Clinical trial NCT04034095: A Registry Study to Observe Clinical Outcomes of Participants With High-risk Metastatic Hormone-naïve Prostate Cancer in Japan
Official title: The Registry to Observe Clinical Outcomes of Patients With High-risk Metastatic Hormone-naïve Prostate Cancer in Japan
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Prostatic Neoplasms
Lead sponsor: Janssen Pharmaceutical K.K.
Sponsor class: INDUSTRY
First posted: 2019-07-26
Enrollment: 979
Sex: MALE
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.


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

Primary outcomes:
measure: Percentage of Participants who Achieve Prostate-specific Antigen (PSA) <=0.2 ng/mL Within a Year from Registration
timeFrame: 1 year
measure: PSA Progression-free Survival (PSA-PFS)
timeFrame: Up to 5 years
measure: Percentage of Participants with PSA-PFS
timeFrame: 2 years
measure: Progression-free Survival (PFS)
timeFrame: Up to 5 years
measure: Percentage of Participants with PFS
timeFrame: 3 years
measure: Overall Survival (OS)
timeFrame: Up to 5 years
measure: Percentage of Participants with Overall Survival (OS)
timeFrame: 3 years
measure: Cancer Specific Survival (CSS)
timeFrame: Up to 5 years
measure: Percentage of Participants with CSS
timeFrame: 3 years
measure: Time to Symptomatic Skeletal Event (TTSSE)
timeFrame: Up to 5 years
measure: Patient Health Questionnaire-9 (PHQ-9) Score
timeFrame: Up to 5 years
measure: Functional Assessment of Cancer Therapy for Prostate Cancer (FACT-P) Questionnaire Score
timeFrame: Up to 5 years
measure: Montreal Cognitive Assessment (MoCA) Score
timeFrame: Up to 5 years
Secondary outcomes:
Other outcomes:
Locations:
city: Akita
country: Japan
facility: Akita University Hospital
city: Bunkyo Ku
country: Japan
facility: Juntendo University Hospital
city: Bunkyo Ku
country: Japan
facility: Tokyo Medical and Dental University Hospital
city: Chiba
country: Japan
facility: Chiba University Hospital
city: Chiba
country: Japan
facility: Chiba Cancer Center
city: Chuo
country: Japan
facility: University of Yamanashi Hospital
city: Fukuoka
country: Japan
facility: Kyushu University Hospital
city: Fukushima
country: Japan
facility: Fukushima Medical University Hospital
city: Gifu
country: Japan
facility: Gifu University Hospital
city: Hakata-Ku
country: Japan
facility: Harasanshin Hospital
city: Hamamatsu
country: Japan
facility: Hamamatsu University Hospital
city: Hidaka
country: Japan
facility: Saitama Medical University International Medical Center
city: Hirosaki
country: Japan
facility: Hirosaki University Hospital
city: Hiroshima shi
country: Japan
facility: Hiroshima University Hospital
city: Hukuoka
country: Japan
facility: Hospital of the University of Occupational and Enviromental Health
city: Ichikawa
country: Japan
facility: Tokyo Dental College Ichikawa General Hospital
city: Inashiki
country: Japan
facility: Tokyo Medical University Ibaraki Medical Center
city: Itabashi Ku
country: Japan
facility: Teikyo University Hospital
city: Kahoku-District
country: Japan
facility: Kanazawa Medical University Hospital
city: Kamigyo
country: Japan
facility: University Hospital Kyoto Prefectural University of Medicine
city: Kanagawa
country: Japan
facility: St Marianna University Hospital
city: Kanazawa
country: Japan
facility: Kanazawa University Hospital
city: Kashihara
country: Japan
facility: Nara Medical University Hospital
city: Kisarazu-shi
country: Japan
facility: Kimitsu Chuo Hospital
city: Kita Gun
country: Japan
facility: Kagawa University Hospital
city: Kobe City
country: Japan
facility: Kobe City Medical Center General Hospital
city: Kobe
country: Japan
facility: Kobe University Hospital
city: Kochi
country: Japan
facility: Kochi Medical School Hospital
city: Koshigaya
country: Japan
facility: Dokkyo Medical University Saitama Medical Center
city: Matsuyama-Shi
country: Japan
facility: National Hospital Organization Shikoku Cancer Center
city: Minami-Ku
country: Japan
facility: Kitasato University Hospital
city: Miyazaki
country: Japan
facility: University of Miyazaki Hospital
city: Morioka
country: Japan
facility: Iwate Medical University Hospital
city: Nagakute
country: Japan
facility: Aichi Medical University Hospital
city: Nagasaki-shi
country: Japan
facility: Nagasaki University Hospital
city: Nagoya
country: Japan
facility: Nagoya City University Hospital
city: Nakagami gun
country: Japan
facility: University of the Ryukyus Hospital
city: Nakano-ku
country: Japan
facility: Tokyo Metropolitan Police Hospital
city: Natori-shi
country: Japan
facility: Miyagi Cancer Center
city: Niigata
country: Japan
facility: Niigata University Medical And Dental Hospital
city: Okayama
country: Japan
facility: Okayama University Hospital
city: Osaka City
country: Japan
facility: Osaka International Cancer Institute
city: Osaka Sayama shi
country: Japan
facility: Kindai University Hospital
city: Ota
country: Japan
facility: Gunma Prefectural Cancer Center
city: Otsu
country: Japan
facility: Shiga University of Medical Science Hospital
city: Saitama
country: Japan
facility: Japan Community Health Care Organization Saitama Medical Center
city: Sapporo-shi
country: Japan
facility: Hokkaido University Hospital
city: Sapporo
country: Japan
facility: Sapporo Medical University Hospital
city: Sendai shi
country: Japan
facility: Tohoku University Hospital
city: Sendai
country: Japan
facility: Tohoku Medical And Pharmaceutical University Hospital
city: Shimotsuke
country: Japan
facility: Jichi Medical University Hospital
city: Shinagawa
country: Japan
facility: Showa University Hospital
city: Shinjuku-ku
country: Japan
facility: Japan Community Health care Organization Tokyo Shinjuku Medical Center
city: Shizuoka
country: Japan
facility: Chutoen General Medical Center
city: Suita-shi
country: Japan
facility: Osaka University Hospital
city: Takatsuki
country: Japan
facility: Osaka Medical and Pharmaceutical University Hospital
city: Tokushima
country: Japan
facility: Tokushima University Hospital
city: Tokyo
country: Japan
facility: The Jikei University Hospital
city: Tokyo
country: Japan
facility: Toranomon Hospital
city: Tokyo
country: Japan
facility: Nippon Medical School Hospital
city: Tokyo
country: Japan
facility: The Cancer Institute Hospital of JFCR
city: Tokyo
country: Japan
facility: Tokyo Medical University Hospital
city: Toon-shi
country: Japan
facility: Ehime University Hospital
city: Toyama-shi
country: Japan
facility: Toyama University Hospital
city: Toyoake
country: Japan
facility: Fujita Health University Hospital
city: Tsukuba City
country: Japan
facility: University of Tsukuba Hospital
city: Tsu
country: Japan
facility: Mie University Hospital
city: Ube
country: Japan
facility: Yamaguchi University Hospital
city: Wakayama
country: Japan
facility: Wakayama Medical University Hospital
city: Yamagata
country: Japan
facility: Yamagata University Hospital
city: Yokohama
country: Japan
facility: Yokohama Rosai Hospital
city: Yokohama
country: Japan
facility: Yokohama City University Medical Center
city: Yokohama
country: Japan
facility: Yokohama City University Hospital
city: Yokosuka
country: Japan
facility: Yokosuka Kyosai Hospital
city: Yonago
country: Japan
facility: Tottori University Hospital
city: Yoshida
country: Japan
facility: University of Fukui Hospital
city: Yufu
country: Japan
facility: Oita University Hospital
Study officials:
affiliation: Janssen Pharmaceutical K.K.
name: Janssen Pharmaceutical K.K., Japan Clinical Trial
role: STUDY_DIRECTOR
References: