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Brief Title: An Expanded Access Protocol for Apalutamide Treatment of Participants With Non-Metastatic Castration-Resistant Prostate Cancer
Official Title: An Open-Label Expanded Access Protocol for Apalutamide Treatment of Subjects With Non Metastatic Castration-Resistant Prostate Cancer
Study ID: NCT03523338
Brief Summary: The purpose of this study is to collect additional safety data until apalutamide is commercially available for participants with non-metastatic castrate-resistant prostate cancer (NM-CRPC).
Detailed Description:
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: MALE
Healthy Volunteers: No
Ynova Pesquisa Clinica, Florianopolis, , Brazil
Instituto de Educacao, Pesquisa e Gestao em Saude Instituto Americas (COI), Rio de Janeiro, , Brazil
Ensino e Terapia de Inovacao Clinica AMO - Etica, Salvador, , Brazil
Fundacao Faculdade de Medicina - Instituto do Cancer do Estado de Sao Paulo, Sao Paulo, , Brazil
Fundacao Antonio Prudente - A.C. Camargo Cancer Center, Sao Paulo, , Brazil
Núcleo de Pesquisa São Camilo, São Paulo, , Brazil
Hospital Pablo Tobon Uribe, Medellin, , Colombia
Instituto Nacional de Cancerologia, Mexico, , Mexico
i Can Oncology Center, Monterrey, , Mexico
Oncologia Integral Satelite, Naucalpan, , Mexico
Centro Oncologico Estatal ISSEMYM, Toluca, , Mexico
Farmaco Oncología especializada S.A. de C.V, Zapopan, , Mexico
Name: Aragon Pharmaceuticals, Inc. Clinical Trial
Affiliation: Aragon Pharmaceuticals, Inc.
Role: STUDY_DIRECTOR