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

Sponsor
Janssen Pharmaceutical K.K.
Study ID
NCT04034095
Status
Completed

Conditions

Eligibility Criteria

Sex
MALE
Age
20 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Androgen-deprivation Therapy (ADT) — DRUG
    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.
  • Bicalutamide — DRUG
    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.
  • Abiraterone — DRUG
    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.
  • Prednisolone — DRUG
    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.
  • Docetaxel — DRUG
    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.
  • Enzalutamide — DRUG
    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.
  • Apalutamide — DRUG
    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.

Study Details

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.

Key Dates

Start date
Jul 8, 2019
Status verified
Dec 2025
Primary completion
Aug 13, 2024
Completion
Aug 13, 2024

Study Design

Enrollment
979 participants (actual)

Arms

  • Arm: 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.
  • Arm: 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.

Primary Outcome Measure

Percentage of Participants who Achieve Prostate-specific Antigen (PSA) <=0.2 ng/mL Within a Year from Registration [ Time Frame: 1 year ]

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