A Study Examining Long-term Access to Abiraterone Acetate
- Conditions
- Metastatic Castration-Resistant Prostate Cancer (PCR)MedDRA version: 14.1Level: PTClassification code 10036909Term: Prostate cancer metastaticSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2011-005243-28-HU
- Lead Sponsor
- Janssen-Cilag International NV
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Male
- Target Recruitment
- 300
Inclusion Criteria
Currently participating in an abiraterone acetate clinical study considered complete and had received at least 3 months of treatment with abiraterone acetate tablets.
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 117
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 183
Exclusion Criteria
- Medical conditions that require hospitalization.
- Any condition or situation which, in the opinion of the investigator, may put the patient at significant risk, may confound the study results, or may interfere significantly with the patient's participation in the study.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method