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| ID | Type | Description | Link |
|---|---|---|---|
| 56021927PCR4009 | Other Identifier | Janssen Research & Development, LLC |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
- has any other active malignancies
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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.
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| Name | Affiliation | Role |
|---|---|---|
| Janssen Pharmaceutical K.K., Japan Clinical Trial | Janssen Pharmaceutical K.K. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Akita University Hospital | Akita | 010-8543 | Japan | |||
| Juntendo University Hospital |
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| 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. |
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| 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. |
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| 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. |
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| 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. |
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| 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. |
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| 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. |
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| 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 |
| Bunkyō City |
| 113 8431 |
| Japan |
| Tokyo Medical and Dental University Hospital | Bunkyō City | 113 8519 | Japan |
| Chiba University Hospital | Chiba | 260 8677 | Japan |
| Chiba Cancer Center | Chiba | 260-8717 | Japan |
| University of Yamanashi Hospital | Chūō | 409-3898 | Japan |
| Hospital of the University of Occupational and Enviromental Health | Fukuoka | 807-8555 | Japan |
| Kyushu University Hospital | Fukuoka | 812 8582 | Japan |
| Fukushima Medical University Hospital | Fukushima | 960 1295 | Japan |
| Gifu University Hospital | Gifu | 501-1194 | Japan |
| Harasanshin Hospital | Hakata-Ku | 812-0033 | Japan |
| Hamamatsu University Hospital | Hamamatsu | 431-3192 | Japan |
| Saitama Medical University International Medical Center | Hidaka | 350-1298 | Japan |
| Hirosaki University Hospital | Hirosaki | 036-8563 | Japan |
| Hiroshima University Hospital | Hiroshima | 734 8551 | Japan |
| Tokyo Dental College Ichikawa General Hospital | Ichikawa | 272-8513 | Japan |
| Tokyo Medical University Ibaraki Medical Center | Inashiki | 300 0395 | Japan |
| Teikyo University Hospital | Itabashi Ku | 173 8606 | Japan |
| Kanazawa Medical University Hospital | Kahoku-District | 920-0293 | Japan |
| University Hospital Kyoto Prefectural University of Medicine | Kamigyo | 602-8566 | Japan |
| St Marianna University Hospital | Kanagawa | 216 8511 | Japan |
| Kanazawa University Hospital | Kanazawa | 920 8641 | Japan |
| Nara Medical University Hospital | Kashihara | 634-8522 | Japan |
| Kimitsu Chuo Hospital | Kisarazu-shi | 292-8535 | Japan |
| Kagawa University Hospital | Kita Gun | 761 0793 | Japan |
| Kobe University Hospital | Kobe | 650 0017 | Japan |
| Kobe City Medical Center General Hospital | Kobe | 650 0047 | Japan |
| Kochi Medical School Hospital | Kochi | 783-8505 | Japan |
| Dokkyo Medical University Saitama Medical Center | Koshigaya | 343-8555 | Japan |
| National Hospital Organization Shikoku Cancer Center | Matsuyama | 791-0280 | Japan |
| Kitasato University Hospital | Minamiku | 252-0375 | Japan |
| University of Miyazaki Hospital | Miyazaki | 889-1692 | Japan |
| Iwate Medical University Hospital | Morioka | 020-8505 | Japan |
| Aichi Medical University Hospital | Nagakute | 480-1195 | Japan |
| Nagasaki University Hospital | Nagasaki | 852-8501 | Japan |
| Nagoya City University Hospital | Nagoya | 467 8602 | Japan |
| University of the Ryukyus Hospital | Nakagami Gun | 903-0215 | Japan |
| Tokyo Metropolitan Police Hospital | Nakano | 1648541 | Japan |
| Miyagi Cancer Center | Natori-shi | 981-1293 | Japan |
| Niigata University Medical And Dental Hospital | Niigata | 951 8520 | Japan |
| Okayama University Hospital | Okayama | 700 8558 | Japan |
| Osaka International Cancer Institute | Osaka | 541 8567 | Japan |
| Kindai University Hospital | Osaka Sayama Shi | 589 8511 | Japan |
| Gunma Prefectural Cancer Center | Ōta-ku | 373 8550 | Japan |
| Shiga University of Medical Science Hospital | Ōtsu | 520-2121 | Japan |
| Japan Community Health Care Organization Saitama Medical Center | Saitama | 350-8550 | Japan |
| Sapporo Medical University Hospital | Sapporo | 060-8543 | Japan |
| Hokkaido University Hospital | Sapporo | 060-8648 | Japan |
| Tohoku University Hospital | Sendai | 980 8574 | Japan |
| Tohoku Medical And Pharmaceutical University Hospital | Sendai | 981-8558 | Japan |
| Jichi Medical University Hospital | Shimotsuke | 329-0498 | Japan |
| Showa University Hospital | Shinagawa City | 142 8666 | Japan |
| Japan Community Health care Organization Tokyo Shinjuku Medical Center | Shinjuku-ku | Japan |
| Chutoen General Medical Center | Shizuoka | 436-0040 | Japan |
| Osaka University Hospital | Suita-shi | 565-0871 | Japan |
| Osaka Medical and Pharmaceutical University Hospital | Takatsuki | 569-8686 | Japan |
| Tokushima University Hospital | Tokushima | 770-8503 | Japan |
| The Jikei University Hospital | Tokyo | 105 8471 | Japan |
| Toranomon Hospital | Tokyo | 105-8470 | Japan |
| Nippon Medical School Hospital | Tokyo | 113 8603 | Japan |
| The Cancer Institute Hospital of JFCR | Tokyo | 135 8550 | Japan |
| Tokyo Medical University Hospital | Tokyo | 160-0023 | Japan |
| Ehime University Hospital | Toon-shi | 791-0295 | Japan |
| Toyama University Hospital | Toyama | 930-0194 | Japan |
| Fujita Health University Hospital | Toyoake | 470-1192 | Japan |
| Mie University Hospital | Tsu | 514 8507 | Japan |
| University of Tsukuba Hospital | Tsukuba | 305 8576 | Japan |
| Yamaguchi University Hospital | Ube | 755-8505 | Japan |
| Wakayama Medical University Hospital | Wakayama | 641 8510 | Japan |
| Yamagata University Hospital | Yamagata | 990-9585 | Japan |
| Yokohama Rosai Hospital | Yokohama | 222-0036 | Japan |
| Yokohama City University Medical Center | Yokohama | 232 0024 | Japan |
| Yokohama City University Hospital | Yokohama | 236 0004 | Japan |
| Yokosuka Kyosai Hospital | Yokosuka | 238 8558 | Japan |
| Tottori University Hospital | Yonago | 683-8504 | Japan |
| University of Fukui Hospital | Yoshida | 910-1193 | Japan |
| Oita University Hospital | Yufu | 879-5593 | Japan |
| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
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| ID | Term |
|---|---|
| D000726 | Androgen Antagonists |
| C053541 | bicalutamide |
| C089740 | abiraterone |
| D011239 | Prednisolone |
| D000077143 | Docetaxel |
| C540278 | enzalutamide |
| C572045 | apalutamide |
| ID | Term |
|---|---|
| D006727 | Hormone Antagonists |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D045505 | Physiological Effects of Drugs |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D004224 | Diterpenes |
| D013729 | Terpenes |
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