Trial Outcomes & Findings for A Study of Abiraterone Acetate (JNJ-212082) and Prednisolone in Patients With Advanced Prostate Cancer (NCT NCT01685983)
NCT ID: NCT01685983
Last Updated: 2019-03-15
Results Overview
The PSA response was evaluated according to Prostate-Specific Antigen Working Group (PSAWG) criterion, which is, greater than or equal to 50 percent decrease in PSA from Baseline during the study, which would be subsequently confirmed by a measurement that is at least 4 or more weeks after initial documentation of PSA response.
COMPLETED
PHASE2
82 participants
Baseline, Month 4
2019-03-15
Participant Flow
Participant milestones
| Measure |
Abiraterone Acetate
Abiraterone acetate 1,000 milligram (mg) (administered as 4 \* 250 mg tablets) orally once daily at least 1 hour before or 2 hours after a meal, and prednisolone 5 mg orally twice daily until documentation of disease progression or unacceptable toxicity.
|
|---|---|
|
Overall Study
STARTED
|
82
|
|
Overall Study
COMPLETED
|
0
|
|
Overall Study
NOT COMPLETED
|
82
|
Reasons for withdrawal
| Measure |
Abiraterone Acetate
Abiraterone acetate 1,000 milligram (mg) (administered as 4 \* 250 mg tablets) orally once daily at least 1 hour before or 2 hours after a meal, and prednisolone 5 mg orally twice daily until documentation of disease progression or unacceptable toxicity.
|
|---|---|
|
Overall Study
Adverse Event
|
7
|
|
Overall Study
Death
|
1
|
|
Overall Study
Withdrawal by Subject
|
19
|
|
Overall Study
Protocol Violation
|
2
|
|
Overall Study
Physician Decision
|
13
|
|
Overall Study
Other
|
7
|
|
Overall Study
Progressive Disease
|
32
|
|
Overall Study
Noncompliance with Study Drug
|
1
|
Baseline Characteristics
A Study of Abiraterone Acetate (JNJ-212082) and Prednisolone in Patients With Advanced Prostate Cancer
Baseline characteristics by cohort
| Measure |
Abiraterone Acetate
n=82 Participants
Abiraterone acetate 1,000 milligram (mg) (administered as 4 \* 250 mg tablets) orally once daily at least 1 hour before or 2 hours after a meal, and prednisolone 5 mg orally twice daily until documentation of disease progression or unacceptable toxicity.
|
|---|---|
|
Age, Continuous
|
71 years
STANDARD_DEVIATION 7.35 • n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
82 Participants
n=5 Participants
|
|
Region of Enrollment
Korea, Republic Of
|
52 Participants
n=5 Participants
|
|
Region of Enrollment
Taiwan, Province Of China
|
30 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline, Month 4Population: Analysis population included all participants who received at least 1 dose of abiraterone acetate.
The PSA response was evaluated according to Prostate-Specific Antigen Working Group (PSAWG) criterion, which is, greater than or equal to 50 percent decrease in PSA from Baseline during the study, which would be subsequently confirmed by a measurement that is at least 4 or more weeks after initial documentation of PSA response.
Outcome measures
| Measure |
Abiraterone Acetate and Prednisolone
n=82 Participants
Abiraterone acetate 1,000 milligram (mg) (administered as 4 \* 250 mg tablets) orally once daily at least 1 hour before or 2 hours after a meal, and prednisolone 5 mg orally twice daily until documentation of disease progression or unacceptable toxicity.
|
|---|---|
|
Percentage of Participants With Prostate-specific Antigen (PSA) Response
|
42.7 Percentage of participants
|
SECONDARY outcome
Timeframe: Up to 3 YearsPopulation: Analysis population included all participants who received at least 1 dose of abiraterone acetate.
Overall survival is defined as the time interval from the date of the first dose to the date of death due to any reason.
Outcome measures
| Measure |
Abiraterone Acetate and Prednisolone
n=82 Participants
Abiraterone acetate 1,000 milligram (mg) (administered as 4 \* 250 mg tablets) orally once daily at least 1 hour before or 2 hours after a meal, and prednisolone 5 mg orally twice daily until documentation of disease progression or unacceptable toxicity.
|
|---|---|
|
Overall Survival
|
538 Days
Interval 358.0 to 660.0
|
SECONDARY outcome
Timeframe: Up to 28 MonthsPopulation: Analysis population included all participants who received at least 1 dose of abiraterone acetate.
Time to PSA progression was measured as the time interval from the date of the first dose to the date of PSA progression as defined in the protocol-specific PSAWG criteria. For participants who have achieved a greater than or equal to (\>=) 50% decrease from the baseline PSA, assessment of time to disease progression is when the PSA has increased 50% above the nadir and at a minimum of 5 nanogram/mililiter (ng/mL). For participants without a PSA decrease of this magnitude or without a decrease, the time for progression is calculated at the time a 25% increase from baseline PSA has been achieved.
Outcome measures
| Measure |
Abiraterone Acetate and Prednisolone
n=82 Participants
Abiraterone acetate 1,000 milligram (mg) (administered as 4 \* 250 mg tablets) orally once daily at least 1 hour before or 2 hours after a meal, and prednisolone 5 mg orally twice daily until documentation of disease progression or unacceptable toxicity.
|
|---|---|
|
Time to PSA Progression
|
141 Days
Interval 112.0 to 170.0
|
SECONDARY outcome
Timeframe: Up to 3 YearsPopulation: Radiographic response-evaluable population included all participants who received at least 1 dose of abiraterone acetate, and had baseline and at least 1 on treatment tumor assessment.
Percentage of participants with radiographic objective response is defined as the percentage of participants with complete response (CR) or partial response (PR) as best overall response based on reconciled radiographic disease assessment according to RECIST Version 1.0. The CR is disappearance of all lesions. The PR is at least 30 percent decrease in sum of the longest diameter of target lesions or persistence of one or more non-target lesion(s) or/and maintenance of tumor marker level above the normal limits.
Outcome measures
| Measure |
Abiraterone Acetate and Prednisolone
n=49 Participants
Abiraterone acetate 1,000 milligram (mg) (administered as 4 \* 250 mg tablets) orally once daily at least 1 hour before or 2 hours after a meal, and prednisolone 5 mg orally twice daily until documentation of disease progression or unacceptable toxicity.
|
|---|---|
|
Percentage of Participants With Objective Radiographic Response
|
6.1 Percentage of participants
|
SECONDARY outcome
Timeframe: Baseline and End-of-Treatment Visit (up to approximately 3 years)Population: Analysis population included all participants who received at least 1 dose of abiraterone acetate. "n" signifies those participants who were evaluated for this measure at the specified time point.
Median serum testosterone concentration was reported at baseline and End-of-Treatment visit.
Outcome measures
| Measure |
Abiraterone Acetate and Prednisolone
n=82 Participants
Abiraterone acetate 1,000 milligram (mg) (administered as 4 \* 250 mg tablets) orally once daily at least 1 hour before or 2 hours after a meal, and prednisolone 5 mg orally twice daily until documentation of disease progression or unacceptable toxicity.
|
|---|---|
|
Serum Testosterone
Baseline
|
1.210 nanomole per liter
Interval 1.21 to 5.02
|
|
Serum Testosterone
End-of-Treatment Visit
|
1.210 nanomole per liter
Interval 1.21 to 1.79
|
SECONDARY outcome
Timeframe: Baseline and End-of-Treatment Visit (up to approximately 3 years)Population: Analysis population included all participants who received at least 1 dose of abiraterone acetate. "n" signifies those participants who were evaluated for this measure at the specified time point.
Median DHEA-S concentration was reported at baseline and End-of-Treatment visit.
Outcome measures
| Measure |
Abiraterone Acetate and Prednisolone
n=82 Participants
Abiraterone acetate 1,000 milligram (mg) (administered as 4 \* 250 mg tablets) orally once daily at least 1 hour before or 2 hours after a meal, and prednisolone 5 mg orally twice daily until documentation of disease progression or unacceptable toxicity.
|
|---|---|
|
Dehydroepiandrosterone Sulfate (DHEA-S)
Baseline
|
0.725 micromole per liter
Interval 0.08 to 6.28
|
|
Dehydroepiandrosterone Sulfate (DHEA-S)
End-of-Treatment Visit
|
0.080 micromole per liter
Interval 0.08 to 0.2
|
SECONDARY outcome
Timeframe: Up to 3 YearsPopulation: Analysis population included all participants who received at least 1 dose of abiraterone acetate.
An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.
Outcome measures
| Measure |
Abiraterone Acetate and Prednisolone
n=82 Participants
Abiraterone acetate 1,000 milligram (mg) (administered as 4 \* 250 mg tablets) orally once daily at least 1 hour before or 2 hours after a meal, and prednisolone 5 mg orally twice daily until documentation of disease progression or unacceptable toxicity.
|
|---|---|
|
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
AEs
|
81 Participants
|
|
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
SAEs
|
40 Participants
|
Adverse Events
Abiraterone Acetate
Serious adverse events
| Measure |
Abiraterone Acetate
n=82 participants at risk
Abiraterone acetate 1,000 milligram (mg) (administered as 4 \* 250 mg tablets) orally once daily at least 1 hour before or 2 hours after a meal, and prednisolone 5 mg orally twice daily until documentation of disease progression or unacceptable toxicity.
|
|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
3.7%
3/82 • Approximately 3 Years
|
|
Cardiac disorders
Microvascular coronary artery disease
|
1.2%
1/82 • Approximately 3 Years
|
|
Eye disorders
Cataract
|
1.2%
1/82 • Approximately 3 Years
|
|
Gastrointestinal disorders
Abdominal discomfort
|
1.2%
1/82 • Approximately 3 Years
|
|
Gastrointestinal disorders
Abdominal distension
|
1.2%
1/82 • Approximately 3 Years
|
|
Gastrointestinal disorders
Abdominal pain
|
2.4%
2/82 • Approximately 3 Years
|
|
Gastrointestinal disorders
Ileus
|
1.2%
1/82 • Approximately 3 Years
|
|
Gastrointestinal disorders
Nausea
|
2.4%
2/82 • Approximately 3 Years
|
|
Gastrointestinal disorders
Vomiting
|
3.7%
3/82 • Approximately 3 Years
|
|
General disorders
Asthenia
|
3.7%
3/82 • Approximately 3 Years
|
|
General disorders
Chest discomfort
|
1.2%
1/82 • Approximately 3 Years
|
|
General disorders
Chills
|
1.2%
1/82 • Approximately 3 Years
|
|
General disorders
Septic shock
|
1.2%
1/82 • Approximately 3 Years
|
|
General disorders
Fatigue
|
1.2%
1/82 • Approximately 3 Years
|
|
General disorders
Generalised oedema
|
1.2%
1/82 • Approximately 3 Years
|
|
General disorders
Non-cardiac chest pain
|
1.2%
1/82 • Approximately 3 Years
|
|
General disorders
Pyrexia
|
2.4%
2/82 • Approximately 3 Years
|
|
Infections and infestations
Appendicitis
|
1.2%
1/82 • Approximately 3 Years
|
|
Infections and infestations
Cellulitis
|
2.4%
2/82 • Approximately 3 Years
|
|
Infections and infestations
Hepatitis A
|
1.2%
1/82 • Approximately 3 Years
|
|
Infections and infestations
Herpes zoster
|
1.2%
1/82 • Approximately 3 Years
|
|
Infections and infestations
Pneumonia
|
1.2%
1/82 • Approximately 3 Years
|
|
Infections and infestations
Pneumonia cryptococcal
|
1.2%
1/82 • Approximately 3 Years
|
|
Infections and infestations
Sepsis
|
1.2%
1/82 • Approximately 3 Years
|
|
Infections and infestations
Septic shock
|
1.2%
1/82 • Approximately 3 Years
|
|
Infections and infestations
Urosepsis
|
1.2%
1/82 • Approximately 3 Years
|
|
Injury, poisoning and procedural complications
Spinal compression fracture
|
2.4%
2/82 • Approximately 3 Years
|
|
Injury, poisoning and procedural complications
Spinal fracture
|
1.2%
1/82 • Approximately 3 Years
|
|
Metabolism and nutrition disorders
Cachexia
|
1.2%
1/82 • Approximately 3 Years
|
|
Metabolism and nutrition disorders
Decreased appetite
|
2.4%
2/82 • Approximately 3 Years
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
1.2%
1/82 • Approximately 3 Years
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
1.2%
1/82 • Approximately 3 Years
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
1.2%
1/82 • Approximately 3 Years
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
2.4%
2/82 • Approximately 3 Years
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
3.7%
3/82 • Approximately 3 Years
|
|
Musculoskeletal and connective tissue disorders
Chest wall mass
|
1.2%
1/82 • Approximately 3 Years
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
2.4%
2/82 • Approximately 3 Years
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
1.2%
1/82 • Approximately 3 Years
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
1.2%
1/82 • Approximately 3 Years
|
|
Musculoskeletal and connective tissue disorders
Pathological fracture
|
1.2%
1/82 • Approximately 3 Years
|
|
Musculoskeletal and connective tissue disorders
Spinal column stenosis
|
1.2%
1/82 • Approximately 3 Years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cancer pain
|
1.2%
1/82 • Approximately 3 Years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to bone
|
1.2%
1/82 • Approximately 3 Years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to central nervous system
|
1.2%
1/82 • Approximately 3 Years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to liver
|
1.2%
1/82 • Approximately 3 Years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to lung
|
1.2%
1/82 • Approximately 3 Years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Thyroid cancer
|
1.2%
1/82 • Approximately 3 Years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour pain
|
1.2%
1/82 • Approximately 3 Years
|
|
Nervous system disorders
Central nervous system lesion
|
1.2%
1/82 • Approximately 3 Years
|
|
Nervous system disorders
Encephalopathy
|
1.2%
1/82 • Approximately 3 Years
|
|
Nervous system disorders
Lethargy
|
1.2%
1/82 • Approximately 3 Years
|
|
Renal and urinary disorders
Dysuria
|
1.2%
1/82 • Approximately 3 Years
|
|
Renal and urinary disorders
Haematuria
|
2.4%
2/82 • Approximately 3 Years
|
|
Renal and urinary disorders
Pelvi-ureteric obstruction
|
1.2%
1/82 • Approximately 3 Years
|
|
Renal and urinary disorders
Renal failure acute
|
1.2%
1/82 • Approximately 3 Years
|
|
Renal and urinary disorders
Urinary retention
|
1.2%
1/82 • Approximately 3 Years
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
1.2%
1/82 • Approximately 3 Years
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
1.2%
1/82 • Approximately 3 Years
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
1.2%
1/82 • Approximately 3 Years
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
1.2%
1/82 • Approximately 3 Years
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory acidosis
|
1.2%
1/82 • Approximately 3 Years
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
2.4%
2/82 • Approximately 3 Years
|
|
Skin and subcutaneous tissue disorders
Drug rash with eosinophilia and systemic symptoms
|
1.2%
1/82 • Approximately 3 Years
|
Other adverse events
| Measure |
Abiraterone Acetate
n=82 participants at risk
Abiraterone acetate 1,000 milligram (mg) (administered as 4 \* 250 mg tablets) orally once daily at least 1 hour before or 2 hours after a meal, and prednisolone 5 mg orally twice daily until documentation of disease progression or unacceptable toxicity.
|
|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
13.4%
11/82 • Approximately 3 Years
|
|
Gastrointestinal disorders
Abdominal discomfort
|
8.5%
7/82 • Approximately 3 Years
|
|
Gastrointestinal disorders
Abdominal distension
|
6.1%
5/82 • Approximately 3 Years
|
|
Gastrointestinal disorders
Abdominal pain
|
7.3%
6/82 • Approximately 3 Years
|
|
Gastrointestinal disorders
Constipation
|
17.1%
14/82 • Approximately 3 Years
|
|
Gastrointestinal disorders
Dyspepsia
|
8.5%
7/82 • Approximately 3 Years
|
|
Gastrointestinal disorders
Nausea
|
22.0%
18/82 • Approximately 3 Years
|
|
Gastrointestinal disorders
Vomiting
|
17.1%
14/82 • Approximately 3 Years
|
|
General disorders
Asthenia
|
8.5%
7/82 • Approximately 3 Years
|
|
General disorders
Face oedema
|
9.8%
8/82 • Approximately 3 Years
|
|
General disorders
Fatigue
|
13.4%
11/82 • Approximately 3 Years
|
|
General disorders
Oedema peripheral
|
14.6%
12/82 • Approximately 3 Years
|
|
General disorders
Pyrexia
|
7.3%
6/82 • Approximately 3 Years
|
|
Infections and infestations
Nasopharyngitis
|
12.2%
10/82 • Approximately 3 Years
|
|
Infections and infestations
Upper respiratory tract infection
|
9.8%
8/82 • Approximately 3 Years
|
|
Infections and infestations
Urinary tract infection
|
6.1%
5/82 • Approximately 3 Years
|
|
Investigations
Alanine aminotransferase increased
|
6.1%
5/82 • Approximately 3 Years
|
|
Investigations
Aspartate aminotransferase increased
|
8.5%
7/82 • Approximately 3 Years
|
|
Investigations
Blood alkaline phosphatase increased
|
9.8%
8/82 • Approximately 3 Years
|
|
Investigations
Weight decreased
|
6.1%
5/82 • Approximately 3 Years
|
|
Metabolism and nutrition disorders
Decreased appetite
|
12.2%
10/82 • Approximately 3 Years
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
8.5%
7/82 • Approximately 3 Years
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
18.3%
15/82 • Approximately 3 Years
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
7.3%
6/82 • Approximately 3 Years
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
23.2%
19/82 • Approximately 3 Years
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
25.6%
21/82 • Approximately 3 Years
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
6.1%
5/82 • Approximately 3 Years
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
15.9%
13/82 • Approximately 3 Years
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
14.6%
12/82 • Approximately 3 Years
|
|
Nervous system disorders
Dizziness
|
7.3%
6/82 • Approximately 3 Years
|
|
Nervous system disorders
Hypoaesthesia
|
7.3%
6/82 • Approximately 3 Years
|
|
Psychiatric disorders
Insomnia
|
12.2%
10/82 • Approximately 3 Years
|
|
Renal and urinary disorders
Haematuria
|
6.1%
5/82 • Approximately 3 Years
|
|
Renal and urinary disorders
Nocturia
|
6.1%
5/82 • Approximately 3 Years
|
|
Renal and urinary disorders
Proteinuria
|
9.8%
8/82 • Approximately 3 Years
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
13.4%
11/82 • Approximately 3 Years
|
|
Skin and subcutaneous tissue disorders
Ecchymosis
|
7.3%
6/82 • Approximately 3 Years
|
|
Vascular disorders
Hypertension
|
18.3%
15/82 • Approximately 3 Years
|
Additional Information
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