Ignite Creation Date:
2025-12-24 @ 12:13 PM
Ignite Modification Date:
2026-01-21 @ 1:15 AM
Study NCT ID:
NCT02066961
Status:
COMPLETED
Last Update Posted:
2019-12-20
First Post:
2014-02-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study to Describe Patterns of Care and Outcomes of Men Who Are at High Risk After Experiencing Biochemical Failure Following Definitive Prostate Cancer Therapy, Men With Castration-resistant Prostate Cancer and Men With Metastatic Prostate Cancer
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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1533}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-12-31', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-12', 'completionDateStruct': {'date': '2019-11-14', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-12-18', 'studyFirstSubmitDate': '2014-02-18', 'studyFirstSubmitQcDate': '2014-02-18', 'lastUpdatePostDateStruct': {'date': '2019-12-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-02-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2019-11-14', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Patterns of disease management', 'timeFrame': 'up to 72 months', 'description': 'Description of disease assessment methods, physician referral patterns and treatments'}, {'measure': 'Clinical outcomes', 'timeFrame': 'up to 72 months', 'description': 'Evidence of disease progression and development of symptomatic disease'}], 'secondaryOutcomes': [{'measure': 'Factors influencing physician treatment decisions', 'timeFrame': 'up to 72 months', 'description': 'Reason/s for treatment choices and trigger/s for treatment changes'}, {'measure': 'Documentation of healthcare resource utilization used to manage treatment-related complications', 'timeFrame': 'up to 72 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['metastatic prostate cancer', 'castration-resistant prostate cancer', 'prostate cancer'], 'conditions': ['Prostate Cancer', 'Castration-resistant Prostate Cancer', 'Metastatic Prostate Cancer']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to describe patterns in disease management and to describe clinical outcomes, as well as to identify factors influencing physician treatment decisions including reason(s) for treatment choices and trigger(s) for treatment changes and to document healthcare resource utilization used to manage treatment-related complications.', 'detailedDescription': 'Each subject will be followed from the time of enrollment for a minimum of 3 years and a maximum of up to 6 years or until death, whichever comes first.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Subjects will be selected from the offices of either a medical oncologist, radiation oncologist, uro-oncologist, urologist, surgeon, or primary care physician.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosis of prostate adenocarcinoma\n* Will receive a new intervention at the time of study entry, for the treatment of:\n\n * Biochemical failure after initial curative-intent surgery (radical prostatectomy) or radiotherapy (external-beam radiation therapy, brachytherapy, or both) and a PSA doubling time of one year or less or a confirmed PSA of ≥ 50 ng/mL (2 consecutive values) within 6 months prior to study entry; or\n * Castration-resistant prostate cancer; or\n * Metastatic prostate cancer at initial diagnosis of prostate cancer\n\nExclusion Criteria:\n\n* Prior treatment of metastatic castration-resistant prostate cancer with systemic chemotherapy\n* Life expectancy of \\<1 year due to comorbidities'}, 'identificationModule': {'nctId': 'NCT02066961', 'acronym': 'ASPIRE-PCa', 'briefTitle': 'A Study to Describe Patterns of Care and Outcomes of Men Who Are at High Risk After Experiencing Biochemical Failure Following Definitive Prostate Cancer Therapy, Men With Castration-resistant Prostate Cancer and Men With Metastatic Prostate Cancer', 'organization': {'class': 'INDUSTRY', 'fullName': 'Astellas Pharma Inc'}, 'officialTitle': 'A Prospective, Longitudinal, Multinational, Observational Study to Describe Patterns of Care and Outcomes of Men Who Are at High Risk for Poor Clinical Outcomes After Experiencing Biochemical Failure Following Definitive Prostate Cancer Therapy, Men With Castration-Resistant Prostate Cancer and Men With Metastatic Prostate Cancer at Initial Diagnosis', 'orgStudyIdInfo': {'id': 'ONC-MA-1001'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Cohort 1', 'description': 'Subjects with biochemical failure experience after primary treatment and have high-risk disease'}, {'label': 'Cohort 2', 'description': 'Subjects with a medical diagnosis of castration-resistant prostate cancer'}, {'label': 'Cohort 3', 'description': 'Subjects with an initial diagnosis of metastatic prostate cancer'}]}, 'contactsLocationsModule': {'locations': [{'zip': '16005', 'city': 'Algiers', 'country': 'Algeria', 'facility': 'Site', 'geoPoint': {'lat': 36.73225, 'lon': 3.08746}}, {'zip': '16006', 'city': 'Algiers', 'country': 'Algeria', 'facility': 'Site', 'geoPoint': {'lat': 36.73225, 'lon': 3.08746}}, {'zip': 'BP 190', 'city': 'Blida', 'country': 'Algeria', 'facility': 'Site', 'geoPoint': {'lat': 36.47004, 'lon': 2.8277}}, {'zip': '1060', 'city': 'Buenos Aires', 'country': 'Argentina', 'facility': 'Site', 'geoPoint': {'lat': -34.61315, 'lon': -58.37723}}, {'zip': '6300', 'city': 'La Pampa', 'country': 'Argentina', 'facility': 'Site', 'geoPoint': {'lat': -30.94279, 'lon': -64.27622}}, {'zip': 'C1120AAT', 'city': 'Paraje Cabal', 'country': 'Argentina', 'facility': 'Site', 'geoPoint': {'lat': -31.09979, 'lon': -60.74656}}, {'zip': '2444', 'city': 'Port Macquarie', 'state': 'New South Wales', 'country': 'Australia', 'facility': 'Site', 'geoPoint': {'lat': -31.43084, 'lon': 152.90894}}, {'zip': '2485', 'city': 'Tweed Heads', 'state': 'New South Wales', 'country': 'Australia', 'facility': 'Site', 'geoPoint': {'lat': -28.17671, 'lon': 153.5452}}, {'zip': '5037', 'city': 'Kurralta Park', 'state': 'South Australia', 'country': 'Australia', 'facility': 'Site', 'geoPoint': {'lat': -34.95142, 'lon': 138.56702}}, {'zip': '3050', 'city': 'Parkville', 'state': 'Victoria', 'country': 'Australia', 'facility': 'Site', 'geoPoint': {'lat': -37.78333, 'lon': 144.95}}, {'zip': '3121', 'city': 'Richmond', 'state': 'Victoria', 'country': 'Australia', 'facility': 'Site', 'geoPoint': {'lat': -37.81819, 'lon': 145.00176}}, {'zip': '1090', 'city': 'Vienna', 'country': 'Austria', 'facility': 'Site', 'geoPoint': {'lat': 48.20849, 'lon': 16.37208}}, {'zip': '30130-100', 'city': 'Belo Horizonte', 'state': 'Minas Gerais', 'country': 'Brazil', 'facility': 'Site', 'geoPoint': {'lat': -19.92083, 'lon': -43.93778}}, {'zip': '98700-000', 'city': 'Ijuí', 'state': 'Rio Grande do Sul', 'country': 'Brazil', 'facility': 'Site', 'geoPoint': {'lat': -28.38778, 'lon': -53.91472}}, {'city': 'Passo Fundo', 'state': 'Rio Grande do Sul', 'country': 'Brazil', 'facility': 'Site', 'geoPoint': {'lat': -28.26278, 'lon': -52.40667}}, {'zip': '90110', 'city': 'Porto Alegre', 'state': 'Rio Grande do Sul', 'country': 'Brazil', 'facility': 'Site', 'geoPoint': {'lat': -30.03283, 'lon': -51.23019}}, {'zip': '01246-000', 'city': 'São Paulo', 'state': 'São Paulo', 'country': 'Brazil', 'facility': 'Site', 'geoPoint': {'lat': -23.5475, 'lon': -46.63611}}, {'zip': '95070-560', 'city': 'Caxias do Sul', 'country': 'Brazil', 'facility': 'Site', 'geoPoint': {'lat': -29.16806, 'lon': -51.17944}}, {'zip': '09060-650', 'city': 'Santo André', 'country': 'Brazil', 'facility': 'Site', 'geoPoint': {'lat': -23.66389, 'lon': -46.53833}}, {'zip': 'J2G8Z9', 'city': 'Granby', 'state': 'Quebec', 'country': 'Canada', 'facility': 'Site', 'geoPoint': {'lat': 45.40008, 'lon': -72.73243}}, {'zip': 'G1R 2J6', 'city': 'Québec', 'state': 'Quebec', 'country': 'Canada', 'facility': 'Site', 'geoPoint': {'lat': 46.81228, 'lon': -71.21454}}, {'zip': '110221', 'city': 'Bogotá', 'state': 'DC', 'country': 'Colombia', 'facility': 'Site', 'geoPoint': {'lat': 4.60971, 'lon': -74.08175}}, {'zip': '111321', 'city': 'Bogotá', 'state': 'DC', 'country': 'Colombia', 'facility': 'Site', 'geoPoint': {'lat': 4.60971, 'lon': -74.08175}}, {'zip': '76001', 'city': 'Cali', 'country': 'Colombia', 'facility': 'Site', 'geoPoint': {'lat': 3.43054, 'lon': -76.5199}}, {'zip': '11566', 'city': 'Cairo', 'country': 'Egypt', 'facility': 'Site', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}, {'zip': '11796', 'city': 'Cairo', 'country': 'Egypt', 'facility': 'Site', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}, {'zip': '12411', 'city': 'Cairo', 'country': 'Egypt', 'facility': 'Site', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}, {'zip': '25030', 'city': 'Besançon', 'country': 'France', 'facility': 'Site', 'geoPoint': {'lat': 47.24878, 'lon': 6.01815}}, {'zip': '59037', 'city': 'Lille', 'country': 'France', 'facility': 'Site', 'geoPoint': {'lat': 50.63391, 'lon': 3.05512}}, {'zip': '30029', 'city': 'Nîmes', 'country': 'France', 'facility': 'Site', 'geoPoint': {'lat': 43.83665, 'lon': 4.35788}}, {'zip': '69310', 'city': 'Pierre-Bénite', 'country': 'France', 'facility': 'Site', 'geoPoint': {'lat': 45.70359, 'lon': 4.82424}}, {'zip': '86021', 'city': 'Poitiers', 'country': 'France', 'facility': 'Site', 'geoPoint': {'lat': 46.58261, 'lon': 0.34348}}, {'zip': '94163', 'city': 'Saint-Mandé', 'country': 'France', 'facility': 'Site', 'geoPoint': {'lat': 48.83864, 'lon': 2.41579}}, {'zip': '92151', 'city': 'Suresnes', 'country': 'France', 'facility': 'Site', 'geoPoint': {'lat': 48.87143, 'lon': 2.22929}}, {'zip': '14197', 'city': 'Berlin', 'country': 'Germany', 'facility': 'Site', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}, {'zip': '79106', 'city': 'Freiburg im Breisgau', 'country': 'Germany', 'facility': 'Site', 'geoPoint': {'lat': 47.9959, 'lon': 7.85222}}, {'zip': '20246', 'city': 'Hamburg', 'country': 'Germany', 'facility': 'Site', 'geoPoint': {'lat': 53.55073, 'lon': 9.99302}}, {'zip': '7743', 'city': 'Jena', 'country': 'Germany', 'facility': 'Site', 'geoPoint': {'lat': 50.92878, 'lon': 11.5899}}, {'zip': '72622', 'city': 'Nürtingen', 'country': 'Germany', 'facility': 'Site', 'geoPoint': {'lat': 48.62565, 'lon': 9.34203}}, {'zip': '18107', 'city': 'Rostock', 'country': 'Germany', 'facility': 'Site', 'geoPoint': {'lat': 54.0887, 'lon': 12.14049}}, {'zip': '89075', 'city': 'Ulm', 'country': 'Germany', 'facility': 'Site', 'geoPoint': {'lat': 48.39841, 'lon': 9.99155}}, {'zip': '10430', 'city': 'Jakarta', 'country': 'Indonesia', 'facility': 'Site', 'geoPoint': {'lat': -6.21462, 'lon': 106.84513}}, {'zip': '70300', 'city': "Beer Ya'akov", 'state': 'Zerifin', 'country': 'Israel', 'facility': 'Site'}, {'zip': '31096', 'city': 'Haifa', 'country': 'Israel', 'facility': 'Site', 'geoPoint': {'lat': 32.81303, 'lon': 34.99928}}, {'zip': '25123', 'city': 'Brescia', 'country': 'Italy', 'facility': 'Site', 'geoPoint': {'lat': 45.53558, 'lon': 10.21472}}, {'zip': '26100', 'city': 'Cremona', 'country': 'Italy', 'facility': 'Site', 'geoPoint': {'lat': 45.13325, 'lon': 10.02129}}, {'zip': '20133', 'city': 'Milan', 'country': 'Italy', 'facility': 'Site', 'geoPoint': {'lat': 42.78235, 'lon': 12.59836}}, {'zip': '10043', 'city': 'Orbassano', 'country': 'Italy', 'facility': 'Site', 'geoPoint': {'lat': 45.00547, 'lon': 7.53813}}, {'zip': '116301', 'city': 'Beirut', 'state': 'BA', 'country': 'Lebanon', 'facility': 'Site', 'geoPoint': {'lat': 33.89332, 'lon': 35.50157}}, {'zip': '166830', 'city': 'Beirut', 'state': 'BA', 'country': 'Lebanon', 'facility': 'Site', 'geoPoint': {'lat': 33.89332, 'lon': 35.50157}}, {'zip': '34000', 'city': 'Durango', 'country': 'Mexico', 'facility': 'Site', 'geoPoint': {'lat': 24.02032, 'lon': -104.65756}}, {'zip': '1105 AZ', 'city': 'Amsterdam', 'country': 'Netherlands', 'facility': 'Site', 'geoPoint': {'lat': 52.37403, 'lon': 4.88969}}, {'zip': '6525 GA', 'city': 'Nijmegen', 'country': 'Netherlands', 'facility': 'Site', 'geoPoint': {'lat': 51.8425, 'lon': 5.85278}}, {'zip': '3204', 'city': 'Hamilton', 'state': 'Waikato Region', 'country': 'New Zealand', 'facility': 'Site', 'geoPoint': {'lat': -37.78333, 'lon': 175.28333}}, {'zip': '8013', 'city': 'Christchurch', 'country': 'New Zealand', 'facility': 'Site', 'geoPoint': {'lat': -43.53333, 'lon': 172.63333}}, {'zip': '3140', 'city': 'Tauranga', 'country': 'New Zealand', 'facility': 'Site', 'geoPoint': {'lat': -37.68611, 'lon': 176.16667}}, {'zip': '622', 'city': 'Tauranga', 'country': 'New Zealand', 'facility': 'Site', 'geoPoint': {'lat': -37.68611, 'lon': 176.16667}}, {'city': 'Muscat', 'country': 'Oman', 'facility': 'Site', 'geoPoint': {'lat': 23.58413, 'lon': 58.40778}}, {'zip': 'Lima18', 'city': 'Miraflores', 'state': 'Lima region', 'country': 'Peru', 'facility': 'Site', 'geoPoint': {'lat': -12.11331, 'lon': -77.03274}}, {'zip': 'Lima 01', 'city': 'Lima', 'country': 'Peru', 'facility': 'Site', 'geoPoint': {'lat': -12.04318, 'lon': -77.02824}}, {'zip': 'Lima 18', 'city': 'Lima', 'country': 'Peru', 'facility': 'Site', 'geoPoint': {'lat': -12.04318, 'lon': -77.02824}}, {'zip': '1229', 'city': 'Makati', 'country': 'Philippines', 'facility': 'Site', 'geoPoint': {'lat': 16.412, 'lon': 121.1226}}, {'zip': '1600', 'city': 'Pasig', 'country': 'Philippines', 'facility': 'Site', 'geoPoint': {'lat': 14.58691, 'lon': 121.0614}}, {'zip': '1502', 'city': 'San Juan City', 'country': 'Philippines', 'facility': 'Site', 'geoPoint': {'lat': 14.6, 'lon': 121.0333}}, {'zip': '11411', 'city': 'Riyadh', 'country': 'Saudi Arabia', 'facility': 'Site', 'geoPoint': {'lat': 24.68773, 'lon': 46.72185}}, {'zip': '119228', 'city': 'Singapore', 'country': 'Singapore', 'facility': 'Site', 'geoPoint': {'lat': 1.28967, 'lon': 103.85007}}, {'zip': '169610', 'city': 'Singapore', 'country': 'Singapore', 'facility': 'Site', 'geoPoint': {'lat': 1.28967, 'lon': 103.85007}}, {'zip': '258499', 'city': 'Singapore', 'country': 'Singapore', 'facility': 'Site', 'geoPoint': {'lat': 1.28967, 'lon': 103.85007}}, {'zip': '308433', 'city': 'Singapore', 'country': 'Singapore', 'facility': 'Site', 'geoPoint': {'lat': 1.28967, 'lon': 103.85007}}, {'zip': '431-070', 'city': 'Anyang', 'country': 'South Korea', 'facility': 'Site', 'geoPoint': {'lat': 36.9577, 'lon': 127.1464}}, {'zip': '602-714', 'city': 'Busan', 'country': 'South Korea', 'facility': 'Site', 'geoPoint': {'lat': 35.10168, 'lon': 129.03004}}, {'zip': '602739', 'city': 'Busan', 'country': 'South Korea', 'facility': 'Site', 'geoPoint': {'lat': 35.10168, 'lon': 129.03004}}, {'zip': '405-760', 'city': 'Incheon', 'country': 'South Korea', 'facility': 'Site', 'geoPoint': {'lat': 37.45646, 'lon': 126.70515}}, {'zip': '110-746', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Site', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'zip': '137-701', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Site', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'zip': '139-872', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Site', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'zip': '442-723', 'city': 'Suwon', 'country': 'South Korea', 'facility': 'Site', 'geoPoint': {'lat': 37.29111, 'lon': 127.00889}}, {'zip': '8035', 'city': "Vall d'Hebron 119-129", 'state': 'Barcelona', 'country': 'Spain', 'facility': 'Site'}, {'zip': '28050', 'city': 'Madrid', 'country': 'Spain', 'facility': 'Site', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'zip': '8208', 'city': 'Sabadell', 'country': 'Spain', 'facility': 'Site', 'geoPoint': {'lat': 41.54329, 'lon': 2.10942}}, {'zip': '333', 'city': 'Guishan Township', 'state': 'Taoyuan County', 'country': 'Taiwan', 'facility': 'Site'}, {'zip': '807', 'city': 'Kaohsiung City', 'country': 'Taiwan', 'facility': 'Site', 'geoPoint': {'lat': 22.61626, 'lon': 120.31333}}, {'zip': '81362', 'city': 'Kaohsiung City', 'country': 'Taiwan', 'facility': 'Site', 'geoPoint': {'lat': 22.61626, 'lon': 120.31333}}, {'zip': '40447', 'city': 'Taichung', 'country': 'Taiwan', 'facility': 'Site', 'geoPoint': {'lat': 24.1469, 'lon': 120.6839}}, {'zip': '10002', 'city': 'Taipei', 'country': 'Taiwan', 'facility': 'Site', 'geoPoint': {'lat': 25.05306, 'lon': 121.52639}}, {'zip': '11211', 'city': 'Taipei', 'country': 'Taiwan', 'facility': 'Site', 'geoPoint': {'lat': 25.05306, 'lon': 121.52639}}, {'zip': '10400', 'city': 'Bangkok', 'country': 'Thailand', 'facility': 'Site', 'geoPoint': {'lat': 13.75398, 'lon': 100.50144}}, {'zip': '10400', 'city': 'Phayathai', 'country': 'Thailand', 'facility': 'Site'}, {'zip': '90110', 'city': 'Songkhla', 'country': 'Thailand', 'facility': 'Site', 'geoPoint': {'lat': 7.19882, 'lon': 100.5951}}, {'zip': 'HU17 8SX', 'city': 'Hull', 'country': 'United Kingdom', 'facility': 'Site', 'geoPoint': {'lat': 53.7446, 'lon': -0.33525}}, {'zip': 'SE1 9RT', 'city': 'London', 'country': 'United Kingdom', 'facility': 'Site', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}, {'zip': 'NE7 7DN', 'city': 'Newcastle upon Tyne', 'country': 'United Kingdom', 'facility': 'Site', 'geoPoint': {'lat': 54.97328, 'lon': -1.61396}}, {'zip': 'SR4 7TP', 'city': 'Sunderland', 'country': 'United Kingdom', 'facility': 'Site', 'geoPoint': {'lat': 54.90465, 'lon': -1.38222}}], 'overallOfficials': [{'name': 'Senior Medical Director', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Astellas Pharma Global Development, Inc.'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Astellas Pharma Global Development, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}