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.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

979

participants targeted

Target at P75+ for all trials

Timeline

Completed

Started Jul 2019

Longer than P75 for all trials

Geographic Reach

1 country

77 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

5.1 years study duration

Study Start

First participant enrolled

July 8, 2019

Completed

8 days until next milestone

First Submitted

Initial submission to the registry

July 16, 2019

Completed

10 days until next milestone

First Posted

Study publicly available on registry

July 26, 2019

Completed

5.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 13, 2024

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 13, 2024

Completed

Last Updated

December 15, 2025

Status Verified

December 1, 2025

Enrollment Period

5.1 years

First QC Date

July 16, 2019

Last Update Submit

December 12, 2025

Conditions

Prostatic Neoplasms

Outcome Measures

Primary Outcomes (13)

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

Study Arms (2)

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.

Drug: Androgen-deprivation Therapy (ADT)Drug: 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.

Drug: Androgen-deprivation Therapy (ADT)Drug: AbirateroneDrug: PrednisoloneDrug: DocetaxelDrug: EnzalutamideDrug: Apalutamide

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.

Cohort 1: ADT alone/ ADT + BicalutamideCohort 2: ADT + AAP/Docetaxel/Enzalutamide/Apalutamide

BicalutamideDRUG

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.

Cohort 1: ADT alone/ ADT + Bicalutamide

AbirateroneDRUG

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.