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 Type
OBSERVATIONAL
Enrollment
979
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.
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.
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.
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.
Time frame: 1 year
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.
Time frame: Up to 5 years
Percentage of Participants with PSA-PFS
Percentage of participants with PSA-PFS at 2 years from registration will be reported.
Time frame: 2 years
Progression-free Survival (PFS)
The PFS is defined as the duration from registration to either radiographic progression, clinical progression or death, whichever occurs first.
Time frame: Up to 5 years
Percentage of Participants with PFS
Percentage of participants with PFS at 3 years from registration will be reported.
Time frame: 3 years
Overall Survival (OS)
The OS is defined as the duration from registration to any death.
Time frame: Up to 5 years
Percentage of Participants with Overall Survival (OS)
Percentage of participants with OS at 3 years from registration will be reported.
Time frame: 3 years
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.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
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.
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.
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.
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.
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
...and 67 more locations
Time frame: Up to 5 years
Percentage of Participants with CSS
Percentage of participants with CSS at 3 years from registration will be reported.
Time frame: 3 years
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.
Time frame: Up to 5 years
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).
Time frame: Up to 5 years
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.
Time frame: Up to 5 years
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.
Time frame: Up to 5 years