Prostate CancerNCT02608359
A Post-marketing Surveillance to Assess Safety of Abiraterone Acetate (Zytiga) in Indian Participants With Metastatic, Castration Resistant Prostate Cancer
An observational study of Prostate Cancer, run by Johnson & Johnson Private Limited at 3 sites in India.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- Abiraterone Acetate
- Type of treatment
- Pill or oral medicine
- How many people
- 0 participants
- Where
- 3 sitesIndia
- Study dates
- 31 May 2016to 31 May 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Study population: Indian participants with metastatic, castration-resistant prostate cancer will be enrolled in this study.
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
3 sites in 1 country.
About this study
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
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.
Read the 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
- Being tested
- Abiraterone Acetate
- Keywords
- Post-Marketing Surveillance, Abiraterone Acetate, Zytiga
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Abiraterone Acetate |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: up to 13 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2015 (estimated)
- Study start31 May 2016
- Primary completion31 May 2022 (estimated)
- Study completion31 May 2022 (estimated)
Why it stopped: No subjects recruited in the study
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johnson & Johnson Private Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Johnson & Johnson Private Limited Clinical Trial, Study director, Johnson & Johnson Private Limited
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02608359
- Sponsor's protocol ID
- CR107096
- Other IDs
- 212082PCR4021
- Status last verified
- Jan 2025
- First submitted
- 17 Nov 2015
- Last updated
- 3 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02608359
- Acronym / sponsor ID
- CR107096
- Conditions
- Prostate Cancer
- Keywords
- Post-Marketing Surveillance, Abiraterone Acetate, Zytiga
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: No subjects recruited in the study
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Johnson & Johnson Private LimitedIndustry (pharma, biotech, devices)
- Study start
- 31 May 2016 (actual)
- Primary completion
- 31 May 2022 (estimated)
- Study completion
- 31 May 2022 (estimated)
- First posted
- 18 Nov 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Abiraterone Acetate (Zytiga) Post-marketing Surveillance (PMS) | – | Drug: Abiraterone AcetateThis 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Indian participants with metastatic, castration-resistant prostate cancer will be enrolled in this study.
Key inclusion criteria (3 listed)
- 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)
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Abiraterone AcetateThis 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 (Zytiga) Post-marketing Surveillance (PMS) |
Primary outcome
The Number and Type of Adverse Events Reported by the Investigator or the Patient
Time frame: up to 13 months
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.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Feb 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Johnson & Johnson Private Limited Clinical Trial study director
Johnson & Johnson Private Limited
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Prostate Cancer, run by Johnson & Johnson Private Limited at 3 sites in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 3 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Number and Type of Adverse Events Reported by the Investigator or the Patient (time frame: up to 13 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Feb 2025.