A Phase 2 Study to Evaluate Safety and Efficacy of Abiraterone in Participants With Prostate Cancer
A Phase II Study of JNJ-212082 (Abiraterone Acetate) in Metastatic Castration Resistant Prostate Cancer Patients Who Are Chemotherapy-Naïve
2 other identifiers
interventional
48
1 country
19
Brief Summary
The purpose of this study is to investigate safety and efficacy of abiraterone in participants with metastatic castration-resistant prostate cancer (mCRPC) and who have not received prior chemotherapy (treatment of disease, usually cancer, by chemical agents).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2 prostate-cancer
Started Jun 2012
Shorter than P25 for phase_2 prostate-cancer
19 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 6, 2012
CompletedFirst Submitted
Initial submission to the registry
December 20, 2012
CompletedFirst Posted
Study publicly available on registry
December 27, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 17, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
October 17, 2014
CompletedOctober 23, 2017
October 1, 2017
2.4 years
December 20, 2012
October 19, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Percentage of participants achieving Prostate-Specific Antigen (PSA) response up to 12 weeks
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.
Baseline up to 12 weeks
Secondary Outcomes (10)
Percentage of participants with Radiographic Objective Response
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
Baseline and Day 1 of each cycle up to 5 years
Percentage of participants achieving Prostate-Specific Antigen (PSA) response
Baseline and Day 1 of each cycle up to 5 years
Clinical benefit
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
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
- +5 more secondary outcomes
Study Arms (1)
Abiraterone plus Prednisolone
EXPERIMENTALAbiraterone 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.
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- In-patients or out-patients with histologically or cytologically confirmed adenocarcinoma of the prostate without neuroendocrine differentiation or small cell histology
- Have surgically or medically castrated, with testosterone levels of less than 50 nanogram per deciliter
- Have prostate-specific antigen (PSA) level of at least 5 nanogram per milliliter
- Be under PSA progression according to Prostate-Specific Antigen Working Group (PSAWG) eligibility criteria or objective progression by Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.0 criteria for participants with measurable disease after androgen deprivation
- Have Eastern Cooperative Oncology Group Performance Status (ECOG PS) score of 0 or 1
You may not qualify if:
- Has received other hormonal therapy, including any dose of finasteride, dutasteride, any herbal product known to decrease PSA levels or any systemic corticosteroid within 4 weeks prior to Cycle 1 Day 1 or has received ketoconazole for prostate cancer
- Has received radiotherapy, chemotherapy (including estramustine) or immunotherapy (including provenge) within 4 weeks, or single fraction of palliative radiotherapy within 2 weeks prior to Cycle 1 Day 1
- Has had surgery or local prostatic intervention within 4 weeks prior to Cycle 1 Day 1. In addition, any clinically relevant sequel from the surgery must have resolved prior to Cycle 1 Day 1
- Has clinically significant heart disease as evidenced by myocardial infarction, or arterial thrombotic events, severe or unstable angina, or New York Heart Association (NYHA) Class 3 to 4 heart disease or cardiac ejection fraction measurement of less than 50 percent within 6 months prior to Cycle 1 Day 1
- Has uncontrolled hypertension (systolic blood pressure greater than or equal to 160 millimeter of mercury or diastolic blood pressure greater than or equal to 95 millimeter of mercury)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (19)
Unknown Facility
Asahi, Japan
Unknown Facility
Fukuoka, Japan
Unknown Facility
Gifu, Japan
Unknown Facility
Kanazawa, Japan
Unknown Facility
Kashiwa, Japan
Unknown Facility
Kita-Gun, Japan
Unknown Facility
Kukichūō, Japan
Unknown Facility
Kurashiki, Japan
Unknown Facility
Maebashi, Japan
Unknown Facility
Matsuyama, Japan
Unknown Facility
Mitaka, Japan
Unknown Facility
Niigata, Japan
Unknown Facility
Osaka, Japan
Unknown Facility
Ōsaka-sayama, Japan
Unknown Facility
Sagamihara, Japan
Unknown Facility
Sakura, Japan
Unknown Facility
Sapporo, Japan
Unknown Facility
Yokohama, Japan
Unknown Facility
Yokosuka, Japan
Related Publications (1)
Matsubara N, Uemura H, Satoh T, Suzuki H, Nishiyama T, Uemura H, Hashine K, Imanaka K, Ozono S, Akaza H. A phase 2 trial of abiraterone acetate in Japanese men with metastatic castration-resistant prostate cancer and without prior chemotherapy (JPN-201 study). Jpn J Clin Oncol. 2014 Dec;44(12):1216-26. doi: 10.1093/jjco/hyu149. Epub 2014 Oct 15.
PMID: 25320340DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Janssen Research & Development, LLC Clinical Trial
Janssen Research & Development, LLC
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 20, 2012
First Posted
December 27, 2012
Study Start
June 6, 2012
Primary Completion
October 17, 2014
Study Completion
October 17, 2014
Last Updated
October 23, 2017
Record last verified: 2017-10