Prostate cancer (PC) is one of the leading cancers and cause of cancer mortality in Asia. However, limited real-world evidence is available on the diagnosis, treatments, clinical progression and outcomes, and health-related quality of life (HRQoL) in Asia. This study reports the initiation of a registry of PC patients in Asia aimed to compile data that may support clinical management and development of new PC therapies.
This large scale, prospective, longitudinal, observational registry of PC is initiated in eight Asian countries: China, Japan, India, South Republic of Korea, Taiwan, Thailand, Malaysia, and Singapore. Men (aged ≥21 years) diagnosed with either high-risk localized, or nonmetastatic biochemically recurrent, or metastatic PC, and those who agree for follow-up are considered eligible for the enrollment in this registry. Informed consent would be collected from all eligible PC patients. This study is expected to enrol more than 3,500 patients from over 30 large tertiary care hospitals. Eligible patients will be consecutively enrolled to the registry to avoid selection bias. Patients' medical information on diagnosis, treatments, and clinical progression will be collected from their medical records; HRQoL will be self-administered by the patients. Additionally, potential risk factors such as lifestyle, healthcare, and socio-economic status as well as certain clinical and pathological factors will be assessed for their associations with disease progression and clinical outcomes. Overall, observation period of the study will be up to 5 years.
Clinical trial identification
H. Uemura: grants and personal fees from AstraZeneca, personal fees from Astellas, Takeda, Janssen, ONO Pharma, Novartis, and grants and personal fees from Pfizer, outside the submitted work. A.H.A. Razack: grants from J&J during the conduct of the study. E. Chiong: funding from National University Hospital, during the conduct of the study. R. Kanesvaran: personal fees from Janssen Research and Development, outside the submitted work. H. Tongaonkar: professional fees for advisory work from Janssen Pharmaceuticals (J & J), outside the submitted work. Y.-S. Pu: receiving sponsorship for clinical study from Janssen and participated in Janssen advisory board membership and received honorarium for attendance. H. Liang, M. van Kooten Losio, Y. Liu: employees of Johnson and Johnson Pvt. Ltd, and hold stock in the company. K.W. Mah: employee of Johnson and Johnson Pvt. Ltd. All other authors have declared no conflicts of interest.