128
Participants
Start Date
October 11, 2017
Primary Completion Date
October 9, 2019
Study Completion Date
June 30, 2021
Apalutamide
APALUTAMIDE 240-mg orally once daily (4 x 60-mg tablets) will be administered on a continual basis. For the purpose of scheduling the study assessments and treatment compliance a treatment cycle is defined as 28 days.
Abiraterone
Abiraterone acetate 1,000 mg (four 250 mg tablets) should be taken orally once daily, in combination with oral dose prednisone 5mg twice daily continuously. For the purpose of scheduling the study assessments and treatment compliance a treatment cycle is defined as 28 days
ADT
Dosing of goserelin (dose and frequency of administration) will be consistent with the prescribing information and should only be adjusted if clinically indicated to achieve and maintain subcastrate concentrations of testosterone (50 ng/dL or 1.7 nM).
Prednisone
Subjects will receive prednisone 10mg/day.
CRIO, Fortaleza
Clínica AMO, Salvador
Hospital Erasto Gaertner, Curitiba
Liga Norte Riograndense de Oncologia, Natal
Hospital de Caridade de Ijuí, Ijuí
CPO - Pucrs, Porto Alegre
Hospital de Câncer de Barretos, Barretos
Centro de Pesquisa Clínica em Hematologia e Oncologia - CEPHO, Santo André
Grupo COI, Rio de Janeiro
Beneficiencia Portuguesa de São Paulo/Hospital São José, São Paulo
Hospital Israelita Albert Einstein, São Paulo
IBCC, São Paulo
ICESP, São Paulo
Oncologia Rede D'Or S.A., Rio de Janeiro
Collaborators (1)
Janssen Pharmaceuticals
INDUSTRY
Latin American Cooperative Oncology Group
OTHER