A Post-marketing Surveillance to Assess Safety of Abiraterone Acetate (Zytiga) in Indian Participants With Metastatic, Castration Resistant Prostate Cancer

• Status: Recruiting
• Trial end date: 2021-11-30
• Target enrollment: 0
• Participant gender: Male

Summary

The purpose of this study is to evaluate the safety of abiraterone acetate in Indian participants with metastatic, castration-resistant prostate cancer who have been prescribed abiraterone acetate as per locally approved prescribing information.

• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Johnson & Johnson Private Limited
• Treatments: Abiraterone Acetate

Criteria

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