gastrointestinal disorders
Abdominal Mass * 1	0/597 (0.00%)	1/602 (0.17%)	0/72 (0.00%)
Abdominal Pain * 1	0/597 (0.00%)	3/602 (0.50%)	0/72 (0.00%)
Constipation * 1	1/597 (0.17%)	4/602 (0.66%)	0/72 (0.00%)
Dental Caries * 1	0/597 (0.00%)	1/602 (0.17%)	0/72 (0.00%)
Duodenal Ulcer * 1	1/597 (0.17%)	0/602 (0.00%)	0/72 (0.00%)
Duodenitis * 1	0/597 (0.00%)	1/602 (0.17%)	0/72 (0.00%)
Gastric Ulcer * 1	0/597 (0.00%)	1/602 (0.17%)	0/72 (0.00%)
Gastric Ulcer Perforation * 1	1/597 (0.17%)	0/602 (0.00%)	0/72 (0.00%)
Gastritis * 1	0/597 (0.00%)	0/602 (0.00%)	1/72 (1.39%)
Gastrointestinal Haemorrhage * 1	2/597 (0.34%)	0/602 (0.00%)	0/72 (0.00%)
Inguinal Hernia * 1	1/597 (0.17%)	0/602 (0.00%)	0/72 (0.00%)
Intestinal Haemorrhage * 1	2/597 (0.34%)	0/602 (0.00%)	0/72 (0.00%)
Intestinal Ischaemia * 1	1/597 (0.17%)	0/602 (0.00%)	0/72 (0.00%)
Intestinal Obstruction * 1	1/597 (0.17%)	0/602 (0.00%)	0/72 (0.00%)
Mouth Haemorrhage * 1	1/597 (0.17%)	0/602 (0.00%)	0/72 (0.00%)
Nausea * 1	2/597 (0.34%)	0/602 (0.00%)	0/72 (0.00%)
Peptic Ulcer * 1	1/597 (0.17%)	0/602 (0.00%)	0/72 (0.00%)
Rectal Haemorrhage * 1	0/597 (0.00%)	1/602 (0.17%)	0/72 (0.00%)
Rectal Polyp * 1	1/597 (0.17%)	0/602 (0.00%)	0/72 (0.00%)
Vomiting * 1	2/597 (0.34%)	1/602 (0.17%)	0/72 (0.00%)
General disorders
Asthenia * 1	0/597 (0.00%)	1/602 (0.17%)	0/72 (0.00%)
Chest Pain * 1	0/597 (0.00%)	1/602 (0.17%)	0/72 (0.00%)
Device Dislocation * 1	1/597 (0.17%)	0/602 (0.00%)	0/72 (0.00%)
General Physical Health Deterioration * 1	2/597 (0.34%)	1/602 (0.17%)	0/72 (0.00%)
Hernia Pain * 1	0/597 (0.00%)	1/602 (0.17%)	0/72 (0.00%)
Multi-Organ Failure * 1	1/597 (0.17%)	1/602 (0.17%)	0/72 (0.00%)
Non-Cardiac Chest Pain * 1	0/597 (0.00%)	2/602 (0.33%)	0/72 (0.00%)
Oedema Peripheral * 1	0/597 (0.00%)	1/602 (0.17%)	0/72 (0.00%)
Pain * 1	0/597 (0.00%)	3/602 (0.50%)	0/72 (0.00%)
Peripheral Swelling * 1	0/597 (0.00%)	1/602 (0.17%)	0/72 (0.00%)
Pyrexia * 1	6/597 (1.01%)	2/602 (0.33%)	0/72 (0.00%)
Hepatobiliary disorders
Bile Duct Stone * 1	1/597 (0.17%)	0/602 (0.00%)	0/72 (0.00%)
Hepatitis Toxic * 1	1/597 (0.17%)	0/602 (0.00%)	0/72 (0.00%)
Hepatobiliary Disease * 1	1/597 (0.17%)	0/602 (0.00%)	0/72 (0.00%)
Hepatocellular Injury * 1	1/597 (0.17%)	0/602 (0.00%)	0/72 (0.00%)
Hypertransaminasaemia * 1	1/597 (0.17%)	0/602 (0.00%)	0/72 (0.00%)
Jaundice * 1	1/597 (0.17%)	0/602 (0.00%)	0/72 (0.00%)
Immune system disorders
Anaphylactic Reaction * 1	0/597 (0.00%)	1/602 (0.17%)	0/72 (0.00%)
Infections and infestations
Appendicitis * 1	1/597 (0.17%)	0/602 (0.00%)	0/72 (0.00%)
Bronchitis * 1	4/597 (0.67%)	0/602 (0.00%)	0/72 (0.00%)
Bronchopneumonia * 1	3/597 (0.50%)	1/602 (0.17%)	0/72 (0.00%)
Bursitis Infective * 1	0/597 (0.00%)	1/602 (0.17%)	0/72 (0.00%)
Cellulitis * 1	1/597 (0.17%)	0/602 (0.00%)	0/72 (0.00%)
Cellulitis Orbital * 1	0/597 (0.00%)	1/602 (0.17%)	0/72 (0.00%)
Cystitis * 1	1/597 (0.17%)	0/602 (0.00%)	0/72 (0.00%)
Device Related Infection * 1	0/597 (0.00%)	1/602 (0.17%)	0/72 (0.00%)
Erysipelas * 1	0/597 (0.00%)	1/602 (0.17%)	0/72 (0.00%)
Eye Infection * 1	1/597 (0.17%)	0/602 (0.00%)	0/72 (0.00%)
Fungaemia * 1	0/597 (0.00%)	1/602 (0.17%)	0/72 (0.00%)
Gangrene * 1	1/597 (0.17%)	0/602 (0.00%)	0/72 (0.00%)
Gastroenteritis * 1	1/597 (0.17%)	0/602 (0.00%)	0/72 (0.00%)
Gastrointestinal Infection * 1	1/597 (0.17%)	0/602 (0.00%)	0/72 (0.00%)
Herpes Zoster * 1	2/597 (0.34%)	0/602 (0.00%)	0/72 (0.00%)
Infection * 1	0/597 (0.00%)	1/602 (0.17%)	0/72 (0.00%)
Localised Infection * 1	1/597 (0.17%)	0/602 (0.00%)	0/72 (0.00%)
Lower Respiratory Tract Infection * 1	1/597 (0.17%)	0/602 (0.00%)	0/72 (0.00%)
Lung Infection * 1	1/597 (0.17%)	0/602 (0.00%)	0/72 (0.00%)
Nasopharyngitis * 1	0/597 (0.00%)	1/602 (0.17%)	0/72 (0.00%)
Orchitis * 1	1/597 (0.17%)	0/602 (0.00%)	0/72 (0.00%)
Osteomyelitis * 1	1/597 (0.17%)	0/602 (0.00%)	0/72 (0.00%)
Osteomyelitis Acute * 1	0/597 (0.00%)	0/602 (0.00%)	1/72 (1.39%)
Otitis Media * 1	0/597 (0.00%)	1/602 (0.17%)	0/72 (0.00%)
Pneumonia * 1	12/597 (2.01%)	2/602 (0.33%)	0/72 (0.00%)
Pyelonephritis * 1	1/597 (0.17%)	1/602 (0.17%)	0/72 (0.00%)
Pyelonephritis Acute * 1	1/597 (0.17%)	2/602 (0.33%)	0/72 (0.00%)
Pyelonephritis Chronic * 1	0/597 (0.00%)	1/602 (0.17%)	0/72 (0.00%)
Respiratory Tract Infection * 1	1/597 (0.17%)	0/602 (0.00%)	0/72 (0.00%)
Sepsis * 1	1/597 (0.17%)	2/602 (0.33%)	0/72 (0.00%)
Sinusitis * 1	0/597 (0.00%)	1/602 (0.17%)	0/72 (0.00%)
Spinal Cord Infection * 1	0/597 (0.00%)	1/602 (0.17%)	0/72 (0.00%)
Staphylococcal Sepsis * 1	1/597 (0.17%)	0/602 (0.00%)	0/72 (0.00%)
Urinary Tract Infection * 1	8/597 (1.34%)	5/602 (0.83%)	0/72 (0.00%)
Urosepsis * 1	1/597 (0.17%)	1/602 (0.17%)	0/72 (0.00%)
Injury, poisoning and procedural complications
Femoral Neck Fracture * 1	2/597 (0.34%)	1/602 (0.17%)	0/72 (0.00%)
Femur Fracture * 1	2/597 (0.34%)	1/602 (0.17%)	0/72 (0.00%)
Fracture * 1	0/597 (0.00%)	1/602 (0.17%)	0/72 (0.00%)
Head Injury * 1	1/597 (0.17%)	0/602 (0.00%)	0/72 (0.00%)
Hip Fracture * 1	2/597 (0.34%)	0/602 (0.00%)	0/72 (0.00%)
Kidney Rupture * 1	0/597 (0.00%)	1/602 (0.17%)	0/72 (0.00%)
Laceration * 1	1/597 (0.17%)	0/602 (0.00%)	0/72 (0.00%)
Ligament Sprain * 1	1/597 (0.17%)	0/602 (0.00%)	0/72 (0.00%)
Lower Limb Fracture * 1	0/597 (0.00%)	1/602 (0.17%)	0/72 (0.00%)
Lumbar Vertebral Fracture * 1	0/597 (0.00%)	2/602 (0.33%)	0/72 (0.00%)
Patella Fracture * 1	1/597 (0.17%)	0/602 (0.00%)	0/72 (0.00%)
Pneumothorax Traumatic * 1	0/597 (0.00%)	1/602 (0.17%)	0/72 (0.00%)
Post Procedural Haematoma * 1	0/597 (0.00%)	1/602 (0.17%)	0/72 (0.00%)
Procedural Pain * 1	0/597 (0.00%)	1/602 (0.17%)	0/72 (0.00%)
Pubis Fracture * 1	0/597 (0.00%)	1/602 (0.17%)	0/72 (0.00%)
Spinal Compression Fracture * 1	0/597 (0.00%)	2/602 (0.33%)	0/72 (0.00%)
Thermal Burn * 1	0/597 (0.00%)	1/602 (0.17%)	0/72 (0.00%)
Traumatic Fracture * 1	1/597 (0.17%)	0/602 (0.00%)	0/72 (0.00%)
Traumatic Intracranial Haemorrhage * 1	0/597 (0.00%)	1/602 (0.17%)	0/72 (0.00%)
Upper Limb Fracture * 1	1/597 (0.17%)	0/602 (0.00%)	0/72 (0.00%)
Investigations
Alanine Aminotransferase Increased * 1	2/597 (0.34%)	0/602 (0.00%)	0/72 (0.00%)
Aspartate Aminotransferase Increased * 1	2/597 (0.34%)	0/602 (0.00%)	0/72 (0.00%)
Biopsy Liver * 1	1/597 (0.17%)	0/602 (0.00%)	0/72 (0.00%)
Blood Glucose Abnormal * 1	0/597 (0.00%)	1/602 (0.17%)	0/72 (0.00%)
Blood Testosterone Increased * 1	0/597 (0.00%)	1/602 (0.17%)	0/72 (0.00%)
Platelet Count Decreased * 1	0/597 (0.00%)	1/602 (0.17%)	0/72 (0.00%)
Metabolism and nutrition disorders
Dehydration * 1	2/597 (0.34%)	0/602 (0.00%)	0/72 (0.00%)
Diabetes Mellitus * 1	0/597 (0.00%)	1/602 (0.17%)	1/72 (1.39%)
Hyperglycaemia * 1	4/597 (0.67%)	1/602 (0.17%)	0/72 (0.00%)
Hypokalaemia * 1	5/597 (0.84%)	0/602 (0.00%)	0/72 (0.00%)
Metabolic Syndrome * 1	0/597 (0.00%)	1/602 (0.17%)	0/72 (0.00%)
Musculoskeletal and connective tissue disorders
Arthralgia * 1	2/597 (0.34%)	4/602 (0.66%)	0/72 (0.00%)
Back Pain * 1	5/597 (0.84%)	10/602 (1.66%)	0/72 (0.00%)
Bone Pain * 1	8/597 (1.34%)	6/602 (1.00%)	0/72 (0.00%)
Gouty Arthritis * 1	1/597 (0.17%)	0/602 (0.00%)	0/72 (0.00%)
Muscular Weakness * 1	2/597 (0.34%)	3/602 (0.50%)	0/72 (0.00%)
Musculoskeletal Chest Pain * 1	1/597 (0.17%)	0/602 (0.00%)	0/72 (0.00%)
Musculoskeletal Pain * 1	0/597 (0.00%)	1/602 (0.17%)	0/72 (0.00%)
Osteoarthritis * 1	0/597 (0.00%)	2/602 (0.33%)	0/72 (0.00%)
Osteonecrosis of Jaw * 1	1/597 (0.17%)	1/602 (0.17%)	0/72 (0.00%)
Pain in Extremity * 1	2/597 (0.34%)	2/602 (0.33%)	0/72 (0.00%)
Pain in Jaw * 1	1/597 (0.17%)	0/602 (0.00%)	0/72 (0.00%)
Pathological Fracture * 1	2/597 (0.34%)	0/602 (0.00%)	0/72 (0.00%)
Spinal Column Stenosis * 1	1/597 (0.17%)	2/602 (0.33%)	0/72 (0.00%)
Spondylitis * 1	1/597 (0.17%)	0/602 (0.00%)	0/72 (0.00%)
Trismus * 1	1/597 (0.17%)	0/602 (0.00%)	0/72 (0.00%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenocarcinoma of Colon * 1	0/597 (0.00%)	1/602 (0.17%)	0/72 (0.00%)
B-Cell Lymphoma * 1	0/597 (0.00%)	1/602 (0.17%)	0/72 (0.00%)
Bladder Neoplasm * 1	1/597 (0.17%)	0/602 (0.00%)	0/72 (0.00%)
Bladder Transitional Cell Carcinoma * 1	1/597 (0.17%)	0/602 (0.00%)	0/72 (0.00%)
Cancer Pain * 1	2/597 (0.34%)	0/602 (0.00%)	0/72 (0.00%)
Chronic Lymphocytic Leukaemia * 1	1/597 (0.17%)	0/602 (0.00%)	0/72 (0.00%)
Chronic Lymphocytic Leukaemia Stage 3 * 1	1/597 (0.17%)	0/602 (0.00%)	0/72 (0.00%)
Chronic Myeloid Leukaemia * 1	1/597 (0.17%)	0/602 (0.00%)	0/72 (0.00%)
Colon Cancer * 1	1/597 (0.17%)	0/602 (0.00%)	0/72 (0.00%)
Colon Neoplasm * 1	0/597 (0.00%)	1/602 (0.17%)	0/72 (0.00%)
Lentigo Maligna * 1	1/597 (0.17%)	0/602 (0.00%)	0/72 (0.00%)
Leukaemia * 1	1/597 (0.17%)	0/602 (0.00%)	0/72 (0.00%)
Lung Adenocarcinoma * 1	0/597 (0.00%)	1/602 (0.17%)	0/72 (0.00%)
Malignant Melanoma * 1	1/597 (0.17%)	0/602 (0.00%)	0/72 (0.00%)
Malignant Neoplasm of Renal Pelvis * 1	1/597 (0.17%)	0/602 (0.00%)	0/72 (0.00%)
Metastases to Meninges * 1	1/597 (0.17%)	0/602 (0.00%)	0/72 (0.00%)
Neoplasm Malignant * 1	0/597 (0.00%)	1/602 (0.17%)	0/72 (0.00%)
Neoplasm of Thymus * 1	0/597 (0.00%)	1/602 (0.17%)	0/72 (0.00%)
Neuroendocrine Tumour * 1	0/597 (0.00%)	1/602 (0.17%)	0/72 (0.00%)
Oesophageal Carcinoma * 1	1/597 (0.17%)	0/602 (0.00%)	0/72 (0.00%)
Plasma Cell Myeloma * 1	1/597 (0.17%)	0/602 (0.00%)	0/72 (0.00%)
Rectal Cancer * 1	1/597 (0.17%)	0/602 (0.00%)	0/72 (0.00%)
Transitional Cell Carcinoma * 1	1/597 (0.17%)	0/602 (0.00%)	0/72 (0.00%)
Nervous system disorders
Balance Disorder * 1	0/597 (0.00%)	1/602 (0.17%)	0/72 (0.00%)
Brain Compression * 1	0/597 (0.00%)	1/602 (0.17%)	0/72 (0.00%)
Carotid Artery Stenosis * 1	0/597 (0.00%)	1/602 (0.17%)	0/72 (0.00%)
Cerebral Haemorrhage * 1	2/597 (0.34%)	0/602 (0.00%)	0/72 (0.00%)
Cerebral Infarction * 1	1/597 (0.17%)	1/602 (0.17%)	0/72 (0.00%)
Cerebral Ischaemia * 1	0/597 (0.00%)	2/602 (0.33%)	0/72 (0.00%)
Cerebrovascular Accident * 1	2/597 (0.34%)	3/602 (0.50%)	0/72 (0.00%)
Cognitive Disorder * 1	0/597 (0.00%)	1/602 (0.17%)	0/72 (0.00%)
Coma * 1	1/597 (0.17%)	0/602 (0.00%)	0/72 (0.00%)
Dizziness * 1	0/597 (0.00%)	1/602 (0.17%)	0/72 (0.00%)
Dysarthria * 1	1/597 (0.17%)	0/602 (0.00%)	0/72 (0.00%)
Epilepsy * 1	1/597 (0.17%)	1/602 (0.17%)	0/72 (0.00%)
Guillain-Barre Syndrome * 1	1/597 (0.17%)	0/602 (0.00%)	0/72 (0.00%)
Haemorrhagic Stroke * 1	1/597 (0.17%)	0/602 (0.00%)	0/72 (0.00%)
Ischaemic Stroke * 1	1/597 (0.17%)	1/602 (0.17%)	0/72 (0.00%)
Lacunar Infarction * 1	1/597 (0.17%)	0/602 (0.00%)	0/72 (0.00%)
Loss of Consciousness * 1	2/597 (0.34%)	0/602 (0.00%)	0/72 (0.00%)
Myasthenia Gravis * 1	0/597 (0.00%)	1/602 (0.17%)	0/72 (0.00%)
Nerve Compression * 1	0/597 (0.00%)	1/602 (0.17%)	0/72 (0.00%)
Neuralgia * 1	1/597 (0.17%)	0/602 (0.00%)	0/72 (0.00%)
Optic Nerve Compression * 1	0/597 (0.00%)	1/602 (0.17%)	0/72 (0.00%)
Paraparesis * 1	0/597 (0.00%)	3/602 (0.50%)	0/72 (0.00%)
Paraplegia * 1	2/597 (0.34%)	1/602 (0.17%)	0/72 (0.00%)
Presyncope * 1	0/597 (0.00%)	1/602 (0.17%)	0/72 (0.00%)
Radiculitis * 1	0/597 (0.00%)	1/602 (0.17%)	0/72 (0.00%)
Sciatica * 1	1/597 (0.17%)	1/602 (0.17%)	0/72 (0.00%)
Speech Disorder * 1	0/597 (0.00%)	1/602 (0.17%)	0/72 (0.00%)
Spinal Cord Compression * 1	11/597 (1.84%)	11/602 (1.83%)	0/72 (0.00%)
Syncope * 1	2/597 (0.34%)	1/602 (0.17%)	0/72 (0.00%)
Transient Ischaemic Attack * 1	2/597 (0.34%)	1/602 (0.17%)	0/72 (0.00%)
Vascular Encephalopathy * 1	0/597 (0.00%)	1/602 (0.17%)	0/72 (0.00%)
Psychiatric disorders
Confusional State * 1	0/597 (0.00%)	1/602 (0.17%)	0/72 (0.00%)
Mental Disorder * 1	0/597 (0.00%)	1/602 (0.17%)	0/72 (0.00%)
Renal and urinary disorders
Acute Kidney Injury * 1	1/597 (0.17%)	2/602 (0.33%)	0/72 (0.00%)
Bladder Outlet Obstruction * 1	0/597 (0.00%)	1/602 (0.17%)	0/72 (0.00%)
Calculus Bladder * 1	0/597 (0.00%)	2/602 (0.33%)	0/72 (0.00%)
Calculus Ureteric * 1	1/597 (0.17%)	1/602 (0.17%)	0/72 (0.00%)
Chronic Kidney Disease * 1	1/597 (0.17%)	0/602 (0.00%)	0/72 (0.00%)
Dysuria * 1	2/597 (0.34%)	2/602 (0.33%)	0/72 (0.00%)
Haematuria * 1	8/597 (1.34%)	3/602 (0.50%)	0/72 (0.00%)
Hydronephrosis * 1	2/597 (0.34%)	2/602 (0.33%)	0/72 (0.00%)
Lower Urinary Tract Symptoms * 1	1/597 (0.17%)	2/602 (0.33%)	0/72 (0.00%)
Micturition Urgency * 1	0/597 (0.00%)	2/602 (0.33%)	0/72 (0.00%)
Pollakiuria * 1	1/597 (0.17%)	1/602 (0.17%)	0/72 (0.00%)
Renal Failure * 1	3/597 (0.50%)	1/602 (0.17%)	0/72 (0.00%)
Renal Injury * 1	1/597 (0.17%)	0/602 (0.00%)	0/72 (0.00%)
Ureteric Obstruction * 1	1/597 (0.17%)	0/602 (0.00%)	0/72 (0.00%)
Urethral Haemorrhage * 1	0/597 (0.00%)	1/602 (0.17%)	0/72 (0.00%)
Urethral Stenosis * 1	1/597 (0.17%)	0/602 (0.00%)	0/72 (0.00%)
Urinary Retention * 1	10/597 (1.68%)	11/602 (1.83%)	0/72 (0.00%)
Urinary Tract Obstruction * 1	3/597 (0.50%)	3/602 (0.50%)	0/72 (0.00%)
Reproductive system and breast disorders
Benign Prostatic Hyperplasia * 1	1/597 (0.17%)	0/602 (0.00%)	0/72 (0.00%)
Pelvic Pain * 1	0/597 (0.00%)	1/602 (0.17%)	0/72 (0.00%)
Prostatic Haemorrhage * 1	1/597 (0.17%)	0/602 (0.00%)	0/72 (0.00%)
Prostatitis * 1	0/597 (0.00%)	1/602 (0.17%)	0/72 (0.00%)
Respiratory, thoracic and mediastinal disorders
Bronchiectasis * 1	0/597 (0.00%)	1/602 (0.17%)	0/72 (0.00%)
Bronchitis Chronic * 1	1/597 (0.17%)	0/602 (0.00%)	0/72 (0.00%)
Bronchospasm * 1	1/597 (0.17%)	0/602 (0.00%)	0/72 (0.00%)
Chronic Obstructive Pulmonary Disease * 1	1/597 (0.17%)	1/602 (0.17%)	0/72 (0.00%)
Dysphonia * 1	1/597 (0.17%)	0/602 (0.00%)	0/72 (0.00%)
Dyspnoea * 1	1/597 (0.17%)	3/602 (0.50%)	0/72 (0.00%)
Emphysema * 1	1/597 (0.17%)	0/602 (0.00%)	0/72 (0.00%)
Epistaxis * 1	0/597 (0.00%)	1/602 (0.17%)	0/72 (0.00%)
Oropharyngeal Pain * 1	1/597 (0.17%)	0/602 (0.00%)	0/72 (0.00%)
Pleural Effusion * 1	0/597 (0.00%)	4/602 (0.66%)	0/72 (0.00%)
Pneumonia Aspiration * 1	1/597 (0.17%)	0/602 (0.00%)	0/72 (0.00%)
Pneumonitis * 1	1/597 (0.17%)	0/602 (0.00%)	0/72 (0.00%)
Pulmonary Embolism * 1	1/597 (0.17%)	1/602 (0.17%)	0/72 (0.00%)
Pulmonary Mass * 1	0/597 (0.00%)	1/602 (0.17%)	0/72 (0.00%)
Pulmonary Oedema * 1	0/597 (0.00%)	1/602 (0.17%)	0/72 (0.00%)
Respiratory Failure * 1	0/597 (0.00%)	1/602 (0.17%)	0/72 (0.00%)
Skin and subcutaneous tissue disorders
Skin Lesion * 1	1/597 (0.17%)	0/602 (0.00%)	0/72 (0.00%)
Surgical and medical procedures
Lipoma Excision * 1	1/597 (0.17%)	0/602 (0.00%)	0/72 (0.00%)
Vascular disorders
Angiopathy * 1	0/597 (0.00%)	1/602 (0.17%)	0/72 (0.00%)
Aortic Aneurysm * 1	1/597 (0.17%)	0/602 (0.00%)	0/72 (0.00%)
Aortic Dissection * 1	0/597 (0.00%)	1/602 (0.17%)	0/72 (0.00%)
Blood Pressure Fluctuation * 1	1/597 (0.17%)	0/602 (0.00%)	0/72 (0.00%)
Deep Vein Thrombosis * 1	4/597 (0.67%)	4/602 (0.66%)	0/72 (0.00%)
Embolism * 1	0/597 (0.00%)	1/602 (0.17%)	0/72 (0.00%)
Hypertension * 1	2/597 (0.34%)	2/602 (0.33%)	0/72 (0.00%)
Hypertensive Crisis * 1	2/597 (0.34%)	0/602 (0.00%)	0/72 (0.00%)
Intermittent Claudication * 1	2/597 (0.34%)	0/602 (0.00%)	0/72 (0.00%)
Peripheral Vascular Disorder * 1	1/597 (0.17%)	0/602 (0.00%)	0/72 (0.00%)
1 Term from vocabulary, MedDRA Version 18.0; * Indicates events were collected by non-systematic assessment
Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events	5%
	Abiraterone Acetate+Prednisone+ADT	Placebo + ADT	DB Period Placebo to Open-label Extension (OLE) Abiraterone Acetate
	Affected / at Risk (%)	Affected / at Risk (%)	Affected / at Risk (%)
Total	533/597 (89.28%)	515/602 (85.55%)	35/72 (48.61%)
Blood and lymphatic system disorders
Anaemia * 1	58/597 (9.72%)	89/602 (14.78%)	3/72 (4.17%)
Gastrointestinal disorders
Abdominal Pain * 1	26/597 (4.36%)	31/602 (5.15%)	0/72 (0.00%)
Constipation * 1	68/597 (11.39%)	67/602 (11.13%)	2/72 (2.78%)
Diarrhoea * 1	37/597 (6.20%)	44/602 (7.31%)	0/72 (0.00%)
Nausea * 1	42/597 (7.04%)	40/602 (6.64%)	1/72 (1.39%)
Vomiting * 1	39/597 (6.53%)	35/602 (5.81%)	0/72 (0.00%)
General disorders
Asthenia * 1	31/597 (5.19%)	27/602 (4.49%)	0/72 (0.00%)
Fatigue * 1	84/597 (14.07%)	90/602 (14.95%)	1/72 (1.39%)
Oedema Peripheral * 1	61/597 (10.22%)	55/602 (9.14%)	2/72 (2.78%)
Infections and infestations
Influenza * 1	42/597 (7.04%)	20/602 (3.32%)	3/72 (4.17%)
Nasopharyngitis * 1	47/597 (7.87%)	36/602 (5.98%)	0/72 (0.00%)
Upper Respiratory Tract Infection * 1	42/597 (7.04%)	29/602 (4.82%)	2/72 (2.78%)
Urinary Tract Infection * 1	39/597 (6.53%)	20/602 (3.32%)	3/72 (4.17%)
Investigations
Alanine Aminotransferase Increased * 1	100/597 (16.75%)	77/602 (12.79%)	5/72 (6.94%)
Aspartate Aminotransferase Increased * 1	91/597 (15.24%)	68/602 (11.30%)	5/72 (6.94%)
Blood Lactate Dehydrogenase Increased * 1	40/597 (6.70%)	32/602 (5.32%)	1/72 (1.39%)
Weight Increased * 1	54/597 (9.05%)	51/602 (8.47%)	0/72 (0.00%)
Metabolism and nutrition disorders
Decreased Appetite * 1	23/597 (3.85%)	33/602 (5.48%)	0/72 (0.00%)
Hyperglycaemia * 1	83/597 (13.90%)	72/602 (11.96%)	5/72 (6.94%)
Hypokalaemia * 1	143/597 (23.95%)	23/602 (3.82%)	9/72 (12.50%)
Musculoskeletal and connective tissue disorders
Arthralgia * 1	96/597 (16.08%)	86/602 (14.29%)	4/72 (5.56%)
Back Pain * 1	120/597 (20.10%)	122/602 (20.27%)	5/72 (6.94%)
Bone Pain * 1	81/597 (13.57%)	90/602 (14.95%)	0/72 (0.00%)
Musculoskeletal Pain * 1	32/597 (5.36%)	42/602 (6.98%)	2/72 (2.78%)
Pain in Extremity * 1	72/597 (12.06%)	69/602 (11.46%)	2/72 (2.78%)
Nervous system disorders
Headache * 1	46/597 (7.71%)	31/602 (5.15%)	2/72 (2.78%)
Psychiatric disorders
Insomnia * 1	32/597 (5.36%)	30/602 (4.98%)	1/72 (1.39%)
Respiratory, thoracic and mediastinal disorders
Cough * 1	41/597 (6.87%)	18/602 (2.99%)	2/72 (2.78%)
Vascular disorders
Hot Flush * 1	92/597 (15.41%)	76/602 (12.62%)	1/72 (1.39%)
Hypertension * 1	229/597 (38.36%)	133/602 (22.09%)	4/72 (5.56%)
1 Term from vocabulary, MedDRA Version 18.0; * Indicates events were collected by non-systematic assessment

Limitations and Caveats

As per protocol the long-term extension (LTE) phase was planned but LTE phase is not included as part of this study hence no data was reported for LTE phase.

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

If an investigator wishes to publish information from the study, 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 by the sponsor in writing, the investigator will withhold such publication for up to an additional 60 days.

Results Point of Contact

• Name/Title: Senior Director Clinical Development
• Organization: Janssen Research & Development, LLC
• Phone: 844-434-4210
• EMail: ClinicalTrialDisclosure@its.jnj.com

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Koroki Y, Taguri M, Matsubara N, Fizazi K. Estimation of Overall Survival with Subsequent Treatment Effect by Applying Inverse Probability of Censoring Weighting in the LATITUDE Study. Eur Urol Open Sci. 2022 Jan 6;36:51-58. doi: 10.1016/j.euros.2021.11.012. eCollection 2022 Feb.

Baciarello G, Ozguroglu M, Mundle S, Leitz G, Richarz U, Hu P, Feyerabend S, Matsubara N, Chi KN, Fizazi K. Impact of abiraterone acetate plus prednisone in patients with castration-sensitive prostate cancer and visceral metastases over four years of follow-up: A post-hoc exploratory analysis of the LATITUDE study. Eur J Cancer. 2022 Feb;162:56-64. doi: 10.1016/j.ejca.2021.11.026. Epub 2021 Dec 23.

Azad AA, Armstrong AJ, Alcaraz A, Szmulewitz RZ, Petrylak DP, Holzbeierlein J, Villers A, Alekseev B, Iguchi T, Shore ND, Gomez-Veiga F, Rosbrook B, Lee HJ, Haas GP, Stenzl A. Efficacy of enzalutamide in subgroups of men with metastatic hormone-sensitive prostate cancer based on prior therapy, disease volume, and risk. Prostate Cancer Prostatic Dis. 2022 Feb;25(2):274-282. doi: 10.1038/s41391-021-00436-y. Epub 2021 Aug 21.

Feyerabend S, Saad F, Perualila NJ, Van Sanden S, Diels J, Ito T, De Porre P, Fizazi K. Adjusting Overall Survival Estimates for Treatment Switching in Metastatic, Castration-Sensitive Prostate Cancer: Results from the LATITUDE Study. Target Oncol. 2019 Dec;14(6):681-688. doi: 10.1007/s11523-019-00685-x.

Fizazi K, Tran N, Fein L, Matsubara N, Rodriguez-Antolin A, Alekseev BY, Ozguroglu M, Ye D, Feyerabend S, Protheroe A, Sulur G, Luna Y, Li S, Mundle S, Chi KN. Abiraterone acetate plus prednisone in patients with newly diagnosed high-risk metastatic castration-sensitive prostate cancer (LATITUDE): final overall survival analysis of a randomised, double-blind, phase 3 trial. Lancet Oncol. 2019 May;20(5):686-700. doi: 10.1016/S1470-2045(19)30082-8. Epub 2019 Apr 12.

Li T, Franco-Villalobos C, Proskorovsky I, Sorensen SV, Tran N, Sulur G, Chi KN. Medical resource utilization of abiraterone acetate plus prednisone added to androgen deprivation therapy in metastatic castration-naive prostate cancer: Results from LATITUDE. Cancer. 2019 Feb 15;125(4):626-632. doi: 10.1002/cncr.31847. Epub 2018 Dec 6.

Chi KN, Protheroe A, Rodriguez-Antolin A, Facchini G, Suttman H, Matsubara N, Ye Z, Keam B, Damiao R, Li T, McQuarrie K, Jia B, De Porre P, Martin J, Todd MB, Fizazi K. Patient-reported outcomes following abiraterone acetate plus prednisone added to androgen deprivation therapy in patients with newly diagnosed metastatic castration-naive prostate cancer (LATITUDE): an international, randomised phase 3 trial. Lancet Oncol. 2018 Feb;19(2):194-206. doi: 10.1016/S1470-2045(17)30911-7. Epub 2018 Jan 8.

Fizazi K, Tran N, Fein L, Matsubara N, Rodriguez-Antolin A, Alekseev BY, Ozguroglu M, Ye D, Feyerabend S, Protheroe A, De Porre P, Kheoh T, Park YC, Todd MB, Chi KN; LATITUDE Investigators. Abiraterone plus Prednisone in Metastatic, Castration-Sensitive Prostate Cancer. N Engl J Med. 2017 Jul 27;377(4):352-360. doi: 10.1056/NEJMoa1704174. Epub 2017 Jun 4.

• Responsible Party: Janssen Research & Development, LLC
• ClinicalTrials.gov Identifier: NCT01715285
• Other Study ID Numbers: CR100900; 212082PCR3011 ( Other Identifier: Janssen Research & Development, LLC ); 2012-002940-26 ( EudraCT Number ); U1111-1135-7146 ( Other Identifier: Universal Trial Number )
• First Submitted: October 24, 2012
• First Posted: October 26, 2012
• Results First Submitted: March 9, 2018
• Results First Posted: October 15, 2018
• Last Update Posted: March 13, 2023