Overview

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