266TiP - A multicenter, prospective, longitudinal registry of prostate cancer in Asia

Date 19 December 2015
Event ESMO Asia 2015 Congress
Session Poster presentation 1
Topics Prostate Cancer
Aetiology, Epidemiology, Screening and Prevention
Basic Scientific Principles
Presenter Hirotsugu Uemura
Citation Annals of Oncology (2015) 26 (suppl_9): 71-79. 10.1093/annonc/mdv524
Authors H. Uemura1, D. Ye2, T. Wu3, J. Lee4, Y.L. Chong5, A.H.A. Razack6, C. Pripatnanont7, E. Chiong8, W.K.O. Lau9, R. Kanesvaran10, C. Li11, S. Rawal12, H. Tongaonkar13, Y. Pu14, A. Santingamkun15, B. Lojanapiwat16, H. Liang17, K.W. Mah18, M. van Kooten Losio19, Y. Liu20
  • 1Department Of Urology, Kinki University Faculty of Medicine, 589-8511 - Osaka/JP
  • 2Department Of Urological Surgery, Fudan University Shanghai Cancer Center (FUSCC), 200032 - Shanghai/CN
  • 3Department Of Surgery, Kaohsiung Veterans General Hospital, Kaohsiung/TW
  • 4Department Of Urology, Seoul St. Mary's Hospital, The Catholic University of Korea, Seoul/KR
  • 5Department Of Urology, Tan Tock Seng Hospital, Singapore/SG
  • 6Department Of Surgery, Faculty Of Medicine, University Malaya Medical Center, Kuala Lumpur/MY
  • 7Department Of Surgery, Faculty Of Medicine, Prince of Songkhla University, Hatyai, Songkhla/TH
  • 8Department Of Urology, University Surgical Cluster, National University Health System (NUHS), Singapore/SG
  • 9Department Of Urology, Singapore General Hospital, Singapore/SG
  • 10Division Of Medical Oncology, National Cancer Center, 169610 - Singapore/SG
  • 11Department Of Urological Oncology, Cancer Institute and Hospital, Chinese Academy of Medical Sciences, Beijing/CN
  • 12Department Of Surgical Oncology, Rajiv Gandhi Cancer Institute & Research Center, New Delhi/IN
  • 13Department Of Surgical Oncology, P.D. Hinduja Hospital & Medical Research Centre, Mumbai/IN
  • 14Department Of Urology, National Taiwan University Hospital, Taipei/TW
  • 15Division Of Urology, Department Of Surgery, Faculty Of Medicine, King Chulalongkorn Memorial Hospital, Bangkok/TH
  • 16Department Of Surgery, Faculty Of Medicine, Maharaj Nakorn Chiang Mai Hospital, Chiang Mai/TH
  • 17Department Of Biostatistics, Janssen Research & Development, Shanghai/CN
  • 18Medical Affairs, Janssen Asia Pacific, Singapore/SG
  • 19Medical Affairs, Janssen Asia Pacific, North Sydney/AU
  • 20Global Epidemiology, Janssen Research & Development, Singapore/SG

Abstract

Background

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.

Trial design

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

Disclosure

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.