NCT02608359

Brief 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.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started May 2016

Longer than P75 for all trials

Geographic Reach
1 country

3 active sites

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 17, 2015

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 18, 2015

Completed
7 months until next milestone

Study Start

First participant enrolled

May 31, 2016

Completed
6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2022

Completed
Last Updated

February 3, 2025

Status Verified

January 1, 2025

Enrollment Period

6 years

First QC Date

November 17, 2015

Last Update Submit

January 31, 2025

Conditions

Prostate Cancer

Keywords

Post-Marketing SurveillanceAbiraterone AcetateZytiga

Outcome Measures

Primary Outcomes (1)

  • The Number and Type of Adverse Events Reported by the Investigator or the Patient

    An AE is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. The severity of adverse events will be graded using National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) Version 4.

    up to 13 months

Study Arms (1)

Abiraterone Acetate (Zytiga) Post-marketing Surveillance (PMS)

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.

Drug: Abiraterone Acetate

Interventions

Abiraterone AcetateDRUG

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.

Abiraterone Acetate (Zytiga) Post-marketing Surveillance (PMS)

Eligibility Criteria

Age18 Years+
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Indian participants with metastatic, castration-resistant prostate cancer will be enrolled in this study.

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Unknown Facility

Bangalore, India

Location

Unknown Facility

Delhi, India

Location

Unknown Facility

New Delhi, India

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Abiraterone Acetate

Condition Hierarchy (Ancestors)

Genital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital Diseases

Intervention Hierarchy (Ancestors)

AndrostenesAndrostanesSteroidsFused-Ring CompoundsPolycyclic Compounds

Study Officials

  • Johnson & Johnson Private Limited Clinical Trial

    Johnson & Johnson Private Limited

    STUDY DIRECTOR
0

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 17, 2015

First Posted

November 18, 2015

Study Start

May 31, 2016

Primary Completion

May 31, 2022

Study Completion

May 31, 2022

Last Updated

February 3, 2025

Record last verified: 2025-01

Locations

IN(3)