The Registry to Observe Clinical Outcomes of Patients With High-risk Metastatic Hormone-naïve Prostate Cancer in Japan
Overview
- Phase
- N/A
- Intervention
- Androgen-deprivation Therapy (ADT)
- Conditions
- Prostatic Neoplasms
- Sponsor
- Janssen Pharmaceutical K.K.
- Enrollment
- 979
- Locations
- 77
- Primary Endpoint
- PSA Progression-free Survival (PSA-PFS)
- Status
- Completed
- Last Updated
- 4 months ago
Overview
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.
Investigators
Eligibility Criteria
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
Arms & Interventions
Cohort 1: ADT alone/ ADT + 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.
Intervention: Androgen-deprivation Therapy (ADT)
Cohort 1: ADT alone/ ADT + 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.
Intervention: Bicalutamide
Cohort 2: ADT + AAP/Docetaxel/Enzalutamide/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.
Intervention: Androgen-deprivation Therapy (ADT)
Cohort 2: ADT + AAP/Docetaxel/Enzalutamide/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.
Intervention: Abiraterone
Cohort 2: ADT + AAP/Docetaxel/Enzalutamide/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.
Intervention: Prednisolone
Cohort 2: ADT + AAP/Docetaxel/Enzalutamide/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.
Intervention: Docetaxel
Cohort 2: ADT + AAP/Docetaxel/Enzalutamide/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.
Intervention: Enzalutamide
Cohort 2: ADT + AAP/Docetaxel/Enzalutamide/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.
Intervention: Apalutamide
Outcomes
Primary Outcomes
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.
Montreal Cognitive Assessment (MoCA) Score
Time Frame: 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
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.
Functional Assessment of Cancer Therapy for Prostate Cancer (FACT-P) Questionnaire Score
Time Frame: 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
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.
Percentage of Participants with CSS
Time Frame: 3 years
Percentage of participants with CSS at 3 years from registration will be reported.
Patient Health Questionnaire-9 (PHQ-9) Score
Time Frame: 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)
Time Frame: 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.