A Study of Abiraterone Acetate (JNJ-212082) and Prednisolone in Patients With Advanced Prostate Cancer
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.
2 other identifiers
interventional
82
2 countries
8
Brief Summary
The purpose of this study is to assess the safety and efficacy in Korea or Taiwan of oral abiraterone acetate and oral prednisolone in men with metastatic-castration resistant prostate cancer (mCRPC) and with disease progression following treatment with a docetaxel-containing chemotherapy.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2 prostate-cancer
Started Aug 2011
Typical duration for phase_2 prostate-cancer
8 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
August 30, 2011
CompletedFirst Submitted
Initial submission to the registry
September 12, 2012
CompletedFirst Posted
Study publicly available on registry
September 17, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 24, 2013
CompletedResults Posted
Study results publicly available
May 23, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
March 6, 2018
CompletedMarch 15, 2019
February 1, 2019
1.4 years
September 12, 2012
March 2, 2016
February 28, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Percentage of Participants With Prostate-specific Antigen (PSA) Response
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.
Baseline, Month 4
Secondary Outcomes (6)
Overall Survival
Up to 3 Years
Time to PSA Progression
Up to 28 Months
Percentage of Participants With Objective Radiographic Response
Up to 3 Years
Serum Testosterone
Baseline and End-of-Treatment Visit (up to approximately 3 years)
Dehydroepiandrosterone Sulfate (DHEA-S)
Baseline and End-of-Treatment Visit (up to approximately 3 years)
- +1 more secondary outcomes
Study Arms (1)
Abiraterone actetate and Prednisolone
EXPERIMENTALInterventions
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.
Type=exact number, unit=mg, number=5, form=tablet, route=oral. Patients will receive 1 tablet of prednisolone twice daily.
Eligibility Criteria
You may qualify if:
- Histologically or cytologically confirmed adenocarcinoma of the prostate (stage IV)
- Has documented Prostate Specific Antigen (PSA) progression according to protocol-specific prostate specific antigen working group (PSAWG) eligibility criteria
- Has undergone prior chemotherapy for prostate cancer with regimen(s) containing Docetaxel
- Has an ongoing androgen deprivation with serum testosterone less than 50 ng/dL
- Has not received radiotherapy, chemotherapy, or immunotherapy at least 30 days prior to the treatment
- Eastern Cooperative Oncology Group Performance Status less than or equal to 2
You may not qualify if:
- Active or uncontrolled autoimmune disease that may require corticosteroid therapy
- Serious or uncontrolled co-existent non-malignant disease, including active and uncontrolled infection
- Uncontrolled hypertension
- Hemoglobin less than or equal to 9.0 g/dL independent of transfusion
- Has abnormal liver function tests
- Surgery or local prostatic intervention within 30 days of the first dose
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (8)
Unknown Facility
Busan, South Korea
Unknown Facility
Cheongju-si, South Korea
Unknown Facility
Seongnam-Si, Gyeonggi-Do, South Korea
Unknown Facility
Seoul, South Korea
Unknown Facility
Kaohsiung City, Taiwan
Unknown Facility
Taichung, Taiwan
Unknown Facility
Taipei, Taiwan
Unknown Facility
Taoyuan, Taiwan
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Senior Director
- Organization
- Janssen R&D BE
Study Officials
- STUDY DIRECTOR
Janssen Research & Development, LLC Clinical Trial
Janssen Research & Development, LLC
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
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
September 12, 2012
First Posted
September 17, 2012
Study Start
August 30, 2011
Primary Completion
January 24, 2013
Study Completion
March 6, 2018
Last Updated
March 15, 2019
Results First Posted
May 23, 2016
Record last verified: 2019-02