Ignite Creation Date:
2025-12-24 @ 2:15 PM
Ignite Modification Date:
2026-03-02 @ 8:19 AM
Study NCT ID:
NCT04034095
Status:
COMPLETED
Last Update Posted:
2025-12-15
First Post:
2019-07-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Registry Study to Observe Clinical Outcomes of Participants With High-risk Metastatic Hormone-naïve Prostate Cancer in Japan
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011471', 'term': 'Prostatic Neoplasms'}], 'ancestors': [{'id': 'D005834', 'term': 'Genital Neoplasms, Male'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D005832', 'term': 'Genital Diseases, Male'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D011469', 'term': 'Prostatic Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000726', 'term': 'Androgen Antagonists'}, {'id': 'C053541', 'term': 'bicalutamide'}, {'id': 'C089740', 'term': 'abiraterone'}, {'id': 'D011239', 'term': 'Prednisolone'}, {'id': 'D000077143', 'term': 'Docetaxel'}, {'id': 'C540278', 'term': 'enzalutamide'}, {'id': 'C572045', 'term': 'apalutamide'}], 'ancestors': [{'id': 'D006727', 'term': 'Hormone Antagonists'}, {'id': 'D006730', 'term': 'Hormones, Hormone Substitutes, and Hormone Antagonists'}, {'id': 'D045505', 'term': 'Physiological Effects of Drugs'}, {'id': 'D020228', 'term': 'Pharmacologic Actions'}, {'id': 'D020164', 'term': 'Chemical Actions and Uses'}, {'id': 'D011246', 'term': 'Pregnadienetriols'}, {'id': 'D011245', 'term': 'Pregnadienes'}, {'id': 'D011278', 'term': 'Pregnanes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D043823', 'term': 'Taxoids'}, {'id': 'D043822', 'term': 'Cyclodecanes'}, {'id': 'D003516', 'term': 'Cycloparaffins'}, {'id': 'D006840', 'term': 'Hydrocarbons, Alicyclic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D004224', 'term': 'Diterpenes'}, {'id': 'D013729', 'term': 'Terpenes'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 979}, 'targetDuration': '5 Years', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-07-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2024-08-13', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-12-12', 'studyFirstSubmitDate': '2019-07-16', 'studyFirstSubmitQcDate': '2019-07-25', 'lastUpdatePostDateStruct': {'date': '2025-12-15', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2019-07-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-08-13', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of Participants who Achieve Prostate-specific Antigen (PSA) <=0.2 ng/mL Within a Year from Registration', 'timeFrame': '1 year', 'description': '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.'}, {'measure': 'PSA Progression-free Survival (PSA-PFS)', 'timeFrame': 'Up to 5 years', 'description': 'The PSA-PFS is defined as the duration from registration to either PSA progression or death, whichever occurs first.'}, {'measure': 'Percentage of Participants with PSA-PFS', 'timeFrame': '2 years', 'description': 'Percentage of participants with PSA-PFS at 2 years from registration will be reported.'}, {'measure': 'Progression-free Survival (PFS)', 'timeFrame': 'Up to 5 years', 'description': 'The PFS is defined as the duration from registration to either radiographic progression, clinical progression or death, whichever occurs first.'}, {'measure': 'Percentage of Participants with PFS', 'timeFrame': '3 years', 'description': 'Percentage of participants with PFS at 3 years from registration will be reported.'}, {'measure': 'Overall Survival (OS)', 'timeFrame': 'Up to 5 years', 'description': 'The OS is defined as the duration from registration to any death.'}, {'measure': 'Percentage of Participants with Overall Survival (OS)', 'timeFrame': '3 years', 'description': 'Percentage of participants with OS at 3 years from registration will be reported.'}, {'measure': 'Cancer Specific Survival (CSS)', 'timeFrame': 'Up to 5 years', 'description': "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."}, {'measure': 'Percentage of Participants with CSS', 'timeFrame': '3 years', 'description': 'Percentage of participants with CSS at 3 years from registration will be reported.'}, {'measure': 'Time to Symptomatic Skeletal Event (TTSSE)', 'timeFrame': 'Up to 5 years', 'description': '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.'}, {'measure': 'Patient Health Questionnaire-9 (PHQ-9) Score', 'timeFrame': 'Up to 5 years', 'description': '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).'}, {'measure': 'Functional Assessment of Cancer Therapy for Prostate Cancer (FACT-P) Questionnaire Score', 'timeFrame': 'Up to 5 years', 'description': '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.'}, {'measure': 'Montreal Cognitive Assessment (MoCA) Score', 'timeFrame': 'Up to 5 years', 'description': '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.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Prostatic Neoplasms']}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '20 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '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.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Documented diagnosis of metastatic, hormone-naïve prostate cancer (mHNPC) after 1 May 2019\n* 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\n* 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\n* Possess Japanese nationality\n* 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)\n\nExclusion Criteria:\n\n\\- has any other active malignancies'}, 'identificationModule': {'nctId': 'NCT04034095', 'briefTitle': 'A Registry Study to Observe Clinical Outcomes of Participants With High-risk Metastatic Hormone-naïve Prostate Cancer in Japan', 'organization': {'class': 'INDUSTRY', 'fullName': 'Janssen Pharmaceutical K.K.'}, 'officialTitle': 'The Registry to Observe Clinical Outcomes of Patients With High-risk Metastatic Hormone-naïve Prostate Cancer in Japan', 'orgStudyIdInfo': {'id': 'CR108675'}, 'secondaryIdInfos': [{'id': '56021927PCR4009', 'type': 'OTHER', 'domain': 'Janssen Research & Development, LLC'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Cohort 1: ADT alone/ ADT + Bicalutamide', 'description': '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.', 'interventionNames': ['Drug: Androgen-deprivation Therapy (ADT)', 'Drug: Bicalutamide']}, {'label': 'Cohort 2: ADT + AAP/Docetaxel/Enzalutamide/Apalutamide', 'description': '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.', 'interventionNames': ['Drug: Androgen-deprivation Therapy (ADT)', 'Drug: Abiraterone', 'Drug: Prednisolone', 'Drug: Docetaxel', 'Drug: Enzalutamide', 'Drug: Apalutamide']}], 'interventions': [{'name': 'Androgen-deprivation Therapy (ADT)', 'type': 'DRUG', 'description': '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.', 'armGroupLabels': ['Cohort 1: ADT alone/ ADT + Bicalutamide', 'Cohort 2: ADT + AAP/Docetaxel/Enzalutamide/Apalutamide']}, {'name': 'Bicalutamide', 'type': 'DRUG', 'description': '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.', 'armGroupLabels': ['Cohort 1: ADT alone/ ADT + Bicalutamide']}, {'name': 'Abiraterone', 'type': 'DRUG', 'description': '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.', 'armGroupLabels': ['Cohort 2: ADT + AAP/Docetaxel/Enzalutamide/Apalutamide']}, {'name': 'Prednisolone', 'type': 'DRUG', 'description': '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.', 'armGroupLabels': ['Cohort 2: ADT + AAP/Docetaxel/Enzalutamide/Apalutamide']}, {'name': 'Docetaxel', 'type': 'DRUG', 'description': '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.', 'armGroupLabels': ['Cohort 2: ADT + AAP/Docetaxel/Enzalutamide/Apalutamide']}, {'name': 'Enzalutamide', 'type': 'DRUG', 'description': '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.', 'armGroupLabels': ['Cohort 2: ADT + AAP/Docetaxel/Enzalutamide/Apalutamide']}, {'name': 'Apalutamide', 'type': 'DRUG', 'description': '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.', 'armGroupLabels': ['Cohort 2: ADT + AAP/Docetaxel/Enzalutamide/Apalutamide']}]}, 'contactsLocationsModule': {'locations': [{'zip': '010-8543', 'city': 'Akita', 'country': 'Japan', 'facility': 'Akita University Hospital', 'geoPoint': {'lat': 39.71667, 'lon': 140.11667}}, {'zip': '113 8431', 'city': 'Bunkyō City', 'country': 'Japan', 'facility': 'Juntendo University Hospital', 'geoPoint': {'lat': 35.5331, 'lon': 139.4217}}, {'zip': '113 8519', 'city': 'Bunkyō City', 'country': 'Japan', 'facility': 'Tokyo Medical and Dental University Hospital', 'geoPoint': {'lat': 35.5331, 'lon': 139.4217}}, {'zip': '260 8677', 'city': 'Chiba', 'country': 'Japan', 'facility': 'Chiba University Hospital', 'geoPoint': {'lat': 35.6, 'lon': 140.11667}}, {'zip': '260-8717', 'city': 'Chiba', 'country': 'Japan', 'facility': 'Chiba Cancer Center', 'geoPoint': {'lat': 35.6, 'lon': 140.11667}}, {'zip': '409-3898', 'city': 'Chūō', 'country': 'Japan', 'facility': 'University of Yamanashi Hospital', 'geoPoint': {'lat': 35.67004, 'lon': 139.77544}}, {'zip': '807-8555', 'city': 'Fukuoka', 'country': 'Japan', 'facility': 'Hospital of the University of Occupational and Enviromental Health', 'geoPoint': {'lat': 33.6, 'lon': 130.41667}}, {'zip': '812 8582', 'city': 'Fukuoka', 'country': 'Japan', 'facility': 'Kyushu University Hospital', 'geoPoint': {'lat': 33.6, 'lon': 130.41667}}, {'zip': '960 1295', 'city': 'Fukushima', 'country': 'Japan', 'facility': 'Fukushima Medical University Hospital', 'geoPoint': {'lat': 37.75, 'lon': 140.46667}}, {'zip': '501-1194', 'city': 'Gifu', 'country': 'Japan', 'facility': 'Gifu University Hospital', 'geoPoint': {'lat': 35.42291, 'lon': 136.76039}}, {'zip': '812-0033', 'city': 'Hakata-Ku', 'country': 'Japan', 'facility': 'Harasanshin Hospital'}, {'zip': '431-3192', 'city': 'Hamamatsu', 'country': 'Japan', 'facility': 'Hamamatsu University Hospital', 'geoPoint': {'lat': 34.7, 'lon': 137.73333}}, {'zip': '350-1298', 'city': 'Hidaka', 'country': 'Japan', 'facility': 'Saitama Medical University International Medical Center', 'geoPoint': {'lat': 35.91664, 'lon': 139.36233}}, {'zip': '036-8563', 'city': 'Hirosaki', 'country': 'Japan', 'facility': 'Hirosaki University Hospital', 'geoPoint': {'lat': 40.59306, 'lon': 140.4725}}, {'zip': '734 8551', 'city': 'Hiroshima', 'country': 'Japan', 'facility': 'Hiroshima University Hospital', 'geoPoint': {'lat': 34.4, 'lon': 132.45}}, {'zip': '272-8513', 'city': 'Ichikawa', 'country': 'Japan', 'facility': 'Tokyo Dental College Ichikawa General Hospital', 'geoPoint': {'lat': 35.73413, 'lon': 139.9065}}, {'zip': '300 0395', 'city': 'Inashiki', 'country': 'Japan', 'facility': 'Tokyo Medical University Ibaraki Medical Center', 'geoPoint': {'lat': 35.95633, 'lon': 140.32356}}, {'zip': '173 8606', 'city': 'Itabashi Ku', 'country': 'Japan', 'facility': 'Teikyo University Hospital'}, {'zip': '920-0293', 'city': 'Kahoku-District', 'country': 'Japan', 'facility': 'Kanazawa Medical University Hospital'}, {'zip': '602-8566', 'city': 'Kamigyo', 'country': 'Japan', 'facility': 'University Hospital Kyoto Prefectural University of Medicine'}, {'zip': '216 8511', 'city': 'Kanagawa', 'country': 'Japan', 'facility': 'St Marianna University Hospital', 'geoPoint': {'lat': 37.58333, 'lon': 139.91667}}, {'zip': '920 8641', 'city': 'Kanazawa', 'country': 'Japan', 'facility': 'Kanazawa University Hospital', 'geoPoint': {'lat': 36.6, 'lon': 136.61667}}, {'zip': '634-8522', 'city': 'Kashihara', 'country': 'Japan', 'facility': 'Nara Medical University Hospital', 'geoPoint': {'lat': 34.58333, 'lon': 135.61667}}, {'zip': '292-8535', 'city': 'Kisarazu-shi', 'country': 'Japan', 'facility': 'Kimitsu Chuo Hospital'}, {'zip': '761 0793', 'city': 'Kita Gun', 'country': 'Japan', 'facility': 'Kagawa University Hospital'}, {'zip': '650 0017', 'city': 'Kobe', 'country': 'Japan', 'facility': 'Kobe University Hospital', 'geoPoint': {'lat': 34.6913, 'lon': 135.183}}, {'zip': '650 0047', 'city': 'Kobe', 'country': 'Japan', 'facility': 'Kobe City Medical Center General Hospital', 'geoPoint': {'lat': 34.6913, 'lon': 135.183}}, {'zip': '783-8505', 'city': 'Kochi', 'country': 'Japan', 'facility': 'Kochi Medical School Hospital', 'geoPoint': {'lat': 33.55, 'lon': 133.53333}}, {'zip': '343-8555', 'city': 'Koshigaya', 'country': 'Japan', 'facility': 'Dokkyo Medical University Saitama Medical Center', 'geoPoint': {'lat': 35.89035, 'lon': 139.78916}}, {'zip': '791-0280', 'city': 'Matsuyama', 'country': 'Japan', 'facility': 'National Hospital Organization Shikoku Cancer Center', 'geoPoint': {'lat': 33.83916, 'lon': 132.76574}}, {'zip': '252-0375', 'city': 'Minamiku', 'country': 'Japan', 'facility': 'Kitasato University Hospital', 'geoPoint': {'lat': 38.44213, 'lon': 141.24144}}, {'zip': '889-1692', 'city': 'Miyazaki', 'country': 'Japan', 'facility': 'University of Miyazaki Hospital', 'geoPoint': {'lat': 31.91667, 'lon': 131.41667}}, {'zip': '020-8505', 'city': 'Morioka', 'country': 'Japan', 'facility': 'Iwate Medical University Hospital', 'geoPoint': {'lat': 39.7, 'lon': 141.15}}, {'zip': '480-1195', 'city': 'Nagakute', 'country': 'Japan', 'facility': 'Aichi Medical University Hospital', 'geoPoint': {'lat': 35.17325, 'lon': 137.05667}}, {'zip': '852-8501', 'city': 'Nagasaki', 'country': 'Japan', 'facility': 'Nagasaki University Hospital', 'geoPoint': {'lat': 32.75, 'lon': 129.88333}}, {'zip': '467 8602', 'city': 'Nagoya', 'country': 'Japan', 'facility': 'Nagoya City University Hospital', 'geoPoint': {'lat': 35.18147, 'lon': 136.90641}}, {'zip': '903-0215', 'city': 'Nakagami Gun', 'country': 'Japan', 'facility': 'University of the Ryukyus Hospital'}, {'zip': '1648541', 'city': 'Nakano', 'country': 'Japan', 'facility': 'Tokyo Metropolitan Police Hospital', 'geoPoint': {'lat': 25.94567, 'lon': 131.31144}}, {'zip': '981-1293', 'city': 'Natori-shi', 'country': 'Japan', 'facility': 'Miyagi Cancer Center', 'geoPoint': {'lat': 38.16667, 'lon': 140.88333}}, {'zip': '951 8520', 'city': 'Niigata', 'country': 'Japan', 'facility': 'Niigata University Medical And Dental Hospital', 'geoPoint': {'lat': 37.92259, 'lon': 139.04125}}, {'zip': '700 8558', 'city': 'Okayama', 'country': 'Japan', 'facility': 'Okayama University Hospital', 'geoPoint': {'lat': 34.65, 'lon': 133.93333}}, {'zip': '541 8567', 'city': 'Osaka', 'country': 'Japan', 'facility': 'Osaka International Cancer Institute', 'geoPoint': {'lat': 34.69379, 'lon': 135.50107}}, {'zip': '589 8511', 'city': 'Osaka Sayama Shi', 'country': 'Japan', 'facility': 'Kindai University Hospital'}, {'zip': '373 8550', 'city': 'Ōta-ku', 'country': 'Japan', 'facility': 'Gunma Prefectural Cancer Center', 'geoPoint': {'lat': 35.56126, 'lon': 139.71605}}, {'zip': '520-2121', 'city': 'Ōtsu', 'country': 'Japan', 'facility': 'Shiga University of Medical Science Hospital', 'geoPoint': {'lat': 35.0, 'lon': 135.86667}}, {'zip': '350-8550', 'city': 'Saitama', 'country': 'Japan', 'facility': 'Japan Community Health Care Organization Saitama Medical Center', 'geoPoint': {'lat': 35.90807, 'lon': 139.65657}}, {'zip': '060-8543', 'city': 'Sapporo', 'country': 'Japan', 'facility': 'Sapporo Medical University Hospital', 'geoPoint': {'lat': 43.06667, 'lon': 141.35}}, {'zip': '060-8648', 'city': 'Sapporo', 'country': 'Japan', 'facility': 'Hokkaido University Hospital', 'geoPoint': {'lat': 43.06667, 'lon': 141.35}}, {'zip': '980 8574', 'city': 'Sendai', 'country': 'Japan', 'facility': 'Tohoku University Hospital', 'geoPoint': {'lat': 38.26667, 'lon': 140.86667}}, {'zip': '981-8558', 'city': 'Sendai', 'country': 'Japan', 'facility': 'Tohoku Medical And Pharmaceutical University Hospital', 'geoPoint': {'lat': 38.26667, 'lon': 140.86667}}, {'zip': '329-0498', 'city': 'Shimotsuke', 'country': 'Japan', 'facility': 'Jichi Medical University Hospital', 'geoPoint': {'lat': 36.41323, 'lon': 139.86622}}, {'zip': '142 8666', 'city': 'Shinagawa City', 'country': 'Japan', 'facility': 'Showa University Hospital', 'geoPoint': {'lat': 33.63627, 'lon': 133.00572}}, {'city': 'Shinjuku-ku', 'country': 'Japan', 'facility': 'Japan Community Health care Organization Tokyo Shinjuku Medical Center'}, {'zip': '436-0040', 'city': 'Shizuoka', 'country': 'Japan', 'facility': 'Chutoen General Medical Center', 'geoPoint': {'lat': 34.98333, 'lon': 138.38333}}, {'zip': '565-0871', 'city': 'Suita-shi', 'country': 'Japan', 'facility': 'Osaka University Hospital'}, {'zip': '569-8686', 'city': 'Takatsuki', 'country': 'Japan', 'facility': 'Osaka Medical and Pharmaceutical University Hospital', 'geoPoint': {'lat': 34.84833, 'lon': 135.61678}}, {'zip': '770-8503', 'city': 'Tokushima', 'country': 'Japan', 'facility': 'Tokushima University Hospital', 'geoPoint': {'lat': 34.06667, 'lon': 134.56667}}, {'zip': '105 8471', 'city': 'Tokyo', 'country': 'Japan', 'facility': 'The Jikei University Hospital', 'geoPoint': {'lat': 35.6895, 'lon': 139.69171}}, {'zip': '105-8470', 'city': 'Tokyo', 'country': 'Japan', 'facility': 'Toranomon Hospital', 'geoPoint': {'lat': 35.6895, 'lon': 139.69171}}, {'zip': '113 8603', 'city': 'Tokyo', 'country': 'Japan', 'facility': 'Nippon Medical School Hospital', 'geoPoint': {'lat': 35.6895, 'lon': 139.69171}}, {'zip': '135 8550', 'city': 'Tokyo', 'country': 'Japan', 'facility': 'The Cancer Institute Hospital of JFCR', 'geoPoint': {'lat': 35.6895, 'lon': 139.69171}}, {'zip': '160-0023', 'city': 'Tokyo', 'country': 'Japan', 'facility': 'Tokyo Medical University Hospital', 'geoPoint': {'lat': 35.6895, 'lon': 139.69171}}, {'zip': '791-0295', 'city': 'Toon-shi', 'country': 'Japan', 'facility': 'Ehime University Hospital'}, {'zip': '930-0194', 'city': 'Toyama', 'country': 'Japan', 'facility': 'Toyama University Hospital', 'geoPoint': {'lat': 36.7, 'lon': 137.21667}}, {'zip': '470-1192', 'city': 'Toyoake', 'country': 'Japan', 'facility': 'Fujita Health University Hospital', 'geoPoint': {'lat': 35.038, 'lon': 136.99931}}, {'zip': '514 8507', 'city': 'Tsu', 'country': 'Japan', 'facility': 'Mie University Hospital', 'geoPoint': {'lat': 34.73333, 'lon': 136.51667}}, {'zip': '305 8576', 'city': 'Tsukuba', 'country': 'Japan', 'facility': 'University of Tsukuba Hospital', 'geoPoint': {'lat': 36.08333, 'lon': 140.11667}}, {'zip': '755-8505', 'city': 'Ube', 'country': 'Japan', 'facility': 'Yamaguchi University Hospital', 'geoPoint': {'lat': 33.94306, 'lon': 131.25111}}, {'zip': '641 8510', 'city': 'Wakayama', 'country': 'Japan', 'facility': 'Wakayama Medical University Hospital', 'geoPoint': {'lat': 34.23333, 'lon': 135.16667}}, {'zip': '990-9585', 'city': 'Yamagata', 'country': 'Japan', 'facility': 'Yamagata University Hospital', 'geoPoint': {'lat': 38.23333, 'lon': 140.36667}}, {'zip': '222-0036', 'city': 'Yokohama', 'country': 'Japan', 'facility': 'Yokohama Rosai Hospital', 'geoPoint': {'lat': 35.43333, 'lon': 139.65}}, {'zip': '232 0024', 'city': 'Yokohama', 'country': 'Japan', 'facility': 'Yokohama City University Medical Center', 'geoPoint': {'lat': 35.43333, 'lon': 139.65}}, {'zip': '236 0004', 'city': 'Yokohama', 'country': 'Japan', 'facility': 'Yokohama City University Hospital', 'geoPoint': {'lat': 35.43333, 'lon': 139.65}}, {'zip': '238 8558', 'city': 'Yokosuka', 'country': 'Japan', 'facility': 'Yokosuka Kyosai Hospital', 'geoPoint': {'lat': 35.28361, 'lon': 139.66722}}, {'zip': '683-8504', 'city': 'Yonago', 'country': 'Japan', 'facility': 'Tottori University Hospital', 'geoPoint': {'lat': 35.43333, 'lon': 133.33333}}, {'zip': '910-1193', 'city': 'Yoshida', 'country': 'Japan', 'facility': 'University of Fukui Hospital', 'geoPoint': {'lat': 30.43252, 'lon': 130.46235}}, {'zip': '879-5593', 'city': 'Yufu', 'country': 'Japan', 'facility': 'Oita University Hospital', 'geoPoint': {'lat': 33.1956, 'lon': 131.37829}}], 'overallOfficials': [{'name': 'Janssen Pharmaceutical K.K., Japan Clinical Trial', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Janssen Pharmaceutical K.K.'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Janssen Pharmaceutical K.K.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}