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
NCT ID: NCT02066961
Last Updated: 2019-12-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
1533 participants
OBSERVATIONAL
2013-12-31
2019-11-14
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Cohort 1
Subjects with biochemical failure experience after primary treatment and have high-risk disease
No interventions assigned to this group
Cohort 2
Subjects with a medical diagnosis of castration-resistant prostate cancer
No interventions assigned to this group
Cohort 3
Subjects with an initial diagnosis of metastatic prostate cancer
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* Will receive a new intervention at the time of study entry, for the treatment of:
* 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
* Castration-resistant prostate cancer; or
* Metastatic prostate cancer at initial diagnosis of prostate cancer
Exclusion Criteria
* Life expectancy of \<1 year due to comorbidities
MALE
No
Sponsors
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Astellas Pharma Global Development, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Senior Medical Director
Role: STUDY_DIRECTOR
Astellas Pharma Global Development, Inc.
Locations
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Site
Algiers, , Algeria
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Algiers, , Algeria
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Blida, , Algeria
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Buenos Aires, , Argentina
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La Pampa, , Argentina
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Paraje Cabal, , Argentina
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Port Macquarie, New South Wales, Australia
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Tweed Heads, New South Wales, Australia
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Kurralta Park, South Australia, Australia
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Parkville, Victoria, Australia
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Richmond, Victoria, Australia
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Vienna, , Austria
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Belo Horizonte, Minas Gerais, Brazil
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Ijuí, Rio Grande do Sul, Brazil
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Passo Fundo, Rio Grande do Sul, Brazil
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Porto Alegre, Rio Grande do Sul, Brazil
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São Paulo, São Paulo, Brazil
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Caxias do Sul, , Brazil
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Santo André, , Brazil
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Granby, Quebec, Canada
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Québec, Quebec, Canada
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Bogotá, DC, Colombia
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Bogotá, DC, Colombia
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Cali, , Colombia
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Cairo, , Egypt
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Cairo, , Egypt
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Cairo, , Egypt
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Besançon, , France
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Lille, , France
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Nîmes, , France
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Pierre-Bénite, , France
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Poitiers, , France
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Saint-Mandé, , France
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Suresnes, , France
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Berlin, , Germany
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Freiburg im Breisgau, , Germany
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Hamburg, , Germany
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Jena, , Germany
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Nürtingen, , Germany
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Rostock, , Germany
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Ulm, , Germany
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Jakarta, , Indonesia
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Beer Ya'akov, Zerifin, Israel
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Haifa, , Israel
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Brescia, , Italy
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Cremona, , Italy
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Milan, , Italy
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Orbassano, , Italy
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Beirut, BA, Lebanon
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Beirut, BA, Lebanon
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Durango, , Mexico
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Amsterdam, , Netherlands
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Nijmegen, , Netherlands
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Hamilton, Waikato Region, New Zealand
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Christchurch, , New Zealand
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Tauranga, , New Zealand
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Tauranga, , New Zealand
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Muscat, , Oman
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Miraflores, Lima region, Peru
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Lima, , Peru
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Lima, , Peru
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Makati, , Philippines
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Pasig, , Philippines
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San Juan City, , Philippines
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Riyadh, , Saudi Arabia
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Singapore, , Singapore
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Singapore, , Singapore
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Singapore, , Singapore
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Singapore, , Singapore
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Anyang, , South Korea
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Busan, , South Korea
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Busan, , South Korea
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Incheon, , South Korea
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Seoul, , South Korea
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Seoul, , South Korea
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Seoul, , South Korea
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Suwon, , South Korea
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Vall d'Hebron 119-129, Barcelona, Spain
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Madrid, , Spain
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Sabadell, , Spain
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Guishan Township, Taoyuan County, Taiwan
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Kaohsiung City, , Taiwan
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Kaohsiung City, , Taiwan
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Taichung, , Taiwan
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Taipei, , Taiwan
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Taipei, , Taiwan
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Bangkok, , Thailand
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Phayathai, , Thailand
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Songkhla, , Thailand
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Hull, , United Kingdom
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London, , United Kingdom
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Newcastle upon Tyne, , United Kingdom
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Sunderland, , United Kingdom
Countries
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Other Identifiers
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ONC-MA-1001
Identifier Type: -
Identifier Source: org_study_id