IMAAGEN: Impact of Abiraterone Acetate in Prostate-Specific Antigen
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|ClinicalTrials.gov Identifier: NCT01314118|
Recruitment Status : Active, not recruiting
First Posted : March 14, 2011
Results First Posted : January 7, 2015
Last Update Posted : December 11, 2017
|Condition or disease||Intervention/treatment||Phase|
|Prostate Cancer Prostatic Neoplasm||Drug: abiraterone acetate in combination with prednisone||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||131 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Multicenter, Open-label, Single-arm, Phase 2 Study of Abiraterone Acetate Plus Prednisone in Subjects With Advanced Prostate Cancer Without Radiographic Evidence of Metastatic Disease|
|Actual Study Start Date :||May 4, 2011|
|Actual Primary Completion Date :||December 24, 2013|
|Estimated Study Completion Date :||July 31, 2019|
abiraterone acetate in combination with prednisone Abiraterone acetate will be taken as 4 x 250 mg tablets by mouth (PO) once daily. Prednisone will be taken as 2 x 2.5 mg tablets PO once daily.
Drug: abiraterone acetate in combination with prednisone
Abiraterone acetate will be taken as 4 x 250 mg tablets by mouth (PO) once daily. Prednisone will be taken as 2 x 2.5 mg tablets PO once daily.
- Percentage of Participants With Greater Than or Equal to (>=) 50 Percent (%) Reduction in Prostate-Specific Antigen (PSA) During the Core Study [ Time Frame: End of core study visit (Approximately at Month 6) ]Percentage of participants with greater than or equal to 50 percent decrease in PSA levels was assessed.
- Time to Radiographic Evidence of Disease Progression (TTRP) [ Time Frame: Maximum up to Month 30.5 ]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 to Prostate-Specific Antigen (PSA) Progression [ Time Frame: Maximum up to Month 30.5 ]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.
- Percentage of Participants With Greater Than or Equal to (>=) 50 Percent (%) Reduction in Prostate-Specific Antigen (PSA) Levels After 3 Cycles of Treatment [ Time Frame: End of Cycle 3 (Approximately Month 3) ]Percentage of participants with greater than or equal to 50 percent decrease in PSA levels was assessed. Decrease in PSA levels represented improvement.
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Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01314118
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|Study Director:||Janssen Services, LLC. Clinical Trial||Janssen Biotech, Inc.|