Prostate cancer in Asia: design of a patient registry to inform real-world treatments, outcomes, and quality of life
Journal
Prostate International
Journal Volume
7
Journal Issue
3
Pages
108-113
Date Issued
2019
Author(s)
Liu Y.
Uemura H.
Ye D.
Lee J.Y.
Chiong E.
Razack A.H.A.
Pripatnanont C.
Rawal S.
Low G.K.M.
Qiu H.
Chow W.H.
Van Kooten Losio M.
Abstract
Background: The incidence of prostate cancer (PC) in Asian countries is increasing for reasons that are not clear. Data describing how PC is diagnosed and treated are fragmented across Asia, with marked intercountry and intracountry differences in outcome and knowledge gaps in clinical diagnostic and treatment practices. To address these knowledge gaps, we have established a PC disease registry with the aim of providing a comprehensive picture of PC diagnosis, prognosis, treatment and outcome, population characteristics, and comorbidities in real-world clinical practice in Asia. Methods: This is a multinational, multicenter, longitudinal, and observational registry of PC patients presenting to participating tertiary-care hospitals in eight Asian countries (www.clinicaltrials.gov NCT02546908. Registry Identifier: NOPRODPCR4001). Approximately 3500-4000 eligible patients with existing or newly diagnosed high-risk localized PC (cohort 1), nonmetastatic biochemically recurrent PC (cohort 2), or metastatic PC (cohort 3) will be consecutively enrolled and followed-up for 5 years. An enrollment cap of 600 patients each will be applied to cohorts 1 and 2. Disease status is collected at enrollment, and outcome variables captured at 3-monthly intervals include diagnostic/staging, treatments including reason for change, laboratory results, comorbidities, and concomitant medications. Treatments and survival outcomes will be captured real time until study end. Patient-reported quality-of-life will be measured every 6 months, and medical resource utilization summarized at study end. Data analysis will include exploratory analyses of potential associations between multiple risk factors and socioeconomic variables with disease progression and evaluation of various treatments for PC including novel therapies on clinical outcome and health-related quality-of-life outcomes. Results: 3636 men with PC were enrolled until July 2018; 416 in cohort 1, 399 in cohort 2 and 2821 in cohort 3. Discussion: A total of 3636 patients were enrolled until July 2018. The prospective disease registry will provide comprehensive and wide-ranging real-world information on how PC is diagnosed and treated in Asia. Such information can be used to inform policy development for best practice and direct clinical study design evaluating new treatments. ? 2019
Subjects
Asia; Overall survival; Prostate cancer; Quality of life; Registry
SDGs
Other Subjects
adult; Article; Asia; biochemical recurrence; cancer diagnosis; cancer epidemiology; cancer incidence; cancer localization; cancer mortality; cancer patient; cancer prognosis; cancer recurrence; cancer registry; cancer staging; cancer survival; clinical outcome; clinical practice; cohort analysis; comorbidity; digital rectal examination; European Quality of Life 5 Dimensions questionnaire; Functional Assessment of Cancer Therapy Prostate; Gleason score; high risk patient; human; longitudinal study; major clinical study; male; metastasis; metastasis free survival; multicenter study; observational study; overall survival; priority journal; progression free survival; prostate cancer; quality of life; risk factor; young adult
Publisher
Elsevier B.V.
Type
journal article