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

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

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.

Study Overview

• Status: Completed
• Conditions: Prostatic Neoplasms
• Intervention / Treatment: Drug: Androgen-deprivation Therapy (ADT); Drug: Bicalutamide; Drug: Abiraterone; Drug: Prednisolone; Drug: Docetaxel; Drug: Enzalutamide; Drug: Apalutamide

• Study Type: Observational
• Enrollment (Actual): 979

Contacts and Locations

Study Locations

• Japan
  • Akita, Japan, 010-8543
    • Akita University Hospital
  • Bunkyō City, Japan, 113 8519
    • Tokyo Medical and Dental University Hospital
  • Bunkyō City, Japan, 113 8431
    • Juntendo University Hospital
  • Chiba, Japan, 260-8717
    • Chiba cancer center
  • Chiba, Japan, 260 8677
    • Chiba University Hospital
  • Chūō, Japan, 409-3898
    • University of Yamanashi Hospital
  • Fukuoka, Japan, 812 8582
    • Kyushu University Hospital
  • Fukuoka, Japan, 807-8555
    • Hospital of the University of Occupational and Enviromental Health
  • Fukushima, Japan, 960 1295
    • Fukushima Medical University Hospital
  • Gifu, Japan, 501-1194
    • Gifu University Hospital
  • Hakata-Ku, Japan, 812-0033
    • Harasanshin Hospital
  • Hamamatsu, Japan, 431-3192
    • Hamamatsu University Hospital
  • Hidaka, Japan, 350-1298
    • Saitama Medical University International Medical Center
  • Hirosaki, Japan, 036-8563
    • Hirosaki University Hospital
  • Hiroshima, Japan, 734 8551
    • Hiroshima University Hospital
  • Ichikawa, Japan, 272-8513
    • Tokyo Dental College Ichikawa General Hospital
  • Inashiki, Japan, 300 0395
    • Tokyo Medical University Ibaraki Medical Center
  • Itabashi Ku, Japan, 173 8606
    • Teikyo University Hospital
  • Kahoku-District, Japan, 920-0293
    • Kanazawa Medical University Hospital
  • Kamigyo, Japan, 602-8566
    • University Hospital Kyoto Prefectural University of Medicine
  • Kanagawa, Japan, 216 8511
    • St Marianna University Hospital
  • Kanazawa, Japan, 920 8641
    • Kanazawa University Hospital
  • Kashihara, Japan, 634-8522
    • Nara Medical University Hospital
  • Kisarazu-shi, Japan, 292-8535
    • Kimitsu Chuo Hospital
  • Kita Gun, Japan, 761 0793
    • Kagawa University Hospital
  • Kobe, Japan, 650 0017
    • Kobe University Hospital
  • Kobe, Japan, 650 0047
    • Kobe City Medical Center General Hospital
  • Kochi, Japan, 783-8505
    • Kochi Medical School Hospital
  • Koshigaya, Japan, 343-8555
    • Dokkyo Medical University Saitama Medical Center
  • Matsuyama, Japan, 791-0280
    • National Hospital Organization Shikoku Cancer Center
  • Minamiku, Japan, 252-0375
    • Kitasato University Hospital
  • Miyazaki, Japan, 889-1692
    • University of Miyazaki Hospital
  • Morioka, Japan, 020-8505
    • Iwate Medical University Hospital
  • Nagakute, Japan, 480-1195
    • Aichi Medical University Hospital
  • Nagasaki, Japan, 852-8501
    • Nagasaki University Hospital
  • Nagoya, Japan, 467 8602
    • Nagoya City University Hospital
  • Nakagami Gun, Japan, 903-0215
    • University of the Ryukyus Hospital
  • Nakano, Japan, 1648541
    • Tokyo Metropolitan Police Hospital
  • Natori-shi, Japan, 981-1293
    • Miyagi Cancer Center
  • Niigata, Japan, 951 8520
    • Niigata University Medical and Dental Hospital
  • Okayama, Japan, 700 8558
    • Okayama University Hospital
  • Osaka, Japan, 541 8567
    • Osaka International Cancer Institute
  • Osaka Sayama Shi, Japan, 589 8511
    • Kindai University Hospital
  • Saitama, Japan, 350-8550
    • Japan Community Health Care Organization Saitama Medical Center
  • Sapporo, Japan, 060-8648
    • Hokkaido University Hospital
  • Sapporo, Japan, 060-8543
    • Sapporo Medical University Hospital
  • Sendai, Japan, 981-8558
    • Tohoku Medical and Pharmaceutical University Hospital
  • Sendai, Japan, 980 8574
    • Tohoku University Hospital
  • Shimotsuke, Japan, 329-0498
    • Jichi Medical University Hospital
  • Shinagawa City, Japan, 142 8666
    • Showa University Hospital
  • Shinjuku-ku, Japan
    • Japan Community Health care Organization Tokyo Shinjuku Medical Center
  • Shizuoka, Japan, 436-0040
    • Chutoen General Medical Center
  • Suita-shi, Japan, 565-0871
    • Osaka University Hospital
  • Takatsuki, Japan, 569-8686
    • Osaka Medical and Pharmaceutical University Hospital
  • Tokushima, Japan, 770-8503
    • Tokushima University Hospital
  • Tokyo, Japan, 160-0023
    • Tokyo Medical University Hospital
  • Tokyo, Japan, 105-8470
    • Toranomon Hospital
  • Tokyo, Japan, 135 8550
    • The Cancer Institute Hospital of JFCR
  • Tokyo, Japan, 105 8471
    • The Jikei University Hospital
  • Tokyo, Japan, 113 8603
    • Nippon Medical School Hospital
  • Toon-shi, Japan, 791-0295
    • Ehime University Hospital
  • Toyama, Japan, 930-0194
    • Toyama University Hospital
  • Toyoake, Japan, 470-1192
    • Fujita Health University Hospital
  • Tsu, Japan, 514 8507
    • Mie University Hospital
  • Tsukuba, Japan, 305 8576
    • University of Tsukuba Hospital
  • Ube, Japan, 755-8505
    • Yamaguchi University Hospital
  • Wakayama, Japan, 641 8510
    • Wakayama Medical University Hospital
  • Yamagata, Japan, 990-9585
    • Yamagata University Hospital
  • Yokohama, Japan, 222-0036
    • Yokohama Rosai Hospital
  • Yokohama, Japan, 232 0024
    • Yokohama City University Medical Center
  • Yokohama, Japan, 236 0004
    • Yokohama City University Hospital
  • Yokosuka, Japan, 238 8558
    • Yokosuka Kyosai Hospital
  • Yonago, Japan, 683-8504
    • Tottori University Hospital
  • Yoshida, Japan, 910-1193
    • University of Fukui Hospital
  • Yufu, Japan, 879-5593
    • Oita University Hospital
  • Ōta-ku, Japan, 373 8550
    • Gunma Prefectural Cancer Center
  • Ōtsu, Japan, 520-2121
    • Shiga University of Medical Science Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Participants with high-risk metastatic hormone-naive prostate cancer (mHNPC) in Japan receiving androgen-deprivation therapy (ADT) containing treatment under routine clinical practice will be observed throughout their course of treatment, during which data on prostate cancer (PC) treatment, radiographic/clinical progression, and outcomes (including death) will be collected. The main source of data collection will be medical records of each participating participant.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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); 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.; Drug: Bicalutamide; 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 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); 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.; Drug: Abiraterone; 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.; Drug: Prednisolone; 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.; Drug: Docetaxel; 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.; Drug: Enzalutamide; 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.; Drug: Apalutamide; 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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Janssen Pharmaceutical K.K.
• Investigators: Study Director: Janssen Pharmaceutical K.K., Japan Clinical Trial, Janssen Pharmaceutical K.K.

Study record dates

Study Major Dates

• Study Start (Actual): July 8, 2019
• Primary Completion (Actual): August 13, 2024
• Study Completion (Actual): August 13, 2024

Study Registration Dates

• First Submitted: July 16, 2019
• First Submitted That Met QC Criteria: July 25, 2019
• First Posted (Actual): July 26, 2019

Study Record Updates

• Last Update Posted (Estimated): December 15, 2025
• Last Update Submitted That Met QC Criteria: December 12, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Prostatic Diseases; Male Urogenital Diseases; Prostatic Neoplasms; Physiological Effects of Drugs; Hormones, Hormone Substitutes, and Hormone Antagonists; Hormone Antagonists; Organic Chemicals; Pharmacologic Actions; Chemical Actions and Uses; Hydrocarbons; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Terpenes; Polycyclic Compounds; Taxoids; Cyclodecanes; Diterpenes; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Pregnadienetriols; Docetaxel; Prednisolone; Androgen Antagonists; abiraterone; enzalutamide; apalutamide; bicalutamide
• Other Study ID Numbers: CR108675; 56021927PCR4009 (Other Identifier: Janssen Research & Development, LLC)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No