A Registry of Participants With Prostate Cancer in Asia

September 21, 2020 updated by: Janssen Research & Development, LLC

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
3644

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • Beijing, China
      • Guangzhou, China
      • Hangzhou, China
      • Shanghai, China
      • Shenyang, China
      • Sichuan, China
      • Su Zhou, China
      • Wuhan, China
  • India
      • Bangalore, India
      • Delhi, India
      • Mumbai, India
      • New Delhi, India
  • Japan
      • Chiba, Japan
      • Hirosaki, Japan
      • Ikoma, Japan
      • Kobe, Japan
      • Koshigaya, Japan
      • Matsuyama, Japan
      • Osaka-Sayama, Japan
      • Suita, Japan
  • Korea, Republic of
      • Seoul, Korea, Republic of
  • Malaysia
      • Kuala Lumpur, Malaysia
      • Kuala Lumpur N/a, Malaysia
      • Kuching, Malaysia
      • Pulau Pinang, Malaysia
  • Singapore
      • Singapore, Singapore
  • Taiwan
      • Kaohsiung, Taiwan
      • Tainan, Taiwan
      • Taipei, Taiwan
  • Thailand
      • Bangkok, Thailand
      • Chiang Mai, Thailand
      • Songkla, Thailand

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

21 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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).
Other: No Intervention
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.
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).
Other: No Intervention
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.
Metastatic PC
No intervention will be administered in this study. Participants with Metastatic PC will be enrolled.
Other: No Intervention
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Overall Survival (OS)
Time Frame: up to 5 years
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)
Time Frame: up to 5 years
PC-related mortality is the death due to prostate cancer.
up to 5 years
Metastasis-free survival (MFS)
Time Frame: up to 5 years
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)
Time Frame: up to 5 years
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)
Time Frame: up to 5 years
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
Time Frame: up to 5 years
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
Time Frame: up to 5 years
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Janssen Research & Development, LLC

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 9, 2015

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 1, 2020

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 1, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 9, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 9, 2015

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 11, 2015

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 22, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 21, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CR107351
  • NOPRODPCR4001 (Other Identifier: Janssen Research & Development, LLC)

Drug and device information, study documents

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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