Clinical trial NCT02608359: A Post-marketing Surveillance to Assess Safety of Abiraterone Acetate (Zytiga) in Indian Participants With Metastatic, Castration Resistant Prostate Cancer
Official title: 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
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Prostate Cancer
Keywords: Post-Marketing Surveillance
Abiraterone Acetate
Zytiga
Lead sponsor: Johnson & Johnson Private Limited
Sponsor class: INDUSTRY
First posted: 2015-11-18
Enrollment: 0
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Indian participants with metastatic, castration-resistant prostate cancer will be enrolled in this study.

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.

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.

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

Primary outcomes:
measure: The Number and Type of Adverse Events Reported by the Investigator or the Patient
timeFrame: up to 13 months
Secondary outcomes:
Other outcomes:
Locations:
city: Bangalore
country: India
city: Delhi
country: India
city: New Delhi
country: India
Study officials:
affiliation: Johnson & Johnson Private Limited
name: Johnson & Johnson Private Limited Clinical Trial
role: STUDY_DIRECTOR
References: