A Registry Study to Observe Clinical Outcomes of Participants With High-risk Metastatic Hormone-naïve Prostate Cancer in Japan

Study Overview
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Brief Summary
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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.

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

Conditions
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Prostatic Neoplasms

Intervention / Treatment
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* Drug: Androgen-deprivation Therapy (ADT)
* Drug: Bicalutamide
* Drug: Abiraterone
* Drug: Prednisolone
* Drug: Docetaxel
* Drug: Enzalutamide
* Drug: Apalutamide


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Cohort 1: ADT alone/ ADT + Bicalutamide<br>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. | Drug: Androgen-deprivation Therapy (ADT)<br>* 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.<br>Drug: Bicalutamide<br>* 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.<br>|
| Cohort 2: ADT + AAP/Docetaxel/Enzalutamide/Apalutamide<br>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. | Drug: Androgen-deprivation Therapy (ADT)<br>* 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.<br>Drug: Abiraterone<br>* 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.<br>Drug: Prednisolone<br>* 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.<br>Drug: Docetaxel<br>* 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.<br>Drug: Enzalutamide<br>* 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.<br>Drug: Apalutamide<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | Up to 5 years | 
| Percentage of Participants with PSA-PFS | Percentage of participants with PSA-PFS at 2 years from registration will be reported. | 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. | Up to 5 years | 
| Percentage of Participants with PFS | Percentage of participants with PFS at 3 years from registration will be reported. | 3 years | 
| Overall Survival (OS) | The OS is defined as the duration from registration to any death. | Up to 5 years | 
| Percentage of Participants with Overall Survival (OS) | Percentage of participants with OS at 3 years from registration will be reported. | 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. | Up to 5 years | 
| Percentage of Participants with CSS | Percentage of participants with CSS at 3 years from registration will be reported. | 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. | 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). | 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. | 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. | Up to 5 years |