A Study of Abiraterone Acetate in Metastatic Castration-Resistant Prostate Cancer Participants Who Responded Poorly to the First-line Combined Androgen Blockade Therapy
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|ClinicalTrials.gov Identifier: NCT02405858|
Recruitment Status : Completed
First Posted : April 1, 2015
Last Update Posted : December 21, 2018
|Condition or disease||Intervention/treatment||Phase|
|Metastatic Castration-Resistant Prostate Cancer||Drug: Abiraterone Acetate Drug: Prednisolone||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||51 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase 4 Study of Zytiga in Poor-risk mCRPC (Metastatic Castration-Resistant Prostate Cancer) Patients Who Was Failed the First-line CAB (Combined Androgen Blockade) Therapy|
|Actual Study Start Date :||April 10, 2015|
|Actual Primary Completion Date :||December 31, 2017|
|Actual Study Completion Date :||December 31, 2017|
Experimental: Abiraterone Acetate
Participants will receive abiraterone acetate 1000 milligram (mg) (four 250 mg tablets) orally once daily, concomitantly with oral prednisolone 10 mg per day. No food should be consumed for at least 2 hours before the dose of abiraterone acetate is taken and for at least one hour after the dose of abiraterone acetate is taken. A 28-daily dosing cycle will continue until disease progression or unacceptable toxicity is observed up to 2 years.
Drug: Abiraterone Acetate
Abiraterone acetate 1000 milligram (mg) (four 250 mg tablets) orally once daily up to Cycle 26.
Other Name: ZYTIGA
Oral prednisolone 5 mg will be concomitantly administered twice a day (10 mg/day) up to Cycle 26.
- Percentage of Participants Achieving Prostate-specific Antigen (PSA) Response (PSA Response Rate) by 12 Weeks of Therapy [ Time Frame: up to 2 years ]A PSA response is defined as the first occurrence of greater than or equal to (>=) 50 percent (%) decrease from baseline by 12 weeks after the first dose of study drug, which would be subsequently confirmed by a measurement that is at least 4 or more weeks after the initial documentation.
- Duration of PSA Response [ Time Frame: Up to 2 years ]Duration of PSA response was defined as the duration between the date of confirmed PSA response and subsequent PSA progression date.
- Time to PSA Response [ Time Frame: Up to 2 years ]Time to PSA response is the time from start of treatment to PSA progression.
- Percentage of Participants Achieving PSA Response by 24 weeks of Therapy [ Time Frame: Up to 2 years ]A PSA response is defined as the first occurrence of greater than or equal to (>=) 50 percent (%) decrease from baseline by 24 weeks after the first dose of study drug, which would be subsequently confirmed by a measurement that is at least 4 or more weeks after the initial documentation.
- PSA-based Progression-free Survival (PSA-PFS) [ Time Frame: Time from randomization up to radiographic progression, clinical progression or death, whichever occurs first (maximum up to 2 years) ]PSA-based Progression-free Survival is the time from randomization to the occurrence of one of the following: radiographic progression, clinical progression or death.
- Maximum Serum PSA Decline Evaluation [ Time Frame: Baseline and Day 1 of each cycle up to 2 years ]Maximum PSA Decline will be calculated as Baseline PSA level minus lowest PSA level, observed during the 2 year monthly planned PSA lab test and lowest PSA data will be used for calculating the maximum serum PSA decline.
- Percentage of Participants With Radiographic Objective Response Rate (RAD-ORR) in Participants with Measurable Lesions at Baseline [ Time Frame: Baseline, Day 1 of Cycle 1, 2,3 and 4 until first documented disease progression or up to 2 years ]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 Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1.
- Radiographic Progression-free Survival (RAD-PFS) [ Time Frame: Time from enrollment up to radiographic progression or death, whichever occurs first (up to 2 years) ]RAD-PFS is defined as the time from enrollment to the occurrence of radiographic progression or death.
- Time to Next Treatment [ Time Frame: up to 2 years ]Time to next treatment was calculated as the number of days from either discontinuation of the study drug or the administration of the last dose, until the participants needed next treatment.
- Overall Survival [ Time Frame: Time from enrollment to date of death due to any cause (up to 2 years) ]Overall survival is defined as the time from enrollment to date of death due to any cause.
- Brief Pain Inventory - Short Form [ Time Frame: Baseline, Day 1 of Cycle 1, 2,3 and 4 up to 2 years ]Pain will be evaluated using the BPI-SF instrument. Total score is an average of the pain interference score (mean value for the 9 BPI-SF questions [questions inquiring about the extent of interference with activities by pain, where the extent is ranked from 0 (does not interfere) to 10 (completely interferes)]) and pain subscale score (mean value for the scores for BPI-SF questions 3, 4, 5 and 6 [questions inquiring about the extent of pain, where the extent is ranked from 0 (no pain) to 10 (pain as bad as you can imagine)]). Total score ranges from 0 to 10 with higher values indicating more pain.
- Number of Participants With Adverse Events (AEs) or Serious Adverse Events (SAEs) [ Time Frame: up to 2 years ]An AE is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; lifethreatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02405858
|Study Director:||Janssen Pharmaceutical K.K., Japan Clinical Trial||Janssen Pharmaceutical K.K.|