A Registry Study to Observe Clinical Outcomes of Participants With High-risk Metastatic Hormone-naïve Prostate Cancer in Japan
- Conditions
- Prostatic Neoplasms
- Interventions
- Drug: Androgen-deprivation Therapy (ADT)
- Registration Number
- NCT04034095
- Lead Sponsor
- Janssen Pharmaceutical K.K.
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 979
- 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)
- has any other active malignancies
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Cohort 1: ADT alone/ ADT + Bicalutamide Androgen-deprivation Therapy (ADT) 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. Cohort 2: ADT + AAP/Docetaxel/Enzalutamide/Apalutamide Androgen-deprivation Therapy (ADT) 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. Cohort 2: ADT + AAP/Docetaxel/Enzalutamide/Apalutamide 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. Cohort 1: ADT alone/ ADT + Bicalutamide 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. Cohort 2: ADT + AAP/Docetaxel/Enzalutamide/Apalutamide Abiraterone 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. Cohort 2: ADT + AAP/Docetaxel/Enzalutamide/Apalutamide Prednisolone 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. Cohort 2: ADT + AAP/Docetaxel/Enzalutamide/Apalutamide Docetaxel 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. Cohort 2: ADT + AAP/Docetaxel/Enzalutamide/Apalutamide Enzalutamide 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.
- Primary Outcome Measures
Name Time Method PSA Progression-free Survival (PSA-PFS) 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 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 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 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 2 years Percentage of participants with PSA-PFS at 2 years from registration will be reported.
Progression-free Survival (PFS) 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 3 years Percentage of participants with PFS at 3 years from registration will be reported.
Overall Survival (OS) Up to 5 years The OS is defined as the duration from registration to any death.
Percentage of Participants with Overall Survival (OS) 3 years Percentage of participants with OS at 3 years from registration will be reported.
Cancer Specific Survival (CSS) 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 3 years Percentage of participants with CSS at 3 years from registration will be reported.
Patient Health Questionnaire-9 (PHQ-9) Score 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) 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.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (77)
Akita University Hospital
🇯🇵Akita, Japan
Juntendo University Hospital
🇯🇵Bunkyo Ku, Japan
Tokyo Medical and Dental University Hospital
🇯🇵Bunkyo Ku, Japan
Chiba University Hospital
🇯🇵Chiba, Japan
Chiba Cancer Center
🇯🇵Chiba, Japan
University of Yamanashi Hospital
🇯🇵Chuo, Japan
Kyushu University Hospital
🇯🇵Fukuoka, Japan
Fukushima Medical University Hospital
🇯🇵Fukushima, Japan
Gifu University Hospital
🇯🇵Gifu, Japan
Harasanshin Hospital
🇯🇵Hakata-Ku, Japan
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