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

NCT02608359

WithdrawnN/A

Sponsor: Johnson & Johnson Private Limited

Conditions: Prostate Cancer

Interventions: Abiraterone Acetate

Countries: India

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.

Eligibility overview

Sex: MALE

Age: 18 Years to —

Healthy volunteers: No

Study type: OBSERVATIONAL

Eligibility 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

Locations (3)

Bangalore, India
Delhi, India
New Delhi, India