Abiraterone With Different Steroid Regimens for Side Effect Related to Mineralcorticoid Excess Prevention in Prostate Cancer Prior to Chemotherapy

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Janssen Pharmaceutica N.V., Belgium
ClinicalTrials.gov Identifier:
NCT01867710
First received: May 30, 2013
Last updated: April 6, 2016
Last verified: March 2016
Results First Received: April 6, 2016  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Prostate Cancer
Interventions: Drug: Abiraterone Acetate
Drug: Prednisone 5 mg twice daily
Drug: Prednisone 5 mg once daily
Drug: Prednisone 2.5 mg twice daily
Drug: Dexamethasone 0.5 mg once daily

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
A total of 164 participants were randomized in this trial. Of which, 163 participants treated with study drug and 1 participant was not eligible and not received the treatment despite randomization done. Data of the first 24 weeks of study treatment was collected and reported.

Reporting Groups
  Description
Abiraterone Acetate 1000 Milligram (mg) QD+Prednisone 5 mg BID Participants received abiraterone acetate 1000 mg tablet orally once daily and prednisone 5 mg tablet orally twice daily up to 156 Weeks.
Abiraterone Acetate 1000 Milligram (mg) QD+Prednisone 5 mg QD Participants received abiraterone acetate 1000 mg and prednisone 5 mg tablet orally once daily up to 156 Weeks.
Abiraterone Acetate 1000 Milligram(mg) QD+Prednisone 2.5mg BID Participants received abiraterone acetate 1000 mg tablet orally once daily and prednisone 2.5 mg tablet orally twice daily up to 156 Weeks.
Abiraterone Acetate 1000milligram(mg)QD+Dexamethasone 0.5mg QD Participants received abiraterone acetate 1000 mg and dexamethasone 0.5 mg tablet orally once daily up to 156 Weeks.

Participant Flow:   Overall Study
    Abiraterone Acetate 1000 Milligram (mg) QD+Prednisone 5 mg BID     Abiraterone Acetate 1000 Milligram (mg) QD+Prednisone 5 mg QD     Abiraterone Acetate 1000 Milligram(mg) QD+Prednisone 2.5mg BID     Abiraterone Acetate 1000milligram(mg)QD+Dexamethasone 0.5mg QD  
STARTED     41     41     40     42  
Treated     41     41     39     42  
COMPLETED     33     34     31     35  
NOT COMPLETED     8     7     9     7  
Disease Progression                 5                 2                 4                 2  
Adverse Event Grade 3 or 4 Hypokalemia                 0                 2                 0                 0  
Adverse Event Sustained Toxicity>Grade 1                 1                 0                 0                 0  
Palliative Radiation Required                 0                 0                 1                 1  
Other Adverse Events                 1                 0                 1                 3  
Death                 0                 1                 1                 0  
Physician Decision                 0                 0                 1                 0  
Protocol Violation                 1                 0                 0                 1  
Withdrawal by Subject                 0                 1                 0                 0  
Eligible Criteria Not Met                 0                 0                 1                 0  
Unspecified                 0                 1                 0                 0  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Abiraterone Acetate 1000 Milligram (mg) QD+Prednisone 5 mg BID Participants received abiraterone acetate 1000 mg tablet orally once daily and prednisone 5 mg tablet orally twice daily up to 156 Weeks.
Abiraterone Acetate 1000 Milligram (mg) QD+Prednisone 5 mg QD Participants received abiraterone acetate 1000 mg and prednisone 5 mg tablet orally once daily up to 156 Weeks.
Abiraterone Acetate 1000 Milligram(mg) QD+Prednisone 2.5mg BID Participants received abiraterone acetate 1000 mg tablet orally once daily and prednisone 2.5 mg tablet orally twice daily up to 156 Weeks.
Abiraterone Acetate 1000milligram(mg)QD+Dexamethasone 0.5mg QD Participants received abiraterone acetate 1000 mg and dexamethasone 0.5 mg tablet orally once daily up to 156 Weeks.
Total Total of all reporting groups

Baseline Measures
    Abiraterone Acetate 1000 Milligram (mg) QD+Prednisone 5 mg BID     Abiraterone Acetate 1000 Milligram (mg) QD+Prednisone 5 mg QD     Abiraterone Acetate 1000 Milligram(mg) QD+Prednisone 2.5mg BID     Abiraterone Acetate 1000milligram(mg)QD+Dexamethasone 0.5mg QD     Total  
Number of Participants  
[units: participants]
  41     41     40     42     164  
Age  
[units: years]
Mean (Standard Deviation)
  68.9  (9.28)     69  (8.44)     69.3  (7.51)     71.3  (8.12)     69.6  (8.35)  
Gender  
[units: participants]
         
Female     0     0     0     0     0  
Male     41     41     40     42     164  
Region of Enrollment  
[units: participants]
         
Belgium     8     9     10     14     41  
Germany     7     10     5     6     28  
Great Britain     10     9     8     8     35  
Hungary     6     4     6     4     20  
Italy     10     9     11     10     40  



  Outcome Measures
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1.  Primary:   Percentage of Participants Experiencing Neither of the 2 Mineralocorticoid Excess Toxicity During the First 24 Weeks of Treatment   [ Time Frame: Week 24 ]

2.  Secondary:   Percentage of Participants With Confirmed Prostate Specific Antigen (PSA) Response Rate [Greater Than or Equal to (>=) 50 Percent (%) Decline From Baseline] at Week 12   [ Time Frame: Week 12 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
Data of the first 24 weeks of study treatment was collected and reported. Study is still ongoing.


  More Information
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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.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Medical Affairs Director
Organization: Janssen Pharmaceutica N.V
e-mail: ClinicalTrialDisclosure@its.jnj.com



Responsible Party: Janssen Pharmaceutica N.V., Belgium
ClinicalTrials.gov Identifier: NCT01867710     History of Changes
Other Study ID Numbers: CR100916
2012-004331-23 ( EudraCT Number )
212082PCR2023 ( Other Identifier: Janssen CTMS ID )
Study First Received: May 30, 2013
Results First Received: April 6, 2016
Last Updated: April 6, 2016
Health Authority: Belgium: Federal Agency for Medicinal Products and Health Products
Germany: Ethics Commission
Great Britain: Medicines and Healthcare Products Regulatory Agency
Hungary: National Institute for Quality and Organizational Development in Healthcare and Medicines
Germany: Federal Institute for Drugs and Medical Devices
Great Britain: Research Ethics Committee