Status
Completed
Phase
Not applicable
Enrollment
979
Locations
77
Results
Not posted
Publications
0
Study 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.
Interventions
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.
DRUG
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.
DRUG
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
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
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
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
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.
Timeline
First posted
Jul 26, 2019
Study start
Jul 8, 2019
Primary completion
Aug 13, 2024
Study completion
Aug 13, 2024
Results posted
Not reported
Registry updated
Dec 15, 2025
Outcomes
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.
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.
Percentage of Participants with PSA-PFS
Time frame · 2 years
Percentage of participants with PSA-PFS at 2 years from registration will be reported.
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.
Percentage of Participants with PFS
Time frame · 3 years
Percentage of participants with PFS at 3 years from registration will be reported.
Overall Survival (OS)
Time frame · Up to 5 years
The OS is defined as the duration from registration to any death.
Percentage of Participants with Overall Survival (OS)
Time frame · 3 years
Percentage of participants with OS at 3 years from registration will be reported.
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.
Not reported in the indexed record.
Eligibility
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 locations
Japan. Showing up to 24 locations stored in the fast local snapshot.
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
Publications
No PMID-linked publications were present in this registry snapshot.
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