The Registry to Observe Clinical Outcomes of Patients With High-risk Metastatic Hormone-naïve Prostate Cancer in Japan

PSA Progression-free Survival (PSA-PFS)

时间窗: Up to 5 years

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

Montreal Cognitive Assessment (MoCA) Score

时间窗: Up to 5 years

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.

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

时间窗: 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.

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

时间窗: Up to 5 years

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.

Percentage of Participants with PSA-PFS

时间窗: 2 years

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

Progression-free Survival (PFS)

时间窗: 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

时间窗: 3 years

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

Overall Survival (OS)

时间窗: Up to 5 years

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

Percentage of Participants with Overall Survival (OS)

时间窗: 3 years

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

Cancer Specific Survival (CSS)

时间窗: 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.

Percentage of Participants with CSS

时间窗: 3 years

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

Patient Health Questionnaire-9 (PHQ-9) Score

时间窗: Up to 5 years

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 to Symptomatic Skeletal Event (TTSSE)

时间窗: Up to 5 years

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.