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Prostatic NeoplasmsNCT02546908

A Registry of Participants With Prostate Cancer in Asia

An observational study of Prostatic Neoplasms, run by Janssen Research & Development, LLC at 31 sites in 8 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The purpose of this study is to document prostate cancer (PC) management including diagnosis, prognosis, treatment, and care in real-world practice. Read more about this study

Who is it for?
Ages 21 years and older, men only
Conditions the study is for
Prostatic Neoplasms
How many people
3,644 participants
Where
31 sitesin 8 countries
Study dates
9 Sep 2015to 1 Sep 2020
How long will I take part?
5 Years
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 21 years and older
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Study population: Participants with High-risk localized prostate cancer (PC), Non-metastatic, biochemically recurrent PC and Metastatic PC will be enrolled in this study.

Who may be able to join

  • 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

Who cannot join

  • No specific exclusion criteria's were defined

Trial locations and contacts

31 sites in 8 countries.

31 sites in 8 countries

China8 sites

  • Study site

    Beijing

  • Study site

    Guangzhou

  • Study site

    Hangzhou

  • Study site

    Shanghai

  • Study site

    Shenyang

  • Study site

    Sichuan

  • Study site

    Suzhou

  • Study site

    Wuhan

Other trials in China

Japan8 sites

  • Study site

    Chiba

  • Study site

    Hirosaki

  • Study site

    Ikoma

  • Study site

    Kobe

  • Study site

    Koshigaya

  • Study site

    Matsuyama

  • Study site

    Ōsaka-sayama

  • Study site

    Suita

Other trials in Japan

India4 sites

  • Study site

    Bangalore

  • Study site

    Delhi

  • Study site

    Mumbai

  • Study site

    New Delhi

Other trials in India

Malaysia3 sites

  • Study site

    Kuala Lumpur

  • Study site

    Kuching

  • Study site

    Pulau Pinang

Other trials in Malaysia

Taiwan3 sites

  • Study site

    Kaohsiung City

  • Study site

    Tainan

  • Study site

    Taipei

Other trials in Taiwan

Thailand3 sites

  • Study site

    Bangkok

  • Study site

    Chiang Mai

  • Study site

    Songkhla

Other trials in Thailand

Singapore1 site

  • Study site

    Singapore

Other trials in Singapore

South Korea1 site

  • Study site

    Seoul

Other trials in South Korea

About this study

Official title: A Multicenter, Prospective, Longitudinal Registry of Patients With Prostate Cancer in Asia

The purpose of this study is to document prostate cancer (PC) management including diagnosis, prognosis, treatment, and care in real-world practice.

Read the 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.

Being tested
No Intervention
Keywords
Prostatic Neoplasms, Non-interventional, Observational
Medical subject headings
Prostatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • No InterventionOther

    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.

Study groups in NCT02546908
Study groupRoleWhat they receive
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).
Receives: Other: No Intervention
Non-metastatic Biochemically Recurrent PCNo 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).
Receives: Other: No Intervention
Metastatic PCNo intervention will be administered in this study. Participants with Metastatic PC will be enrolled.
Receives: Other: No Intervention

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Overall Survival (OS)

    Overall survival is defined as the time from enrollment to date of death due to any cause.

    Measured: up to 5 years

  2. Prostate Cancer (PC)-related Mortality (PM)

    PC-related mortality is the death due to prostate cancer.

    Measured: up to 5 years

  3. 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.

    Measured: up to 5 years

  4. Progression-free Survival (PFS)

    Progression-free Survival is the time from enrollment to the occurrence of disease progression or death.

    Measured: up to 5 years

  5. 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.

    Measured: up to 5 years

  6. 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.

    Measured: up to 5 years

  7. 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.

    Measured: up to 5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Sep 2015 (estimated)
  2. Study start9 Sep 2015
  3. Primary completion1 Sep 2020
  4. Study completion1 Sep 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
3,644 participants (actual)
Target duration
5 Years
IDs, dates and publications
ClinicalTrials.gov ID
NCT02546908
Sponsor's protocol ID
CR107351
Other IDs
NOPRODPCR4001
Status last verified
Sep 2020
First submitted
9 Sep 2015
Last updated
22 Sep 2020
Results posted
No
Data monitoring committee
No
FDA-regulated device
No

Publications

  • 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.

    PubMed 39583953

  • 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.

    PubMed 31868997

  • 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.

    PubMed 31485435

Questions about this trial

What is this clinical trial studying?

An observational study of Prostatic Neoplasms, run by Janssen Research & Development, LLC at 31 sites in 8 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 22 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 31 sites in China, Japan, India, Malaysia, Taiwan and 3 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overall Survival (OS) (time frame: up to 5 years). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02546908, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Sep 2020.

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