A post marketing study to monitor safety of Abiraterone Acetate (Zytiga) in Indian patients with Prostate Cancer
Phase 4
- Conditions
- Health Condition 1: null- Indian participants with metastatic, castration-resistant prostate cancer will be enrolled in this study.
- Registration Number
- CTRI/2016/04/006854
- Lead Sponsor
- Johnson Johnson Private Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Closed to Recruitment of Participants
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
Participants with established diagnosis of metastatic castration-resistant prostate carcinoma
Being newly initiated on Zytiga treatment (abiraterone acetate tablets 250 mg) based on independent clinical judgment of treating physicians as per locally approved prescribing information
Willing to provide written informed consent indicating that they understand the purpose and are willing to participate in the post-marketing
surveillance (PMS)
Exclusion Criteria
Participants who are not eligible to receive Zytiga as per the locally approved prescribing information
Participants participating or planning to participate in any interventional drug trial during the course of this PMS
Contacts and
Study & Design
- Study Type
- PMS
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The Number and Type of Adverse Events Reported by the Investigator or the PatientTimepoint: Up to 13 months
- Secondary Outcome Measures
Name Time Method To assess the following parameters associated with usage of Zytiga�® (abiraterone acetate tablets 250 mg) <br/ ><br>â�¢ Baseline patient and disease characteristics <br/ ><br>â�¢ Progression of disease <br/ ><br>â�¢ Change in patient reported outcomes (a) Quality of Life using FACT-P Instrument (b) Fatigue using Brief fatigue inventory assessment (C) Pain using Brief pain inventory assessment.Timepoint: Up to 13 months