A Study of Abiraterone Acetate Plus Prednisone in Asymptomatic or Mildly Symptomatic Patients With Metastatic Castration-Resistant Prostate Cancer
NCT01834209 · Status: NO_LONGER_AVAILABLE · Type: EXPANDED_ACCESS
Last updated 2018-11-07
Summary
The purpose of this study is to collect additional safety data during treatment with abiraterone acetate plus prednisone or prednisolone among adult participants with asymptomatic or mildly symptomatic metastatic castration-resistant prostate cancer (mCRPC) who reside in areas in which abiraterone acetate is not yet available for this indication through local healthcare providers, and who are not eligible for enrollment into an available ongoing clinical study of abiraterone acetate.
Conditions
- Prostate Neoplasms
Interventions
- DRUG
-
Abiraterone acetate
Abiraterone 1000 mg (4 x 250 mg tablets) taken orally once daily for 28-day cycles
- DRUG
-
Prednisone or prednisolone
5 mg tablet taken orally once daily
Sponsors & Collaborators
-
Janssen Research & Development, LLC
lead INDUSTRY
Principal Investigators
-
Janssen Research & Development, LLC Clinical Trial · Janssen Research & Development, LLC
Eligibility
- Min Age
- 18 Years
- Sex
- MALE
- Healthy Volunteers
- No
Timeline & Regulatory
Countries
- Brazil
Study Locations
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