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

Prostatic Neoplasms Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04034095
• Other study ID #: CR108675
• Secondary ID: 56021927PCR4009
• Status: Active, not recruiting
• Start date: July 8, 2019
• Est. completion date: October 8, 2025

Study information

• Verified date: June 2024
• Source: Janssen Pharmaceutical K.K.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 979
• Est. completion date: October 8, 2025
• Est. primary completion date: August 31, 2024
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 20 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Prostatic Neoplasms

Intervention

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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.

Locations

Country	Name	City	State
Japan	Akita University Hospital	Akita
Japan	Juntendo University Hospital	Bunkyo Ku
Japan	Tokyo Medical and Dental University Hospital	Bunkyo Ku
Japan	Chiba Cancer Center	Chiba
Japan	Chiba University Hospital	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	Hamamatsu University Hospital	Hamamatsu
Japan	Saitama Medical University International Medical Center	Hidaka
Japan	Hirosaki University Hospital	Hirosaki
Japan	Hiroshima University Hospital	Hiroshima shi
Japan	Hospital of the University of Occupational and Environmental Health	Hukuoka
Japan	Tokyo Dental College Ichikawa General Hospital	Ichikawa
Japan	Tokyo Medical University Ibaraki Medical Center	Inashiki
Japan	Teikyo University Hospital	Itabashi Ku
Japan	Kanazawa Medical University Hospital	Kahoku-District
Japan	University Hospital Kyoto Perfectural University of Medicine	Kamigyo
Japan	St Marianna University Hospital	Kanagawa
Japan	Kanazawa University Hospital	Kanazawa
Japan	Nara Medical University Hospital	Kashihara
Japan	Kimitsu Chuo Hospital	Kisarazu-shi
Japan	Kagawa University Hospital	Kita-Gun
Japan	Kobe University Hospital	Kobe
Japan	Kobe City Medical Center General Hospital	Kobe City
Japan	Kochi Medical School Hospital	Kochi
Japan	Dokkyo Medical University Saitama Medical Center	Koshigaya
Japan	National Hospital Organizaiton Shikoku Cancer Center	Matsuyama-Shi
Japan	Kitasato University Hospital	Minami-Ku, Sagamihara-Shi
Japan	University of Miyazaki Hospital	Miyazaki
Japan	Iwate Medical University Hospital	Morioka
Japan	Aichi Medical University Hospital	Nagakute
Japan	Nagasaki University Hospital	Nagasaki-shi
Japan	Nagoya City University Hospital	Nagoya
Japan	University of the Ryukyus Hospital	Nakagami gun
Japan	Tokyo Metropolitan Police Hospital	Nakano-ku
Japan	Miyagi Cancer Center	Natori-shi
Japan	Niigata University Medical And Dental Hospital	Niigata
Japan	Okayama University Hospital	Okayama
Japan	Osaka International Cancer Institute	Osaka City
Japan	Kindai University Hospital	Osaka Sayama shi
Japan	Gunma Prefectural Cancer Center	Ota
Japan	Shiga University of Medical Science Hospital	Otsu
Japan	Japan Community Health Care Organization Saitama Medical Center	Saitama
Japan	Sapporo Medical University Hospital	Sapporo
Japan	Hokkaido University Hospital	Sapporo-shi
Japan	Tohoku Medical And Pharmaceutical University Hospital	Sendai
Japan	Tohoku University Hospital	Sendai shi
Japan	Jichi Medical University Hospital	Shimotsuke
Japan	Showa University Hospital	Shinagawa
Japan	Japan Community Health care Organization Tokyo Shinjuku Medical Center	Shinjuku-ku
Japan	Chutoen General Medical Center	Shizuoka
Japan	Osaka University Hospital	Suita-shi
Japan	Osaka Medical and Pharmaceutical University Hospital	Takatsuki
Japan	Tokushima University Hospital	Tokushima
Japan	Nippon Medical School Hospital	Tokyo
Japan	The Cancer Institute Hospital of JFCR	Tokyo
Japan	The Jikei University Hospital	Tokyo
Japan	Tokyo Medical University Hospital	Tokyo
Japan	Toranomon Hospital	Tokyo
Japan	Ehime University Hospital	Toon-shi
Japan	Toyama University Hospital	Toyama-shi
Japan	Fujita Health University Hospital	Toyoake
Japan	Mie University Hospital	Tsu
Japan	University of Tsukuba Hospital	Tsukuba City
Japan	Yamaguchi University Hospital	Ube
Japan	Wakayama Medical University Hospital	Wakayama
Japan	Yamagata University Hospital	Yamagata
Japan	Yokohama City University Hospital	Yokohama
Japan	Yokohama City University Medical Center	Yokohama
Japan	Yokohama Rosai Hospital	Yokohama
Japan	Yokosuka Kyosai Hospital	Yokosuka
Japan	Tottori University Hospital	Yonago
Japan	University of Fukui Hospital	Yoshida
Japan	Oita University Hospital	Yufu

Sponsors (1)

Lead Sponsor	Collaborator
Janssen Pharmaceutical K.K.

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	Percentage of Participants with PSA-PFS	Percentage of participants with PSA-PFS at 2 years from registration will be reported.	2 years
Primary	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
Primary	Percentage of Participants with PFS	Percentage of participants with PFS at 3 years from registration will be reported.	3 years
Primary	Overall Survival (OS)	The OS is defined as the duration from registration to any death.	Up to 5 years
Primary	Percentage of Participants with Overall Survival (OS)	Percentage of participants with OS at 3 years from registration will be reported.	3 years
Primary	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
Primary	Percentage of Participants with CSS	Percentage of participants with CSS at 3 years from registration will be reported.	3 years
Primary	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
Primary	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
Primary	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
Primary	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