A Registry Study to Observe Clinical Outcomes of Participants With High-risk Metastatic Hormone-naïve Prostate Cancer in Japan
NCT ID: NCT04034095
Last Updated: 2025-12-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
979 participants
OBSERVATIONAL
2019-07-08
2024-08-13
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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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.
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.
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.
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.
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.
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.
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.
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.
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.
Interventions
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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.
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.
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.
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.
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.
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.
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.
Eligibility Criteria
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Inclusion Criteria
* 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
20 Years
MALE
No
Sponsors
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Janssen Pharmaceutical K.K.
INDUSTRY
Responsible Party
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Principal Investigators
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Janssen Pharmaceutical K.K., Japan Clinical Trial
Role: STUDY_DIRECTOR
Janssen Pharmaceutical K.K.
Locations
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Akita University Hospital
Akita, , Japan
Juntendo University Hospital
Bunkyō City, , Japan
Tokyo Medical and Dental University Hospital
Bunkyō City, , Japan
Chiba University Hospital
Chiba, , Japan
Chiba Cancer Center
Chiba, , Japan
University of Yamanashi Hospital
Chūō, , Japan
Hospital of the University of Occupational and Enviromental Health
Fukuoka, , Japan
Kyushu University Hospital
Fukuoka, , Japan
Fukushima Medical University Hospital
Fukushima, , Japan
Gifu University Hospital
Gifu, , Japan
Harasanshin Hospital
Hakata-Ku, , Japan
Hamamatsu University Hospital
Hamamatsu, , Japan
Saitama Medical University International Medical Center
Hidaka, , Japan
Hirosaki University Hospital
Hirosaki, , Japan
Hiroshima University Hospital
Hiroshima, , Japan
Tokyo Dental College Ichikawa General Hospital
Ichikawa, , Japan
Tokyo Medical University Ibaraki Medical Center
Inashiki, , Japan
Teikyo University Hospital
Itabashi Ku, , Japan
Kanazawa Medical University Hospital
Kahoku-District, , Japan
University Hospital Kyoto Prefectural University of Medicine
Kamigyo, , Japan
St Marianna University Hospital
Kanagawa, , Japan
Kanazawa University Hospital
Kanazawa, , Japan
Nara Medical University Hospital
Kashihara, , Japan
Kimitsu Chuo Hospital
Kisarazu-shi, , Japan
Kagawa University Hospital
Kita Gun, , Japan
Kobe University Hospital
Kobe, , Japan
Kobe City Medical Center General Hospital
Kobe, , Japan
Kochi Medical School Hospital
Kochi, , Japan
Dokkyo Medical University Saitama Medical Center
Koshigaya, , Japan
National Hospital Organization Shikoku Cancer Center
Matsuyama, , Japan
Kitasato University Hospital
Minamiku, , Japan
University of Miyazaki Hospital
Miyazaki, , Japan
Iwate Medical University Hospital
Morioka, , Japan
Aichi Medical University Hospital
Nagakute, , Japan
Nagasaki University Hospital
Nagasaki, , Japan
Nagoya City University Hospital
Nagoya, , Japan
University of the Ryukyus Hospital
Nakagami Gun, , Japan
Tokyo Metropolitan Police Hospital
Nakano, , Japan
Miyagi Cancer Center
Natori-shi, , Japan
Niigata University Medical And Dental Hospital
Niigata, , Japan
Okayama University Hospital
Okayama, , Japan
Osaka International Cancer Institute
Osaka, , Japan
Kindai University Hospital
Osaka Sayama Shi, , Japan
Gunma Prefectural Cancer Center
Ōta-ku, , Japan
Shiga University of Medical Science Hospital
Ōtsu, , Japan
Japan Community Health Care Organization Saitama Medical Center
Saitama, , Japan
Sapporo Medical University Hospital
Sapporo, , Japan
Hokkaido University Hospital
Sapporo, , Japan
Tohoku University Hospital
Sendai, , Japan
Tohoku Medical And Pharmaceutical University Hospital
Sendai, , Japan
Jichi Medical University Hospital
Shimotsuke, , Japan
Showa University Hospital
Shinagawa City, , Japan
Japan Community Health care Organization Tokyo Shinjuku Medical Center
Shinjuku-ku, , Japan
Chutoen General Medical Center
Shizuoka, , Japan
Osaka University Hospital
Suita-shi, , Japan
Osaka Medical and Pharmaceutical University Hospital
Takatsuki, , Japan
Tokushima University Hospital
Tokushima, , Japan
The Jikei University Hospital
Tokyo, , Japan
Toranomon Hospital
Tokyo, , Japan
Nippon Medical School Hospital
Tokyo, , Japan
The Cancer Institute Hospital of JFCR
Tokyo, , Japan
Tokyo Medical University Hospital
Tokyo, , Japan
Ehime University Hospital
Toon-shi, , Japan
Toyama University Hospital
Toyama, , Japan
Fujita Health University Hospital
Toyoake, , Japan
Mie University Hospital
Tsu, , Japan
University of Tsukuba Hospital
Tsukuba, , Japan
Yamaguchi University Hospital
Ube, , Japan
Wakayama Medical University Hospital
Wakayama, , Japan
Yamagata University Hospital
Yamagata, , Japan
Yokohama Rosai Hospital
Yokohama, , Japan
Yokohama City University Medical Center
Yokohama, , Japan
Yokohama City University Hospital
Yokohama, , Japan
Yokosuka Kyosai Hospital
Yokosuka, , Japan
Tottori University Hospital
Yonago, , Japan
University of Fukui Hospital
Yoshida, , Japan
Oita University Hospital
Yufu, , Japan
Countries
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Other Identifiers
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56021927PCR4009
Identifier Type: OTHER
Identifier Source: secondary_id
CR108675
Identifier Type: -
Identifier Source: org_study_id
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