A Phase 2 interventional study of Abiraterone and Prednisolone in Prostate Cancer, sponsored by Janssen Research & Development, LLC. Completed at 18 sites in Japan. Open to male participants aged 20 Years and older. Per ClinicalTrials.gov, last updated 2015-11-04.
Sponsored by Janssen Research & Development, LLC · Phase 2, Interventional, and Treatment
The purpose of this study is to investigate the safety and efficacy of abiraterone in participants with metastatic castration-resistant prostate cancer (mCRPC) who have received docetaxel-based chemotherapy (treatment of disease, usually cancer, by chemical agents).
This is a multi-center (conducted in more than one center), open-label (all people know the identity of the intervention), single-arm study to investigate safety and efficacy of abiraterone. The study consists of 3 phases: Screening phase (consists of 14 days before study commences on Day -1); Treatment phase (consists of 28-daily dosing cycles wherein abiraterone 1000 milligram [mg] once daily and 5 mg prednisolone twice daily will be given until disease progression or unacceptable toxicity is observed); and Follow-up phase (up to 5 years or until survival after the first dose of study drug). Abiraterone will be administered orally daily as at least 1 hour before the meal or 2 hours after the meal. Dose reduction will be allowed at the Investigator's discretion but not lower than 500 mg per day. Participants will discontinue study treatment at disease progression unless, in the Investigator's opinion, it is deemed that the participants will continue to derive benefit from abiraterone. Efficacy will be evaluated primarily through decline in prostate-specific antigen (substance in blood that is measured to check for prostate cancer) after 12 weeks of therapy. Participants' safety will be monitored throughout the study.
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This study's enrollment of 47 is below the median of 58 across 4,822 interventional studies indexed under Prostatic Neoplasms.
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Abiraterone 1000 milligram (mg) oral tablets will be administered once daily along with 5 mg oral prednisolone tablet administered twice daily for 28-daily dosing cycles and will be continued until disease progression or unacceptable toxicity.
Drug: Abiraterone · Drug: Prednisolone
Abiraterone will be administered orally as 1000 milligram (mg) per day for 28-daily dosing cycles which will be continued until disease progression or unacceptable toxicity.
Also known as: JNJ-212082
Prednisolone will be administered orally as 5 mg tablets twice daily for 28-daily dosing cycle which will be continued until disease progression or unacceptable toxicity.
Percentage of Participants Achieving Prostate Specific Antigen (PSA) Response at Week 12
The PSA response will be evaluated according to Prostate-Specific Antigen Working Group (PSAWG) criterion, which is, greater than or equal to 50 percent decrease in PSA from Baseline up to 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 initial documentation of PSA.
Time frame: Week 12
Percentage of Participants With Radiographic Objective Response
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 1.0. 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.
Time frame: Baseline, Day 1 of Cycle 4, 7 and 10, and thereafter every third cycle until first documented disease progression or up to 5 years
Duration of Prostate Specific Antigen (PSA) Response
Duration of a PSA response is the time taken to achieve a PSA response that is decrease in PSA from Baseline by greater than or equal to 50 percent.
Time frame: Baseline and Day 1 of each cycle up to 5 years
Percentage of Participants Achieving Prostate Specific Antigen (PSA) Response
The PSA response is decrease in PSA from Baseline by greater than or equal to 50 percent.
Time frame: Baseline and Day 1 of each cycle up to 5 years
Clinical Benefit
Clinical Benefit is defined as a confirmed complete response (CR), confirmed partial response (PR), or stable disease (SD) 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. The SD is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease since treatment started.
Time frame: Baseline, Day 1 of Cycle 4, 7 and 10, and thereafter every third cycle up to 5 years
Eastern Cooperative Oncology Group Performance Status (ECOG PS) Score
The ECOG PS score 0 versus 1, wherein 0 signifies fully active, able to carry all pre-disease performance without restriction and 1 signifies restriction in physically strenuous activity but ambulatory and able to carry out work on a light or sedentary nature, for example, light housework, office work.
Time frame: Baseline, Day 1, 8, 15 and 22 of Cycle 1 and 2, and thereafter Day 1 and 15 of all cycles up to 5 years
Decline in Serum Prostate Specific Antigen (PSA)
Decrease in serum PSA according to Prostate Cancer Clinical Trials Working Group 2 (PCWG2) criterion, which is, 25 percent increase in PSA and an absolute increase in PSA level by 2 nanogram per milliliter or more, from Baseline which would be subsequently confirmed by a measurement that is at least 4 or more weeks after initial documentation of PSA.
Time frame: Baseline and Day 1 of each cycle up to 5 years
Overall Survival
Overall survival is defined as the time interval from the date of first dose to date of death.
Time frame: Every 3 months until death or up to 5 years
Prostate Specific Antigen Based Progression-Free Survival (PSA-PFS)
The PSA-PFS is defined as time to first PSA failure that is, two consecutive increases in PSA of 50 percent and greater than or equal to 5 nanogram per milliliter or death as per Prostate-Specific Antigen Working Group (PSAWG) criterion.
Time frame: Baseline and Day 1 of each cycle until first documented disease progression or up to 5 years
Radiographic Progression-Free Survival (RAD-PFS)
The RAD-PFS is defined as time from randomization to the earliest objective evidence of radiographic progression or death due to any cause. RAD-PFS will be evaluated according to RECIST Version 1.0.
Time frame: Baseline, Day 1 of Cycle 4, 7 and 10, and thereafter every third cycle until first documented disease progression, or up to 5 years
Percentage of Participants With Circulating Tumor Cell (CTC) Conversion
The CTC is the pharmacodynamic potential predictive biomarker for tumor sensitivity.
Time frame: Day 1 of Cycle 2, 3, and 4
This study is completed, as verified in Nov 2015. You cannot join it, but the record below documents what was studied.
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