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IMAAGEN: Impact of Abiraterone Acetate in Prostate-Specific Antigen

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01314118
Recruitment Status : Active, not recruiting
First Posted : March 14, 2011
Results First Posted : January 7, 2015
Last Update Posted : December 3, 2021
Sponsor:
Information provided by (Responsible Party):
Janssen Biotech, Inc.

Study Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Prostate Cancer
Prostatic Neoplasm
Intervention Drug: abiraterone acetate in combination with prednisone
Enrollment 131
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Abiraterone Acetate
Hide Arm/Group Description Participants were given Abiraterone Acetate 1000 milligram (mg) (4*250 mg) tablets and Prednisone 5 mg (2*2.5 mg) tablets orally once daily in Core Study Treatment Phase (comprised of 6, 28 day cycles). After the Core Study Treatment Phase, participants who entered the Pre-metastatic Disease Follow-up Phase continued the study treatment until radiographic confirmation of disease progression, intolerable toxicity, investigator's decision, and withdrawal by participant or until the sponsor decided to stop the trial.
Period Title: Overall Study
Started 131
Completed 0
Not Completed 131
Reason Not Completed
Adverse Event             9
Progressive disease             27
Physician Decision             11
Death             4
Protocol Violation             5
Withdrawal by Subject             11
Other             2
Ongoing             62
Arm/Group Title Abiraterone Acetate
Hide Arm/Group Description Participants were given Abiraterone Acetate 1000 milligram (mg) (4*250 mg) tablets and Prednisone 5 mg (2*2.5 mg) tablets orally once daily in Core Study Treatment Phase (comprised of 6, 28 day cycles). After the Core Study Treatment Phase, participants who entered the Pre-metastatic Disease Follow-up Phase continued the study treatment until radiographic confirmation of disease progression, intolerable toxicity, investigator's decision, and withdrawal by participant or until the sponsor decided to stop the trial.
Overall Number of Baseline Participants 131
Hide Baseline Analysis Population Description
All participants who received at least 1 dose of study drug.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 131 participants
71.2  (8.82)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 131 participants
Female
0
   0.0%
Male
131
 100.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
USA Number Analyzed 131 participants
131
1.Primary Outcome
Title Percentage of Participants With Greater Than or Equal to (>=) 50 Percent (%) Reduction in Prostate-Specific Antigen (PSA) During the Core Study
Hide Description Percentage of participants with greater than or equal to 50 percent decrease in PSA levels was assessed.
Time Frame End of core study visit (Approximately at Month 6)
Hide Outcome Measure Data
Hide Analysis Population Description
Efficacy evaluable set included all participants who received at least one dose of study drug, completed at least 1 cycle of treatment and had at least 1 post-baseline PSA assessment.
Arm/Group Title Abiraterone Acetate and Prednisone
Hide Arm/Group Description:
Participants were given Abiraterone Acetate 1000 milligram (mg) (4*250 mg) tablets and Prednisone 5 mg (2*2.5 mg) tablets orally once daily in Core Study Treatment Phase (comprised of 6, 28 day cycles). After the Core Study Treatment Phase, participants who entered the Pre-metastatic Disease Follow-up Phase continued the study treatment until radiographic confirmation of disease progression, intolerable toxicity, investigator's decision, and withdrawal by participant or until the sponsor decided to stop the trial.
Overall Number of Participants Analyzed 122
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
86.9
(80.9 to 92.9)
2.Secondary Outcome
Title Time to Radiographic Evidence of Disease Progression (TTRP)
Hide Description Time to radiographic evidence of disease progression is defined as the time interval from the date of enrollment (Day 1) to the date of disease progression. A participant was considered as progressed by bone scan if: 1) The appearance of greater than or equal to (>=) 2 new lesions, and, following the first assessment, a confirmatory scan performed 6 or more weeks later that shows a minimum of 2 or more additional new lesions, 2) If >=2 new lesions are seen on scans following the first assessment, the confirmation is still required after 6 weeks; however, 2 addition lesions are not required to confirm progression, and 3) The date of progression is the date of the first scan that shows the changes.
Time Frame Maximum up to Month 30.5
Hide Outcome Measure Data
Hide Analysis Population Description
All enrolled set included all participants who received at least 1 dose of study drug.
Arm/Group Title Abiraterone Acetate and Prednisone
Hide Arm/Group Description:
Participants were given Abiraterone Acetate 1000 milligram (mg) (4*250 mg) tablets and Prednisone 5 mg (2*2.5 mg) tablets orally once daily in Core Study Treatment Phase (comprised of 6, 28 day cycles). After the Core Study Treatment Phase, participants who entered the Pre-metastatic Disease Follow-up Phase continued the study treatment until radiographic confirmation of disease progression, intolerable toxicity, investigator's decision, and withdrawal by participant or until the sponsor decided to stop the trial.
Overall Number of Participants Analyzed 131
Median (95% Confidence Interval)
Unit of Measure: Months
NA [1] 
(NA to NA)
[1]
Data was not evaluable as insufficient number of participants had the event.
3.Secondary Outcome
Title Time to Prostate-Specific Antigen (PSA) Progression
Hide Description Time to PSA progression is defined as the time interval from the date of enrollment (Day 1) to the date of first evidence of PSA progression. A participant was considered to have a PSA progression if the PSA level had a 25 percent (%) or greater increase and an absolute increase of 2 nanogram (ng)/milliliter (mL) or more, which is confirmed by a second value obtained in 3 or more weeks.
Time Frame Maximum up to Month 30.5
Hide Outcome Measure Data
Hide Analysis Population Description
All enrolled set included all participants who received at least 1 dose of study drug.
Arm/Group Title Abiraterone Acetate and Prednisone
Hide Arm/Group Description:
Participants were given Abiraterone Acetate 1000 milligram (mg) (4*250 mg) tablets and Prednisone 5 mg (2*2.5 mg) tablets orally once daily in Core Study Treatment Phase (comprised of 6, 28 day cycles). After the Core Study Treatment Phase, participants who entered the Pre-metastatic Disease Follow-up Phase continued the study treatment until radiographic confirmation of disease progression, intolerable toxicity, investigator's decision, and withdrawal by participant or until the sponsor decided to stop the trial.
Overall Number of Participants Analyzed 131
Median (95% Confidence Interval)
Unit of Measure: Months
28.7 [1] 
(21.2 to NA)
[1]
Data was not evaluable as insufficient number of participants had the event.
4.Secondary Outcome
Title Percentage of Participants With Greater Than or Equal to (>=) 50 Percent (%) Reduction in Prostate-Specific Antigen (PSA) Levels After 3 Cycles of Treatment
Hide Description Percentage of participants with greater than or equal to 50 percent decrease in PSA levels was assessed. Decrease in PSA levels represented improvement.
Time Frame End of Cycle 3 (Approximately Month 3)
Hide Outcome Measure Data
Hide Analysis Population Description
Efficacy evaluable set included all participants who received at least 1 dose of study drug, completed at least 1 cycle of treatment and had at least 1 post-baseline PSA assessment.
Arm/Group Title Abiraterone Acetate and Prednisone
Hide Arm/Group Description:
Participants were given Abiraterone Acetate 1000 milligram (mg) (4*250 mg) tablets and Prednisone 5 mg (2*2.5 mg) tablets orally once daily in Core Study Treatment Phase (comprised of 6, 28 day cycles). After the Core Study Treatment Phase, participants who entered the Pre-metastatic Disease Follow-up Phase continued the study treatment until radiographic confirmation of disease progression, intolerable toxicity, investigator's decision, and withdrawal by participant or until the sponsor decided to stop the trial.
Overall Number of Participants Analyzed 122
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of Participants
85.2
(79.0 to 91.5)
Time Frame Screening up to Month 30.5
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Abiraterone Acetate
Hide Arm/Group Description Participants were given Abiraterone Acetate 1000 milligram (mg) (4*250 mg) tablets and Prednisone 5 mg (2*2.5 mg) tablets orally once daily in Core Study Treatment Phase (comprised of 6, 28 day cycles). After the Core Study Treatment Phase, participants who entered the Pre-metastatic Disease Follow-up Phase continued the study treatment until radiographic confirmation of disease progression, intolerable toxicity, investigator's decision, and withdrawal by participant or until the sponsor decided to stop the trial.
All-Cause Mortality
Abiraterone Acetate
Affected / at Risk (%)
Total   --/-- 
Hide Serious Adverse Events
Abiraterone Acetate
Affected / at Risk (%)
Total   50/131 (38.17%) 
Blood and lymphatic system disorders   
Anaemia * 1  1/131 (0.76%) 
Cardiac disorders   
Acute Myocardial Infarction * 1  1/131 (0.76%) 
Atrial Fibrillation * 1  2/131 (1.53%) 
Bradycardia * 1  2/131 (1.53%) 
Cardio-Respiratory Arrest * 1  1/131 (0.76%) 
Coronary Artery Disease * 1  3/131 (2.29%) 
Myocardial Infarction * 1  2/131 (1.53%) 
Cardiac Failure Congestive * 1  1/131 (0.76%) 
Ear and labyrinth disorders   
Meniere's Disease * 1  1/131 (0.76%) 
Gastrointestinal disorders   
Colitis Ulcerative * 1  1/131 (0.76%) 
Gastrointestinal Haemorrhage * 1  1/131 (0.76%) 
Gastrointestinal Pain * 1  1/131 (0.76%) 
Abdominal Pain * 1  1/131 (0.76%) 
Obstruction Gastric * 1  1/131 (0.76%) 
Rectourethral Fistula * 1  1/131 (0.76%) 
Small Intestinal Obstruction * 1  1/131 (0.76%) 
General disorders   
Chest Pain * 1  1/131 (0.76%) 
Oedema Peripheral * 1  1/131 (0.76%) 
Systemic Inflammatory Response Syndrome * 1  1/131 (0.76%) 
Asthenia * 1  1/131 (0.76%) 
Infections and infestations   
Lobar Pneumonia * 1  1/131 (0.76%) 
Osteomyelitis * 1  1/131 (0.76%) 
Pneumonia * 1  6/131 (4.58%) 
Sepsis * 1  4/131 (3.05%) 
Urinary Tract Infection * 1  1/131 (0.76%) 
Urosepsis * 1  1/131 (0.76%) 
Injury, poisoning and procedural complications   
Cystitis Radiation * 1  1/131 (0.76%) 
Fall * 1  2/131 (1.53%) 
Femur Fracture * 1  1/131 (0.76%) 
Spinal Fracture * 1  1/131 (0.76%) 
Transplant Failure * 1  1/131 (0.76%) 
Investigations   
Alanine Aminotransferase Increased * 1  4/131 (3.05%) 
Hepatic Enzyme Increased * 1  1/131 (0.76%) 
Blood Glucose Increased * 1  1/131 (0.76%) 
Blood Potassium Increased * 1  1/131 (0.76%) 
Liver Function Test Abnormal * 1  2/131 (1.53%) 
Metabolism and nutrition disorders   
Dehydration * 1  3/131 (2.29%) 
Electrolyte Imbalance * 1  1/131 (0.76%) 
Failure to Thrive * 1  1/131 (0.76%) 
Hyperglycaemia * 1  1/131 (0.76%) 
Hypokalaemia * 1  1/131 (0.76%) 
Musculoskeletal and connective tissue disorders   
Back Pain * 1  1/131 (0.76%) 
Flank Pain * 1  1/131 (0.76%) 
Intervertebral Disc Protrusion * 1  1/131 (0.76%) 
Muscular Weakness * 1  2/131 (1.53%) 
Rheumatoid Arthritis * 1  1/131 (0.76%) 
Lumbar Spinal Stenosis * 1  1/131 (0.76%) 
Nervous system disorders   
Dizziness * 1  1/131 (0.76%) 
Neurological Symptom * 1  1/131 (0.76%) 
Presyncope * 1  1/131 (0.76%) 
Syncope * 1  3/131 (2.29%) 
Brain Mass * 1  1/131 (0.76%) 
Renal and urinary disorders   
Bladder Obstruction * 1  1/131 (0.76%) 
Obstructive Uropathy * 1  1/131 (0.76%) 
Renal Failure Acute * 1  2/131 (1.53%) 
Urinary Retention * 1  4/131 (3.05%) 
Urinary Tract Obstruction * 1  1/131 (0.76%) 
Haematuria * 1  2/131 (1.53%) 
Respiratory, thoracic and mediastinal disorders   
Acute Respiratory Failure * 1  1/131 (0.76%) 
Pleural Effusion * 1  1/131 (0.76%) 
Pneumonia Aspiration * 1  1/131 (0.76%) 
Surgical and medical procedures   
Nephrectomy * 1  1/131 (0.76%) 
Transurethral Prostatectomy * 1  1/131 (0.76%) 
Vascular disorders   
Hypertension * 1  2/131 (1.53%) 
Hypertensive Crisis * 1  1/131 (0.76%) 
Hypotension * 1  1/131 (0.76%) 
Embolism * 1  1/131 (0.76%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA Version 14.0
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Abiraterone Acetate
Affected / at Risk (%)
Total   118/131 (90.08%) 
Blood and lymphatic system disorders   
Anaemia * 1  9/131 (6.87%) 
Gastrointestinal disorders   
Constipation * 1  21/131 (16.03%) 
Diarrhoea * 1  23/131 (17.56%) 
Nausea * 1  25/131 (19.08%) 
Vomiting * 1  20/131 (15.27%) 
General disorders   
Fatigue * 1  47/131 (35.88%) 
Influenza Like Illness * 1  7/131 (5.34%) 
Oedema Peripheral * 1  29/131 (22.14%) 
Chest Pain * 1  7/131 (5.34%) 
Infections and infestations   
Nasopharyngitis * 1  15/131 (11.45%) 
Sinusitis * 1  10/131 (7.63%) 
Upper Respiratory Tract Infection * 1  21/131 (16.03%) 
Urinary Tract Infection * 1  13/131 (9.92%) 
Bronchitis * 1  7/131 (5.34%) 
Injury, poisoning and procedural complications   
Fall * 1  7/131 (5.34%) 
Investigations   
Alanine Aminotransferase Increased * 1  9/131 (6.87%) 
Aspartate Aminotransferase Increased * 1  9/131 (6.87%) 
Blood Creatine Phosphokinase Increased * 1  7/131 (5.34%) 
Metabolism and nutrition disorders   
Hyperglycaemia * 1  11/131 (8.40%) 
Hypokalaemia * 1  42/131 (32.06%) 
Musculoskeletal and connective tissue disorders   
Arthralgia * 1  19/131 (14.50%) 
Back Pain * 1  18/131 (13.74%) 
Muscle Spasms * 1  10/131 (7.63%) 
Musculoskeletal Pain * 1  10/131 (7.63%) 
Pain in Extremity * 1  9/131 (6.87%) 
Musculoskeletal Chest Pain * 1  9/131 (6.87%) 
Myalgia * 1  7/131 (5.34%) 
Nervous system disorders   
Dizziness * 1  22/131 (16.79%) 
Headache * 1  22/131 (16.79%) 
Psychiatric disorders   
Anxiety * 1  7/131 (5.34%) 
Insomnia * 1  9/131 (6.87%) 
Renal and urinary disorders   
Haematuria * 1  15/131 (11.45%) 
Micturition Urgency * 1  7/131 (5.34%) 
Pollakiuria * 1  11/131 (8.40%) 
Urinary Incontinence * 1  8/131 (6.11%) 
Urinary Retention * 1  10/131 (7.63%) 
Respiratory, thoracic and mediastinal disorders   
Cough * 1  20/131 (15.27%) 
Dyspnoea * 1  11/131 (8.40%) 
Nasal Congestion * 1  9/131 (6.87%) 
Skin and subcutaneous tissue disorders   
Rash * 1  7/131 (5.34%) 
Vascular disorders   
Hot Flush * 1  13/131 (9.92%) 
Hypertension * 1  53/131 (40.46%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA Version 14.0
These results are up to clinical cutoff 31 December 2013 when all enrolled subjects either completed 6 cycles of treatment or withdrew from study prior to end of cycle 6. Primary endpoint results are complete.
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. The sponsor will not mandate modifications to scientific content and does not have the right to suppress information.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Strategic Lead Oncology Tas
Organization: Janssen Services, LLC
EMail: ClinicalTrialDisclosure@its.jnj.com
Layout table for additonal information
Responsible Party: Janssen Biotech, Inc.
ClinicalTrials.gov Identifier: NCT01314118    
Other Study ID Numbers: CR017932
Protocol 212082PCR2005 ( Other Identifier: Janssen Biotech Inc. )
First Submitted: March 4, 2011
First Posted: March 14, 2011
Results First Submitted: December 24, 2014
Results First Posted: January 7, 2015
Last Update Posted: December 3, 2021