Trial Outcomes & Findings for IMAAGEN: Impact of Abiraterone Acetate in Prostate-Specific Antigen (NCT NCT01314118)
NCT ID: NCT01314118
Last Updated: 2025-11-12
Results Overview
Percentage of participants with greater than or equal to 50 percent decrease in PSA levels was assessed.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
131 participants
Primary outcome timeframe
End of core study visit (Approximately at Month 6)
Results posted on
2025-11-12
Participant Flow
Participant milestones
| Measure |
Abiraterone Acetate
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 Study
STARTED
|
131
|
|
Overall Study
COMPLETED
|
0
|
|
Overall Study
NOT COMPLETED
|
131
|
Reasons for withdrawal
| Measure |
Abiraterone Acetate
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 Study
Adverse Event
|
9
|
|
Overall Study
Progressive disease
|
27
|
|
Overall Study
Physician Decision
|
11
|
|
Overall Study
Death
|
4
|
|
Overall Study
Protocol Violation
|
5
|
|
Overall Study
Withdrawal by Subject
|
11
|
|
Overall Study
Other
|
2
|
|
Overall Study
Ongoing
|
62
|
Baseline Characteristics
IMAAGEN: Impact of Abiraterone Acetate in Prostate-Specific Antigen
Baseline characteristics by cohort
| Measure |
Abiraterone Acetate
n=131 Participants
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.
|
|---|---|
|
Age, Continuous
|
71.2 years
STANDARD_DEVIATION 8.82 • n=10 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=10 Participants
|
|
Sex: Female, Male
Male
|
131 Participants
n=10 Participants
|
|
Region of Enrollment
USA
|
131 participants
n=10 Participants
|
PRIMARY outcome
Timeframe: End of core study visit (Approximately at Month 6)Population: 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.
Percentage of participants with greater than or equal to 50 percent decrease in PSA levels was assessed.
Outcome measures
| Measure |
Abiraterone Acetate and Prednisone
n=122 Participants
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.
|
|---|---|
|
Percentage of Participants With Greater Than or Equal to (>=) 50 Percent (%) Reduction in Prostate-Specific Antigen (PSA) During the Core Study
|
86.9 Percentage of participants
Interval 80.9 to 92.9
|
SECONDARY outcome
Timeframe: Maximum up to Month 30.5Population: All enrolled set included all participants who received at least 1 dose of study drug.
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.
Outcome measures
| Measure |
Abiraterone Acetate and Prednisone
n=131 Participants
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.
|
|---|---|
|
Time to Radiographic Evidence of Disease Progression (TTRP)
|
NA Months
Data was not evaluable as insufficient number of participants had the event.
|
SECONDARY outcome
Timeframe: Maximum up to Month 30.5Population: All enrolled set included all participants who received at least 1 dose of study drug.
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.
Outcome measures
| Measure |
Abiraterone Acetate and Prednisone
n=131 Participants
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.
|
|---|---|
|
Time to Prostate-Specific Antigen (PSA) Progression
|
28.7 Months
Interval 21.2 to
Data was not evaluable as insufficient number of participants had the event.
|
SECONDARY outcome
Timeframe: End of Cycle 3 (Approximately Month 3)Population: 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.
Percentage of participants with greater than or equal to 50 percent decrease in PSA levels was assessed. Decrease in PSA levels represented improvement.
Outcome measures
| Measure |
Abiraterone Acetate and Prednisone
n=122 Participants
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.
|
|---|---|
|
Percentage of Participants With Greater Than or Equal to (>=) 50 Percent (%) Reduction in Prostate-Specific Antigen (PSA) Levels After 3 Cycles of Treatment
|
85.2 Percentage of Participants
Interval 79.0 to 91.5
|
Adverse Events
Abiraterone Acetate
Serious events: 50 serious events
Other events: 118 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Abiraterone Acetate
n=131 participants at risk
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.
|
|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.76%
1/131 • Screening up to Month 30.5
|
|
Cardiac disorders
Acute Myocardial Infarction
|
0.76%
1/131 • Screening up to Month 30.5
|
|
Cardiac disorders
Atrial Fibrillation
|
1.5%
2/131 • Screening up to Month 30.5
|
|
Cardiac disorders
Bradycardia
|
1.5%
2/131 • Screening up to Month 30.5
|
|
Cardiac disorders
Cardio-Respiratory Arrest
|
0.76%
1/131 • Screening up to Month 30.5
|
|
Cardiac disorders
Coronary Artery Disease
|
2.3%
3/131 • Screening up to Month 30.5
|
|
Cardiac disorders
Myocardial Infarction
|
1.5%
2/131 • Screening up to Month 30.5
|
|
Ear and labyrinth disorders
Meniere's Disease
|
0.76%
1/131 • Screening up to Month 30.5
|
|
Gastrointestinal disorders
Colitis Ulcerative
|
0.76%
1/131 • Screening up to Month 30.5
|
|
Gastrointestinal disorders
Gastrointestinal Haemorrhage
|
0.76%
1/131 • Screening up to Month 30.5
|
|
Gastrointestinal disorders
Gastrointestinal Pain
|
0.76%
1/131 • Screening up to Month 30.5
|
|
General disorders
Chest Pain
|
0.76%
1/131 • Screening up to Month 30.5
|
|
General disorders
Oedema Peripheral
|
0.76%
1/131 • Screening up to Month 30.5
|
|
General disorders
Systemic Inflammatory Response Syndrome
|
0.76%
1/131 • Screening up to Month 30.5
|
|
Infections and infestations
Lobar Pneumonia
|
0.76%
1/131 • Screening up to Month 30.5
|
|
Infections and infestations
Osteomyelitis
|
0.76%
1/131 • Screening up to Month 30.5
|
|
Infections and infestations
Pneumonia
|
4.6%
6/131 • Screening up to Month 30.5
|
|
Infections and infestations
Sepsis
|
3.1%
4/131 • Screening up to Month 30.5
|
|
Injury, poisoning and procedural complications
Cystitis Radiation
|
0.76%
1/131 • Screening up to Month 30.5
|
|
Investigations
Alanine Aminotransferase Increased
|
3.1%
4/131 • Screening up to Month 30.5
|
|
Investigations
Hepatic Enzyme Increased
|
0.76%
1/131 • Screening up to Month 30.5
|
|
Metabolism and nutrition disorders
Dehydration
|
2.3%
3/131 • Screening up to Month 30.5
|
|
Metabolism and nutrition disorders
Electrolyte Imbalance
|
0.76%
1/131 • Screening up to Month 30.5
|
|
Metabolism and nutrition disorders
Failure to Thrive
|
0.76%
1/131 • Screening up to Month 30.5
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.76%
1/131 • Screening up to Month 30.5
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.76%
1/131 • Screening up to Month 30.5
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
0.76%
1/131 • Screening up to Month 30.5
|
|
Musculoskeletal and connective tissue disorders
Flank Pain
|
0.76%
1/131 • Screening up to Month 30.5
|
|
Musculoskeletal and connective tissue disorders
Intervertebral Disc Protrusion
|
0.76%
1/131 • Screening up to Month 30.5
|
|
Musculoskeletal and connective tissue disorders
Muscular Weakness
|
1.5%
2/131 • Screening up to Month 30.5
|
|
Musculoskeletal and connective tissue disorders
Rheumatoid Arthritis
|
0.76%
1/131 • Screening up to Month 30.5
|
|
Nervous system disorders
Dizziness
|
0.76%
1/131 • Screening up to Month 30.5
|
|
Nervous system disorders
Neurological Symptom
|
0.76%
1/131 • Screening up to Month 30.5
|
|
Nervous system disorders
Presyncope
|
0.76%
1/131 • Screening up to Month 30.5
|
|
Nervous system disorders
Syncope
|
2.3%
3/131 • Screening up to Month 30.5
|
|
Renal and urinary disorders
Bladder Obstruction
|
0.76%
1/131 • Screening up to Month 30.5
|
|
Renal and urinary disorders
Obstructive Uropathy
|
0.76%
1/131 • Screening up to Month 30.5
|
|
Renal and urinary disorders
Renal Failure Acute
|
1.5%
2/131 • Screening up to Month 30.5
|
|
Renal and urinary disorders
Urinary Retention
|
3.1%
4/131 • Screening up to Month 30.5
|
|
Renal and urinary disorders
Urinary Tract Obstruction
|
0.76%
1/131 • Screening up to Month 30.5
|
|
Respiratory, thoracic and mediastinal disorders
Acute Respiratory Failure
|
0.76%
1/131 • Screening up to Month 30.5
|
|
Respiratory, thoracic and mediastinal disorders
Pleural Effusion
|
0.76%
1/131 • Screening up to Month 30.5
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia Aspiration
|
0.76%
1/131 • Screening up to Month 30.5
|
|
Surgical and medical procedures
Nephrectomy
|
0.76%
1/131 • Screening up to Month 30.5
|
|
Surgical and medical procedures
Transurethral Prostatectomy
|
0.76%
1/131 • Screening up to Month 30.5
|
|
Vascular disorders
Hypertension
|
1.5%
2/131 • Screening up to Month 30.5
|
|
Vascular disorders
Hypertensive Crisis
|
0.76%
1/131 • Screening up to Month 30.5
|
|
Vascular disorders
Hypotension
|
0.76%
1/131 • Screening up to Month 30.5
|
|
Cardiac disorders
Cardiac Failure Congestive
|
0.76%
1/131 • Screening up to Month 30.5
|
|
Gastrointestinal disorders
Abdominal Pain
|
0.76%
1/131 • Screening up to Month 30.5
|
|
Gastrointestinal disorders
Obstruction Gastric
|
0.76%
1/131 • Screening up to Month 30.5
|
|
Gastrointestinal disorders
Rectourethral Fistula
|
0.76%
1/131 • Screening up to Month 30.5
|
|
Gastrointestinal disorders
Small Intestinal Obstruction
|
0.76%
1/131 • Screening up to Month 30.5
|
|
General disorders
Asthenia
|
0.76%
1/131 • Screening up to Month 30.5
|
|
Infections and infestations
Urinary Tract Infection
|
0.76%
1/131 • Screening up to Month 30.5
|
|
Infections and infestations
Urosepsis
|
0.76%
1/131 • Screening up to Month 30.5
|
|
Injury, poisoning and procedural complications
Fall
|
1.5%
2/131 • Screening up to Month 30.5
|
|
Injury, poisoning and procedural complications
Femur Fracture
|
0.76%
1/131 • Screening up to Month 30.5
|
|
Injury, poisoning and procedural complications
Spinal Fracture
|
0.76%
1/131 • Screening up to Month 30.5
|
|
Injury, poisoning and procedural complications
Transplant Failure
|
0.76%
1/131 • Screening up to Month 30.5
|
|
Investigations
Blood Glucose Increased
|
0.76%
1/131 • Screening up to Month 30.5
|
|
Investigations
Blood Potassium Increased
|
0.76%
1/131 • Screening up to Month 30.5
|
|
Investigations
Liver Function Test Abnormal
|
1.5%
2/131 • Screening up to Month 30.5
|
|
Musculoskeletal and connective tissue disorders
Lumbar Spinal Stenosis
|
0.76%
1/131 • Screening up to Month 30.5
|
|
Nervous system disorders
Brain Mass
|
0.76%
1/131 • Screening up to Month 30.5
|
|
Renal and urinary disorders
Haematuria
|
1.5%
2/131 • Screening up to Month 30.5
|
|
Vascular disorders
Embolism
|
0.76%
1/131 • Screening up to Month 30.5
|
Other adverse events
| Measure |
Abiraterone Acetate
n=131 participants at risk
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.
|
|---|---|
|
Gastrointestinal disorders
Constipation
|
16.0%
21/131 • Screening up to Month 30.5
|
|
Gastrointestinal disorders
Diarrhoea
|
17.6%
23/131 • Screening up to Month 30.5
|
|
Gastrointestinal disorders
Nausea
|
19.1%
25/131 • Screening up to Month 30.5
|
|
Gastrointestinal disorders
Vomiting
|
15.3%
20/131 • Screening up to Month 30.5
|
|
General disorders
Fatigue
|
35.9%
47/131 • Screening up to Month 30.5
|
|
General disorders
Influenza Like Illness
|
5.3%
7/131 • Screening up to Month 30.5
|
|
General disorders
Oedema Peripheral
|
22.1%
29/131 • Screening up to Month 30.5
|
|
Infections and infestations
Nasopharyngitis
|
11.5%
15/131 • Screening up to Month 30.5
|
|
Infections and infestations
Sinusitis
|
7.6%
10/131 • Screening up to Month 30.5
|
|
Infections and infestations
Upper Respiratory Tract Infection
|
16.0%
21/131 • Screening up to Month 30.5
|
|
Infections and infestations
Urinary Tract Infection
|
9.9%
13/131 • Screening up to Month 30.5
|
|
Investigations
Alanine Aminotransferase Increased
|
6.9%
9/131 • Screening up to Month 30.5
|
|
Investigations
Aspartate Aminotransferase Increased
|
6.9%
9/131 • Screening up to Month 30.5
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
8.4%
11/131 • Screening up to Month 30.5
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
32.1%
42/131 • Screening up to Month 30.5
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
14.5%
19/131 • Screening up to Month 30.5
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
13.7%
18/131 • Screening up to Month 30.5
|
|
Musculoskeletal and connective tissue disorders
Muscle Spasms
|
7.6%
10/131 • Screening up to Month 30.5
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal Pain
|
7.6%
10/131 • Screening up to Month 30.5
|
|
Musculoskeletal and connective tissue disorders
Pain in Extremity
|
6.9%
9/131 • Screening up to Month 30.5
|
|
Nervous system disorders
Dizziness
|
16.8%
22/131 • Screening up to Month 30.5
|
|
Nervous system disorders
Headache
|
16.8%
22/131 • Screening up to Month 30.5
|
|
Renal and urinary disorders
Haematuria
|
11.5%
15/131 • Screening up to Month 30.5
|
|
Renal and urinary disorders
Micturition Urgency
|
5.3%
7/131 • Screening up to Month 30.5
|
|
Renal and urinary disorders
Pollakiuria
|
8.4%
11/131 • Screening up to Month 30.5
|
|
Renal and urinary disorders
Urinary Incontinence
|
6.1%
8/131 • Screening up to Month 30.5
|
|
Renal and urinary disorders
Urinary Retention
|
7.6%
10/131 • Screening up to Month 30.5
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
15.3%
20/131 • Screening up to Month 30.5
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
8.4%
11/131 • Screening up to Month 30.5
|
|
Respiratory, thoracic and mediastinal disorders
Nasal Congestion
|
6.9%
9/131 • Screening up to Month 30.5
|
|
Skin and subcutaneous tissue disorders
Rash
|
5.3%
7/131 • Screening up to Month 30.5
|
|
Vascular disorders
Hot Flush
|
9.9%
13/131 • Screening up to Month 30.5
|
|
Vascular disorders
Hypertension
|
40.5%
53/131 • Screening up to Month 30.5
|
|
Blood and lymphatic system disorders
Anaemia
|
6.9%
9/131 • Screening up to Month 30.5
|
|
General disorders
Chest Pain
|
5.3%
7/131 • Screening up to Month 30.5
|
|
Infections and infestations
Bronchitis
|
5.3%
7/131 • Screening up to Month 30.5
|
|
Injury, poisoning and procedural complications
Fall
|
5.3%
7/131 • Screening up to Month 30.5
|
|
Investigations
Blood Creatine Phosphokinase Increased
|
5.3%
7/131 • Screening up to Month 30.5
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal Chest Pain
|
6.9%
9/131 • Screening up to Month 30.5
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
5.3%
7/131 • Screening up to Month 30.5
|
|
Psychiatric disorders
Anxiety
|
5.3%
7/131 • Screening up to Month 30.5
|
|
Psychiatric disorders
Insomnia
|
6.9%
9/131 • Screening up to Month 30.5
|
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. The sponsor will not mandate modifications to scientific content and does not have the right to suppress information.
- Publication restrictions are in place
Restriction type: OTHER