Trial Outcomes & Findings for A Study That Provides Long-term Safety Follow-up and Examines Long-term Exposure to Abiraterone Acetate (NCT NCT01517802)

Last Updated: 2022-05-10

Results Overview

An SAE is defined as any untoward medical occurrence that results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, leads to a congenital anomaly/birth defect in the offspring of a participant, or is an important medical event.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

32 participants

Primary outcome timeframe

Up to 9 years

Results posted on

2022-05-10

Participant Flow

Out of 32 randomized participants, 1 participant did not receive any dose of drug and hence was excluded from all the analyses.

Participant milestones

Participant milestones
Measure	Abiraterone Acetate + Prednisone/Prednisolone Participants who received at least 3 months of abiraterone acetate treatment in previously completed abiraterone acetate studies (COU-AA-001 \[NCT00473512\], COU-AA-002 \[NCT00473746\], COU-AA-006 \[NCT00910754\], COU-AA-206 \[NCT01400555\], COU-AA-301 \[NCT00638690\], COU-AA-302 \[NCT00887198\], COU-AA-BMA \[NCT00544440\]) continued to receive abiraterone acetate 1000 milligrams (mg) (four 250 mg tablets) along with low dose corticosteroid (prednisone/prednisolone) 5 mg tablet orally twice daily starting Day 1 Cycle 1 (each cycle was of 28 days) according to dosing regimen established in the previously completed study until the investigator determined that the participant no longer received benefit or the sponsor terminated the study or the participant had continued the treatment in this study and were followed-up for safety for up to 9 years.
Overall Study STARTED	31
Overall Study COMPLETED	30
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Abiraterone Acetate + Prednisone/Prednisolone Participants who received at least 3 months of abiraterone acetate treatment in previously completed abiraterone acetate studies (COU-AA-001 \[NCT00473512\], COU-AA-002 \[NCT00473746\], COU-AA-006 \[NCT00910754\], COU-AA-206 \[NCT01400555\], COU-AA-301 \[NCT00638690\], COU-AA-302 \[NCT00887198\], COU-AA-BMA \[NCT00544440\]) continued to receive abiraterone acetate 1000 milligrams (mg) (four 250 mg tablets) along with low dose corticosteroid (prednisone/prednisolone) 5 mg tablet orally twice daily starting Day 1 Cycle 1 (each cycle was of 28 days) according to dosing regimen established in the previously completed study until the investigator determined that the participant no longer received benefit or the sponsor terminated the study or the participant had continued the treatment in this study and were followed-up for safety for up to 9 years.
Overall Study Death	1

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Abiraterone Acetate + Prednisone/Prednisolone n=31 Participants Participants who received at least 3 months of abiraterone acetate treatment in previously completed abiraterone acetate studies (COU-AA-001 \[NCT00473512\], COU-AA-002 \[NCT00473746\], COU-AA-006 \[NCT00910754\], COU-AA-206 \[NCT01400555\], COU-AA-301 \[NCT00638690\], COU-AA-302 \[NCT00887198\], COU-AA-BMA \[NCT00544440\]) continued to receive abiraterone acetate 1000 milligrams (mg) (four 250 mg tablets) along with low dose corticosteroid (prednisone/prednisolone) 5 mg tablet orally twice daily starting Day 1 Cycle 1 (each cycle was of 28 days) according to dosing regimen established in the previously completed study until the investigator determined that the participant no longer received benefit or the sponsor terminated the study or the participant had continued the treatment in this study and were followed-up for safety for up to 9 years.
Age, Customized 63-90 years	31 Participants n=31 Participants
Sex: Female, Male Female	0 Participants n=31 Participants
Sex: Female, Male Male	31 Participants n=31 Participants

PRIMARY outcome

Timeframe: Up to 9 years

Population: Safety analysis set included participants that received at least 1 dose of study drug.

Outcome measures

Outcome measures
Measure	Abiraterone Acetate + Prednisone/Prednisolone n=31 Participants Participants who received at least 3 months of abiraterone acetate treatment in previously completed abiraterone acetate studies (COU-AA-001 \[NCT00473512\], COU-AA-002 \[NCT00473746\], COU-AA-006 \[NCT00910754\], COU-AA-206 \[NCT01400555\], COU-AA-301 \[NCT00638690\], COU-AA-302 \[NCT00887198\], COU-AA-BMA \[NCT00544440\]) continued to receive abiraterone acetate 1000 milligrams (mg) (four 250 mg tablets) along with low dose corticosteroid (prednisone/prednisolone) 5 mg tablet orally twice daily starting Day 1 Cycle 1 (each cycle was of 28 days) according to dosing regimen established in the previously completed study until the investigator determined that the participant no longer received benefit or the sponsor terminated the study or the participant had continued the treatment in this study and were followed-up for safety for up to 9 years.
Number of Participants With Serious Adverse Events (SAEs)	16 Participants

Adverse Events

Abiraterone Acetate + Prednisone/Prednisolone

Serious events: 16 serious events

Other events: 0 other events

Deaths: 1 deaths

Serious adverse events

Serious adverse events
Measure	Abiraterone Acetate + Prednisone/Prednisolone n=31 participants at risk Participants who received at least 3 months of abiraterone acetate treatment in previously completed abiraterone acetate studies (COU-AA-001 \[NCT00473512\], COU-AA-002 \[NCT00473746\], COU-AA-006 \[NCT00910754\], COU-AA-206 \[NCT01400555\], COU-AA-301 \[NCT00638690\], COU-AA-302 \[NCT00887198\], COU-AA-BMA \[NCT00544440\]) continued to receive abiraterone acetate 1000 milligrams (mg) (four 250 mg tablets) along with low dose corticosteroid (prednisone/prednisolone) 5 mg tablet orally twice daily starting Day 1 Cycle 1 (each cycle was of 28 days) according to dosing regimen established in the previously completed study until the investigator determined that the participant no longer received benefit or the sponsor terminated the study or the participant had continued the treatment in this study and were followed-up for safety for up to 9 years.
Infections and infestations Lower Respiratory Tract Infection	3.2% 1/31 • Up to 9 years Safety analysis set included participants who received at least 1 dose of study drug.
Infections and infestations Urinary Tract Infection	3.2% 1/31 • Up to 9 years Safety analysis set included participants who received at least 1 dose of study drug.
Metabolism and nutrition disorders Dehydration	3.2% 1/31 • Up to 9 years Safety analysis set included participants who received at least 1 dose of study drug.
Nervous system disorders Cerebrovascular Accident	3.2% 1/31 • Up to 9 years Safety analysis set included participants who received at least 1 dose of study drug.
Nervous system disorders Encephalopathy	3.2% 1/31 • Up to 9 years Safety analysis set included participants who received at least 1 dose of study drug.
Nervous system disorders Spinal Cord Compression	3.2% 1/31 • Up to 9 years Safety analysis set included participants who received at least 1 dose of study drug.
Nervous system disorders Syncope	3.2% 1/31 • Up to 9 years Safety analysis set included participants who received at least 1 dose of study drug.
Cardiac disorders Cardiac Failure	3.2% 1/31 • Up to 9 years Safety analysis set included participants who received at least 1 dose of study drug.
Cardiac disorders Cardiac Failure Congestive	3.2% 1/31 • Up to 9 years Safety analysis set included participants who received at least 1 dose of study drug.
Cardiac disorders Myocardial Infarction	3.2% 1/31 • Up to 9 years Safety analysis set included participants who received at least 1 dose of study drug.
Vascular disorders Aortic Thrombosis	3.2% 1/31 • Up to 9 years Safety analysis set included participants who received at least 1 dose of study drug.
Vascular disorders Hypertension	3.2% 1/31 • Up to 9 years Safety analysis set included participants who received at least 1 dose of study drug.
Respiratory, thoracic and mediastinal disorders Dyspnoea	3.2% 1/31 • Up to 9 years Safety analysis set included participants who received at least 1 dose of study drug.
Respiratory, thoracic and mediastinal disorders Pulmonary Embolism	9.7% 3/31 • Up to 9 years Safety analysis set included participants who received at least 1 dose of study drug.
Gastrointestinal disorders Diarrhoea	6.5% 2/31 • Up to 9 years Safety analysis set included participants who received at least 1 dose of study drug.
Gastrointestinal disorders Nausea	3.2% 1/31 • Up to 9 years Safety analysis set included participants who received at least 1 dose of study drug.
Gastrointestinal disorders Oesophagitis	3.2% 1/31 • Up to 9 years Safety analysis set included participants who received at least 1 dose of study drug.
Gastrointestinal disorders Vomiting	3.2% 1/31 • Up to 9 years Safety analysis set included participants who received at least 1 dose of study drug.
Musculoskeletal and connective tissue disorders Musculoskeletal Pain	3.2% 1/31 • Up to 9 years Safety analysis set included participants who received at least 1 dose of study drug.
Renal and urinary disorders Acute Kidney Injury	3.2% 1/31 • Up to 9 years Safety analysis set included participants who received at least 1 dose of study drug.
Renal and urinary disorders Urinary Retention	3.2% 1/31 • Up to 9 years Safety analysis set included participants who received at least 1 dose of study drug.
General disorders Fatigue	3.2% 1/31 • Up to 9 years Safety analysis set included participants who received at least 1 dose of study drug.
Investigations Weight Decreased	3.2% 1/31 • Up to 9 years Safety analysis set included participants who received at least 1 dose of study drug.
Injury, poisoning and procedural complications Fall	6.5% 2/31 • Up to 9 years Safety analysis set included participants who received at least 1 dose of study drug.
Injury, poisoning and procedural complications Skin Laceration	6.5% 2/31 • Up to 9 years Safety analysis set included participants who received at least 1 dose of study drug.
Injury, poisoning and procedural complications Upper Limb Fracture	3.2% 1/31 • Up to 9 years Safety analysis set included participants who received at least 1 dose of study drug.
Surgical and medical procedures Aortic Valve Replacement	3.2% 1/31 • Up to 9 years Safety analysis set included participants who received at least 1 dose of study drug.

Other adverse events

Other adverse events
Measure	Abiraterone Acetate + Prednisone/Prednisolone n=31 participants at risk Participants who received at least 3 months of abiraterone acetate treatment in previously completed abiraterone acetate studies (COU-AA-001 \[NCT00473512\], COU-AA-002 \[NCT00473746\], COU-AA-006 \[NCT00910754\], COU-AA-206 \[NCT01400555\], COU-AA-301 \[NCT00638690\], COU-AA-302 \[NCT00887198\], COU-AA-BMA \[NCT00544440\]) continued to receive abiraterone acetate 1000 milligrams (mg) (four 250 mg tablets) along with low dose corticosteroid (prednisone/prednisolone) 5 mg tablet orally twice daily starting Day 1 Cycle 1 (each cycle was of 28 days) according to dosing regimen established in the previously completed study until the investigator determined that the participant no longer received benefit or the sponsor terminated the study or the participant had continued the treatment in this study and were followed-up for safety for up to 9 years.
Infections and infestations Lower Respiratory Tract Infection	0.00% 0/31 • Up to 9 years Safety analysis set included participants who received at least 1 dose of study drug.
Infections and infestations Urinary Tract Infection	0.00% 0/31 • Up to 9 years Safety analysis set included participants who received at least 1 dose of study drug.
Metabolism and nutrition disorders Dehydration	0.00% 0/31 • Up to 9 years Safety analysis set included participants who received at least 1 dose of study drug.
Nervous system disorders Cerebrovascular Accident	0.00% 0/31 • Up to 9 years Safety analysis set included participants who received at least 1 dose of study drug.
Nervous system disorders Encephalopathy	0.00% 0/31 • Up to 9 years Safety analysis set included participants who received at least 1 dose of study drug.
Nervous system disorders Spinal Cord Compression	0.00% 0/31 • Up to 9 years Safety analysis set included participants who received at least 1 dose of study drug.
Nervous system disorders Syncope	0.00% 0/31 • Up to 9 years Safety analysis set included participants who received at least 1 dose of study drug.
Cardiac disorders Cardiac Failure	0.00% 0/31 • Up to 9 years Safety analysis set included participants who received at least 1 dose of study drug.
Cardiac disorders Cardiac Failure Congestive	0.00% 0/31 • Up to 9 years Safety analysis set included participants who received at least 1 dose of study drug.
Cardiac disorders Myocardial Infarction	0.00% 0/31 • Up to 9 years Safety analysis set included participants who received at least 1 dose of study drug.
Vascular disorders Aortic Thrombosis	0.00% 0/31 • Up to 9 years Safety analysis set included participants who received at least 1 dose of study drug.
Vascular disorders Hypertension	0.00% 0/31 • Up to 9 years Safety analysis set included participants who received at least 1 dose of study drug.
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.00% 0/31 • Up to 9 years Safety analysis set included participants who received at least 1 dose of study drug.
Respiratory, thoracic and mediastinal disorders Pulmonary Embolism	0.00% 0/31 • Up to 9 years Safety analysis set included participants who received at least 1 dose of study drug.
Gastrointestinal disorders Diarrhoea	0.00% 0/31 • Up to 9 years Safety analysis set included participants who received at least 1 dose of study drug.
Gastrointestinal disorders Nausea	0.00% 0/31 • Up to 9 years Safety analysis set included participants who received at least 1 dose of study drug.
Gastrointestinal disorders Oesophagitis	0.00% 0/31 • Up to 9 years Safety analysis set included participants who received at least 1 dose of study drug.
Gastrointestinal disorders Vomiting	0.00% 0/31 • Up to 9 years Safety analysis set included participants who received at least 1 dose of study drug.
Musculoskeletal and connective tissue disorders Musculoskeletal Pain	0.00% 0/31 • Up to 9 years Safety analysis set included participants who received at least 1 dose of study drug.
Renal and urinary disorders Acute Kidney Injury	0.00% 0/31 • Up to 9 years Safety analysis set included participants who received at least 1 dose of study drug.
Renal and urinary disorders Urinary Retention	0.00% 0/31 • Up to 9 years Safety analysis set included participants who received at least 1 dose of study drug.
General disorders Fatigue	0.00% 0/31 • Up to 9 years Safety analysis set included participants who received at least 1 dose of study drug.
Investigations Weight Decreased	0.00% 0/31 • Up to 9 years Safety analysis set included participants who received at least 1 dose of study drug.
Injury, poisoning and procedural complications Fall	0.00% 0/31 • Up to 9 years Safety analysis set included participants who received at least 1 dose of study drug.
Injury, poisoning and procedural complications Skin Laceration	0.00% 0/31 • Up to 9 years Safety analysis set included participants who received at least 1 dose of study drug.
Injury, poisoning and procedural complications Upper Limb Fracture	0.00% 0/31 • Up to 9 years Safety analysis set included participants who received at least 1 dose of study drug.
Surgical and medical procedures Aortic Valve Replacement	0.00% 0/31 • Up to 9 years Safety analysis set included participants who received at least 1 dose of study drug.

Additional Information

DIRECTOR CLINICAL RESEARCH

Janssen Research & Development, LLC

Phone: 844-434-4210

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee If an investigator wishes to publish information from the study, a copy of the manuscript must be provided to the sponsor for review at least 60 days before submission for publication or presentation. If requested by the sponsor in writing, the investigator will withhold such publication for up to an additional 60 days.
Publication restrictions are in place

Restriction type: OTHER