Study of Abiraterone Acetate Plus Prednisone in Patients With Chemo-naive Metastatic Castration-Resistant Prostate Cancer
A Phase 3, Randomized, Double-blind, Placebo-Controlled Study of Abiraterone Acetate (JNJ-212082) Plus Prednisone in Asymptomatic or Mildly Symptomatic Patients With Metastatic Castration-Resistant Prostate Cancer
2 other identifiers
interventional
313
4 countries
22
Brief Summary
The purpose of this study is to demonstrate the safety and effectiveness of abiraterone acetate when co-administered with prednisone in patients with chemo-naive metastatic castration resistant prostate Cancer (mCRPC).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3 prostate-cancer
Started Mar 2012
Typical duration for phase_3 prostate-cancer
22 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 27, 2012
CompletedFirst Submitted
Initial submission to the registry
May 2, 2012
CompletedFirst Posted
Study publicly available on registry
May 3, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
January 31, 2019
CompletedJanuary 21, 2020
January 1, 2020
4.8 years
May 2, 2012
January 16, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Time to prostate specific antigen (PSA) progression (TTPP)
Measured from the time interval from the date of randomization to the date of the PSA progression based on prostate cancer clinical trials working group 2 (PCWG2) criteria
14 months
Secondary Outcomes (8)
Overall survival
5 years
Time to initiation of cytotoxic chemotherapy
5 years
Prostate specific antigen (PSA) response rate
14 months
Objective response rate
14 months
Quality of life (QoL) total score and each subscale score
14 months
- +3 more secondary outcomes
Study Arms (2)
Abiraterone acetate and prednisone
EXPERIMENTALPlacebo and prednisone
ACTIVE COMPARATORInterventions
Placebo: Form=tablet, route=oral. Four tablets daily on an empty stomach. Prednisone: Type=exact number, unit=mg, number=5, form=tablet, route=oral, twice daily.
Abiraterone acetate: Type=exact number, unit=mg, number=250, form=tablet, route=oral. Four tablets daily on an empty stomach Prednisone: Type=exact number, unit=mg, number=5, form=tablet, route=oral, twice daily
Eligibility Criteria
You may qualify if:
- Has a confirmed diagnosis of adenocarcinoma of the prostate with evidence of metastatic disease
- Prostate cancer progression documented by PSA progression or radiographic progression
- Asymptomatic or mildly symptomatic from prostate cancer
- Surgically or medically castrated, with testosterone levels of \<50 ng/dL
- Previous anti-androgen therapy and progression after withdrawal
- ECOG performance status score of 0 or 1
- If opiate analgesics for cancer-related pain, treatment must not be administered within 4 weeks of Cycle 1 Day 1
- If radiation therapy for treatment of the primary tumor is given, treatment must not be administered within 6 weeks of Cycle 1 Day 1
- If previously treated with ketoconazole for prostate cancer, duration of treatment must not be greater than 7 days
- Life expectancy of at least 6 months
You may not qualify if:
- Active infection or other medical condition that would make prednisone (corticosteroid) use contraindicated
- Any chronic medical condition requiring a higher dose of corticosteroid than 5 mg prednisone twice daily
- Pathological finding consistent with small cell carcinoma of the prostate
- Liver or visceral organ metastasis, brain metastasis, and other malignancy, except non-melanoma skin cancer, with a 30% probability of recurrence within 24 months
- Prior cytotoxic chemotherapy or biologic therapy for the treatment of metastatic castration-resistant prostate cancer (mCRPC)
- Radiation or radionuclide therapy for treatment of mCRPC
- Uncontrolled hypertension, patients with a history of hypertension are allowed provided blood pressure is controlled by anti hypertensive treatment
- History of pituitary or adrenal dysfunction
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (22)
Unknown Facility
Beijing, China
Unknown Facility
Chengdu, China
Unknown Facility
Chongqing, China
Unknown Facility
Guangzhou, China
Unknown Facility
Hangzhou, China
Unknown Facility
Jinan, China
Unknown Facility
Nanjing, China
Unknown Facility
Shanghai, China
Unknown Facility
Tianjin, China
Unknown Facility
Wuhan, China
Unknown Facility
Kuala Lumpur, Malaysia
Unknown Facility
Arkhangelsk, Russia
Unknown Facility
Moscow, Russia
Unknown Facility
Pyatigorsk, Russia
Unknown Facility
Rostov-on-Don, Russia
Unknown Facility
Saint Petersburg, Russia
Unknown Facility
Sochi, Russia
Unknown Facility
Stavropol, Russia
Unknown Facility
Ufa, Russia
Unknown Facility
Yekaterinburg, Russia
Unknown Facility
Yoshkar-Ola, Russia
Unknown Facility
Bangkok, Thailand
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 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 2, 2012
First Posted
May 3, 2012
Study Start
March 27, 2012
Primary Completion
December 31, 2016
Study Completion
January 31, 2019
Last Updated
January 21, 2020
Record last verified: 2020-01