A Study of Abiraterone Acetate (JNJ-212082) and Prednisolone in Patients With Advanced Prostate Cancer
|ClinicalTrials.gov Identifier: NCT01685983|
Recruitment Status : Active, not recruiting
First Posted : September 17, 2012
Results First Posted : May 23, 2016
Last Update Posted : February 2, 2018
|Condition or disease||Intervention/treatment||Phase|
|Prostate Cancer||Drug: Abiraterone acetate Drug: Prednisolone||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||82 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase 2 Open Label Study of Abiraterone Acetate (JNJ-212082) and Prednisolone in Patients With Advanced Prostate Cancer Who Have Failed Androgen Deprivation and Docetaxel-Based Chemotherapy.|
|Actual Study Start Date :||August 30, 2011|
|Actual Primary Completion Date :||January 24, 2013|
|Estimated Study Completion Date :||November 6, 2020|
|Experimental: Abiraterone actetate and Prednisolone||
Drug: Abiraterone acetate
Type=exact number, unit=mg, number=250, form=tablet, route=oral. Patients will receive 4 tablets of abiraterone acetate at least 1 hour before a meal or 2 hours after a meal any time up to 10 pm every day.
Other Name: JNJ-212082Drug: Prednisolone
Type=exact number, unit=mg, number=5, form=tablet, route=oral. Patients will receive 1 tablet of prednisolone twice daily.
- Percentage of Participants With Prostate-specific Antigen (PSA) Response [ Time Frame: Baseline, Month 4 ]The PSA response was evaluated according to Prostate-Specific Antigen Working Group (PSAWG) criterion, which is, greater than or equal to 50 percent decrease in PSA from Baseline during the study, which would be subsequently confirmed by a measurement that is at least 4 or more weeks after initial documentation of PSA response.
- Overall Survival [ Time Frame: up to 5 years ]Overall survival is defined as the time interval from the date of the first dose to the date of death.
- Time to PSA Progression [ Time Frame: up to 15 months ]Time to PSA progression was measured as the time interval from the date of the first dose to the date of PSA progression as defined in the protocol-specific PSAWG criteria. For participants who have achieved a greater than or equal to (>=) 50% decrease from the baseline PSA, assessment of time to disease progression is when the PSA has increased 50% above the nadir and at a minimum of 5 nanogram/mililiter (ng/mL). For participants without a PSA decrease of this magnitude or without a decrease, the time for progression is calculated at the time a 25% increase from baseline PSA has been achieved.
- Percentage of Participants With Objective Radiographic Response [ Time Frame: up to 15 months ]Percentage of participants with radiographic objective response is defined as the percentage of participants with complete response (CR) or partial response (PR) as best overall response based on reconciled radiographic disease assessment according to RECIST Version 1.0. The CR is disappearance of all lesions. The PR is at least 30 percent decrease in sum of the longest diameter of target lesions or persistence of one or more non-target lesion(s) or/and maintenance of tumor marker level above the normal limits.
- Serum Testosterone [ Time Frame: Baseline up to 15 months ]Median baseline testosterone concentration was reported at baseline.
- Dehydroepiandrosterone (DHEA) Sulfate [ Time Frame: Baseline up to 15 months ]
- Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) [ Time Frame: up to 15 months ]An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01685983
|Korea, Republic of|
|Busan, Korea, Republic of|
|Cheongju-Si, Korea, Republic of|
|Seongnam-Si, Gyeonggi-Do, Korea, Republic of|
|Seoul, Korea, Republic of|
|Taichung City, Taiwan|
|Taoyuan County, Taiwan|
|Study Director:||Janssen Research & Development, LLC Clinical Trial||Janssen Research & Development, LLC|