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Trial record 1 of 3 for:    Janssen 3001 | prostate cancer
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A Study of Abiraterone Acetate Plus Prednisone in Patients With Metastatic Castration-Resistant Prostate Cancer Who Have Failed Docetaxel-Based Chemotherapy

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ClinicalTrials.gov Identifier: NCT01695135
Recruitment Status : Completed
First Posted : September 27, 2012
Results First Posted : July 18, 2019
Last Update Posted : July 18, 2019
Sponsor:
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: Placebo
Drug: Prednisone
Enrollment 214
Recruitment Details A total of 214 participants were enrolled in the study (143 participants in abiraterone acetate group and 71 participants in placebo group).
Pre-assignment Details  
Arm/Group Title Placebo + Prednisone (Double-blind [DB]) Abiraterone Acetate + Prednisone (Double-blind) Placebo + Prednisone (DB) to AA + Prednisone (Open-label) AA + Prednisone to AA + Prednisone (Open-label)
Hide Arm/Group Description Participants received placebo (4 tablets) once daily + prednisone 5 milligram (mg) twice daily on Cycle 1 Day 1 until disease progression or unacceptable toxicity. Each cycle of 28 days. Participants received abiraterone acetate (AA) 1000 mg (4*250 mg tablets) once daily + prednisone 5 mg twice daily on Cycle 1 Day 1 until disease progression or unacceptable toxicity. Each cycle of 28 days. Participants with disease progression during the double-blind treatment phase received abiraterone acetate 1000 mg once daily + prednisone 5 mg twice daily in open-label extension treatment phase based on the participant's choice and treating physician's decision if they met the criteria for subsequent abiraterone acetate treatment until they no longer derive clinical benefit, unacceptable toxicity, initiation of a subsequent anticancer therapy, or serious protocol violation. Participants with disease progression during the double-blind treatment phase received abiraterone acetate 1000 mg once daily + prednisone 5 mg twice daily in open-label extension treatment phase based on the participant's choice and treating physician's decision if they met the criteria for subsequent abiraterone acetate treatment until they no longer derive clinical benefit, unacceptable toxicity, initiation of a subsequent anticancer therapy, or serious protocol violation.
Period Title: Double-blind Treatment Phase
Started 71 143 0 0
Completed 0 4 0 0
Not Completed 71 139 0 0
Reason Not Completed
Progressive disease             50             110             0             0
Withdrawal by Subject             6             14             0             0
Adverse Event             7             7             0             0
Other             1             3             0             0
Physician Decision             6             3             0             0
Death             1             1             0             0
Noncompliance with study drug             0             1             0             0
Period Title: Open Label Extension Treatment Phase
Started 0 0 49 80
Completed 0 0 9 10
Not Completed 0 0 40 70
Reason Not Completed
Progressive disease             0             0             13             22
Withdrawal by Subject             0             0             6             16
Adverse Event             0             0             11             16
Other             0             0             4             7
Physician Decision             0             0             4             1
Death             0             0             2             7
Noncompliance with study drug             0             0             0             1
Arm/Group Title Placebo + Prednisone (Double-blind) Abiraterone Acetate + Prednisone (Double-blind) Total
Hide Arm/Group Description Participants received placebo (4 tablets) once daily + prednisone 5 milligram (mg) twice daily on Cycle 1 Day 1 until disease progression or unacceptable toxicity. Each cycle of 28 days. Participants received abiraterone acetate (AA) 1000 mg (4*250 mg tablets) once daily + prednisone 5 mg twice daily on Cycle 1 Day 1 until disease progression or unacceptable toxicity. Each cycle of 28 days. Total of all reporting groups
Overall Number of Baseline Participants 71 143 214
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 71 participants 143 participants 214 participants
67.7  (7.75) 68.2  (8.3) 68  (8.11)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 71 participants 143 participants 214 participants
Female
0
   0.0%
0
   0.0%
0
   0.0%
Male
71
 100.0%
143
 100.0%
214
 100.0%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 71 participants 143 participants 214 participants
Asian
71
 100.0%
143
 100.0%
214
 100.0%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
China Number Analyzed 71 participants 143 participants 214 participants
71
 100.0%
143
 100.0%
214
 100.0%
1.Primary Outcome
Title DB Phase: Time to Prostate-Specific Antigen Progression (PSA)
Hide Description Time to PSA progression was defined as time interval from the date of randomization to the date of the prostate-specific antigen (PSA) progression as defined in the Prostate Specific Antigen Working Group (PSAWG) criteria. PSAWG criteria- Decline from baseline and reach response criteria: greater than or equal to (>=) 50 percent (%) increase over the nadir and the increase in the absolute-value by at least 5 nanogram per milliliter (ng/mL) (or back to the baseline), which is confirmed by a second value 4 or more weeks later; Decline from baseline but not reach response criteria: >=25% increase over the nadir and the increase in the absolute-value by at least 5 ng/mL, which is confirmed by a second value 4 or more weeks later; and No decline from baseline: >=25% increase over the baseline and the increase in the absolute-value by at least 5 ng/mL, which is confirmed by a second value 4 or more weeks later.
Time Frame Up to 1.8 years
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-Treat (ITT) analysis set included all participants randomized into the study and classified according to their assigned treatment group, regardless of the actual treatment received.
Arm/Group Title Placebo + Prednisone (Double-blind) Abiraterone Acetate + Prednisone (Double-blind)
Hide Arm/Group Description:
Participants received placebo (4 tablets) once daily + prednisone 5 milligram (mg) twice daily on Cycle 1 Day 1 until disease progression or unacceptable toxicity. Each cycle of 28 days.
Participants received abiraterone acetate (AA) 1000 mg (4*250 mg tablets) once daily + prednisone 5 mg twice daily on Cycle 1 Day 1 until disease progression or unacceptable toxicity. Each cycle of 28 days.
Overall Number of Participants Analyzed 71 143
Median (95% Confidence Interval)
Unit of Measure: Days
84.00
(31.00 to 113.00)
169.00
(141.00 to 197.00)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo + Prednisone (Double-blind), Abiraterone Acetate + Prednisone (Double-blind)
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0002
Comments [Not Specified]
Method Log Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.528
Confidence Interval (2-Sided) 95%
0.376 to 0.740
Estimation Comments [Not Specified]
2.Secondary Outcome
Title DB Phase: Overall Survival
Hide Description Overall survival was defined as the time interval from the date of randomization to the date of death from any cause.
Time Frame From randomization to the date of death due to any cause (up to approximately 3.8 years)
Hide Outcome Measure Data
Hide Analysis Population Description
ITT analysis set included all participants randomized into the study and classified according to their assigned treatment group, regardless of the actual treatment received.
Arm/Group Title Placebo + Prednisone (Double-blind) Abiraterone Acetate + Prednisone (Double-blind)
Hide Arm/Group Description:
Participants received placebo (4 tablets) once daily + prednisone 5 milligram (mg) twice daily on Cycle 1 Day 1 until disease progression or unacceptable toxicity. Each cycle of 28 days.
Participants received abiraterone acetate (AA) 1000 mg (4*250 mg tablets) once daily + prednisone 5 mg twice daily on Cycle 1 Day 1 until disease progression or unacceptable toxicity. Each cycle of 28 days.
Overall Number of Participants Analyzed 71 143
Median (95% Confidence Interval)
Unit of Measure: Days
561.00
(352.00 to 787.00)
579.00
(504.00 to 731.00)
3.Secondary Outcome
Title DB Phase: Percentage of Participants Who Achieved PSA Response
Hide Description Percentage of participants who achieved PSA response (defined as >= 50% PSA decline from baseline) according to PSAWG criteria were reported. PSAWG criteria- Decline from baseline and reach response criteria: >= 50% increase over the nadir and the increase in the absolute-value by at least 5 ng/mL (or back to the baseline), which is confirmed by a second value 4 or more weeks later; Decline from baseline but not reach response criteria: >=25% increase over the nadir and the increase in the absolute-value by at least 5 ng/mL, which is confirmed by a second value 4 or more weeks later; and No decline from baseline: >=25% increase over the baseline and the increase in the absolute-value by at least 5 ng/mL, which is confirmed by a second value 4 or more weeks later.
Time Frame Approximately up to 3.8 years
Hide Outcome Measure Data
Hide Analysis Population Description
ITT analysis set included all participants randomized into the study and classified according to their assigned treatment group, regardless of the actual treatment received.
Arm/Group Title Placebo + Prednisone (Double-blind) Abiraterone Acetate + Prednisone (Double-blind)
Hide Arm/Group Description:
Participants received placebo (4 tablets) once daily + prednisone 5 milligram (mg) twice daily on Cycle 1 Day 1 until disease progression or unacceptable toxicity. Each cycle of 28 days.
Participants received abiraterone acetate (AA) 1000 mg (4*250 mg tablets) once daily + prednisone 5 mg twice daily on Cycle 1 Day 1 until disease progression or unacceptable toxicity. Each cycle of 28 days.
Overall Number of Participants Analyzed 71 143
Measure Type: Number
Unit of Measure: Percentage of Participants
18.3 54.5
4.Secondary Outcome
Title DB Phase: Objective Response Rate (ORR)
Hide Description 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 and normalization of tumor marker level. PR: At least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD.
Time Frame Approximately up to 3.8 years
Hide Outcome Measure Data
Hide Analysis Population Description
ITT analysis set included all participants randomized into the study and classified according to their assigned treatment group, regardless of the actual treatment received. Population included only participants with measurable disease at baseline.
Arm/Group Title Placebo + Prednisone (Double-blind) Abiraterone Acetate + Prednisone (Double-blind)
Hide Arm/Group Description:
Participants received placebo (4 tablets) once daily + prednisone 5 milligram (mg) twice daily on Cycle 1 Day 1 until disease progression or unacceptable toxicity. Each cycle of 28 days.
Participants received abiraterone acetate (AA) 1000 mg (4*250 mg tablets) once daily + prednisone 5 mg twice daily on Cycle 1 Day 1 until disease progression or unacceptable toxicity. Each cycle of 28 days.
Overall Number of Participants Analyzed 24 57
Measure Type: Number
Unit of Measure: Percentage of Participants
4.2 17.5
5.Secondary Outcome
Title DB Phase: Change From Baseline in Functional Assessment of Cancer Therapy-Prostate (FACT-P) Questionnaire: Total Scores at the End of Treatment
Hide Description FACT-P assesses symptoms/problems related to prostate carcinoma and its treatment. It is a combination of the FACT- General + the Prostate Cancer Subscale (PCS) (Range 1-156, higher scores better). The FACT-General (FACT-G) is a 28 item Quality of Life (QOL) measure that provides a total score as well as subscale scores: Physical (0-28), Functional (0-28), Social (0-28), and Emotional (0-24) Well-being. The total range was between 1-108, higher scores better. Functional Assessment of Cancer Therapy-Treatment Outcome Index (FACT-TOI) is derived from the sum of the Physical Well-Being, Functional Well-Being, and Prostate Cancer subscale scores; a sensitive measure of patient-reported health (Range 1-104, higher scores better). PCS is a 12-item prostate cancer subscale that asks about symptoms and problems specific to prostate cancer (Range 0-48, higher scores better).
Time Frame Baseline, at End of Treatment (15 and 30 days after the last dose [up to 3.8 years])
Hide Outcome Measure Data
Hide Analysis Population Description
ITT analysis set included all participants randomized into the study and classified according to their assigned treatment group, regardless of the actual treatment received. Here 'N' (number of participants analyzed) signifies number of participants who were evaluable for this outcome measure.
Arm/Group Title Placebo + Prednisone (Double-blind) Abiraterone Acetate + Prednisone (Double-blind)
Hide Arm/Group Description:
Participants received placebo (4 tablets) once daily + prednisone 5 milligram (mg) twice daily on Cycle 1 Day 1 until disease progression or unacceptable toxicity. Each cycle of 28 days.
Participants received abiraterone acetate (AA) 1000 mg (4*250 mg tablets) once daily + prednisone 5 mg twice daily on Cycle 1 Day 1 until disease progression or unacceptable toxicity. Each cycle of 28 days.
Overall Number of Participants Analyzed 52 97
Mean (Standard Deviation)
Unit of Measure: Units on a scale
Total Score -19.9  (22.07) -16.1  (22.74)
Physical Well-being -6.7  (6.52) -4.9  (6.85)
Functional Well-being -5.1  (6.60) -2.7  (7.31)
Emotional Well-being -2.1  (4.48) -2.4  (4.87)
Social Well-being -0.8  (3.82) -1.2  (6.55)
FACT-G Total Score -14.6  (16.25) -11.2  (17.19)
Prostate Cancer Subscale (PCS) -5.3  (7.99) -4.9  (7.70)
Treatment Outcome Index (FACT-TOI) -17.1  (17.76) -12.5  (17.52)
6.Secondary Outcome
Title DB Phase: Time to Pain Progression
Hide Description Time to Pain progression calculated as number of days from date of randomization to date of pain progression. Pain progression- worsening of pain due to metastatic bone disease defined as increase of >=30% in worst pain over past 24 hours on BPI-SF numeric rating scale at 2 consecutive evaluations 4 weeks apart without decrease in analgesic usage score (in 2 corresponding consecutive evaluation in analgesic usage score, if there is missing visit, use existing visit only) or increase in analgesic usage score >=30% at 2 consecutive evaluations 4 weeks apart. BPI-SF is 11-item questionnaire which includes 4 questions that assess pain intensity and 7 questions that assess impact of pain on daily functions. Total score (average of individual questions) ranges from 0=No pain to 10=Pain as bad as you can imagine; Higher scores= greater pain. Analgesic usage was scored on scale of 0 to 3 where 0=no analgesic, 1=non-opioid analgesics, 2=opioids for moderate pain and 3=opioids for severe pain.
Time Frame Approximately up to 3.8 years
Hide Outcome Measure Data
Hide Analysis Population Description
ITT analysis set included all participants randomized into the study and classified according to their assigned treatment group, regardless of the actual treatment received.
Arm/Group Title Placebo + Prednisone (Double-blind) Abiraterone Acetate + Prednisone (Double-blind)
Hide Arm/Group Description:
Participants received placebo (4 tablets) once daily + prednisone 5 milligram (mg) twice daily on Cycle 1 Day 1 until disease progression or unacceptable toxicity. Each cycle of 28 days.
Participants received abiraterone acetate (AA) 1000 mg (4*250 mg tablets) once daily + prednisone 5 mg twice daily on Cycle 1 Day 1 until disease progression or unacceptable toxicity. Each cycle of 28 days.
Overall Number of Participants Analyzed 71 143
Median (95% Confidence Interval)
Unit of Measure: Days
169.00
(85.00 to 253.00)
505.00 [1] 
(365.00 to NA)
[1]
Here 'NA' represents that upper limit of Confidence Interval (CI) was not estimable due to lesser number of events.
7.Secondary Outcome
Title DB Phase: Percentage of Participants Experiencing Pain Palliation
Hide Description Percentage of participants experiencing pain palliation were reported. A participant is responder if experienced >=30% reduction in Brief Pain Inventory - Short Form (BPI-SF) worst pain intensity score over 24 hours observed at 2 consecutive evaluations 4 weeks apart without any increase in analgesic usage score (best response). Analgesic usage was scored on a scale of 0 to 3 where 0=no analgesic, 1=non-opioid analgesics, 2=opioids for moderate pain and 3=opioids for severe pain. BPI-SF is 11-item self-reported questionnaire designed to assess severity and impact of pain on daily functions. It includes 4 questions that assess pain intensity (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). Total score (average of individual questions) ranges from 0=No pain to 10=Pain as bad as you can imagine; Higher scores indicate greater pain.
Time Frame Approximately up to 3.8 years
Hide Outcome Measure Data
Hide Analysis Population Description
ITT analysis set included all participants randomized into the study and classified according to their assigned treatment group, regardless of the actual treatment received. Population included only participants whose pain score was >= 4 at baseline.
Arm/Group Title Placebo + Prednisone (Double-blind) Abiraterone Acetate + Prednisone (Double-blind)
Hide Arm/Group Description:
Participants received placebo (4 tablets) once daily + prednisone 5 milligram (mg) twice daily on Cycle 1 Day 1 until disease progression or unacceptable toxicity. Each cycle of 28 days.
Participants received abiraterone acetate (AA) 1000 mg (4*250 mg tablets) once daily + prednisone 5 mg twice daily on Cycle 1 Day 1 until disease progression or unacceptable toxicity. Each cycle of 28 days.
Overall Number of Participants Analyzed 22 55
Measure Type: Number
Unit of Measure: Percentage of Participants
31.8 54.5
8.Secondary Outcome
Title DB Phase: Change From Baseline in Brief Fatigue Inventory (BFI) Score at End of Treatment
Hide Description The Brief Fatigue Inventory (BFI) is a brief participant-reported questionnaire that measures the severity of fatigue based on the worst fatigue experienced during the past 24-hours. BFI has nine items. Three items ask patients to rate the severity of their fatigue at its "worst," "usual," and "now" during normal waking hours, with 0 being "no fatigue" and 10 being "fatigue as bad as you can imagine." Six items assess the amount that fatigue has interfered with different aspects of the patient's life during the past 24 hours. The interference items include general activity, mood, walking ability, normal work (includes both work outside the home and housework), relations with other people, and enjoyment of life. The interference items are measured on a 0-10 scale, with 0 being "does not interfere" and 10 being "completely interferes." BFI Total Score is the average of the nine items, ranging from 0 (no fatigue) to 10 (high fatigue).
Time Frame Baseline, at End of Treatment (15 and 30 days after the last dose [up to 3.8 years])
Hide Outcome Measure Data
Hide Analysis Population Description
ITT analysis set included all participants randomized into the study and classified according to their assigned treatment group, regardless of the actual treatment received. Here 'N' (number of participants analyzed) signifies number of participants who were evaluable for this outcome measure.
Arm/Group Title Placebo + Prednisone (Double-blind) Abiraterone Acetate + Prednisone (Double-blind)
Hide Arm/Group Description:
Participants received placebo (4 tablets) once daily + prednisone 5 milligram (mg) twice daily on Cycle 1 Day 1 until disease progression or unacceptable toxicity. Each cycle of 28 days.
Participants received abiraterone acetate (AA) 1000 mg (4*250 mg tablets) once daily + prednisone 5 mg twice daily on Cycle 1 Day 1 until disease progression or unacceptable toxicity. Each cycle of 28 days.
Overall Number of Participants Analyzed 52 98
Mean (Standard Deviation)
Unit of Measure: Units on a scale
Fatigue Now 2.4  (3.59) 1.7  (3.34)
Usual Fatigue 2.4  (3.53) 1.5  (3.18)
Worst Fatigue 2.6  (3.73) 1.6  (3.49)
General Activity 2.3  (3.65) 1.7  (3.38)
Mood 2.7  (3.39) 1.8  (3.40)
Walking Ability 2.4  (3.28) 1.8  (3.50)
Normal Work 2.2  (3.84) 2.0  (3.71)
Relations with Other People 2.0  (3.08) 1.6  (3.25)
Enjoyment of Life 2.5  (3.33) 1.9  (3.64)
Time Frame Approximately up to 3.8 years
Adverse Event Reporting Description Safety analysis set included all randomized participants who received at least one dose of study drug and classified to the treatment group according to their actual treatment received.
 
Arm/Group Title Placebo + Prednisone (Double-blind) Abiraterone Acetate + Prednisone (Double-blind) Placebo + Prednisone (DB) to AA + Prednisone (Open-label) AA + Prednisone to AA + Prednisone (Open-label)
Hide Arm/Group Description Participants received placebo (4 tablets) once daily + prednisone 5 milligram (mg) twice daily on Cycle 1 Day 1 until disease progression or unacceptable toxicity. Each cycle of 28 days. Participants received abiraterone acetate (AA) 1000 mg (4*250 mg tablets) once daily + prednisone 5 mg twice daily on Cycle 1 Day 1 until disease progression or unacceptable toxicity. Each cycle of 28 days. Participants with disease progression during the double-blind treatment phase received abiraterone acetate 1000 mg once daily + prednisone 5 mg twice daily in open-label extension treatment phase based on the participant's choice and treating physician's decision if they met the criteria for subsequent abiraterone acetate treatment until they no longer derive clinical benefit, unacceptable toxicity, initiation of a subsequent anticancer therapy, or serious protocol violation. Participants with disease progression during the double-blind treatment phase received abiraterone acetate 1000 mg once daily + prednisone 5 mg twice daily in open-label extension treatment phase based on the participant's choice and treating physician's decision if they met the criteria for subsequent abiraterone acetate treatment until they no longer derive clinical benefit, unacceptable toxicity, initiation of a subsequent anticancer therapy, or serious protocol violation.
All-Cause Mortality
Placebo + Prednisone (Double-blind) Abiraterone Acetate + Prednisone (Double-blind) Placebo + Prednisone (DB) to AA + Prednisone (Open-label) AA + Prednisone to AA + Prednisone (Open-label)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/--   --/-- 
Hide Serious Adverse Events
Placebo + Prednisone (Double-blind) Abiraterone Acetate + Prednisone (Double-blind) Placebo + Prednisone (DB) to AA + Prednisone (Open-label) AA + Prednisone to AA + Prednisone (Open-label)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   20/71 (28.17%)   33/143 (23.08%)   25/49 (51.02%)   41/80 (51.25%) 
Blood and lymphatic system disorders         
Anaemia * 1  0/71 (0.00%)  3/143 (2.10%)  2/49 (4.08%)  5/80 (6.25%) 
Disseminated intravascular coagulation * 1  0/71 (0.00%)  1/143 (0.70%)  0/49 (0.00%)  0/80 (0.00%) 
Thrombocytopenia * 1  0/71 (0.00%)  0/143 (0.00%)  0/49 (0.00%)  1/80 (1.25%) 
Cardiac disorders         
Cardiac disorder * 1  0/71 (0.00%)  1/143 (0.70%)  0/49 (0.00%)  0/80 (0.00%) 
Cardiac failure * 1  0/71 (0.00%)  1/143 (0.70%)  1/49 (2.04%)  1/80 (1.25%) 
Acute myocardial infarction * 1  1/71 (1.41%)  0/143 (0.00%)  1/49 (2.04%)  1/80 (1.25%) 
Coronary artery disease * 1  1/71 (1.41%)  0/143 (0.00%)  0/49 (0.00%)  0/80 (0.00%) 
Myocardial infarction * 1  0/71 (0.00%)  0/143 (0.00%)  0/49 (0.00%)  1/80 (1.25%) 
Eye disorders         
Blindness * 1  0/71 (0.00%)  1/143 (0.70%)  0/49 (0.00%)  0/80 (0.00%) 
Blindness unilateral * 1  0/71 (0.00%)  1/143 (0.70%)  0/49 (0.00%)  0/80 (0.00%) 
Cataract * 1  0/71 (0.00%)  0/143 (0.00%)  1/49 (2.04%)  0/80 (0.00%) 
Gastrointestinal disorders         
Gastrointestinal disorder * 1  0/71 (0.00%)  1/143 (0.70%)  0/49 (0.00%)  0/80 (0.00%) 
Gastrointestinal motility disorder * 1  0/71 (0.00%)  1/143 (0.70%)  0/49 (0.00%)  0/80 (0.00%) 
Intestinal obstruction * 1  1/71 (1.41%)  1/143 (0.70%)  1/49 (2.04%)  0/80 (0.00%) 
Pancreatitis acute * 1  0/71 (0.00%)  1/143 (0.70%)  0/49 (0.00%)  0/80 (0.00%) 
Diarrhoea * 1  0/71 (0.00%)  0/143 (0.00%)  1/49 (2.04%)  0/80 (0.00%) 
Enterovesical fistula * 1  1/71 (1.41%)  0/143 (0.00%)  0/49 (0.00%)  0/80 (0.00%) 
Gastritis * 1  0/71 (0.00%)  0/143 (0.00%)  0/49 (0.00%)  1/80 (1.25%) 
Vomiting * 1  0/71 (0.00%)  0/143 (0.00%)  1/49 (2.04%)  0/80 (0.00%) 
General disorders         
Disease progression * 1  5/71 (7.04%)  6/143 (4.20%)  8/49 (16.33%)  17/80 (21.25%) 
Chest discomfort * 1  0/71 (0.00%)  1/143 (0.70%)  0/49 (0.00%)  0/80 (0.00%) 
Multi-organ failure * 1  0/71 (0.00%)  1/143 (0.70%)  2/49 (4.08%)  3/80 (3.75%) 
Oedema peripheral * 1  1/71 (1.41%)  1/143 (0.70%)  0/49 (0.00%)  0/80 (0.00%) 
Pyrexia * 1  1/71 (1.41%)  1/143 (0.70%)  1/49 (2.04%)  4/80 (5.00%) 
Death * 1  0/71 (0.00%)  0/143 (0.00%)  0/49 (0.00%)  2/80 (2.50%) 
Fatigue * 1  0/71 (0.00%)  0/143 (0.00%)  1/49 (2.04%)  0/80 (0.00%) 
Pain * 1  0/71 (0.00%)  0/143 (0.00%)  0/49 (0.00%)  1/80 (1.25%) 
Sudden death * 1  0/71 (0.00%)  0/143 (0.00%)  1/49 (2.04%)  0/80 (0.00%) 
Hepatobiliary disorders         
Jaundice cholestatic * 1  0/71 (0.00%)  1/143 (0.70%)  0/49 (0.00%)  0/80 (0.00%) 
Hepatic function abnormal * 1  0/71 (0.00%)  0/143 (0.00%)  1/49 (2.04%)  0/80 (0.00%) 
Infections and infestations         
Lung infection * 1  0/71 (0.00%)  2/143 (1.40%)  3/49 (6.12%)  4/80 (5.00%) 
Biliary tract infection * 1  0/71 (0.00%)  1/143 (0.70%)  0/49 (0.00%)  0/80 (0.00%) 
Bronchitis * 1  0/71 (0.00%)  1/143 (0.70%)  0/49 (0.00%)  0/80 (0.00%) 
Kidney infection * 1  0/71 (0.00%)  1/143 (0.70%)  0/49 (0.00%)  0/80 (0.00%) 
Pneumonia * 1  0/71 (0.00%)  1/143 (0.70%)  0/49 (0.00%)  1/80 (1.25%) 
Pulpitis dental * 1  0/71 (0.00%)  1/143 (0.70%)  0/49 (0.00%)  0/80 (0.00%) 
Pyelonephritis acute * 1  0/71 (0.00%)  1/143 (0.70%)  0/49 (0.00%)  0/80 (0.00%) 
Respiratory tract infection * 1  0/71 (0.00%)  1/143 (0.70%)  0/49 (0.00%)  0/80 (0.00%) 
Septic shock * 1  0/71 (0.00%)  1/143 (0.70%)  0/49 (0.00%)  0/80 (0.00%) 
Urinary tract infection * 1  0/71 (0.00%)  1/143 (0.70%)  1/49 (2.04%)  0/80 (0.00%) 
Herpes zoster * 1  0/71 (0.00%)  0/143 (0.00%)  1/49 (2.04%)  0/80 (0.00%) 
Upper respiratory tract infection * 1  0/71 (0.00%)  0/143 (0.00%)  1/49 (2.04%)  0/80 (0.00%) 
Injury, poisoning and procedural complications         
Femur fracture * 1  0/71 (0.00%)  1/143 (0.70%)  0/49 (0.00%)  1/80 (1.25%) 
Hip fracture * 1  0/71 (0.00%)  1/143 (0.70%)  0/49 (0.00%)  0/80 (0.00%) 
Spinal compression fracture * 1  0/71 (0.00%)  1/143 (0.70%)  0/49 (0.00%)  0/80 (0.00%) 
Fracture * 1  1/71 (1.41%)  0/143 (0.00%)  0/49 (0.00%)  0/80 (0.00%) 
Investigations         
Alanine aminotransferase increased * 1  0/71 (0.00%)  0/143 (0.00%)  1/49 (2.04%)  0/80 (0.00%) 
Aspartate aminotransferase increased * 1  0/71 (0.00%)  0/143 (0.00%)  1/49 (2.04%)  0/80 (0.00%) 
Platelet count decreased * 1  0/71 (0.00%)  0/143 (0.00%)  0/49 (0.00%)  2/80 (2.50%) 
Metabolism and nutrition disorders         
Dehydration * 1  0/71 (0.00%)  1/143 (0.70%)  0/49 (0.00%)  0/80 (0.00%) 
Ketoacidosis * 1  0/71 (0.00%)  1/143 (0.70%)  0/49 (0.00%)  0/80 (0.00%) 
Decreased appetite * 1  0/71 (0.00%)  0/143 (0.00%)  1/49 (2.04%)  0/80 (0.00%) 
Hypoglycaemia * 1  0/71 (0.00%)  0/143 (0.00%)  0/49 (0.00%)  1/80 (1.25%) 
Malnutrition * 1  0/71 (0.00%)  0/143 (0.00%)  0/49 (0.00%)  1/80 (1.25%) 
Musculoskeletal and connective tissue disorders         
Bone pain * 1  2/71 (2.82%)  3/143 (2.10%)  2/49 (4.08%)  3/80 (3.75%) 
Back pain * 1  0/71 (0.00%)  1/143 (0.70%)  0/49 (0.00%)  0/80 (0.00%) 
Musculoskeletal disorder * 1  0/71 (0.00%)  1/143 (0.70%)  0/49 (0.00%)  0/80 (0.00%) 
Pain in extremity * 1  0/71 (0.00%)  1/143 (0.70%)  1/49 (2.04%)  0/80 (0.00%) 
Pathological fracture * 1  0/71 (0.00%)  1/143 (0.70%)  0/49 (0.00%)  1/80 (1.25%) 
Spinal disorder * 1  1/71 (1.41%)  0/143 (0.00%)  0/49 (0.00%)  0/80 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)         
Bladder cancer * 1  0/71 (0.00%)  1/143 (0.70%)  0/49 (0.00%)  0/80 (0.00%) 
Metastases to lung * 1  0/71 (0.00%)  1/143 (0.70%)  0/49 (0.00%)  0/80 (0.00%) 
Squamous cell carcinoma of lung * 1  0/71 (0.00%)  1/143 (0.70%)  0/49 (0.00%)  0/80 (0.00%) 
Colon cancer * 1  0/71 (0.00%)  0/143 (0.00%)  0/49 (0.00%)  1/80 (1.25%) 
Nervous system disorders         
Cerebral infarction * 1  1/71 (1.41%)  1/143 (0.70%)  0/49 (0.00%)  1/80 (1.25%) 
Spinal cord compression * 1  1/71 (1.41%)  1/143 (0.70%)  0/49 (0.00%)  1/80 (1.25%) 
Viith nerve paralysis * 1  0/71 (0.00%)  1/143 (0.70%)  0/49 (0.00%)  0/80 (0.00%) 
Coma * 1  0/71 (0.00%)  0/143 (0.00%)  1/49 (2.04%)  0/80 (0.00%) 
Dyskinesia * 1  0/71 (0.00%)  0/143 (0.00%)  0/49 (0.00%)  1/80 (1.25%) 
Renal and urinary disorders         
Haematuria * 1  1/71 (1.41%)  1/143 (0.70%)  1/49 (2.04%)  0/80 (0.00%) 
Hydronephrosis * 1  0/71 (0.00%)  1/143 (0.70%)  0/49 (0.00%)  1/80 (1.25%) 
Renal failure * 1  0/71 (0.00%)  1/143 (0.70%)  0/49 (0.00%)  0/80 (0.00%) 
Renal failure acute * 1  1/71 (1.41%)  1/143 (0.70%)  0/49 (0.00%)  0/80 (0.00%) 
Ureteric obstruction * 1  0/71 (0.00%)  1/143 (0.70%)  0/49 (0.00%)  0/80 (0.00%) 
Urethral haemorrhage * 1  0/71 (0.00%)  1/143 (0.70%)  0/49 (0.00%)  0/80 (0.00%) 
Urinary bladder haemorrhage * 1  0/71 (0.00%)  0/143 (0.00%)  0/49 (0.00%)  1/80 (1.25%) 
Urinary retention * 1  0/71 (0.00%)  0/143 (0.00%)  0/49 (0.00%)  1/80 (1.25%) 
Reproductive system and breast disorders         
Prostatic haemorrhage * 1  1/71 (1.41%)  0/143 (0.00%)  0/49 (0.00%)  0/80 (0.00%) 
Respiratory, thoracic and mediastinal disorders         
Chronic obstructive pulmonary disease * 1  1/71 (1.41%)  0/143 (0.00%)  1/49 (2.04%)  0/80 (0.00%) 
Haemoptysis * 1  1/71 (1.41%)  0/143 (0.00%)  0/49 (0.00%)  0/80 (0.00%) 
Pleural effusion * 1  0/71 (0.00%)  0/143 (0.00%)  0/49 (0.00%)  1/80 (1.25%) 
Pulmonary embolism * 1  1/71 (1.41%)  0/143 (0.00%)  0/49 (0.00%)  0/80 (0.00%) 
Respiratory failure * 1  2/71 (2.82%)  0/143 (0.00%)  0/49 (0.00%)  2/80 (2.50%) 
Sleep apnoea syndrome * 1  1/71 (1.41%)  0/143 (0.00%)  0/49 (0.00%)  0/80 (0.00%) 
Vascular disorders         
Hypotension * 1  0/71 (0.00%)  2/143 (1.40%)  0/49 (0.00%)  0/80 (0.00%) 
Peripheral embolism * 1  0/71 (0.00%)  1/143 (0.70%)  0/49 (0.00%)  0/80 (0.00%) 
Circulatory collapse * 1  0/71 (0.00%)  0/143 (0.00%)  0/49 (0.00%)  1/80 (1.25%) 
Deep vein thrombosis * 1  0/71 (0.00%)  0/143 (0.00%)  0/49 (0.00%)  1/80 (1.25%) 
Haemorrhagic infarction * 1  1/71 (1.41%)  0/143 (0.00%)  0/49 (0.00%)  0/80 (0.00%) 
Thrombosis * 1  0/71 (0.00%)  0/143 (0.00%)  1/49 (2.04%)  0/80 (0.00%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA Version 16.0
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Placebo + Prednisone (Double-blind) Abiraterone Acetate + Prednisone (Double-blind) Placebo + Prednisone (DB) to AA + Prednisone (Open-label) AA + Prednisone to AA + Prednisone (Open-label)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   62/71 (87.32%)   134/143 (93.71%)   35/49 (71.43%)   54/80 (67.50%) 
Blood and lymphatic system disorders         
Anaemia * 1  16/71 (22.54%)  38/143 (26.57%)  13/49 (26.53%)  29/80 (36.25%) 
Gastrointestinal disorders         
Constipation * 1  5/71 (7.04%)  12/143 (8.39%)  2/49 (4.08%)  4/80 (5.00%) 
Nausea * 1  3/71 (4.23%)  5/143 (3.50%)  1/49 (2.04%)  4/80 (5.00%) 
Vomiting * 1  6/71 (8.45%)  4/143 (2.80%)  3/49 (6.12%)  3/80 (3.75%) 
General disorders         
Fatigue * 1  5/71 (7.04%)  13/143 (9.09%)  1/49 (2.04%)  1/80 (1.25%) 
Pyrexia * 1  3/71 (4.23%)  12/143 (8.39%)  3/49 (6.12%)  5/80 (6.25%) 
Oedema peripheral * 1  9/71 (12.68%)  10/143 (6.99%)  2/49 (4.08%)  5/80 (6.25%) 
Pain * 1  4/71 (5.63%)  1/143 (0.70%)  0/49 (0.00%)  0/80 (0.00%) 
Hepatobiliary disorders         
Hyperbilirubinaemia * 1  1/71 (1.41%)  5/143 (3.50%)  4/49 (8.16%)  2/80 (2.50%) 
Infections and infestations         
Urinary tract infection * 1  6/71 (8.45%)  13/143 (9.09%)  6/49 (12.24%)  7/80 (8.75%) 
Upper respiratory tract infection * 1  5/71 (7.04%)  10/143 (6.99%)  4/49 (8.16%)  4/80 (5.00%) 
Investigations         
Aspartate aminotransferase increased * 1  12/71 (16.90%)  29/143 (20.28%)  7/49 (14.29%)  9/80 (11.25%) 
Alanine aminotransferase increased * 1  9/71 (12.68%)  20/143 (13.99%)  6/49 (12.24%)  5/80 (6.25%) 
Blood lactate dehydrogenase increased * 1  6/71 (8.45%)  10/143 (6.99%)  3/49 (6.12%)  3/80 (3.75%) 
Blood albumin decreased * 1  4/71 (5.63%)  8/143 (5.59%)  0/49 (0.00%)  2/80 (2.50%) 
Weight decreased * 1  3/71 (4.23%)  8/143 (5.59%)  3/49 (6.12%)  9/80 (11.25%) 
Blood alkaline phosphatase increased * 1  6/71 (8.45%)  6/143 (4.20%)  2/49 (4.08%)  3/80 (3.75%) 
Platelet count decreased * 1  2/71 (2.82%)  6/143 (4.20%)  4/49 (8.16%)  6/80 (7.50%) 
White blood cell count decreased * 1  3/71 (4.23%)  3/143 (2.10%)  4/49 (8.16%)  3/80 (3.75%) 
Blood phosphorus decreased * 1  0/71 (0.00%)  2/143 (1.40%)  0/49 (0.00%)  4/80 (5.00%) 
Gamma-glutamyltransferase increased * 1  0/71 (0.00%)  2/143 (1.40%)  2/49 (4.08%)  7/80 (8.75%) 
White blood cells urine positive * 1  0/71 (0.00%)  1/143 (0.70%)  3/49 (6.12%)  0/80 (0.00%) 
Metabolism and nutrition disorders         
Hypokalaemia * 1  10/71 (14.08%)  39/143 (27.27%)  8/49 (16.33%)  14/80 (17.50%) 
Hyperglycaemia * 1  6/71 (8.45%)  17/143 (11.89%)  4/49 (8.16%)  6/80 (7.50%) 
Decreased appetite * 1  9/71 (12.68%)  3/143 (2.10%)  4/49 (8.16%)  2/80 (2.50%) 
Hypoalbuminaemia * 1  6/71 (8.45%)  3/143 (2.10%)  1/49 (2.04%)  0/80 (0.00%) 
Musculoskeletal and connective tissue disorders         
Bone pain * 1  15/71 (21.13%)  36/143 (25.17%)  6/49 (12.24%)  4/80 (5.00%) 
Back pain * 1  9/71 (12.68%)  20/143 (13.99%)  5/49 (10.20%)  4/80 (5.00%) 
Arthralgia * 1  5/71 (7.04%)  17/143 (11.89%)  2/49 (4.08%)  0/80 (0.00%) 
Pain in extremity * 1  11/71 (15.49%)  17/143 (11.89%)  2/49 (4.08%)  1/80 (1.25%) 
Musculoskeletal pain * 1  5/71 (7.04%)  10/143 (6.99%)  1/49 (2.04%)  3/80 (3.75%) 
Nervous system disorders         
Hypoaesthesia * 1  3/71 (4.23%)  9/143 (6.29%)  3/49 (6.12%)  1/80 (1.25%) 
Renal and urinary disorders         
Haematuria * 1  4/71 (5.63%)  9/143 (6.29%)  2/49 (4.08%)  1/80 (1.25%) 
Proteinuria * 1  5/71 (7.04%)  9/143 (6.29%)  0/49 (0.00%)  0/80 (0.00%) 
Respiratory, thoracic and mediastinal disorders         
Cough * 1  2/71 (2.82%)  7/143 (4.90%)  3/49 (6.12%)  0/80 (0.00%) 
Vascular disorders         
Hypertension * 1  9/71 (12.68%)  22/143 (15.38%)  3/49 (6.12%)  4/80 (5.00%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA Version 16.0
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.
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.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Senior Director
Organization: Janssen Research & Development, LLC
Phone: 844-434-4210
EMail: ClinicalTrialDisclosure@its.jnj.com
Layout table for additonal information
Responsible Party: Janssen Research & Development, LLC
ClinicalTrials.gov Identifier: NCT01695135    
Other Study ID Numbers: CR100010
ABI-PRO-3001 ( Other Identifier: Janssen Research & Development, LLC )
First Submitted: September 25, 2012
First Posted: September 27, 2012
Results First Submitted: May 7, 2019
Results First Posted: July 18, 2019
Last Update Posted: July 18, 2019