Clinical trial · Observational
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): No subjects recruited in the study
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Abiraterone Acetate | Drug | Abiraterone Acetate | ALIAS |
Design
Arms and outcomes
Arms (1)
- label
- Abiraterone Acetate (Zytiga) Post-marketing Surveillance (PMS)
- description
- 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.
- interventionNames
- Drug: Abiraterone Acetate
Primary outcomes (1)
- measure
- The Number and Type of Adverse Events Reported by the Investigator or the Patient
- timeFrame
- up to 13 months
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available