NCT04034095Completed
A Registry Study to Observe Clinical Outcomes of Participants With High-risk Metastatic Hormone-naïve Prostate Cancer in Japan
The Registry to Observe Clinical Outcomes of Patients With High-risk Metastatic Hormone-naïve Prostate Cancer in Japan
Source: ClinicalTrials.gov · Last updated 15 Dec 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 979 (actual)
- First submitted
- 16 Jul 2019
- Start date
- 8 Jul 2019
- Primary completion date
- 13 Aug 2024
- Lead sponsor
- Janssen Pharmaceutical K.K.
- Diseases
- Prostate cancer
- NCT number
- NCT04034095
What you commit to
- Study type: Observational
- Participants enrolled: 979
- From 8 Jul 2019 to the primary completion date, 13 Aug 2024
- 77 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- \- has any other active malignancies
Who the study is looking for
- 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)
Age in the registry: 20 years to - · Sex: Male · Does not accept healthy volunteers
Sites (77)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Akita University Hospital Coordinator of this site? Confirm its status | Akita | Japan | Unknown status |
| Juntendo University Hospital Coordinator of this site? Confirm its status | Bunkyō City | Japan | Unknown status |
| Tokyo Medical and Dental University Hospital Coordinator of this site? Confirm its status | Bunkyō City | Japan | Unknown status |
| Chiba Cancer Center Coordinator of this site? Confirm its status | Chiba | Japan | Unknown status |
| Chiba University Hospital Coordinator of this site? Confirm its status | Chiba | Japan | Unknown status |
| University of Yamanashi Hospital Coordinator of this site? Confirm its status | Chūō | Japan | Unknown status |
| Kyushu University Hospital Coordinator of this site? Confirm its status | Fukuoka | Japan | Unknown status |
| Hospital of the University of Occupational and Enviromental Health Coordinator of this site? Confirm its status | Fukuoka | Japan | Unknown status |
| Fukushima Medical University Hospital Coordinator of this site? Confirm its status | Fukushima | Japan | Unknown status |
| Gifu University Hospital Coordinator of this site? Confirm its status | Gifu | Japan | Unknown status |
| Harasanshin Hospital Coordinator of this site? Confirm its status | Hakata-Ku | Japan | Unknown status |
| Hamamatsu University Hospital Coordinator of this site? Confirm its status | Hamamatsu | Japan | Unknown status |
| Saitama Medical University International Medical Center Coordinator of this site? Confirm its status | Hidaka | Japan | Unknown status |
| Hirosaki University Hospital Coordinator of this site? Confirm its status | Hirosaki | Japan | Unknown status |
| Hiroshima University Hospital Coordinator of this site? Confirm its status | Hiroshima | Japan | Unknown status |
| Tokyo Dental College Ichikawa General Hospital Coordinator of this site? Confirm its status | Ichikawa | Japan | Unknown status |
| Tokyo Medical University Ibaraki Medical Center Coordinator of this site? Confirm its status | Inashiki | Japan | Unknown status |
| Kanazawa Medical University Hospital Coordinator of this site? Confirm its status | Kahoku-District | Japan | Unknown status |
| University Hospital Kyoto Prefectural University of Medicine Coordinator of this site? Confirm its status | Kamigyo | Japan | Unknown status |
| St Marianna University Hospital Coordinator of this site? Confirm its status | Kanagawa | Japan | Unknown status |
| Kanazawa University Hospital Coordinator of this site? Confirm its status | Kanazawa | Japan | Unknown status |
| Nara Medical University Hospital Coordinator of this site? Confirm its status | Kashihara | Japan | Unknown status |
| Kimitsu Chuo Hospital Coordinator of this site? Confirm its status | Kisarazu-shi | Japan | Unknown status |
| Kagawa University Hospital Coordinator of this site? Confirm its status | Kita-gun | Japan | Unknown status |
| Kobe City Medical Center General Hospital Coordinator of this site? Confirm its status | Kobe | Japan | Unknown status |
| Kobe University Hospital Coordinator of this site? Confirm its status | Kobe | Japan | Unknown status |
| Kochi Medical School Hospital Coordinator of this site? Confirm its status | Kochi | Japan | Unknown status |
| Dokkyo Medical University Saitama Medical Center Coordinator of this site? Confirm its status | Koshigaya | Japan | Unknown status |
| National Hospital Organization Shikoku Cancer Center Coordinator of this site? Confirm its status | Matsuyama | Japan | Unknown status |
| Kitasato University Hospital Coordinator of this site? Confirm its status | Minamiku | Japan | Unknown status |
| University of Miyazaki Hospital Coordinator of this site? Confirm its status | Miyazaki | Japan | Unknown status |
| Iwate Medical University Hospital Coordinator of this site? Confirm its status | Morioka | Japan | Unknown status |
| Aichi Medical University Hospital Coordinator of this site? Confirm its status | Nagakute | Japan | Unknown status |
| Nagasaki University Hospital Coordinator of this site? Confirm its status | Nagasaki | Japan | Unknown status |
| Nagoya City University Hospital Coordinator of this site? Confirm its status | Nagoya | Japan | Unknown status |
| University of the Ryukyus Hospital Coordinator of this site? Confirm its status | Nakagami Gun | Japan | Unknown status |
| Tokyo Metropolitan Police Hospital Coordinator of this site? Confirm its status | Nakano | Japan | Unknown status |
| Miyagi Cancer Center Coordinator of this site? Confirm its status | Natori-shi | Japan | Unknown status |
| Niigata University Medical and Dental Hospital Coordinator of this site? Confirm its status | Niigata | Japan | Unknown status |
| Okayama University Hospital Coordinator of this site? Confirm its status | Okayama | Japan | Unknown status |
| Osaka International Cancer Institute Coordinator of this site? Confirm its status | Osaka | Japan | Unknown status |
| Kindai University Hospital Coordinator of this site? Confirm its status | Osaka Sayama Shi | Japan | Unknown status |
| Gunma Prefectural Cancer Center Coordinator of this site? Confirm its status | Ōta-ku | Japan | Unknown status |
| Shiga University of Medical Science Hospital Coordinator of this site? Confirm its status | Ōtsu | Japan | Unknown status |
| Japan Community Health Care Organization Saitama Medical Center Coordinator of this site? Confirm its status | Saitama | Japan | Unknown status |
| Hokkaido University Hospital Coordinator of this site? Confirm its status | Sapporo | Japan | Unknown status |
| Sapporo Medical University Hospital Coordinator of this site? Confirm its status | Sapporo | Japan | Unknown status |
| Tohoku Medical and Pharmaceutical University Hospital Coordinator of this site? Confirm its status | Sendai | Japan | Unknown status |
| Tohoku University Hospital Coordinator of this site? Confirm its status | Sendai | Japan | Unknown status |
| Jichi Medical University Hospital Coordinator of this site? Confirm its status | Shimotsuke | Japan | Unknown status |
| Showa University Hospital Coordinator of this site? Confirm its status | Shinagawa City | Japan | Unknown status |
| Japan Community Health care Organization Tokyo Shinjuku Medical Center Coordinator of this site? Confirm its status | Shinjuku-ku | Japan | Unknown status |
| Chutoen General Medical Center Coordinator of this site? Confirm its status | Shizuoka | Japan | Unknown status |
| Osaka University Hospital Coordinator of this site? Confirm its status | Suita-shi | Japan | Unknown status |
| Teikyo University Hospital Coordinator of this site? Confirm its status | tabashi City | Japan | Unknown status |
| Osaka Medical and Pharmaceutical University Hospital Coordinator of this site? Confirm its status | Takatsuki | Japan | Unknown status |
| Tokushima University Hospital Coordinator of this site? Confirm its status | Tokushima | Japan | Unknown status |
| Tokyo Medical University Hospital Coordinator of this site? Confirm its status | Tokyo | Japan | Unknown status |
| Toranomon Hospital Coordinator of this site? Confirm its status | Tokyo | Japan | Unknown status |
| Nippon Medical School Hospital Coordinator of this site? Confirm its status | Tokyo | Japan | Unknown status |
| The Jikei University Hospital Coordinator of this site? Confirm its status | Tokyo | Japan | Unknown status |
| The Cancer Institute Hospital of JFCR Coordinator of this site? Confirm its status | Tokyo | Japan | Unknown status |
| Ehime University Hospital Coordinator of this site? Confirm its status | Toon-shi | Japan | Unknown status |
| Toyama University Hospital Coordinator of this site? Confirm its status | Toyama | Japan | Unknown status |
| Fujita Health University Hospital Coordinator of this site? Confirm its status | Toyoake | Japan | Unknown status |
| Mie University Hospital Coordinator of this site? Confirm its status | Tsu | Japan | Unknown status |
| University of Tsukuba Hospital Coordinator of this site? Confirm its status | Tsukuba | Japan | Unknown status |
| Yamaguchi University Hospital Coordinator of this site? Confirm its status | Ube | Japan | Unknown status |
| Wakayama Medical University Hospital Coordinator of this site? Confirm its status | Wakayama | Japan | Unknown status |
| Yamagata University Hospital Coordinator of this site? Confirm its status | Yamagata | Japan | Unknown status |
| Yokohama City University Hospital Coordinator of this site? Confirm its status | Yokohama | Japan | Unknown status |
| Yokohama Rosai Hospital Coordinator of this site? Confirm its status | Yokohama | Japan | Unknown status |
| Yokohama City University Medical Center Coordinator of this site? Confirm its status | Yokohama | Japan | Unknown status |
| Yokosuka Kyosai Hospital Coordinator of this site? Confirm its status | Yokosuka | Japan | Unknown status |
| Tottori University Hospital Coordinator of this site? Confirm its status | Yonago | Japan | Unknown status |
| University of Fukui Hospital Coordinator of this site? Confirm its status | Yoshida | Japan | Unknown status |
| Oita University Hospital Coordinator of this site? Confirm its status | Yufu | Japan | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.