857PUnited in fight against prostate cancer registry (UFO): First results from a large, multi-center, prospective, longitudinal cohort study in Asia

Background: The way in which prostate cancer (PC) is diagnosed and treated is fragmented across some Asian countries. We have established a PC registry (UFO) with the aim of providing a comprehensive picture of PC diagnosis, prognosis, treatment and outcome. The registry will collect patient-reported treatment outcomes and underlying reasons for clinical decision-making. Methods: This is a large multi-national, prospective, observational registry of PC patients presenting to tertiary care hospitals in China, India, Japan, Malaysia, Singapore, South Korea, Taiwan and Thailand. Patients with existing or newly diagnosed high-risk localized PC (HRL), non-metastatic biochemically recurrent PC (M0), or metastatic PC (M1), are being consecutively enrolled and followed for up to 5 years. Patient history, demographic and disease characteristics were collected at first PC diagnosis and enrollment. The first interim analysis of baseline characteristics includes all patients enrolled from study start (15 Sept 2015) until 17 May 2017. Results: 2,063 eligible patients were enrolled in the interim analysis: 357 (17%), 378 (19%), and 1328 (64%) had HRL, M0 or M1 PC. Among M1 patients, 1038 had hormone-sensitive PC (mHSPC) and 290 had castration-resistant PC (mCRPC). Mean age at first diagnosis was similar in each group (Table). At enrollment, 62% of patients had at least one co-morbidity; mainly cardiovascular disease or diabetes and 14.3% of M0 patients were castration-resistant. A total of 84.5% of patients with mHSPC and 75.9% with mCRPC had de novo metastases. Decisions to start therapy were mainly driven by PSA or clinical progression. Decision to discontinue therapy was most often due to disease progression (hormonal therapy) or completion of therapy (chemotherapy).Table: 857PBaseline characteristics of patients with prostate cancerCharacteristicHRL N = 357M0 N = 378mHSPC N = 1038mCRPC N = 290Years from diagnosis until enrolment, median (IQR)2.7 (0.5-4.0)6.7 (3.7-9.7)2.5 (0.2-3.5)4.3 (1.8-5.5)Age at first diagnosis (years) mean (SD)68.3 (8.10)65.7 (6.83)69.1 (7.91)67.6 (8.38)PSA at diagnosis (ng/mL), median (IQR)29.1 (14.7-59.5)13.2 (7.7-25.1)105 (40.8-498)100 (3.5-9883)Reasons that triggered suspicion of PCSymptom driven56.9%42.1%68.6%77.5%During regular health screening31.4%46.1%14.5%13.0%Incidental finding11.7%11.8%16.9%9.5%Had undergone radiologic imaging at enrollment29.1%16.7%100%100%% castrated at enrollment79.3%70.4%85.6%100%Prior treatmentRadiotherapy37.4%52.4%11.8%26.9%Hormonal therapy56.9%58.7%55.2%79.7%Chemotherapy0.0%0.0%8.8%21.4%Orchiectomy2.3%2.6%11.0%24.1%Prostatectomy37.7%65.3%7.8%9.3%Reason for initiating hormonal therapyPSA progression17%52%24.6%37.5%Clinical progression10%8.3%11.4%11.2%Radiographic progression2%0.5%3.7%13.3%Following treatment guidelines (international, national or site)40.6%23.2%36.3%55.8%Disease characteristics7.4%11.2%13.6%11.2%Reason for initiating chemotherapyPSA progression--30.4%48.3%Clinical progression--12.5%25.0%Radiographic progression--8.3%15.0%Following treatment guidelines (international, national or site)--29.2%15.0%Disease characteristics--7.7%1.7%Reason for stopping hormonal therapyTreatment-related side-effects2.3%2.6%2.8%14.0%Stable disease5.8%9.2%--Disease progression26.7%39.5%42.0%62.3%Reason for stopping chemotherapyTreatment-related side-effects--8.0%9.1%Completed therapy--54.5%50.0%Disease progression--20.5%34.1%New or deterioration of existing comorbidities---4.5%Patient’s decision--1.1%2.3%SD = standard deviation, IQR = interquartile range Open table in a new tab SD = standard deviation, IQR = interquartile range Conclusions: The UFO registry will provide descriptive data on current disease characteristics and treatment landscape among patients with PC in Asia. Editorial acknowledgement: Writing assistance was provided by Joanne Wolter (independent) on behalf of of Janssen. Legal entity responsible for the study: Johnson & Johnson. Funding: Janssen. Disclosure: H. Uemura: Grants: Janssen, Astellas, Takeda, AstraZeneca; Personal fees: AstraZeneca, Astellas, Sanofi; Other: Sanofi, outside the submitted work. R. Kanesvaran: Grants, Personal fees: Johnson & Johnson, outside the submitted work. E. Chiong: Institutional grants: Janssen during the conduct of the study; Honoraria, Conference support: Janssen outside the submitted work. Y. Liu: Employee: Janssen Research and Development, LLC; Stock owner: J&J. M. Asinas-Tan: Employee: Johnson & Johnson Pte Ltd. W. Liu: Employee: Johnson & Johnson (China) Investment Ltd. G.K.M. Low: Employee: Janssen Asia Pacific, Medical affairs; Stock owner: J&J. M.A.G. van Kooten Losio: Employee: Johnson & Johnson Pte Ltd; Stock owner: J&J. All other authors have declared no conflicts of interest.