Clinical trial NCT02546908: A Registry of Participants With Prostate Cancer in Asia
Official title: A Multicenter, Prospective, Longitudinal Registry of Patients With Prostate Cancer in Asia
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Prostatic Neoplasms
Keywords: Prostatic Neoplasms
Non-interventional
Observational
Lead sponsor: Janssen Research & Development, LLC
Sponsor class: INDUSTRY
First posted: 2015-09-11
Enrollment: 3644
Sex: MALE
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants with High-risk localized prostate cancer (PC), Non-metastatic, biochemically recurrent PC and Metastatic PC will be enrolled in this study.

Brief 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.

Eligibility criteria: Inclusion Criteria:

* Male aged 21 years or older
* Documented diagnosis of PC with either: High-risk localized PC; Non-metastatic, biochemically recurrent PC; Metastatic PC
* Signed participation agreement/Informed Consent Form (ICF) by the patient or a legally acceptable representative
* Agree to be followed-up for PC per routine clinical care

Exclusion Criteria:

* No specific exclusion criteria's were defined

Primary outcomes:
measure: Overall Survival (OS)
timeFrame: up to 5 years
measure: Prostate Cancer (PC)-related Mortality (PM)
timeFrame: up to 5 years
measure: Metastasis-free survival (MFS)
timeFrame: up to 5 years
measure: Progression-free Survival (PFS)
timeFrame: up to 5 years
measure: Time to Prostate-specific Antigen (PSA) Progression (TTPP)
timeFrame: up to 5 years
measure: European Quality of Life-5 Dimensions, 5 Levels (EQ-5D-5L) Score
timeFrame: up to 5 years
measure: Functional Assessment of Cancer Therapy for Prostate Cancer (FACT-P) Score
timeFrame: up to 5 years
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
city: Guangzhou
country: China
city: Hangzhou
country: China
city: Shanghai
country: China
city: Shenyang
country: China
city: Sichuan
country: China
city: Su Zhou
country: China
city: Wuhan
country: China
city: Bangalore
country: India
city: Delhi
country: India
city: Mumbai
country: India
city: New Delhi
country: India
city: Chiba
country: Japan
city: Hirosaki
country: Japan
city: Ikoma
country: Japan
city: Kobe
country: Japan
city: Koshigaya
country: Japan
city: Matsuyama
country: Japan
city: Osaka-Sayama
country: Japan
city: Suita
country: Japan
city: Seoul
country: Korea, Republic of
city: Kuala Lumpur N/a
country: Malaysia
city: Kuala Lumpur
country: Malaysia
city: Kuching
country: Malaysia
city: Pulau Pinang
country: Malaysia
city: Singapore
country: Singapore
city: Kaohsiung
country: Taiwan
city: Tainan
country: Taiwan
city: Taipei
country: Taiwan
city: Bangkok
country: Thailand
city: Chiang Mai
country: Thailand
city: Songkla
country: Thailand
Study officials:
affiliation: Janssen Research & Development, LLC
name: Janssen Research & Development, LLC Clinical Trial
role: STUDY_DIRECTOR
References:
citation: Uemura H, Ye D, Kanesvaran R, Chiong E, Lojanapiwat B, Pu YS, Rawal SK, Abdul Razack AH, Zeng H, Chung BH, Md Yusoff NA, Ohyama C, Kim CS, Leewansangtong S, Tsai YS, Liu Y, Liu W, van Kooten Losio M, Asinas-Tan M. United in Fight against prOstate cancer (UFO) registry: first results from a large, multi-centre, prospective, longitudinal cohort study of advanced prostate cancer in Asia. BJU Int. 2020 Apr;125(4):541-552. doi: 10.1111/bju.14980. Epub 2020 Jan 30.
citation: Liu Y, Uemura H, Ye D, Lee JY, Chiong E, Pu YS, Razack AHA, Pripatnanont C, Rawal S, Low GKM, Qiu H, Chow WH, Van Kooten Losio M. Prostate cancer in Asia: design of a patient registry to inform real-world treatments, outcomes, and quality of life. Prostate Int. 2019 Sep;7(3):108-113. doi: 10.1016/j.prnil.2018.12.001. Epub 2018 Dec 24.