A Registry of Participants With Prostate Cancer in Asia
A Multicenter, Prospective, Longitudinal Registry of Patients With Prostate Cancer in Asia
2 other identifiers
observational
3,644
8 countries
31
Brief Summary
The purpose of this study is to document prostate cancer (PC) management including diagnosis, prognosis, treatment, and care in real-world practice.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Sep 2015
Longer than P75 for all trials
31 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 9, 2015
CompletedStudy Start
First participant enrolled
September 9, 2015
CompletedFirst Posted
Study publicly available on registry
September 11, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2020
CompletedSeptember 22, 2020
September 1, 2020
5 years
September 9, 2015
September 21, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (7)
Overall Survival (OS)
Overall survival is defined as the time from enrollment to date of death due to any cause.
up to 5 years
Prostate Cancer (PC)-related Mortality (PM)
PC-related mortality is the death due to prostate cancer.
up to 5 years
Metastasis-free survival (MFS)
MFS is defined as the time from enrollment to the date of the first occurrence of radiographic bone or soft tissue distant metastasis, incidental pathologic finding of distant metastasis, or death from any cause, whichever occurs first.
up to 5 years
Progression-free Survival (PFS)
Progression-free Survival is the time from enrollment to the occurrence of disease progression or death.
up to 5 years
Time to Prostate-specific Antigen (PSA) Progression (TTPP)
TTPP is defined as time from enrollment to the date of PSA progression. In participants who has PSA level decreased, PSA progression is defined as 25 percent (%) increase (greater than or equal to \[\>=\] 25%) from nadir (lowest value including baseline) and an increase in the absolute value of at least 2 nanogram per milliliter (ng/mL (\>=2ng/mL) and is confirmed by a subsequent measurement at least 3 weeks (\>=21 days; PCWG2) after the increase. In participants in whom the PSA level had not decreased, PSA progression is defined as 25% increase (\>=25%) from baseline and an increase in the absolute value of at least 2ng/mL (\>=2ng/mL) after 12 weeks.
up to 5 years
European Quality of Life-5 Dimensions, 5 Levels (EQ-5D-5L) Score
The EQ-5D-5L is the new 5-level version of EQ-5D. It describes health-related quality of life (HRQoL) states consisting of 5 dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression). Each item of the EQ-5D within these dimensions has 5 response options (no problems, slight problems, moderate problems, severe problems, or extreme problems). Data captured by EQ-5D-5L relates to the patient's status at the time of completion, and takes approximately 5 minutes to complete.
up to 5 years
Functional Assessment of Cancer Therapy for Prostate Cancer (FACT-P) Score
The FACT-P consists of the FACT-General (FACT-G) and a PC-specific subscale. The FACT-G contains a 27-item questionnaire and is composed of 4 dimensions of HRQoL: physical well-being, social/family well-being, emotional well-being, and functional well-being. The PC-specific subscale is composed of 12 items, which span the dimensions of sexual function, bowel/bladder function, and pain. The FACT-P questionnaire has a 7 day recall, and takes approximately 15 minutes to complete.
up to 5 years
Study Arms (3)
High-risk localized Prostate Cancer (PC)
No intervention will be administered in this study. Participants with High-risk localized PC will be enrolled. High-risk localized PC involves clinical T stage greater than or equal to (\>=) cT3a and one of the following high risk features: Gleason score 8-10 or prostate specific antigen (PSA) level above 20 nanogram per milliliter (ng/mL).
Non-metastatic Biochemically Recurrent PC
No intervention will be administered in this study. Participants with Non-metastatic biochemically recurrent PC will be enrolled. A non-metastatic biochemically recurrent PC involves a confirmed PSA value of \>0.2 ng/mL following prostatectomy (European Association of Urology (EAU) guidelines), a PSA value of 2 ng/mL or more above the nadir following radiation therapy (American Society for Radiation Oncology (ASTRO) guidelines).
Metastatic PC
No intervention will be administered in this study. Participants with Metastatic PC will be enrolled.
Interventions
This is an observational study. No study medication is provided will be provided as part of participation. Participants disease status, overall survival (OS), PFS, MFS, SRE-free survival, and time to castration (TTC) will be analyzed according to treatments prescribed while enrolled in the registry. All treatment decisions will be made at the discretion of the investigator or treating physician.
Eligibility Criteria
Participants with High-risk localized prostate cancer (PC), Non-metastatic, biochemically recurrent PC and Metastatic PC will be enrolled in this study.
You may qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (31)
Unknown Facility
Beijing, China
Unknown Facility
Guangzhou, China
Unknown Facility
Hangzhou, China
Unknown Facility
Shanghai, China
Unknown Facility
Shenyang, China
Unknown Facility
Sichuan, China
Unknown Facility
Suzhou, China
Unknown Facility
Wuhan, China
Unknown Facility
Bangalore, India
Unknown Facility
Delhi, India
Unknown Facility
Mumbai, India
Unknown Facility
New Delhi, India
Unknown Facility
Chiba, Japan
Unknown Facility
Hirosaki, Japan
Unknown Facility
Ikoma, Japan
Unknown Facility
Kobe, Japan
Unknown Facility
Koshigaya, Japan
Unknown Facility
Matsuyama, Japan
Unknown Facility
Ōsaka-sayama, Japan
Unknown Facility
Suita, Japan
Unknown Facility
Kuala Lumpur, Malaysia
Unknown Facility
Kuching, Malaysia
Unknown Facility
Pulau Pinang, Malaysia
Unknown Facility
Singapore, Singapore
Unknown Facility
Seoul, South Korea
Unknown Facility
Kaohsiung City, Taiwan
Unknown Facility
Tainan, Taiwan
Unknown Facility
Taipei, Taiwan
Unknown Facility
Bangkok, Thailand
Unknown Facility
Chiang Mai, Thailand
Unknown Facility
Songkhla, Thailand
Related Publications (3)
Ye D, Kanesvaran R, Chiong E, Lojanapiwat B, Pu YS, Rawal SK, Aik OT, Zeng H, Chung BH, Ashani MYN, Ohyama C, Kim CS, Hu Z, Tsai YS, Razack AHA, Singh A, Liu Y, Uemura H. UFO registry: final analysis of baseline data from patients with advanced prostate cancer in Asia. Ther Adv Med Oncol. 2024 Nov 23;16:17588359241293393. doi: 10.1177/17588359241293393. eCollection 2024.
PMID: 39583953DERIVEDUemura 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.
PMID: 31868997DERIVEDLiu 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.
PMID: 31485435DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Janssen Research & Development, LLC Clinical Trial
Janssen Research & Development, LLC
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Target Duration
- 5 Years
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 9, 2015
First Posted
September 11, 2015
Study Start
September 9, 2015
Primary Completion
September 1, 2020
Study Completion
September 1, 2020
Last Updated
September 22, 2020
Record last verified: 2020-09