A Registry Study to Observe Clinical Outcomes of Participants With High-risk Metastatic Hormone-naïve Prostate Cancer in Japan

December 12, 2025 updated by: Janssen Pharmaceutical K.K.

The Registry to Observe Clinical Outcomes of Patients With High-risk Metastatic Hormone-naïve Prostate Cancer in Japan

The purpose of this registry study is to longitudinally observe clinical outcomes and patient-reported outcomes (PRO) for participants with high-risk metastatic hormone-naive prostate cancer (mHNPC) in the real-world setting in Japan.

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.

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.
979

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

  • Japan
      • Akita, Japan, 010-8543
        • Akita University Hospital
      • Bunkyō City, Japan, 113 8519
        • Tokyo Medical and Dental University Hospital
      • Bunkyō City, Japan, 113 8431
        • Juntendo University Hospital
      • Chiba, Japan, 260-8717
        • Chiba cancer center
      • Chiba, Japan, 260 8677
        • Chiba University Hospital
      • Chūō, Japan, 409-3898
        • University of Yamanashi Hospital
      • Fukuoka, Japan, 812 8582
        • Kyushu University Hospital
      • Fukuoka, Japan, 807-8555
        • Hospital of the University of Occupational and Enviromental Health
      • Fukushima, Japan, 960 1295
        • Fukushima Medical University Hospital
      • Gifu, Japan, 501-1194
        • Gifu University Hospital
      • Hakata-Ku, Japan, 812-0033
        • Harasanshin Hospital
      • Hamamatsu, Japan, 431-3192
        • Hamamatsu University Hospital
      • Hidaka, Japan, 350-1298
        • Saitama Medical University International Medical Center
      • Hirosaki, Japan, 036-8563
        • Hirosaki University Hospital
      • Hiroshima, Japan, 734 8551
        • Hiroshima University Hospital
      • Ichikawa, Japan, 272-8513
        • Tokyo Dental College Ichikawa General Hospital
      • Inashiki, Japan, 300 0395
        • Tokyo Medical University Ibaraki Medical Center
      • Itabashi Ku, Japan, 173 8606
        • Teikyo University Hospital
      • Kahoku-District, Japan, 920-0293
        • Kanazawa Medical University Hospital
      • Kamigyo, Japan, 602-8566
        • University Hospital Kyoto Prefectural University of Medicine
      • Kanagawa, Japan, 216 8511
        • St Marianna University Hospital
      • Kanazawa, Japan, 920 8641
        • Kanazawa University Hospital
      • Kashihara, Japan, 634-8522
        • Nara Medical University Hospital
      • Kisarazu-shi, Japan, 292-8535
        • Kimitsu Chuo Hospital
      • Kita Gun, Japan, 761 0793
        • Kagawa University Hospital
      • Kobe, Japan, 650 0017
        • Kobe University Hospital
      • Kobe, Japan, 650 0047
        • Kobe City Medical Center General Hospital
      • Kochi, Japan, 783-8505
        • Kochi Medical School Hospital
      • Koshigaya, Japan, 343-8555
        • Dokkyo Medical University Saitama Medical Center
      • Matsuyama, Japan, 791-0280
        • National Hospital Organization Shikoku Cancer Center
      • Minamiku, Japan, 252-0375
        • Kitasato University Hospital
      • Miyazaki, Japan, 889-1692
        • University of Miyazaki Hospital
      • Morioka, Japan, 020-8505
        • Iwate Medical University Hospital
      • Nagakute, Japan, 480-1195
        • Aichi Medical University Hospital
      • Nagasaki, Japan, 852-8501
        • Nagasaki University Hospital
      • Nagoya, Japan, 467 8602
        • Nagoya City University Hospital
      • Nakagami Gun, Japan, 903-0215
        • University of the Ryukyus Hospital
      • Nakano, Japan, 1648541
        • Tokyo Metropolitan Police Hospital
      • Natori-shi, Japan, 981-1293
        • Miyagi Cancer Center
      • Niigata, Japan, 951 8520
        • Niigata University Medical and Dental Hospital
      • Okayama, Japan, 700 8558
        • Okayama University Hospital
      • Osaka, Japan, 541 8567
        • Osaka International Cancer Institute
      • Osaka Sayama Shi, Japan, 589 8511
        • Kindai University Hospital
      • Saitama, Japan, 350-8550
        • Japan Community Health Care Organization Saitama Medical Center
      • Sapporo, Japan, 060-8648
        • Hokkaido University Hospital
      • Sapporo, Japan, 060-8543
        • Sapporo Medical University Hospital
      • Sendai, Japan, 981-8558
        • Tohoku Medical and Pharmaceutical University Hospital
      • Sendai, Japan, 980 8574
        • Tohoku University Hospital
      • Shimotsuke, Japan, 329-0498
        • Jichi Medical University Hospital
      • Shinagawa City, Japan, 142 8666
        • Showa University Hospital
      • Shinjuku-ku, Japan
        • Japan Community Health care Organization Tokyo Shinjuku Medical Center
      • Shizuoka, Japan, 436-0040
        • Chutoen General Medical Center
      • Suita-shi, Japan, 565-0871
        • Osaka University Hospital
      • Takatsuki, Japan, 569-8686
        • Osaka Medical and Pharmaceutical University Hospital
      • Tokushima, Japan, 770-8503
        • Tokushima University Hospital
      • Tokyo, Japan, 160-0023
        • Tokyo Medical University Hospital
      • Tokyo, Japan, 105-8470
        • Toranomon Hospital
      • Tokyo, Japan, 135 8550
        • The Cancer Institute Hospital of JFCR
      • Tokyo, Japan, 105 8471
        • The Jikei University Hospital
      • Tokyo, Japan, 113 8603
        • Nippon Medical School Hospital
      • Toon-shi, Japan, 791-0295
        • Ehime University Hospital
      • Toyama, Japan, 930-0194
        • Toyama University Hospital
      • Toyoake, Japan, 470-1192
        • Fujita Health University Hospital
      • Tsu, Japan, 514 8507
        • Mie University Hospital
      • Tsukuba, Japan, 305 8576
        • University of Tsukuba Hospital
      • Ube, Japan, 755-8505
        • Yamaguchi University Hospital
      • Wakayama, Japan, 641 8510
        • Wakayama Medical University Hospital
      • Yamagata, Japan, 990-9585
        • Yamagata University Hospital
      • Yokohama, Japan, 222-0036
        • Yokohama Rosai Hospital
      • Yokohama, Japan, 232 0024
        • Yokohama City University Medical Center
      • Yokohama, Japan, 236 0004
        • Yokohama City University Hospital
      • Yokosuka, Japan, 238 8558
        • Yokosuka Kyosai Hospital
      • Yonago, Japan, 683-8504
        • Tottori University Hospital
      • Yoshida, Japan, 910-1193
        • University of Fukui Hospital
      • Yufu, Japan, 879-5593
        • Oita University Hospital
      • Ōta-ku, Japan, 373 8550
        • Gunma Prefectural Cancer Center
      • Ōtsu, Japan, 520-2121
        • Shiga University of Medical Science Hospital

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

20 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Participants with high-risk metastatic hormone-naive prostate cancer (mHNPC) in Japan receiving androgen-deprivation therapy (ADT) containing treatment under routine clinical practice will be observed throughout their course of treatment, during which data on prostate cancer (PC) treatment, radiographic/clinical progression, and outcomes (including death) will be collected. The main source of data collection will be medical records of each participating participant.

Description

Inclusion Criteria:

  • Documented diagnosis of metastatic, hormone-naïve prostate cancer (mHNPC) after 1 May 2019
  • Should have at least 2 of the 3 following high-risk factors: a Gleason score of greater than or equal to (>=) 8, at least 3-bone lesions, or the presence of visceral metastasis
  • Willing to receive androgen-deprivation therapy (ADT) containing regimens for high-risk metastatic, hormone-naïve prostate cancer (mHNPC) in the hospital which have the contract with sponsor for this study, or patient received a regimen containing ADT for high-risk mHNPC
  • Possess Japanese nationality
  • Each patient (or their legally acceptable representative) must sign an informed consent form (ICF) indicating that he understands the purpose of, and procedures required for the study and is willing to participate in the study. For dead cases, the ICF can be waived after approved by Independent Ethics Committee/Institutional Review Board (IEC/IRB)

Exclusion Criteria:

- has any other active malignancies

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.
Cohort 1: ADT alone/ ADT + Bicalutamide
Participants with diagnosis of metastatic hormone-naive prostate cancer (mHNPC) receiving androgen-deprivation therapy (ADT) alone or ADT plus bicalutamide (combined androgen blockade [CAB]) under routine clinical practice will be observed.
Drug: Androgen-deprivation Therapy (ADT)
Participants enrolled in this study will continue to receive ADT (example- Leuprorelin, Goserelin and Degarelix) alone or in combination with other therapies in routine clinical practice as directed by their treating physician. No intervention will be administered as a part of this study.
Drug: Bicalutamide
Participants enrolled in this study will continue to receive bicalutamide along with ADT in routine clinical practice as directed by their treating physician. No intervention will be administered as a part of this study.
Cohort 2: ADT + AAP/Docetaxel/Enzalutamide/Apalutamide
Participants with diagnosis of mHNPC receiving ADT plus abiraterone plus prednisolone (AAP) or Docetaxel or Enzalutamide or Apalutamide under routine clinical practice will be observed.
Drug: Androgen-deprivation Therapy (ADT)
Participants enrolled in this study will continue to receive ADT (example- Leuprorelin, Goserelin and Degarelix) alone or in combination with other therapies in routine clinical practice as directed by their treating physician. No intervention will be administered as a part of this study.
Drug: Abiraterone
Participants enrolled in this study will continue to receive abiraterone in combination with prednisolone along with ADT in routine clinical practice as directed by their treating physician. No intervention will be administered as a part of this study.
Drug: Prednisolone
Participants enrolled in this study will continue to receive prednisolone in combination with abiraterone along with ADT in routine clinical practice as directed by their treating physician. No intervention will be administered as a part of this study.
Drug: Docetaxel
Participants enrolled in this study will continue to receive docetaxel along with ADT in routine clinical practice as directed by their treating physician. No intervention will be administered as a part of this study.
Drug: Enzalutamide
Participants enrolled in this study will continue to receive enzalutamide along with ADT in routine clinical practice as directed by their treating physician. No intervention will be administered as a part of this study.
Drug: Apalutamide
Participants enrolled in this study will continue to receive apalutamide along with ADT in routine clinical practice as directed by their treating physician. No intervention will be administered as a part of this study.

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
Percentage of Participants who Achieve Prostate-specific Antigen (PSA) <=0.2 ng/mL Within a Year from Registration
Time Frame: 1 year
Percentage of participants who achieve prostate-specific antigen (PSA) less than or equal to (<=)0.2 nanogram per milliliter (ng/mL) within a year from registration will be reported.
1 year
PSA Progression-free Survival (PSA-PFS)
Time Frame: Up to 5 years
The PSA-PFS is defined as the duration from registration to either PSA progression or death, whichever occurs first.
Up to 5 years
Percentage of Participants with PSA-PFS
Time Frame: 2 years
Percentage of participants with PSA-PFS at 2 years from registration will be reported.
2 years
Progression-free Survival (PFS)
Time Frame: Up to 5 years
The PFS is defined as the duration from registration to either radiographic progression, clinical progression or death, whichever occurs first.
Up to 5 years
Percentage of Participants with PFS
Time Frame: 3 years
Percentage of participants with PFS at 3 years from registration will be reported.
3 years
Overall Survival (OS)
Time Frame: Up to 5 years
The OS is defined as the duration from registration to any death.
Up to 5 years
Percentage of Participants with Overall Survival (OS)
Time Frame: 3 years
Percentage of participants with OS at 3 years from registration will be reported.
3 years
Cancer Specific Survival (CSS)
Time Frame: Up to 5 years
The CSS is defined as the duration from registration to prostate cancer (PC)-related death. The PC-related death will be determined by each physician's discretion.
Up to 5 years
Percentage of Participants with CSS
Time Frame: 3 years
Percentage of participants with CSS at 3 years from registration will be reported.
3 years
Time to Symptomatic Skeletal Event (TTSSE)
Time Frame: Up to 5 years
The TTSSE is defined as the duration from registration to any first symptomatic skeletal event (SSE). The SSE is defined as 1 of the following: symptomatic pathological fracture, spinal cord compression, palliative radiation to bone and surgery to bone.
Up to 5 years
Patient Health Questionnaire-9 (PHQ-9) Score
Time Frame: Up to 5 years
The PHQ-9 is a multipurpose self-reported inventory used for screening, diagnosing, and measuring the severity of mental status or depression of the patient. It contains 2 weeks recall of information and scores each of the 9 Diagnostic and Statistical Manual of Mental Disorders (4th edition; DSM-IV) criteria as "0" (not at all) to "3" (nearly every day).
Up to 5 years
Functional Assessment of Cancer Therapy for Prostate Cancer (FACT-P) Questionnaire 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 (Version 4) contains a 27-item questionnaire and is composed of 4 dimensions of health-related quality of life (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. Each item for FACT-G subscale and PC-specific subscale is rated on a 0 to 4 Likert type scale. Higher scores represent better QoL.
Up to 5 years
Montreal Cognitive Assessment (MoCA) Score
Time Frame: Up to 5 years
The MoCA is a rapid screening instrument for mild cognitive dysfunction. It assesses different cognitive domains: attention and concentration, executive functions, memory, language, visuoconstructional skills, conceptual thinking, calculations, and orientation. The total possible score is 30 points; a score of 26 or above is considered normal.
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 Pharmaceutical K.K.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Janssen Pharmaceutical K.K., Japan Clinical Trial, Janssen Pharmaceutical K.K.

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.
July 8, 2019

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.
August 13, 2024

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.
August 13, 2024

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).
July 16, 2019

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.
July 25, 2019

First Posted (Actual)

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.
July 26, 2019

Study Record Updates

Last Update Posted (Estimated)

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.
December 15, 2025

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.
December 12, 2025

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.
December 1, 2025

More Information

Terms related to this study

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.
  • CR108675
  • 56021927PCR4009 (Other Identifier: Janssen Research & Development, LLC)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

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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