NCT02608359

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

A Prospective, Multicenter, Post-marketing Surveillance to Assess Safety of Zytiga (Abiraterone Acetate Tablets 250 mg) in Indian Patients With Metastatic, Castration Resistant Prostate Cancer as Per Locally Approved Prescribing Information

• Status: Withdrawn
• Phase: —
• Study type: Observational
• Enrollment: 0 (actual)
• Sponsor: Johnson & Johnson Private Limited · Industry
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This is a prospective (the participants are identified and then followed forward in time for the outcome of the study), multicenter (when more than one hospital or medical school team work on a medical research study), post-marketing surveillance (\[PMS\], surveillance of drugs, devices, appliances, etc., for efficacy or adverse effects, after they have been released for general sale) study. The study will consist of Screening and Enrolment Visit (Day 1) and Follow-up Period (12 months). For each participant, the follow-up visits will be conducted as per routine clinical practice at month 3, 6 and 9. The End-of-Study (EOS) Visit will be conducted after the completion of 12-months abiraterone acetate (Zytiga) and a telephonic follow-up will be conducted 30 days after the EOS Visit. The total duration of the study will be 13 months. Participants receiving abiraterone acetate as per locally approved prescribing information will be enrolled in the PMS. The use of abiraterone acetate will follow dosing and frequency stipulated in the locally approved prescribing information. Participants will be monitored during treatment of abiraterone acetate and up to 30 days post treatment for collection of adverse events. Participants' safety will be monitored throughout the study.

Conditions

• Prostate Cancer

Interventions

Type	Name	Description
DRUG	Abiraterone Acetate	This is an observational study and participants will not receive any intervention as a part of this study. All prospective participants who will be prescribed abiraterone acetate tablets 250 milligram (mg) treatment based on independent clinical judgment and as per locally approved prescribing information will be enrolled in the PMS. Participants will be exclusively observed for safety.

Timeline

• Start date: 2016-05-31
• Primary completion: 2022-05-31
• Completion: 2022-05-31
• First posted: 2015-11-18
• Last updated: 2025-02-03

Locations

3 sites across 1 country: India