NCT02546908

A Registry of Participants With Prostate Cancer in Asia

A Multicenter, Prospective, Longitudinal Registry of Patients With Prostate Cancer in Asia

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 3,644 (actual)
• Sponsor: Janssen Research & Development, LLC · Industry
• Sex: Male
• Age: 21 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to document prostate cancer (PC) management including diagnosis, prognosis, treatment, and care in real-world practice.

Detailed description

This is a multicenter (when more than one hospital or medical school team work on a medical research study), prospective (observation of a population for a sufficient number of persons over a sufficient number of years to generate incidence or mortality rates subsequent to the selection of the study group), longitudinal, observational registry (clinical study in which participants may receive diagnostic, therapeutic, or other types of interventions, but the investigator does not assign participants to specific interventions \[as in an interventional study\])of PC participants. The following 3 participant cohorts will be enrolled: high-risk localized PC, non-metastatic biochemically recurrent PC, and metastatic PC. This is an observational study and treatment decisions and clinical management of participants will follow routine clinical practice. Medical care given to participants will not be influenced by participation in the study. Enrolled participants will be prospectively followed throughout their course of treatment, during which data on PC treatment, clinical progression, and outcomes (including death) will be collected. At the end of registry medical resource utilization (MRU) will also be collected. The maximum observational period will be 5 years. Safety will be monitored throughout the study for participants being treated with JNJ products.

Conditions

• Prostatic Neoplasms

Interventions

Type	Name	Description
OTHER	No Intervention	This is an observational study. No study medication is provided will be provided as part of participation. Participants disease status, overall survival (OS), PFS, MFS, SRE-free survival, and time to castration (TTC) will be analyzed according to treatments prescribed while enrolled in the registry. All treatment decisions will be made at the discretion of the investigator or treating physician.

Timeline

• Start date: 2015-09-09
• Primary completion: 2020-09-01
• Completion: 2020-09-01
• First posted: 2015-09-11
• Last updated: 2020-09-22

Locations

31 sites across 8 countries: China, India, Japan, Malaysia, Singapore, South Korea, Taiwan, Thailand