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Prostatic NeoplasmsNCT04034095

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

An observational study of Prostatic Neoplasms, run by Janssen Pharmaceutical K.K. at 77 sites in Japan.

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 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. Read more about this study

Who is it for?
Ages 20 years and older, men only
Conditions the study is for
Prostatic Neoplasms
What is being tested?
Androgen-deprivation Therapy (ADT), Bicalutamide and Abiraterone
How many people
979 participants
Where
77 sitesJapan
Study dates
8 Jul 2019to 13 Aug 2024
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 20 years and older
  • Men only
  • No healthy volunteers
  • Adult, Older adult

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.

Who may be able to join

  • 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)

Who cannot join

  • has any other active malignancies

Trial locations and contacts

77 sites in 1 country.

77 sites in 1 country

Japan77 sites

  • Akita University Hospital

    Akita, 010-8543

  • Juntendo University Hospital

    Bunkyō City, 113 8431

  • Tokyo Medical and Dental University Hospital

    Bunkyō City, 113 8519

  • Chiba University Hospital

    Chiba, 260 8677

  • Chiba Cancer Center

    Chiba, 260-8717

  • University of Yamanashi Hospital

    Chūō, 409-3898

  • Hospital of the University of Occupational and Enviromental Health

    Fukuoka, 807-8555

  • Kyushu University Hospital

    Fukuoka, 812 8582

  • Fukushima Medical University Hospital

    Fukushima, 960 1295

  • Gifu University Hospital

    Gifu, 501-1194

  • Harasanshin Hospital

    Hakata-Ku, 812-0033

  • Hamamatsu University Hospital

    Hamamatsu, 431-3192

  • Saitama Medical University International Medical Center

    Hidaka, 350-1298

  • Hirosaki University Hospital

    Hirosaki, 036-8563

  • Hiroshima University Hospital

    Hiroshima, 734 8551

  • Tokyo Dental College Ichikawa General Hospital

    Ichikawa, 272-8513

  • Tokyo Medical University Ibaraki Medical Center

    Inashiki, 300 0395

  • Kanazawa Medical University Hospital

    Kahoku-District, 920-0293

  • University Hospital Kyoto Prefectural University of Medicine

    Kamigyo, 602-8566

  • St Marianna University Hospital

    Kanagawa, 216 8511

  • Kanazawa University Hospital

    Kanazawa, 920 8641

  • Nara Medical University Hospital

    Kashihara, 634-8522

  • Kimitsu Chuo Hospital

    Kisarazu-shi, 292-8535

  • Kagawa University Hospital

    Kita Gun, 761 0793

  • Kobe University Hospital

    Kobe, 650 0017

  • Kobe City Medical Center General Hospital

    Kobe, 650 0047

  • Kochi Medical School Hospital

    Kochi, 783-8505

  • Dokkyo Medical University Saitama Medical Center

    Koshigaya, 343-8555

  • National Hospital Organization Shikoku Cancer Center

    Matsuyama, 791-0280

  • Kitasato University Hospital

    Minamiku, 252-0375

  • University of Miyazaki Hospital

    Miyazaki, 889-1692

  • Iwate Medical University Hospital

    Morioka, 020-8505

  • Aichi Medical University Hospital

    Nagakute, 480-1195

  • Nagasaki University Hospital

    Nagasaki, 852-8501

  • Nagoya City University Hospital

    Nagoya, 467 8602

  • University of the Ryukyus Hospital

    Nakagami Gun, 903-0215

  • Tokyo Metropolitan Police Hospital

    Nakano, 1648541

  • Miyagi Cancer Center

    Natori-shi, 981-1293

  • Niigata University Medical And Dental Hospital

    Niigata, 951 8520

  • Okayama University Hospital

    Okayama, 700 8558

  • Osaka International Cancer Institute

    Osaka, 541 8567

  • Kindai University Hospital

    Osaka Sayama Shi, 589 8511

  • Gunma Prefectural Cancer Center

    Ōta-ku, 373 8550

  • Shiga University of Medical Science Hospital

    Ōtsu, 520-2121

  • Japan Community Health Care Organization Saitama Medical Center

    Saitama, 350-8550

  • Sapporo Medical University Hospital

    Sapporo, 060-8543

  • Hokkaido University Hospital

    Sapporo, 060-8648

  • Tohoku University Hospital

    Sendai, 980 8574

  • Tohoku Medical And Pharmaceutical University Hospital

    Sendai, 981-8558

  • Jichi Medical University Hospital

    Shimotsuke, 329-0498

  • Showa University Hospital

    Shinagawa City, 142 8666

  • Japan Community Health care Organization Tokyo Shinjuku Medical Center

    Shinjuku-ku

  • Chutoen General Medical Center

    Shizuoka, 436-0040

  • Osaka University Hospital

    Suita-shi, 565-0871

  • Teikyo University Hospital

    tabashi City, 173 8606

  • Osaka Medical and Pharmaceutical University Hospital

    Takatsuki, 569-8686

  • Tokushima University Hospital

    Tokushima, 770-8503

  • The Jikei University Hospital

    Tokyo, 105 8471

  • Toranomon Hospital

    Tokyo, 105-8470

  • Nippon Medical School Hospital

    Tokyo, 113 8603

  • The Cancer Institute Hospital of JFCR

    Tokyo, 135 8550

  • Tokyo Medical University Hospital

    Tokyo, 160-0023

  • Ehime University Hospital

    Toon-shi, 791-0295

  • Toyama University Hospital

    Toyama, 930-0194

  • Fujita Health University Hospital

    Toyoake, 470-1192

  • Mie University Hospital

    Tsu, 514 8507

  • University of Tsukuba Hospital

    Tsukuba, 305 8576

  • Yamaguchi University Hospital

    Ube, 755-8505

  • Wakayama Medical University Hospital

    Wakayama, 641 8510

  • Yamagata University Hospital

    Yamagata, 990-9585

  • Yokohama Rosai Hospital

    Yokohama, 222-0036

  • Yokohama City University Medical Center

    Yokohama, 232 0024

  • Yokohama City University Hospital

    Yokohama, 236 0004

  • Yokosuka Kyosai Hospital

    Yokosuka, 238 8558

  • Tottori University Hospital

    Yonago, 683-8504

  • University of Fukui Hospital

    Yoshida, 910-1193

  • Oita University Hospital

    Yufu, 879-5593

Other trials in Japan

About this study

Official title: 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.

Being tested
Androgen-deprivation Therapy (ADT), Bicalutamide, Abiraterone, Prednisolone, Docetaxel
Medical subject headings
Prostatic Neoplasms

What participants receive

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

  • Androgen-deprivation Therapy (ADT)Drug

    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.

  • BicalutamideDrug

    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.

  • AbirateroneDrug

    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.

  • PrednisoloneDrug

    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.

  • DocetaxelDrug

    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.

  • EnzalutamideDrug

    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.

  • ApalutamideDrug

    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.

Study groups in NCT04034095
Study groupRoleWhat they receive
Cohort 1: ADT alone/ ADT + BicalutamideParticipants 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.
Receives: Drug: Androgen-deprivation Therapy (ADT); Drug: Bicalutamide
Cohort 2: ADT + AAP/Docetaxel/Enzalutamide/ApalutamideParticipants with diagnosis of mHNPC receiving ADT plus abiraterone plus prednisolone (AAP) or Docetaxel or Enzalutamide or Apalutamide under routine clinical practice will be observed.
Receives: Drug: Androgen-deprivation Therapy (ADT); Drug: Abiraterone; Drug: Prednisolone; Drug: Docetaxel; Drug: Enzalutamide; Drug: Apalutamide

What is being measured

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

  1. Percentage of Participants who Achieve Prostate-specific Antigen (PSA) <=0.2 ng/mL Within a Year from Registration

    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.

    Measured: 1 year

  2. PSA Progression-free Survival (PSA-PFS)

    The PSA-PFS is defined as the duration from registration to either PSA progression or death, whichever occurs first.

    Measured: Up to 5 years

  3. Percentage of Participants with PSA-PFS

    Percentage of participants with PSA-PFS at 2 years from registration will be reported.

    Measured: 2 years

  4. Progression-free Survival (PFS)

    The PFS is defined as the duration from registration to either radiographic progression, clinical progression or death, whichever occurs first.

    Measured: Up to 5 years

  5. Percentage of Participants with PFS

    Percentage of participants with PFS at 3 years from registration will be reported.

    Measured: 3 years

  6. Overall Survival (OS)

    The OS is defined as the duration from registration to any death.

    Measured: Up to 5 years

  7. Percentage of Participants with Overall Survival (OS)

    Percentage of participants with OS at 3 years from registration will be reported.

    Measured: 3 years

  8. Cancer Specific Survival (CSS)

    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.

    Measured: Up to 5 years

  9. Percentage of Participants with CSS

    Percentage of participants with CSS at 3 years from registration will be reported.

    Measured: 3 years

  10. Time to Symptomatic Skeletal Event (TTSSE)

    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.

    Measured: Up to 5 years

  11. Patient Health Questionnaire-9 (PHQ-9) Score

    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).

    Measured: Up to 5 years

  12. Functional Assessment of Cancer Therapy for Prostate Cancer (FACT-P) Questionnaire Score

    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.

    Measured: Up to 5 years

  13. Montreal Cognitive Assessment (MoCA) Score

    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.

    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 posted26 Jul 2019
  2. Study start8 Jul 2019
  3. Primary completion13 Aug 2024
  4. Study completion13 Aug 2024

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
979 participants (actual)
Target duration
5 Years
IDs, dates and publications
ClinicalTrials.gov ID
NCT04034095
Sponsor's protocol ID
CR108675
Other IDs
56021927PCR4009
Status last verified
Dec 2025
First submitted
16 Jul 2019
Last updated
15 Dec 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Miyake H, Matsumoto R, Fujimoto K, Mizokami A, Uemura H, Kamoto T, Kawakami S, Nakamura K, Maekawa S, Shibayama K, Watanabe A, Ito M, Tajima Y, Matsuyama H, Uemura H. Clinical Outcomes of Patients with High-risk Metastatic Hormone-naive Prostate Cancer: A 3-year Interim Analysis of the Observational J-ROCK Study. Eur Urol Oncol. 2024 Jun;7(3):625-632. doi: 10.1016/j.euo.2023.12.013. Epub 2024 Jan 30.

    PubMed 38296736

Questions about this trial

What is this clinical trial studying?

An observational study of Prostatic Neoplasms, run by Janssen Pharmaceutical K.K. at 77 sites in Japan.

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 5 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 15 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 77 sites in Japan. 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?

Percentage of Participants who Achieve Prostate-specific Antigen (PSA) <=0.2 ng/mL Within a Year from Registration (time frame: 1 year). The study lists 13 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 NCT04034095, which also lists 1 linked publication.

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 15 Dec 2025.

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